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Archive for the ‘biologicals’ Category

Procrit

Posted by admin on November 2nd, 2009

Procrit

Generic Name: epoetin alfa (e POE e tin AL fa)

What is Procrit?

Procrit is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Procrit is used to treat anemia (a lack of red blood cells in the body).

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

What is the most important information I should know about Procrit?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Procrit. Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.

Before using Procrit, tell your doctor if you have epilepsy or a history of seizures. Procrit may cause seizures. Be careful if you drive or do anything that requires you to be awake and alert.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of all items used in giving the medicine. Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Procrit. Some women using Procrit have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Procrit is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before using Procrit?

Do not use this medication if you are allergic to epoetin alfa, darbepoetin alfa (Aranesp), or if you have:

untreated or uncontrolled high blood pressure;

an allergy to animal products; or

an allergy to albumin.

Before using Procrit, tell your doctor if you have:

heart disease, congestive heart failure, or high blood pressure (hypertension);

kidney disease (or if you are on dialysis);

a history of stroke, heart attack, or blood clots;

a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

cancer; or

epilepsy or another seizure disorder.

If you have any of the conditions listed above, you may need a dose adjustment or special tests to safely use Procrit.

Procrit is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Procrit.

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 Procrit passes into breast milk or if it could harm a nursing baby. Do not use Procrit without telling your doctor if you are breast-feeding a baby. Some women using Procrit have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using Procrit.

Procrit may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Procrit may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

How should I use Procrit?

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

Your doctor may occasionally change your dose to make sure you get the best results from Procrit.

Procrit is given as an injection under the skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. With your medication you will receive patient instructions.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your Procrit dose into a syringe until you are ready to give yourself 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.

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.

Store Procrit in the refrigerator and do not allow it to freeze.

To be sure this medication is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Procrit.

What happens if I overdose?

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

Overdose symptoms may include headache, dizziness, itching (especially after bathing), fullness in your upper stomach, redness of the face, shortness of breath, and vision problems.

What should I avoid while using Procrit?

Procrit 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.

Procrit side effects

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Procrit.

Procrit can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Procrit. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

feeling short of breath, even with mild exertion;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance; or

pain or swelling in one or both legs.

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness);

feeling light-headed, fainting; or

seizure (black-out or convulsions).

Less serious side effects may include:

dizziness, mild headache;

fever, sore throat, body aches, flu symptoms;

nausea, vomiting, diarrhea, constipation; or

pain or tenderness where you injected the medication.

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 the FDA at 1-800-FDA-1088.

What other drugs will affect Procrit?

There may be other drugs that can affect Procrit. 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.

Posted in recombinant human erythropoietins Tags: , No Comments »

Mircera

Posted by admin on November 2nd, 2009

Mircera

Generic Name: epoetin beta-methoxy polyethylene glycol (e POE e tin BAY ta meth OX ee pol ee ETH il een GLYE kol)

What is Mircera?

Mircera is a man-made form of a protein that is normally produced by the kidneys to help your body produce red blood cells. This protein in your body may be reduced when you have kidney failure. When fewer red blood cells are produced, you can develop a condition called anemia.

Mircera is used to treat anemia (a lack of red blood cells in the body). Mircera is not for treating anemia caused by cancer chemotherapy.

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

Important information about Mircera

Do not use Mircera if you are allergic to epoetin beta-methoxy polyethylene glycol, if you have untreated or uncontrolled high blood pressure.

Before using Mircera, tell your doctor if you have heart disease, high blood pressure, cancer, seizures, a blood cell disorder, a blood clotting disorder, or a history of stroke, blood clots, or heart attack.

While using Mircera, contact your doctor if you feel weak, tired, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Mircera can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have symptoms of heart or circulation problems, such as: chest pain, sudden numbness on one side of the body, sudden headache or confusion, vision or speech problems, pain or swelling in your legs, or sudden cough and trouble breathing.

Mircera may shorten remission time or survival time in people with certain types of cancer. Mircera is not for treating anemia in chemotherapy patients. Tell your doctor if have cancer or are receiving chemotherapy.

Do not self-inject Mircera if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

It may take up to 6 weeks of using Mircera before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Mircera is only part of a complete program of treatment that may also include diet, dialysis, and other medications. Follow your doctor’s instructions very closely.

Before using Mircera

Do not use this medication if you are allergic to epoetin beta-methoxy polyethylene glycol, if you have untreated or uncontrolled high blood pressure.

