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Archive for the ‘miscellaneous coagulation modifiers’ Category

Evithrom

Posted by admin on November 4th, 2009

Evithrom

Generic Name:

Treatment for:

FDA Approves Evithrom

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Highlights of Evithrom Prescribing Information

These highlights do not include all the information needed to use Evithrom safely and effectively. See

Indications and Usage

Dosage and Administration

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at (877) 384-4266 or FDA at 1-800-FDA-1088 or

Use in Specific Populations

Patient Counseling Information

Some viruses such as hepatitis A virus and parvovirus B19 are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include: fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear. If absorbed systemically Evithrom could potentially cause blood clotting disorders. Patients should be encouraged to consult their physician for any new or unusual symptoms.

 

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Cyklokapron

Posted by admin on November 4th, 2009

Cyklokapron

Cyklokapron is used for:

Short-term use (2 to 8 days) for reducing or preventing excessive bleeding and reducing the need for blood clotting factor transfusions during or after tooth extractions in patients with hemophilia.

Cyklokapron is an antifibrinolytic agent. It works by blocking the breakdown of blood clots.

Do NOT use Cyklokapron if:

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

Before using Cyklokapron :

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

Use Cyklokapron 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 Cyklokapron .

Important safety information:

Possible side effects of Cyklokapron :

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

Diarrhea; giddiness; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain, swelling, or tenderness; changes in vision (disturbance of color, sharpness, or field of vision); chest pain; decreased urination; one-sided weakness; pain, swelling, or redness at the injection site; severe headache; shortness of breath; speech problems.

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 Cyklokapron 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 Cyklokapron 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 Cyklokapron . 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 Cyklokapron resources

Compare Cyklokapron with other medications for the treatment of:

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Cinryze

Posted by admin on November 4th, 2009

Cinryze

Generic Name: complement C1 esterase inhibitor (KOM ple ment C1 ES ter ase in HIB it or)

What is Cinryze?

Cinryze (complement C1 esterase inhibitor) is a man-made form of a protein that occurs naturally in the bloodstream and helps control inflammation in the body. In people with hereditary angioedema, complement C1 esterase inhibitor does not function properly or occurs in low levels.

Cinryze is used to prevent atttacks of angioedema in people with hereditary angioedema.

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

Important information about Cinryze

You should not use Cinryze if you have ever had an allergic reaction to complement C1 esterase inhibitor, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Cinryze, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject Cinryze 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. Cinryze comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the Cinryze injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling, and problems with vision, speech, or balance.

Cinryze 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 health care provider before using Cinryze?

You should not use Cinryze if you have ever had an allergic reaction to complement C1 esterase inhibitor, or if you have ever had any other life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Cinryze, tell your doctor if you have a history of stroke or blood clot.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using Cinryze, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether complement C1 esterase inhibitor 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.

Cinryze 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.

Do not give Cinryze to a child, even if you think the child has the same condition you have.

How should I use Cinryze?

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

Cinryze is given as an injection 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. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Cinryze is usually given every 3 or 4 days for routine prevention of angioedema attack. An IV infusion takes about 10 minutes to complete.

Cinryze is a dry powder that must be mixed with a liquid (diluent) before using it. If you do not receive the diluent with your medication at the pharmacy, talk to your pharmacist.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Cinryze contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away.

Each single-use vial (bottle) of this medicine 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.

After mixing Cinryze with the diluent, use it right away or store the mixture at room temperature and use it within 3 hours. The mixed medicine should be clear or slightly blue in color. Do not use the mixed medication if it has changed colors, is cloudy, or has any particles 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.

Store the unmixed dry powder in a refrigerator or in a dark cool place. Keep the medicine protected from light and do not allow it to freeze. Throw away any unused vial after the expiration date on the label has passed.

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.

What happens if I overdose?

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

Overdose symptoms may include sudden headache, numbness, weakness, or problems with your speech, vision, or balance.

What should I avoid while using Cinryze?

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

Cinryze side effects

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction to Cinryze: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effect, such as:

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

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

stomach pain or swelling;

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

pain or swelling in one or both legs.

