Archive for the ‘bisphosphonates’ Category

Skelid

Skelid

Skelid is used for:

Treating adults with Paget disease. It may also be used for other conditions as determined by your doctor.

Skelid is a bisphosphonate. It works by slowing the resorption of bone and allowing new bone to be formed.

Do NOT use Skelid if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Skelid :

Some medical conditions may interact with Skelid . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Skelid . However, no specific interactions with Skelid are known at this time.

Ask your health care provider if Skelid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Skelid :

Use Skelid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Skelid .

Important safety information:

Possible side effects of Skelid :

All medicines may cause side effects, but many people have no, or minor, side effects.

Abnormal skin sensations; diarrhea; gas; nausea; stomach upset; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; chest pain; difficulty swallowing; new, worsening, or severe heartburn; pain upon swallowing; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain; severe or persistent stomach pain; swelling of the hands or feet; swelling or pain in the jaw; throat pain or irritation; vision changes; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Skelid at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Skelid out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Skelid . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Skelid resources

Compare Skelid with other medications for the treatment of:

Aredia

Aredia

Aredia is used for:

Treating high calcium levels in the blood due to cancer. It is also used to treat Paget disease of the bone and bone tumors caused by certain cancers. It may also be used for other conditions as determined by your doctor.

Aredia is a bisphosphonate. It works by reducing normal and abnormal bone loss, which helps to maintain bone strength. This also helps to reduce the amount of calcium in the blood in situations in which the levels of blood calcium may be too high.

Do NOT use Aredia if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aredia :

Some medical conditions may interact with Aredia . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Aredia . Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aredia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aredia :

Use Aredia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Aredia .

Important safety information:

Possible side effects of Aredia :

All medicines may cause side effects, but many people have no, or minor, side effects.

Back pain; constipation; coughing; dizziness; drowsiness; headache; increased sweating; indigestion; loss of appetite; mild bone, joint, or muscle pain; mild fever for 24 to 48 hours; nausea; stomach pain; stuffy or runny nose; trouble sleeping; unusual tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); confusion; decreased urination; fainting; fast or irregular heartbeat; frequent or painful urination; hallucinations; jaw pain or swelling; mental or mood changes; muscle cramps or spasms; numbness or tingling of the skin; pain, swelling, or redness at injection site; persistent or high fever; seizures; severe or persistent stomach pain, headache, or dizziness; severe or persistent tiredness or weakness; severe or prolonged bone, joint, or muscle pain; shortness of breath; vision changes; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Aredia is usually handled and stored by a health care provider. If you are using Aredia at home, store Aredia as directed by your pharmacist or health care provider. Keep Aredia out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Aredia . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Aredia resources

Compare Aredia with other medications for the treatment of:

Actonel with Calcium

Actonel with Calcium

Generic Name: calcium carbonate and risedronate (KAL see um KAR bo nate and RYE e droe nate)

What is Actonel with Calcium?

Actonel with Calcium (risedronate and calcium) is packaged as two separate medicines: 4 Actonel tablets and 24 calcium tablets. Actonel (risedronate) is in the group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance.

Actonel is used to treat or prevent postmenopausal and steroid-induced osteoporosis. It is also used to treat Paget’s disease of bone.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Actonel with Calcium may also be used for other purposes not listed in this medication guide.

Important information about Actonel with Calcium?

Actonel with Calcium is packaged as two separate medicines: 4 risedronate tablets and 24 calcium tablets. Take an Actonel tablet one day per week, first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take a calcium tablet with food every day for the 6 days in between your Actonel doses. Only the calcium tablet should be taken with food. Actonel must be taken on an empty stomach.

Do not take an Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication. Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Actonel tablet.

For at least the first 30 minutes after taking an Actonel tablet, do not lie down or recline, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Actonel with Calcium is only part of a complete program of treatment that may also include diet changes, exercise, and taking vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Take only the amount of calcium that your doctor recommends. Do not use other calcium supplements unless your doctor has told you to.