Before using Mircera, tell your doctor if you have:

heart disease, congestive heart failure, or high blood pressure (hypertension);

a history of stroke, heart attack, or blood clots;

a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

cancer; or

epilepsy or another seizure disorder.

If you have any of the conditions listed above, you may need a dose adjustment or special tests to safely use Mircera.

Mircera may shorten remission time or survival time in people with certain types of cancer. Mircera is not for treating anemia in chemotherapy patients. Tell your doctor if have cancer or are receiving chemotherapy.

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 Mircera passes into breast milk or if it could harm a nursing baby. Do not use Mircera without telling your doctor if you are breast-feeding a baby.

How should I use Mircera?

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

Mircera is usually given once every 2 weeks or once a month.

Mircera is given as an injection under the skin of your upper arm, thigh, or lower stomach. It may also be given through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use 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 needles, IV tubing, and other items used in giving the medicine.

Use a different place on your skin each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication. Do not inject into the same place two times in a row.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your dose into a syringe until you are ready to give yourself 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.

Keep each vial or prefilled syringe in its original container until you are ready to use it. Each vial (bottle) or prefilled syringe of this medicine is for one use only. Throw away any medicine that is leftover after you use a vial or syringe.

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.

To be sure this medication is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

It may take up to 6 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Mircera is only part of a complete program of treatment that may also include diet, dialysis, and other medications. Follow your doctor’s instructions very closely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using Mircera. Store this medication in the refrigerator, protected from light. Do not freeze or shake the medication. If you need to store the medication at room temperature (77 degrees F or cooler), the vials will be good for up to 7 days. Prefilled syringes can be kept at room temperature for up to 30 days.

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, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Call your doctor for instructions if you miss more than one 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 chest pain, trouble breathing, sudden numbness or weakness, confusion, problems with speech or vision, fast heart rate, feeling light-headed, or fainting.

What should I avoid while using Mircera?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using Mircera.

What are the possible side effects of Mircera?

Contact your doctor if you feel weak, tired, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Mircera.

Mircera can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

feeling short of breath, even with mild exertion;

swelling, rapid weight gain;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

pain or swelling in one or both legs.

feeling like you might pass out;

seizure (convulsions);

pain or burning when you urinate; or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

stuffy nose, sore throat, cough;

headache;

muscle aches, back pain;

nausea, vomiting, diarrhea, constipation; or

itching, redness, bruising, or swelling where you injected the medication.

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 Mircera?

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

Posted in recombinant human erythropoietins Tags: , No Comments »

Epogen

Posted by admin on November 2nd, 2009

Epogen

Generic Name: epoetin alfa (e POE e tin AL fa)

What is Epogen?

Epogen is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Epogen is used to treat anemia (a lack of red blood cells in the body).

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

Important information about Epogen

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Epogen. Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.

Before using Epogen, tell your doctor if you have epilepsy or a history of seizures. Epogen may cause seizures. Be careful if you drive or do anything that requires you to be awake and alert.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of all items used in giving the medicine. Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Epogen. Some women using Epogen have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Epogen is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Epogen.

What should I discuss with my healthcare provider before using Epogen?

Do not use Epogen if you are allergic to epoetin alfa, darbepoetin alfa (Aranesp), or if you have:

untreated or uncontrolled high blood pressure;

an allergy to animal products; or

an allergy to albumin.

Before using Epogen, tell your doctor if you have:

heart disease, congestive heart failure, or high blood pressure (hypertension);

kidney disease (or if you are on dialysis);

a history of stroke, heart attack, or blood clots;

a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

cancer; or

epilepsy or another seizure disorder.

If you have any of the conditions listed above, you may need a dose adjustment or special tests to safely use Epogen.

Epogen is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Epogen.

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 Epogen 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. Some women using Epogen have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using Epogen.

Epogen may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Epogen may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

How should I use Epogen?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Epogen is given as an injection under the skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. With your medication you will receive patient instructions.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your Epogen dose into a syringe until you are ready to give yourself 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.

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.

Store Epogen in the refrigerator and do not allow it to freeze.

To be sure this medication is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Epogen.

What happens if I overdose?

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

Overdose symptoms may include headache, dizziness, itching (especially after bathing), fullness in your upper stomach, redness of the face, shortness of breath, and vision problems.

What should I avoid while using Epogen?

Epogen 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.

Epogen side effects

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epogen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Epogen. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

feeling short of breath, even with mild exertion;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance; or

pain or swelling in one or both legs.

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness);

feeling light-headed, fainting; or

seizure (black-out or convulsions).

