Helixate FS

 
Generic Name: antihemophilic factor (factor VIII) (injectable)

Brands: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Hyate C, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

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What is the most important information I should know about Helixate FS?

· Some forms of Helixate FS are made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although Helixate FS 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 Helixate FS from human sources.

· Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from Helixate FS. 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 Helixate FS.

· 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 is Helixate FS?

· Antihemophilic factor (factor VIII) is a natural protein, normally present in the blood that helps blood to clot. A deficiency of factor VIII is the cause of hemophilia A.

· Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

· Antihemophilic factor (factor VIII) may also be used for purposes other than those listed here.

 

What should I discuss with my healthcare provider before using Helixate FS?

· Do not use Helixate FS without first talking to your doctor if you have      ·had an unusual or allergic reaction to this medication, a similar medication, a human or animal (cow, hamster, mouse, or pig) protein, dyes, additives, or preservatives;     ·hardening of the arteries;     ·severe injury or infection; or     ·other bleeding or blood clotting disorders.

· You may not be able to use Helixate FS or you may require a dosage adjustment or special monitoring during treatment.

· Antihemophilic factor (factor VIII) 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 Helixate FS without first talking to your doctor if you are pregnant.

· It is not known whether Helixate FS could be harmful to a nursing baby. Do not use Helixate FS without first talking to your doctor if you are breast-feeding a baby.

 

How should I use Helixate FS?

· Antihemophilic factor (factor VIII) 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 Helixate FS 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 Helixate FS as directed by the manufacturer.

· If you are using Helixate FS 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 Helixate FS is missed.

 

What happens if I overdose?

· Seek emergency medical attention if an overdose of Helixate FS is suspected.

 

What should I avoid while using Helixate FS?

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

 

What are the possible side effects of Helixate FS?

· Some forms of Helixate FS are made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although Helixate FS 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 Helixate FS from human sources.

· Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from Helixate FS. 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 Helixate FS.

· 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); or     ·fever;     ·nausea or vomiting;     ·increased heart rate;     ·decreased blood pressure (may result in dizziness or fainting);     ·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 Helixate FS 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.

 

What other drugs will affect Helixate FS?

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

 

Where can I get more information?

· Your pharmacist has additional information about Helixate FS written for health professionals that you may read.

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