Less serious Cinryze side effects may include:

cold symptoms such as stuffy nose, sneezing, sore throat;

mild itching or rash;

mild headache; or

back pain.

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 Cinryze?

There may be other drugs that can interact with Cinryze. 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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Ceprotin

Posted by admin on November 4th, 2009

Ceprotin

Generic Name:

Treatment for:

Ceprotin approved by FDA

Severe congenital Protein C deficiency results in a hypercoagulable state, meaning there is an abnormal tendency for blood clotting. This can cause severe, often life-threatening blood clots in small blood vessels, which if left untreated could result in blindness, severe brain damage, multi-organ failure and death. The disease manifests in children very early in life, often in utero or in the first few days of life. Incidence of severe congenital Protein C deficiency has been estimated to be one to two for every million births. Currently, there are fewer than 20 known cases of severe congenital Protein C deficiency in the United States. FDA has granted Ceprotin orphan drug status.

Ceprotin is the first FDA approved therapy for patients with severe congenital Protein C deficiency. It is indicated for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans (PF) (a severe skin and systematic blood clotting disorder). Ceprotin is indicated as a replacement therapy for pediatric and adult patients.

Ceprotin Clinical Data

Ceprotin’s approval is based on data from a pivotal multi-center, open- label, non-randomized, Phase II/III study, which evaluated the safety and efficacy of Ceprotin in subjects with severe congenital Protein C deficiency for the (on-demand) treatment of acute thrombotic episodes, such as PF, warfarin-induced skin necrosis (WISN), and other thromboembolic events, and for short-term or long-term prophylaxis. The study included 18 patients (nine male and nine female) ranging in age from newborn to 25.7 years. Ceprotin was demonstrated to be effective in 94 percent of the episodes of PF. In the remaining six percent of patients, the treatment was found “effective with complications” because they required a dosage adjustment. Inadequate data were available for the treatment of WISN.

When compared with the efficacy ratings for 21 episodes of PF (historical control group), subjects with severe congenital Protein C deficiency were more effectively treated with Ceprotin than those treated with modalities such as fresh frozen plasma or conventional anticoagulants. Ceprotin also demonstrated effectiveness in reducing the size and number of skin lesions in patients. Treatment with Ceprotin healed non-necrotic skin lesions after a median of four days, and necrotic skin lesions were healed after a median of 11 days.

Seven patients took Ceprotin as a preventive measure before surgery or anticoagulation therapy and had no associated blood clotting complications. Eight patients who were given Ceprotin as a long term preventive measure, again did not experience any blood clotting complications.

In the clinical development period, no serious adverse reactions related to Ceprotin were reported. The most common adverse reactions observed in clinical trials were rash, itching, and lightheadedness.

About Ceprotin

Ceprotin [Protein C Concentrate (Human)] is indicated for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. Ceprotin is indicated as a replacement therapy for pediatric and adult patients.

Important Safety Information

The most serious and common adverse reactions observed in clinical trials were rash, itching and lightheadedness.

The following adverse reactions have been identified during postapproval use of Ceprotin: hemothorax, hypotension, hyperhydrosis, fever and restlessness.

Patients on low sodium/renal impairment diet should be informed that the quantity of sodium in the maximum daily dose of Ceprotin exceeds 200mg.

Ceprotin contains trace amounts of heparin, which may lead to Heparin- induced Thrombocytopenia.

As with all plasma-derived therapeutics, the potential to transmit infectious agents (e.g. viruses) cannot be totally eliminated.

Source:

Ceprotin Patient Information

Protein C Concentrate (Human)

Please read this leaflet carefully before using Ceprotin [Protein C Concentrate (Human)]. This leaflet is based on the information provided to your doctor, and is a summary of the important information you need to know about your medicine for your severe congenital Protein C deficiency. This leaflet does not take the place of talking with your doctor and does not contain all of the information available about Ceprotin.

This leaflet should be used only after you have received instructions from your doctor. If you have any questions after reading this leaflet, ask your doctor or pharmacist.

What is Ceprotin?

The name of your medicine is Ceprotin, pronounced “see PRO ten”.

