Archive for the ‘miscellaneous antivirals’ Category

Synagis

Synagis

Generic Name: palivizumab (PAL i VIZ oo mab)

What is Synagis?

Synagis (palivizumab) is a man-made antibody to respiratory syncytial virus (RSV), a virus that can cause serious illness in children. Palivizumab inhibits the actions of RSV and helps to prevent the disease.

Synagis is used to prevent serious lung disease caused by respiratory syncytial virus in premature infants, and infants born with certain lung disorders or heart disease.

Synagis will not treat a child who is already sick with RSV disease.

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

Important information about Synagis

Synagis should not be given to a child who has had a severe allergic reaction to it.

Before your child receives a Synagis injection, tell your doctor if the child has a bleeding or blood-clotting disorder; or a low level of platelets in the blood.

Do not use Synagis at home if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Call your doctor at once if your child has a serious side effect after receiving Synagis, such as high fever, ear pain or drainage, warmth or swelling of the ear; crying or fussiness, change in appetite or sleeping patterns, easy bruising or bleeding, or trouble breathing.

Call your doctor for instructions if you miss an appointment for your child’s Synagis injection.

Before receiving Synagis

Synagis should not be given to a child who has had a severe allergic reaction to it.

If your child has any of these other conditions, he or she may need a dose adjustment or special tests to safely use Synagis:

a bleeding or blood clotting disorder; or

a low level of platelets in the blood.

It is not known whether Synagis is harmful to use while pregnant or breast-feeding. Although this medication is generally not used in adults, a woman of child-bearing age who is treated with Synagis should tell her doctor if she is pregnant or breast-feeding.

How is Synagis given?

Synagis is given once a month during the RSV season, which is usually November through April but may be different where you live. Your child’s doctor will tell you when the medication should be given.

Synagis is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give this injection. You may be shown how to use the medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Each single-use vial (bottle) of Synagis is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw the Synagis dose into a syringe until you are ready to give an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. If you keep this medication at home, store it in the refrigerator. Do not freeze.

Do not use Synagis if the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your child’s Synagis injection.

What happens if I overdose?

Seek emergency medical attention if you think your child has received too much of this medicine.

Symptoms of a Synagis overdose are not known.

What should I avoid while receiving Synagis?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Synagis side effects

Get emergency medical help if your child has any of these signs of an allergic reaction to Synagis: hives; difficult breathing; swelling of the face, lips, tongue, or throat. Call your doctor at once if your child has a serious side effect such as:

high fever, ear pain or drainage, tugging at the ear;

warmth or swelling of the ear;

crying or fussiness, especially while lying down;

change in sleeping patterns;

poor feeding or loss of appetite;

easy bruising or bleeding; or

trouble breathing.

Less serious Synagis side effects may include:

low fever;

cold symptoms such as stuffy nose, sneezing, cough;

vomiting, diarrhea; or

pain, redness, or swelling where the shot was given.

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 Synagis?

There may be other drugs that can interact with Synagis. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child’s doctor.

Hepsera

Hepsera

Some patients have developed severe and sometimes fatal worsening of hepatitis after they stop taking Hepsera . If you stop taking Hepsera , your doctor will need to perform liver function tests and check you closely for signs of worsening liver problems for at least several months. Be sure to keep all doctor and lab appointments.

Hepsera may cause serious kidney problems, especially if you already have or are at risk for kidney problems. Tell your doctor if you have a history of kidney problems. They may need to perform kidney function tests or adjust your dose of Hepsera . Contact your doctor right away if you develop a change in the amount of urine that you produce.

Use of Hepsera for hepatitis B infection in patients with untreated or unknown HIV infection may result in strains of the HIV virus that are resistent to treatment. Tell your doctor if you have HIV infection or may be at risk for HIV infection.

