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Alphanate

"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...

Alphanate

Alphanate

Alphanate Patient Information Including Side Effects

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

Generic Name: antihemophilic factor (factor VIII) (injection) (Pronunciation: an TEE hee moe FIH lick FAC tor)

What is antihemophilic factor (factor VIII) (Alphanate)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack 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 in this medication guide.

What are the possible side effects of antihemophilic factor (factor VIII)?

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

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;
  • fast heart rate, chest pain, trouble breathing;
  • feeling light-headed, fainting; or
  • pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

  • unusual taste in your mouth;
  • cough, runny or stuffy nose;
  • mild itching;
  • swelling in your hands, ankles, or feet;
  • headache or dizziness;
  • mild nausea, diarrhea, stomach pain;
  • sweating;
  • joint pain; or
  • chills or flushing (warmth or tingly feeling).

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.

Read the Alphanate (antihemophilic factor) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are 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.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak 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 stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

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 disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Side Effects Centers
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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