Ceprotin contains Protein C, a natural protein that is made in the liver and is present in your blood. Protein C is a part of human plasma that regulates the blood clotting (coagulation) system and prevents abnormal clot formation (thrombosis). Plasma is the liquid part of human blood.

Ceprotin is used to treat patients with Severe Congenital Protein C Deficiency for the prevention and treatment of:

How does Ceprotin work?

Ceprotin temporarily raises the levels of Protein C in the body. Protein C plays a major role in preventing your body from forming too many blood clots. Ceprotin is for those patients who either don

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Berinert

Posted by admin on November 4th, 2009

Berinert

Generic Name: C1 esterase inhibitor (human)

FDA Approves Berinert

The U.S. Food and Drug Administration (FDA) has approved for Berinert (C1-esterase inhibitor, human) for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients.

Berinert Medication Guide

This leaflet summarizes important information about Berinert. Please read it carefully before using Berinert and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Berinert. If you have any questions after reading this, ask your healthcare provider.

What is Berinert?

Berinert is an injectable medicine used to treat swelling and /or painful attacks in adults and adolescents with Hereditary Angioedema (HAE). HAE is caused by the poor functioning of a protein called C1 that is present in your blood and helps control inflammation (swelling) and parts of the immune system. Berinert contains C1 esterase inhibitor, a protein that helps control C1.

Who should not use Berinert?

You should not use Berinert if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.

Before using Berinert

Tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

How is Berinert given?

Your healthcare provider will infuse Berinert into your vein (intravenous injection). Before infusing, he or she must dissolve the Berinert powder using the sterile water provided. Your healthcare provider will prescribe the dose that you should be given.

Berinert side effects

Allergic reactions may occur with Berinert. Call your healthcare provider or the emergency department right away if you have any of the following symptoms after using Berinert:

Signs of a blood clot include:

In clinical studies, the most severe side effect reported in subjects who received Berinert was an increase in the severity of pain associated with HAE.

Other side effects patients experienced during clinical research studies include:

Because Berinert is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent.

These are not all the possible side effects of Berinert.

Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.

What else should I know about Berinert?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Berinert for a condition for which it is not prescribed. Do not share Berinert with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about Berinert. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Berinert that was written for healthcare professionals.

Talk to your healthcare provider before traveling.

 

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BeneFix

Posted by admin on November 4th, 2009

BeneFix

BeneFix is used for:

Preventing and controlling bleeding in patients with factor IX deficiency (hemophilia B or Christmas disease), including control and prevention of bleeding in surgical settings.

BeneFix is a synthetic protein, clotting factor IX. It works by helping the blood form clots, which stops bleeding.

Do NOT use BeneFix if:

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

Before using BeneFix :

Some medical conditions may interact with BeneFix . 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 BeneFix . However, no specific interactions with BeneFix are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if BeneFix 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 BeneFix :

Use BeneFix 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 BeneFix .

Important safety information:

Possible side effects of BeneFix :

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

Mild chills; nausea; stinging at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; faintness; fever; flushing; headache; lethargy; lightheadedness, especially upon standing; nausea; rapid heart rate; 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 the unmixed medicine in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Prior to the expiration date, it may also be stored at room temperature not to exceed 77 degrees F (25 degrees C) for up to 6 months. You should make note of the date the product was placed at room temperature in the space provided on the outer carton. The product does not contain a preservative. After mixing it may be stored between 36 and 46 degrees F (2 and 8 degrees C) and must be used within 3 hours. Do not freeze. Keep BeneFix 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 BeneFix . 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 BeneFix resources

Compare BeneFix with other medications for the treatment of:

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Bebulin VH

Posted by admin on November 4th, 2009

Bebulin VH

Generic Name: factor IX complex (FAK tor NINE KOM plex)

What is Bebulin VH (factor IX complex)?

Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

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

What is the most important information I should know about Bebulin VH (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

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. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Factor IX complex 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 Bebulin VH (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

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 factor IX complex 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.

Factor IX complex 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.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

How should I use Bebulin VH (factor IX complex)?

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. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Factor IX complex is given as an injection 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.

Always wash your hands before preparing and giving your injection.

Factor IX complex must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to warm to room temperature before mixing them. Do not heat the medicine or diluent.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Draw your dose into a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use this medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

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.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and the diluent in the refrigerator and do not allow them to freeze.

Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Factor IX is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, 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?

Call your doctor if you think you have used too much of this medicine. An overdose of factor IX complex is not expected to produce life-threatening symptoms.

What should I avoid while using Bebulin VH (factor IX complex)?

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

Bebulin VH (factor IX complex) side effects

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

cough, chest pain;

weak or shallow breathing;

feeling short of breath;

headache, feeling like you might pass out;

fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

easy bruising, increased bleeding episodes; or

bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

mild nausea or stomach pain; or

mild tingly or jittery feeling.

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 Bebulin VH (factor IX complex)?

There may be other drugs that can affect factor IX complex. 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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Autoplex T

Posted by admin on November 4th, 2009

Autoplex T

Generic Name: anti-inhibitor coagulant complex (injectable) (an TEE in HIH bih tor coe AG you lant COM plex)

What is anti-inhibitor coagulant complex?

Anti-inhibitor coagulant complex is made up of proteins normally present in the blood that allow the blood to clot.

Anti-inhibitor coagulant complex is used to treat or prevent bleeding in people with hemophilia and Factor VIII inhibitors.

Anti-inhibitor coagulant complex may also be used for purposes other than those listed here.

What is the most important information I should know about anti-inhibitor coagulant complex?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from anti-inhibitor coagulant complex. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with anti-inhibitor coagulant complex.

Carry or wear identification that will alert others that you have hemophilia or another blood clotting disorder in the case of an emergency.

Tell your doctor and dentist that you have hemophilia or another blood clotting disorder before having surgery or other invasive procedures.

What should I discuss with my healthcare provider before using anti-inhibitor coagulant complex?

Do not use anti-inhibitor coagulant complex without first talking to your doctor if you have

severe injury or infection;

other bleeding or blood clotting disorders.

You may not be able to use anti-inhibitor coagulant complex or you may require a dosage adjustment or special monitoring during treatment.

Anti-inhibitor coagulant complex is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use anti-inhibitor coagulant complex without first talking to your doctor if you are pregnant. It is not known whether anti-inhibitor coagulant complex could be harmful to a nursing baby. Do not use anti-inhibitor coagulant complex without first talking to your doctor if you are breast-feeding a baby.

How should I use anti-inhibitor coagulant complex?

Anti-inhibitor coagulant complex will be administered by intravenous (into a vein) injection by a healthcare provider.

Your doctor may want you to have blood tests or other medical evaluations during treatment with anti-inhibitor coagulant complex to monitor progress and side effects.

Carry or wear identification that will alert others that you have hemophilia or another blood clotting disorder in the case of an emergency.

Your healthcare provider will store anti-inhibitor coagulant complex as directed by the manufacturer.

If you are using anti-inhibitor coagulant complex at home, your doctor or healthcare provider will give you detailed instructions on how to administer and store the medication.

What happens if I miss a dose?

Contact your doctor if a dose of anti-inhibitor coagulant complex is missed.

What happens if I overdose?

Seek emergency medical attention if an overdose of anti-inhibitor coagulant complex is suspected.

What should I avoid while using anti-inhibitor coagulant complex?

Tell your doctor and dentist that you have hemophilia or another blood clotting disorder before having surgery or other invasive procedures.

Anti-inhibitor coagulant complex side effects

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from anti-inhibitor coagulant complex. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with anti-inhibitor coagulant complex.

If you experience any of the following serious side effects, contact your healthcare provider immediately or seek emergency medical attention:

an allergic reaction (shortness of breath; wheezing; tightness of the chest; closing of the throat; hives; swelling of the lips, face, or tongue; hives or rash; dizziness or fainting);

changes in pulse rate or blood pressure;

difficulty breathing, chest pain, or cough; or

pain, redness, or swelling at the injection site.

Other, less serious side effects may be more likely to occur. Continue to use anti-inhibitor coagulant complex and talk to your doctor if you experience

headache; or

flushing.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect anti-inhibitor coagulant complex?