Less serious side effects may include:

dizziness, mild headache;

fever, sore throat, body aches, flu symptoms;

nausea, vomiting, diarrhea, constipation; or

pain or tenderness where you injected the medication.

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 Epogen?

There may be other drugs that can affect Epogen. 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.

Posted in recombinant human erythropoietins Tags: , No Comments »

Aranesp

Posted by admin on November 2nd, 2009

Aranesp

Generic Name: darbepoetin alfa (DAR be POE e tin AL fa)

What is Aranesp?

Aranesp is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Aranesp is used to treat anemia (a lack of red blood cells in the body).

Aranesp may also be used for purposes other than those listed.

Important information about Aranesp

Aranesp can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Aranesp. Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance. Do not use Aranesp if you have high blood pressure (hypertension) that is not controlled by diet and/or medication.

Before using Aranesp, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, epilepsy or another seizure disorder, or a history of stroke, heart attack, or blood clots.

To be sure Aranesp is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Aranesp.

Some women using Aranesp have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Aranesp is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Aranesp.

Before using Aranesp

Do not use Aranesp if you are allergic to darbepoetin alfa, epoetin alfa (Epogen or Procrit), or if you have:

untreated or uncontrolled high blood pressure;

an allergy to animal products; or

an allergy to albumin.

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

heart disease, congestive heart failure, or high blood pressure;

kidney disease (or if you are on dialysis);

a history of stroke, heart attack, or blood clots;

a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

cancer; or

epilepsy or another seizure disorder.

Aranesp is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Aranesp.

FDA pregnancy category C. It is not known whether Aranesp is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Aranesp passes into breast milk or if it could harm a nursing baby. Do not use Aranesp without telling your doctor if you are breast-feeding a baby. Some women using Aranesp have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using Aranesp.

Aranesp may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Aranesp may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

How should I use Aranesp?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Aranesp is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. With your medication you will receive patient instructions.

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.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your Aranesp dose into a syringe until you are ready to give yourself 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.

Use each disposable needle and syringe only one time. Throw away used needles and syringes 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.

Store Aranesp in the refrigerator and do not allow it to freeze.

To be sure Aranesp is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Aranesp.

What happens if I overdose?

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

Overdose symptoms may include headache, dizziness, itching (especially after bathing), fullness in your upper stomach, redness of the face, shortness of breath, and vision problems.

What should I avoid while using Aranesp?

Aranesp 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.

Aranesp side effects

Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Aranesp.

Aranesp can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Aranesp. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

feeling short of breath, even with mild exertion;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance; or

pain or swelling in one or both legs.

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 Aranesp and call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

feeling light-headed, fainting; or

seizure (black-out or convulsions).

Less serious Aranesp side effects may include:

dizziness, mild headache;

fever, sore throat, body aches, flu symptoms;

joint or muscle pain;

nausea, vomiting, diarrhea, stomach pain, constipation; or

bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is 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 Aranesp?

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

Posted in recombinant human erythropoietins Tags: , No Comments »

Tubersol

Posted by admin on November 2nd, 2009

Tubersol

Tubersol is used for:

Detecting tuberculosis (TB) infection.

Tubersol is a diagnostic agent. It works by causing a mild, delayed allergic reaction in patients infected with TB or who have had a past infection, which allows for detection of TB.

Do NOT use Tubersol if:

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

Before using Tubersol :

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

Use Tubersol 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 Tubersol .

Important safety information:

Possible side effects of Tubersol :

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

Pain, itching, or redness at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters; open sores.

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 (

Tubersol is usually handled and stored by a health care provider. If you are using Tubersol at home, store Tubersol as directed by your pharmacist or health care provider. Keep Tubersol 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 Tubersol . 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.

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Metopirone

Posted by admin on November 2nd, 2009

Metopirone

Metopirone is used for:

Testing pituitary function.

Metopirone is a diagnostic aid. It works by blocking the body’s natural production of cortisol and corticosterone. This causes the pituitary gland to increase production of corticotropin (ACTH), which causes an increase in the body’s production of certain chemicals. These chemicals can be measured in the urine to determine how well the pituitary gland is working.

Do NOT use Metopirone if:

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

Before using Metopirone :

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

Use Metopirone 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 Metopirone .

Important safety information:

Possible side effects of Metopirone :

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

Dizziness; drowsiness; headache; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; confusion; dehydration; diarrhea; fast or irregular heartbeat; severe dizziness or drowsiness; weakness.