Before taking Actonel with Calcium

Do not take an Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

low or high levels of calcium in your blood;

kidney disease;

trouble swallowing; or

an ulcer in your stomach or esophagus.

Some people using medicines similar to Actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. It is not known whether Actonel with Calcium is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Actonel with Calcium?

Take Actonel with Calcium exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

Actonel with Calcium is packaged as two separate medicines: 4 risedronate tablets and 24 calcium tablets. Take a risedronate tablet one day per week, first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take a calcium tablet with food every day for the 6 days in between your risedronate doses.

Only the calcium tablet should be taken with food. Actonel must be taken on an empty stomach.

Take the Actonel tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take the Actonel tablet on the same day each week and always first thing in the morning.

Take the Actonel tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Actonel tablet. Do not crush, chew, or suck the Actonel tablet. Swallow the pill whole.

After taking a Actonel tablet, carefully follow these instructions:

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Actonel with Calcium is only part of a complete program of treatment that may also include diet changes, exercise, and taking vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Take only the amount of calcium that your doctor recommends. Do not use other calcium supplements unless your doctor has told you to.

Store Actonel with Calcium tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

If you forget to take an Actonel tablet: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you forget to take a calcium carbonate tablet: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much risedronate. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking Actonel with Calcium?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an Actonel tablet. Do not lie down for at least 30 minutes after you take an Actonel tablet. Do not take an iron supplement at the same time you take a calcium tablet. Take these minerals at separate times of the day.

Actonel with Calcium side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actonel with Calcium and call your doctor at once if you have any of these serious side effects:

chest pain;

difficulty or pain when swallowing;

pain or burning under the ribs or in the back;

new or worsening heartburn;

severe joint, bone, or muscle pain; or

jaw pain, numbness, or swelling.

Less serious Actonel with Calcium side effects may include:

mild heartburn, nausea, or stomach upset;

diarrhea, gas, or constipation;

muscle, joint, or back pain;

pain or burning with urination;

mild skin rash; or

headache or depressed mood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Actonel with Calcium?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs risedronate. If you use these other medicines, do not that take them for at least 30 minutes after taking an Actonel tablet.

Before using Actonel with Calcium, tell your doctor if you use any of the following drugs:

levothyroxine (Synthroid);

diuretics (water pills);

steroids (prednisone and others);

an antibiotic such as ciprofloxacin (Cipro), doxycycline (Doryx, Vibramycin), gatifloxacin (Tequin), levofloxacin (Levaquin), minocycline (Minocin), moxifloxacin (Avelox), ofloxacin (Floxin), sparfloxacin (Zagam), tetracycline (Sumycin, Achromycin, Robitet), and others; or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can affect Actonel with Calcium. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Aclasta

Aclasta

Generic Name: zoledronic acid (zole DRO nik AS sid)

What is Aclasta?

Aclasta contains zoledronic acid (sometimes called zoledronate). It belongs to a group of medicines called bisphosphonates. Zoledronic acid inhibits the release of calcium from bones.

Aclasta is used to treats Paget’s disease and osteoporosis in postmenopausal women.

Aclasta may also be used for other purposes not listed in this medication guide.

Important information about Aclasta

Do not receive Aclasta without telling your doctor if you have had an allergic reaction to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid). Do not use Aclasta without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Aclasta. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Aclasta have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with Aclasta. It may take longer than normal for you to recover.

Before receiving Aclasta

You should not receive Aclasta if you are allergic to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

You should also not receive Aclasta if you have:

low levels of calcium in your blood; or

if you are pregnant or breast-feeding.

Zometa and Reclast are two different brands of zoledronic acid. You should not be treated with Reclast if you are already receiving Zometa. Before receiving a Reclast injection, tell your doctor if you are already being treated with Zometa.