Other drugs that affect bleeding or blood-clotting processes can interact with anti-inhibitor coagulant complex resulting in dangerous side effects and/or altered effectiveness. Do not take any other prescription or over-the-counter medicines, including herbal products, without first talking to your doctor during treatment with anti-inhibitor coagulant complex.

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ATryn

Posted by admin on November 4th, 2009

ATryn

Generic Name: Antithrombin [Recombinant]

FDA Approves ATryn

The U.S. Food and Drug Administration (FDA) has approved ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

ATryn is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S.

People with hereditary antithrombin deficiency are at increased risk for venous thromboembolic events, including pulmonary embolism and deep vein thrombosis, which can be life-threatening, particularly in high risk situations. Antithrombin is a natural anticoagulant that plays an important role in controlling the formation of blood clots. Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma.

The safety and efficacy of ATryn was established in clinical studies conducted in hereditary antithrombin deficient patients with a history of thromboembolic events in the U.S., Europe and Canada. During these studies, ATryn was shown to prevent the formation of clinically overt thromboembolic events. Post-marketing studies will be performed to assess safety and immunogenicity after repeat dosing.

About ATryn

ATryn is the first recombinant antithrombin product approved in the world and the first antithrombin product that has been approved through the centralized procedure in the European Union. It is now also the first recombinant antithrombin product approved by the FDA.

Important Safety Information

ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis are possible. If these reactions occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.

The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients must be monitored for the occurrence of bleeding or thrombosis in such situations.

The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of = 5% are hemorrhage and infusion site reaction.

Highlights of Prescribing Information

These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn.

ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

ATryn Side Effects

Most common adverse reactions reported in clinical trials at a frequency of = 5% were hemorrhage and infusion site reaction.

To report suspected adverse reactions, contact Ovation Pharmaceuticals at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patient Counseling Information for ATryn

Inform patients that allergic-type hypersensitivity reactions are possible and instruct them to inform their physicians about any past or present known hypersensitivity to goats or goat milk proteins prior to treatment with ATryn. Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis and to notify their health care provider immediately if these events develop.

Inform patients about the risk of bleeding when ATryn is administered with other anticoagulants and instruct them to notify their physicians of any bleeding events while on treatment with ATryn.

More ATryn resources

Compare ATryn with other medications for the treatment of:

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Artiss

Posted by admin on November 4th, 2009

Artiss

Generic Name: fibrin sealant topical (FYE brin SEE lant TOP i kal)

What is Artiss?

Artiss is used to cause blood clotting during surgery or due to trauma when natural blood clotting processes are deficient.

Fibrinolysis inhibitor and thrombin are agents that are involved in blood clotting.

Artiss may also be used for purposes other than those listed here.

Important information about Artiss

Artiss is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although Artiss is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using Artiss.

Contact your doctor if you develop fever, drowsiness, chills, runny nose, rash, joint pain, poor appetite, tiredness, nausea, vomiting, abdominal pain, dark-colored urine, or yellowing of the skin or eyes following treatment with Artiss. These may be symptoms of infections that may occur due to use of this product.

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

Do not use Artiss without first talking to your doctor if you are allergic to cows or products derived from cows.

Artiss is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use Artiss without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Artiss will be harmful to a nursing baby. Do not use this medicine without first talking to your doctor if you are breast-feeding a baby.

How should I use Artiss?

Artiss will be administered by a healthcare professional as a topical application.

What happens if I miss a dose?

Due to the indications for use and the method of application of Artiss, missing a dose is not likely to occur.

What happens if I overdose?

Due to the indications for use and the method of application of Artiss, an overdose of the medication is unlikely to occur. Contact your doctor or a poison control center for advice if an overdose is suspected.

What should I avoid while taking Artiss?

There are no restrictions on food, beverages, or activity following the use of Artiss, unless otherwise directed by your doctor.

Artiss side effects

Artiss is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although Artiss is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using Artiss.

Contact your doctor if you develop fever, drowsiness, chills, runny nose, rash, joint pain, poor appetite, tiredness, nausea, vomiting, abdominal pain, dark-colored urine, or yellowing of the skin or eyes following treatment with Artiss. These may be symptoms of infections that may occur due to use of this product.

Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to Artiss.

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 Artiss

It is not known whether other medications will interact with Artiss. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with Artiss.

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