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 Metopirone at room temperature below 86 degrees F (30 degrees C). Keep Metopirone 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 Metopirone . 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.

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Human Secretin

Posted by admin on November 2nd, 2009

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Human Secretin

Generic Name:

FDA approves Human Secretin

The FDA has approved three indications. The indications of Human Secretin are the following:

The FDA stated that they have completed the review of the NDA applications, as amended. The FDA has concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon indications.

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ChiRhoStim

Posted by admin on November 2nd, 2009

ChiRhoStim

Indications and Usage for ChiRhoStim

ChiRhoStim

1.1 Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction,

1.2 Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and

1.3 Facilitation of the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).

ChiRhoStim Dosage and Administration

2.1 Stimulation of Pancreatic Secretions, Including Bicarbonate to Aid in the Diagnosis of Exocrine Pancreas Dysfunction:

0.2 mcg/kg body weight by intravenous injection over 1 minute.

Gastroduodenal (Dreiling) Tube Collection Method

A radiopaque, double-lumen tube is passed through the mouth following a 12-15 hour fast. Under fluoroscopic control, the opening of the proximal lumen of the tube is placed in the gastric antrum and the opening of the distal lumen just beyond the papilla of Vater. The positioning of the tube must be confirmed and the tube secured prior to synthetic human secretin testing. Intermittent negative pressure of 25-40 mmHg is applied to both lumens and maintained throughout the test. When duodenal contents have a pH of ≥ 6, a baseline sample of duodenal fluids is collected for a 10 minute period. A test dose of ChiRhoStim

Endoscopic Collection Method: Endoscopic Pancreatic Function Test (ePFT)

After assessment of patients for sedation and analgesia, a test dose of ChiRhoStim

2.2 Stimulation of Gastrin Secretion to Aid in Diagnosis of Gastrinoma:

0.4 mcg/kg body weight by intravenous injection over 1 minute.

The patient should fast for at least 12 hours prior to beginning the test. Prior to injection of ChiRhoStim®, two blood samples are drawn for determination of fasting serum gastrin levels (baseline values). Subsequently, a test dose of ChiRhoStim

Gastrinoma is strongly indicated in patients who show an increase in serum gastrin concentrations of 110 pg/mL over basal level on any of the post injection samples.

2.3 Facilitation of the Identification of the Ampulla of Vater and Accessory Papilla During Endoscopic Retrograde Cholangiopancreatography (ERCP) to aid in cannulation of the pancreatic duct:

0.2 mcg/kg body weight by intravenous injection over 1 minute.

Administration of ChiRhoStim

2.4 ADMINISTRATION

ChiRhoStim

ChiRhoStim

For both strengths, the reconstituted drug product should be inspected visually prior to administration. If particulate matter or discoloration is seen, the product should be discarded.

3 DOSAGE FORMS AND STRENGTHS

ChiRhoStim

As a lyophilized sterile powder in 10 mL vials containing 16 mcg of human secretin.

As a lyophilized sterile powder in 10 mL vials containing 40 mcg of human secretin.

Contraindications

Patients suffering from acute pancreatitis should not receive ChiRhoStim

Warnings and Precautions

5.1 Allergic Reactions

Because of a potential allergic reaction to ChiRhoStim

5.2 Vagotomy or Inflammatory Bowel Disease

Patients who have undergone vagotomy or who have inflammatory bowel disease may be hyporesponsive to secretin stimulation. This response does not indicate pancreatic disease, and results of secretin stimulation tests in these patients should be interpreted with caution.

5.3 Alcoholic or Other Liver Disease

A greater than normal volume response to secretin stimulation, which may mask coexisting pancreatic disease, is occasionally encountered in patients with alcoholic or other liver disease. Results of secretin stimulation tests in these patients should thus be interpreted with caution.

6 ADVERSE REACTIONS

Mild to moderate adverse reactions have been noted for synthetic human secretin in clinical studies in 533 patients and 51 healthy volunteers. Two severe adverse reactions, nausea and abdominal pain, occurred in one patient. Table 1 details the type and number of patients with adverse reactions.

Of the 584 patients and healthy volunteers treated with ChiRhoStim

Drug Interactions

The concomitant use of anticholinergic agents may make patients hyporesponsive to secretin stimulation and may produce a false result. Any results of secretin stimulation tests in these patients should thus be interpreted with caution.

USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Animal reproduction studies have not been conducted with synthetic human secretin. It is also not known whether synthetic human secretin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Synthetic human secretin should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

It is not known whether synthetic human secretin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when synthetic human secretin is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Among the 533 patients who have received ChiRhoStim

ChiRhoStim Description

Human secretin is a gastrointestinal peptide hormone produced by cells in the duodenum in response to acidification. ChiRhoStim

Molecular Weight 3039.44

Structural Formula:

ChiRhoStim

As a 10 ml vial which contains 16 mcg of purified synthetic human secretin, 1.5 mg of L-cysteine hydrochloride, 20 mg of mannitol, and 9 mg of sodium chloride per vial. When reconstituted in 8 mL of Sodium Chloride Injection USP, each mL of solution contains 2 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.

As a 10 ml vial which contains 40 mcg of purified synthetic human secretin, 3.75 mg of L-cysteine hydrochloride, 50 mg of mannitol, and 22.5 mg of sodium chloride per vial. When reconstituted in 10 mL of Sodium Chloride Injection USP, each mL of solution contains 4 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.

ChiRhoStim – Clinical Pharmacology

The primary action of ChiRhoStim

12.1 Mechanism of Action

Secretin is a hormone that is normally released from the duodenum upon exposure of the proximal intestinal lumen to gastric acid, fatty acids and amino acids. Secretin is released from enterochromaffin cells in the intestinal mucosa. Secretin receptors have been identified in the pancreas, stomach, liver, colon and other tissues. When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid. Secretin may also work through vagal-vagal neural pathways since stimulation of the efferent vagus nerve stimulates bicarbonate secretion and atropine blocks secretin-stimulated pancreatic secretion. See references 6 and 7 for additional details on mechanism of action of secretin and feedback controls.

12.3 Pharmacokinetics

The PK profile for synthetic human secretin was evaluated in 12 normal subjects. After intravenous bolus administration of 0.4 mcg/kg, synthetic human secretin concentration rapidly declines to baseline secretin levels within 90 to 120 minutes. The elimination half-life of synthetic human secretin is 45 minutes. The clearance of synthetic human secretin is 580.9 ± 51.3 mL/min and the volume of distribution is 2.7 L.

Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of synthetic human secretin. Studies to evaluate the potential for impairment of fertility or mutagenicity of synthetic human secretin have not been performed.

13.2 Animal Toxicology and/or Pharmacology

A single intravenous dose of synthetic human secretin at 20 mcg/kg was not lethal to mice or rabbits.

Clinical Studies

14.1 Stimulation of pancreatic secretions, including bicarbonate to aid in the diagnosis of Exocrine Pancreas Dysfunction:

ChiRhoStim

In two crossover studies (CRC98-2 and CRC99-9), a total of 18 patients with a documented history of chronic pancreatitis were given sHS, sPS and bPS. The results appear in Figures 1 and 2. In another study, 35 normal volunteers were given sHS. The results appear in Figures 1 and 2.

The values obtained for Figures 1 and 2 were performed by investigators skilled in performing secretin stimulation testing and are to be taken only as guidelines. These results should not be generalized to results of secretin stimulation testing conducted in other laboratories. However, a volume response of less than 2 mL/kg/hr, bicarbonate concentration of less than 80 mEq/L, and a bicarbonate output of less than 0.2 mEq/kg/hr are consistent with impaired pancreatic function.

A physician or institution planning to perform secretin stimulation testing as an aid to the diagnosis of pancreatic disease should begin by assessing enough normal subjects (>5) to develop proficiency in proper techniques and to generate normal response ranges for the commonly assessed parameters for pancreatic exocrine response to ChiRhoStim

In three crossover studies (CRC 98-1, CRC 98-2, and CRC 99-9) evaluating 21 different patients with a documented history of chronic pancreatitis, synthetic human secretin (sHS) was compared to synthetic porcine secretin (sPS) and biologically derived secretin (bPS). All of the patients treated with these drugs had peak bicarbonate concentrations of < 80 mEq/L.

Pancreatic secretory response to intravenous synthetic human secretin in 35 normal healthy subjects demonstrated a mean peak bicarbonate concentration of 100 mEq/L and a mean total volume over one hour of 260.7 mL. All 35 subjects had peak bicarbonate concentrations ≥ 80 mEq/L.

14.2 Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma

ChiRhoStim

In a three way crossover study of 6 patients with tissue diagnosed gastrinoma, there was agreement among synthetic human secretin (ChiRhoStim

14.3 Facilitation of identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) to assist in cannulation of the pancreatic ducts

In a randomized, placebo controlled crossover study in 24 patients with pancreas divisum undergoing ERCP, synthetic human secretin administration at a dose of 0.2 mcg/kg resulted in 16 of 24 successful cannulations of the minor duct compared to 2 of 24 for placebo.