Before receiving Aclasta, tell your doctor if you have:

aspirin-sensitive asthma;

a thyroid or parathyroid disorder;

malabsorption syndrome (an inability to absorb food and nutrients properly);

a history of surgical removal of part of your intestine;

bone cancer; or

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Aclasta. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Aclasta have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive Aclasta without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Aclasta can pass into breast milk and may harm a nursing baby. Do not receive Aclasta without telling your doctor if you are breast-feeding a baby.

How is Aclasta given?

Aclasta is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

Aclasta is sometimes given only once per year. Follow your doctor’s instructions.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

Your doctor may want you to take a calcium and/or vitamin D supplement while you are being treated with Aclasta. Carefully follow your doctor’s instructions about the type and strength of calcium to take.

To be sure Aclasta is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Aclasta.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much Aclasta. Overdose symptoms may include numbness or tingling in your hands and feet, muscle stiffness, spasms in the muscles of your face, uneven heartbeats, and wheezing or trouble breathing.

What should I avoid while receiving Aclasta?

Avoid having any type of dental surgery while you are being treated with Aclasta. It may take longer than normal for you to recover.

Aclasta side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

muscle spasms, numb or tingly feeling (especially around your mouth);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising, unusual weakness; or

severe joint, bone, or muscle pain.

Less serious Aclasta side effects may include:

cough;

loss of appetite, nausea, vomiting;

diarrhea, constipation;

headache, tired feeling;

mild joint or muscle pain; or

redness or swelling where the needle was placed.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Aclasta?

Before receiving Aclasta, tell your doctor if you are using any of the following drugs:

a diuretic (water pill);

an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), netilmicin (Netromycin), streptomycin, tobramycin (Nebcin, Tobi);

other medicines that can harm your kidneys, such as pentamidine (Nebupent), tacrolimus (Prograf), amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled), acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), thalidomide (Thalomid), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with Aclasta. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Actonel

Actonel

Generic Name: risedronate (rih SED ro nayt)

What is Actonel?

Actonel is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures.

Actonel is used to treat or prevent osteoporosis in men and women. Actonel is also used to treat Paget’s disease of bone.

Actonel may also be used for other purposes not listed.

Important information about Actonel

Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the Actonel tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Actonel tablet.

For at least the first 30 minutes after taking a Actonel tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to Actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Actonel is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking Actonel?

Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Before using Actonel, tell your doctor if you have:

low blood calcium (hypocalcemia);

a vitamin D deficiency;

kidney disease; or

an ulcer in your stomach or esophagus.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

Some people using medicines similar to Actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Actonel passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Actonel?

Take Actonel exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Actonel tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day or once each week. The stronger tablets may be taken only 1 or 2 times each month. Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Take the Actonel tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take a Actonel tablet only once a week, take it on the same day each week and always first thing in the morning.

Take each Actonel tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Actonel tablet. Do not crush, chew, or suck the Actonel tablet. Swallow the pill whole.

After taking a Actonel tablet, carefully follow these instructions:

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Actonel is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store Actonel tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take Actonel tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take Actonel tablets once a week, or once or twice per month: If you forget to take Actonel on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking Actonel?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an Actonel tablet. Do not lie down for at least 30 minutes after you take a Actonel tablet.

Actonel side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actonel and call your doctor at once if you have any of these serious side effects:

chest pain;

difficulty or pain when swallowing;

pain or burning under the ribs or in the back;

new or worsening heartburn;

severe joint, bone, or muscle pain; or

jaw pain, numbness, or swelling.

Less serious side effects may include:

mild heartburn or stomach upset;

diarrhea, gas, or constipation;

mild joint or back pain; or

headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Actonel?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Actonel. If you use these other medicines, do not that take them for at least 30 minutes after taking a Actonel tablet.

Before using Actonel, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can affect Actonel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Didronel

Didronel

Generic Name: etidronate (e ti DROE nate)

What is Didronel?

Didronel is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body.