High levels of lactic acid in the blood and severe liver problems have infrequently been reported with the use of Hepsera either alone or with other medicines. These effects have been fatal in some cases. The risk of developing these problems may be greater if you are very overweight or have been using a nucleoside analog (eg, didanosine, lamivudine) for a long time. Notify your doctor immediately if you develop unusual weakness or fatigue, dark urine, yellowing of the skin or eyes, light-colored stools, loss of appetite, abdominal or stomach pain with or without nausea or vomiting, drowsiness, muscle aches or weakness, dizziness, lightheadedness, coldness (especially in the arms or legs), trouble breathing, or fast or irregular heartbeat.

Hepsera is used for:

Treating chronic hepatitis B virus (HBV) infection.

Hepsera is a nucleotide analog. It works by slowing the growth of the virus. It is not a cure for hepatitis B.

Do NOT use Hepsera if:

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

Before using Hepsera :

Some medical conditions may interact with Hepsera . 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 Hepsera . 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 Hepsera 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 Hepsera :

Use Hepsera 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 Hepsera .

Important safety information:

Possible side effects of Hepsera :

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

Diarrhea; fever; gas; headache; increased cough; indigestion; nausea; sore throat; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine you produce; cold arms and legs; dark urine; dizziness; fast or irregular heartbeat; light-colored bowel movements; loss of appetite; muscle pain; severe or persistent stomach pain, nausea, or vomiting; unusual drowsiness; unusual weakness or fatigue; or yellowing of the skin or eyes.

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 Hepsera at 77 degrees F (25 degrees C) in the original container. Store away from heat, moisture, and light. Do not use if the seal over the bottle opening is broken or missing. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Hepsera 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 Hepsera . 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 Hepsera resources

Compare Hepsera with other medications for the treatment of:

Foscavir

Foscavir

Foscavir may cause kidney damage or seizures. Notify your doctor immediately if you experience a change in the amount of urine. It is important you receive appropriate amounts of fluid (hydration) when Foscavir is used. Your doctor will monitor your blood and kidneys while you are using Foscavir .

Foscavir is used for:

Managing cytomegalovirus (CMV) retinitis (a viral infection that can lead to blindness) in patients with AIDS. It may also be used to treat resistant herpes simplex virus (HSV) of the skin or mucous membranes in patients with weakened immune systems who have failed to respond to standard treatment. It may also be used for other conditions as determined by your doctor.

Foscavir is an antiviral agent. It works by inhibiting the growth and reproduction of viruses, which helps fight off infections caused by viruses.

Do NOT use Foscavir if:

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

Before using Foscavir :

Some medical conditions may interact with Foscavir . 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 Foscavir . 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 Foscavir 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 Foscavir :

Use Foscavir 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 Foscavir .

Important safety information:

Possible side effects of Foscavir :

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

Anxiety; appetite loss; chills; confusion; decreased sensitivity to touch; depression; fatigue; general body discomfort; headache; involuntary muscle movements; joint pain; nausea; pain; rigid muscles; stomach pain; sweating; vision problems.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; cough; decreased urination; diarrhea; dizziness; fainting; fast heartbeat; genital ulcers or irritation; infection (fever, chills, sore throat); irregular heartbeat; numbness in hands, arms, legs, and feet; pain or redness at the injection site; rectal bleeding; seizures; tingling in fingers or around the mouth; unusual tiredness or weakness; urination problems; vomiting.

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 Foscavir 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 Foscavir 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 Foscavir . 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 Foscavir resources

Compare Foscavir with other medications for the treatment of:

Fuzeon

Fuzeon

Generic Name: enfuvirtide (en FYOO vir tide)

What is Fuzeon?

Fuzeon is an antiviral medication in a group of HIV medicines called fusion inhibitors. Fuzeon prevents human immunodeficiency virus (HIV) from entering and taking over the cells in your body.

Fuzeon is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Fuzeon is not a cure for HIV or AIDS.

Fuzeon is usually given after other medications have been tried without successful treatment of HIV.

Important information about Fuzeon

Before using Fuzeon, tell your doctor if you are allergic to any drugs, if you take a blood thinner such as Coumadin, or if you have a bleeding or blood clotting disorder, such as hemophilia. You may not be able to use Fuzeon, or you may need dosage adjustments or special tests during treatment.