15 REFERENCES

How Supplied/Storage and Handling

16.1 Supplied

ChiRhoStim

As a lyophilized sterile powder in vials containing 16 mcg of human secretin.

As a lyophilized sterile powder in vials containing 40 mcg of human secretin.

16.2 Storage

The unreconstituted product should be stored at -20°C (freezer). Expiration date is marked on the label. Protect from light.

PATIENT COUNSELING INFORMATION

Since there is no data on pregnant or nursing mothers, physicians should discuss these matters with the patient before using this product.

ChiRhoStim

Manufactured for:

Manufactured by:

005PI504

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Aplisol

Posted by admin on November 2nd, 2009

Aplisol

Aplisol is used for:

Detecting tuberculosis (TB) infection.

Aplisol is a diagnostic agent. It works by causing a mild, delayed allergic reaction in patients infected with TB or who have had a past infection, which allows for detection of TB.

Do NOT use Aplisol if:

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

Before using Aplisol :

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

Use Aplisol 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 Aplisol .

Important safety information:

Possible side effects of Aplisol :

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

Pain, itching, or redness at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters; open sores.

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 (

Aplisol is usually handled and stored by a health care provider. If you are using Aplisol at home, store Aplisol as directed by your pharmacist or health care provider. Keep Aplisol 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 Aplisol . 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.

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Mozobil

Posted by admin on November 2nd, 2009

Mozobil

Generic Name: plerixafor (pler IX a fore)

What is Mozobil?

Mozobil works by helping your bone marrow release stem cells into your bloodstream so they can be collected and transplanted back into the body.

Mozobil is used in people with non-Hodgkin’s lymphoma or multiple myeloma.

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

Important information about Mozobil

Do not receive Mozobil without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not receive Mozobil if you are allergic to plerixafor, or if you have leukemia.

Before you take Mozobil, tell your doctor if you have kidney disease.

Mozobil is given as an injection in a hospital or clinic setting.

Before receiving Mozobil, you will be given another medication that will help your bone marrow produce stem cells and certain white blood cells that help support your immune system.

To be sure this medication is not causing harmful effects, your blood will need to be tested often.

What should I discuss with my health care provider before taking Mozobil?

You should not receive Mozobil if you are allergic to plerixafor, or if you have leukemia.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Mozobil, tell your doctor if you have kidney disease.

FDA pregnancy category D. Mozobil can cause harm to an unborn baby or cause birth defects. Before you receive Mozobil, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether plerixafor 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 is Mozobil given?

Mozobil is given as an injection under the skin. You will receive this injection in a hospital or clinic setting.

Before receiving Mozobil, you will be given a medication called a granulocyte (GRAN-yoo-loe-site) colony stimulating factor, also called G-CSF. Some examples of a G-CSF are filgrastim (Neupogen), pegfilgrastim (Neulasta), and sargramostim (Leukine).

A G-CSF will cause your bone marrow to produce stem cells and certain white blood cells called granulocytes, which help support your immune system.

Mozobil works together with the G-CSF by causing stem cells and granulocytes produced in the bone marrow to circulate into your blood stream where they can be collected in blood drawn from your vein.

After your blood is drawn, it will be processed so that the needed stem cells and granulocytes can be separated from other unneeded parts of the blood. These stem cells and granulocytes will then be “transplanted” back into your vein through an IV injection.

To be sure Mozobil is not causing harmful effects, your blood will need to be tested often during your treatment.

What happens if I miss a dose?

Because you will receive Mozobil in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Overdose with Mozobil is not likely to occur because this medication is given by a healthcare professional in a clinical setting.

Overdose symptoms may include stomach discomfort, severe dizziness, or fainting.

What should I avoid while taking Mozobil?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are receiving Mozobil.

Mozobil 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. Tell your caregivers at once if you have a serious side effect such as:

easy bruising or bleeding, unusual weakness;

feeling like you might pass out; or

pain in your upper stomach, spreading to your shoulder or back.

Less serious Mozobil side effects may include:

nausea, vomiting;

diarrhea, constipation;

dry mouth, numbness in or around your mouth;

upset stomach, bloating, gas;

tired feeling, trouble sleeping;

headache, dizziness;

joint or muscle pain;

increased sweating; or

itching, rash, or other irritation where the medication was injected.

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 Mozobil?

There may be other drugs that can interact with Mozobil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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