Didronel is used to treat Paget’s disease, and to treat conditions of irregular bone growth due to hip fracture or spinal cord injury.

Didronel may also be used for other purposes not listed in this medication guide.

Important information about Didronel

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Didronel tablet. For at least the first 2 hours after taking Didronel, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins or mineral supplements.

Especially avoid drinking milk or eating dairy products within 2 hours after taking Didronel. Also avoid taking supplements that contain calcium, magnesium, iron, or aluminum (such as in multivitamins with iron, and in many types of antacids).

Some people using medicines similar to Didronel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Before taking Didronel

Do not take Didronel if you have a condition called osteomalacia (softening of the bones).

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking Didronel, tell your doctor if you have:

diarrhea;

a bone fracture;

a stomach or esophageal ulcer or disease; or

Some people using medicines similar to Didronel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. It is not known whether Didronel is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether etidronate passes into breast milk or if it could harm a nursing baby. Do not use Didronel without telling your doctor if you are breast-feeding a baby.

How should I take Didronel?

Take Didronel exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not crush, chew, or suck the pill. Swallow it whole. Take each Didronel tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Didronel tablet. For at least the first 2 hours after taking Didronel, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins or mineral supplements.

It is important to take Didronel regularly to get the most benefit.

Paget’s disease is usually treated for 30 to 60 days with Didronel. After you stop taking Didronel, you must stay off the medication for at least 90 days before starting Didronel therapy again.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Didronel is only part of a complete program of treatment that may also include taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store Didronel at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include muscle cramps, stiffness, or twitching, breathing problems, swelling in your hands or feet, and muscle movements in your face that you cannot control.

What should I avoid while taking Didronel?

Avoid drinking milk or eating dairy products within 2 hours after taking Didronel. Also avoid taking supplements that contain calcium, magnesium, iron, or aluminum (such as in multivitamins with iron, and in many types of antacids).

Didronel side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Didronel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Didronel and call your doctor at once if you have any of these serious side effects:

severe joint, bone, or muscle pain;

jaw pain, numbness, or swelling;

severe diarrhea;

bone fracture; or

a red, blistering, peeling skin rash.

Less serious Didronel side effects may include:

mild diarrhea;

headache, confusion;

nausea; or

numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Didronel?

Before taking Didronel, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with Didronel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Fosamax

Fosamax

Generic Name: alendronate (a LEN dro nate)

What is Fosamax?

Fosamax is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Fosamax slows bone loss while increasing bone mass, which may prevent bone fractures.

Fosamax is used to treat or prevent postmenopausal osteoporosis and steroid-induced osteoporosis. It is also used to treat Pagets disease of bone.

Fosamax may also be used for purposes other than those listed in this medication guide.

Important information about Fosamax

Do not take a Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Fosamax tablet.

For at least the first 30 minutes after taking a Fosamax tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking Fosamax?

Do not take a Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Before using Fosamax, tell your doctor if you have:

low blood calcium (hypocalcemia);

a vitamin D deficiency;

kidney disease; or

an ulcer in your stomach or esophagus.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Fosamax.

Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Fosamax passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Fosamax?

Take Fosamax exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Fosamax tablets are taken either once each day or once each week.

Take the tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take a Fosamax tablet only once a week, take it on the same day each week and always first thing in the morning.

Take each tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Fosamax tablet. Do not crush, chew, or suck the Fosamax tablet. Swallow the pill whole.

After taking a Fosamax tablet, carefully follow these instructions:

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store Fosamax tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take Fosamax tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take Fosamax tablets once a week: If you forget to take Fosamax on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking Fosamax?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a Fosamax tablet. Do not lie down for at least 30 minutes after you take a Fosamax tablet.

What are the possible side effects of Fosamax?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fosamax and call your doctor at once if you have any of these serious side effects:

chest pain;

difficulty or pain when swallowing;

pain or burning under the ribs or in the back;

new or worsening heartburn;

severe joint, bone, or muscle pain; or

jaw pain, numbness, or swelling.