Fuzeon may increase your risk of developing pneumonia, especially if you have a high viral load, a history of lung disease, or if you smoke. Call your doctor at once if you have symptoms of pneumonia, such as cough, fever, rapid breathing, or shortness of breath.

Do not use Fuzeon as your only HIV medication. HIV/AIDS is usually treated with a combination of different drugs. Your disease may become resistant to Fuzeon if you do not use it in combination with other HIV medicines your doctor has prescribed.

To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

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

Stop using Fuzeon and call your doctor at once if you have serious side effects such as a signs of a new infection, such as fever or chills, cough, or flu symptoms; or severe pain, irritation, or skin changes where you injected the medicine.

Before using Fuzeon

Do not use this medication if you are allergic to enfuvirtide.

Before using Fuzeon, tell your doctor if you are allergic to any drugs, or if you have a bleeding or blood clotting disorder, such as hemophilia. You may need a dose adjustment or special tests to safely use Fuzeon.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. You should not breast-feed while you are using Fuzeon. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Fuzeon may increase your risk of developing pneumonia, especially if you have a high viral load, a history of lung disease, or if you smoke. Call your doctor at once if you have symptoms of pneumonia, such as cough, fever, rapid breathing, or shortness of breath.

How should I use Fuzeon?

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

Fuzeon is given as an injection under the skin of your arm, upper thigh, or stomach. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Carefully follow all instructions about giving yourself an Fuzeon injection. Most people using this medication have a skin reaction where the medicine is injected. Your caregivers can tell you what type of skin reactions are serious and when to call your doctor.

Fuzeon is usually injected twice a day. Each vial of Fuzeon is for a single use only.

Fuzeon is a powder that must be mixed with a liquid (sterile water) provided with the medicine. After mixing the powder and the liquid, gently tap the vial for 10 seconds and then slowly roll it between your hands. Let the vial stand until the powder completely dissolves (up to 45 minutes). If the mixture is foamy or gel-like, allow more time for it to dissolve.

Do not shake the mixture. Shaking will make the medicine foam and it will take much longer to dissolve. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. You may mix both of your day’s doses at the same time, but once the medicine is mixed you must keep it in a refrigerator and use it within 24 hours.

When you are ready to use the medicine, take the vial out of the refrigerator and allow it to reach room temperature. Inspect the mixture again for particles or change in color. Do not draw your Fuzeon dose into a syringe until you are ready to give yourself an injection. Then throw away the vial, even if there is medicine left in it.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not use Fuzeon as your only HIV medication. HIV/AIDS is usually treated with a combination of different drugs. Your disease may become resistant to Fuzeon if you do not use it in combination with other HIV medicines your doctor has prescribed.

To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

It is important to use Fuzeon regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store unmixed Fuzeon powder at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use 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. Symptoms of an Fuzeon overdose are unknown.

What should I avoid while using Fuzeon?

Avoid injecting this medication near your elbow, knee, groin, navel, or buttocks. Do not inject into moles, scars, tattoos, burns, bruises, or skin that is not otherwise healthy.

Using Fuzeon will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

Fuzeon can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Fuzeon side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; fever, chills; nausea, vomiting; difficulty breathing; feeling light-headed or fainting; swelling of your face, lips, tongue, or throat. Stop using Fuzeon and call your doctor at once if you have any of these serious side effects:

cough with fever, chest congestion, and shortness of breath;

signs of a new infection, such as fever or chills, cough, or flu symptoms.

nerve pain lasting for several weeks or months; or

severe or prolonged (more than 7 days) injection site reaction.

Less serious side effects may include:

pain, itching, irritation, redness, swelling, or raised bumps under your skin where the medicine was injected;

pain or numbness in your feet or legs;

weakness or loss of strength;

muscle pain;

sleep problems (insomnia);

depression;

loss of appetite; or

constipation.

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 Fuzeon?

Before using Fuzeon, tell your doctor if you are using a blood thinner such as warfarin (Coumadin). You may need a dosage dose adjustment or special tests during treatment.

There may be other drugs that can interact with Fuzeon. 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.

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