Less serious Fosamax side effects may include:

mild heartburn or stomach upset;

diarrhea, gas, or constipation;

joint pain or swelling;

swelling in your hands or feet;

back pain; or

dizziness, weakness, or headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fosamax?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Fosamax. If you use these other medicines, do not that take them for at least 30 minutes after taking a Fosamax tablet.

Before using Fosamax, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can affect Fosamax. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Reclast

Reclast

Generic Name: zoledronic acid (zole DRO nik AS sid)

What is Reclast?

Reclast (zoledronic acid, sometimes called zoledronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronic acid inhibits the release of calcium from bones.

Reclast is used to treat Paget’s disease in men and women.

Reclast is also used to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis. It is used to treat or prevent osteoporosis in people who will be taking certain steroid medicines for 12 months or longer.

Reclast may also be used for other purposes not listed here.

Important information about Reclast

Do not receive Reclast without telling your doctor if you have had an allergic reaction to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid). Do not use Reclast without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Reclast. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to zoledronic acid have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with Reclast. It may take longer than normal for you to recover.

Before receiving Reclast

You should not receive Reclast if you are allergic to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

You should also not receive Reclast if you have:

low levels of calcium in your blood; or

if you are pregnant or breast-feeding.

Zometa and Reclast are two different brands of zoledronic acid. You should not be treated with Reclast if you are already receiving Zometa. Before receiving a Reclast injection, tell your doctor if you are already being treated with Zometa.

Before receiving Reclast, tell your doctor if you have:

aspirin-sensitive asthma;

a thyroid or parathyroid disorder;

malabsorption syndrome (an inability to absorb food and nutrients properly);

a history of surgical removal of part of your intestine;

bone cancer; or

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Reclast. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to zoledronic acid have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive Reclast without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Zoledronic acid can pass into breast milk and may harm a nursing baby. Do not receive Reclast without telling your doctor if you are breast-feeding a baby.

How is Reclast given?

Reclast is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

Reclast is sometimes given only once per year. Follow your doctor’s instructions.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

Your doctor may want you to take a calcium and/or vitamin D supplement while you are being treated with Reclast. Carefully follow your doctor’s instructions about the type and strength of calcium to take.

To be sure Reclast is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Reclast.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include numbness or tingling in your hands and feet, muscle stiffness, spasms in the muscles of your face, uneven heartbeats, and wheezing or trouble breathing.

What should I avoid while receiving Reclast?

Avoid having any type of dental surgery while you are being treated with Reclast. It may take longer than normal for you to recover.

Reclast side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Reclast: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

muscle spasms, numb or tingly feeling (especially around your mouth);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising, unusual weakness;

severe joint, bone, or muscle pain; or

bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious Reclast side effects may include:

cough;

loss of appetite, nausea, vomiting;

diarrhea, constipation;

headache, tired feeling;

mild joint or muscle pain; or

redness or swelling where the needle was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Reclast?

Before receiving Reclast, tell your doctor if you are using any of the following drugs:

a diuretic (water pill);

an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), streptomycin, tobramycin (Nebcin, Tobi);

other medicines that can harm your kidneys, such as pentamidine (Nebupent), tacrolimus (Prograf), amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled), acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), thalidomide (Thalomid), or tretinoin (Vesanoid); or

a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with Reclast. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Zometa

Zometa

Generic Name: zoledronic acid (zole DRO nik AS sid)

What is Zometa?

Zometa (zoledronic acid – sometimes called zoledronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronic acid inhibits the release of calcium from bones.

Zometa is used to treat high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zometa also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.

Zometa may also be used for other purposes not listed in this medication guide.

Important information about Zometa

Do not receive Zometa without telling your doctor if you have had an allergic reaction to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid). Do not use Zometa without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Zometa. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Zometa have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with Zometa. It may take longer than normal for you to recover.

Before receiving Zometa

You should not receive Zometa if you are allergic to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

You should also not receive Zometa if you have:

low levels of calcium in your blood; or

if you are pregnant or breast-feeding.

Zometa and Reclast are two different brands of zoledronic acid. You should not be treated with Reclast if you are already receiving Zometa. Before receiving a Reclast injection, tell your doctor if you are already being treated with Zometa.

Before receiving Zometa, tell your doctor if you have:

aspirin-sensitive asthma;

a thyroid or parathyroid disorder;

malabsorption syndrome (an inability to absorb food and nutrients properly);

a history of surgical removal of part of your intestine;

bone cancer; or

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Zometa. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Zometa have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category D. Zometa can cause harm to an unborn baby. Do not receive Zometa without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Zometa can pass into breast milk and may harm a nursing baby. Do not receive Zometa without telling your doctor if you are breast-feeding a baby.

How is Zometa given?

Zometa is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

Zometa is sometimes given only once per year. Follow your doctor’s instructions.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

Your doctor may want you to take a calcium and/or vitamin D supplement while you are being treated with Zometa. Carefully follow your doctor’s instructions about the type and strength of calcium to take.

To be sure this medication is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Zometa.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include numbness or tingling in your hands and feet, muscle stiffness, spasms in the muscles of your face, uneven heartbeats, and wheezing or trouble breathing.

What should I avoid while receiving Zometa?

Avoid having any type of dental surgery while you are being treated with Zometa. It may take longer than normal for you to recover.

Zometa side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

muscle spasms, numb or tingly feeling (especially around your mouth);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising, unusual weakness;

severe joint, bone, or muscle pain: or

bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious Zometa side effects may include:

cough;

loss of appetite, nausea, vomiting;

diarrhea, constipation;

headache, tired feeling;

mild joint or muscle pain; or

redness or swelling where the needle was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zometa?

Before receiving Zometa, tell your doctor if you are using any of the following drugs:

a diuretic (water pill);

an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), streptomycin, tobramycin (Nebcin, Tobi);

other medicines that can harm your kidneys, such as pentamidine (Nebupent), tacrolimus (Prograf), amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled), acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin(Zanosar), thalidomide (Thalomid), or tretinoin (Vesanoid); or

a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with Zometa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Boniva

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Boniva

Generic Name:

FDA approves once-monthly Boniva

Boniva is the first-ever oral treatment administered as one tablet once a month for any chronic disease. With once-monthly Boniva, an effective bisphosphonate, patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments.

Why Monthly Boniva?

This new treatment option comes in the wake of the Surgeon General’s Report elevating osteoporosis to a major public health threat on par with smoking and obesity.

Developed in response to patient need, once-monthly Boniva was approved based on a supplemental new drug application. Once-monthly oral Boniva is not currently approved for use outside of the U.S., although it is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark Bonviva.

Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly Boniva is expected to be available by prescription in U.S. pharmacies in April.

Boniva Clinical Trial Results

Daily Boniva (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that, over three years, it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density (BMD) in postmenopausal women without osteoporosis. Once-monthly oral Boniva (150 mg) was approved based on results from the MOBILE study (Monthly Oral iBandronate In LadiEs), a randomized, double-blind, multinational, non-inferiority trial in 1,602 women with postmenopausal osteoporosis. MOBILE showed the following:

Important Safety Information

Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and Vitamin D is important in all patients.

Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures.

The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent).

About Once-Monthly Oral Boniva

Once-monthly Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take Boniva with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes.

Patients who take Boniva are eligible to sign up for MyBONIVA, a patient support program designed to help enhance compliance (taking therapy as directed) and persistence (staying on therapy) with this unique once-monthly regimen.

About Osteoporosis

Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. In the U.S. today, ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass (osteopenia),

Roche and GSK Collaboration

In December 2001, F. Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche and GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

About GSK

GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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