Alphanate

DRUG DESCRIPTION

Antihemophilic Factor (Human), Alphanate (antihemophilic factor) ®, Solvent Detergent / Heat Treated, is a single dose, sterile, lyophilized concentrate of Factor VIII (AHF) intended for intravenous administration in the treatment of hemophilia A, or acquired Factor VIII deficiency.

Alphanate (antihemophilic factor) ® is prepared from pooled human plasma by cryoprecipitation of the Factor VIII, fractional solubilization, and further purification employing heparin-coupled, cross-linked agarose which has an affinity to the heparin binding domain of vWf/FVIII:C complex.1 The product is treated with a mixture of tri(n-butyl) phosphate (TNBP) and polysorbate 80 to reduce the risks of transmission of viral infection. In order to provide an additional safeguard against potential non-lipid enveloped viral contaminants, the product is also subjected to a 80 °C heat treatment step for 72 hours. However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products.

Alphanate® is labeled with the antihemophilic factor potency (Factor VIIIC activity) expressed in International Units (I U) per vial, which is referenced to the WHO International Standard.

Alphanate (antihemophilic factor) ® contains Albumin (Human) as a stabilizer, resulting in a final container concentrate with a specific activity of at least 5 IU FVIII:C/mg total protein. Prior to the addition of the Albumin (Human) stabilizer, the specific activity is significantly higher.

When reconstituted with the appropriate volume of Sterile Water for Injection, USP, Alphanate (antihemophilic factor) ® contains 0.3 - 0.9 g Albumin (Human)/100 mL; NMT 5 mmol calcium/L; NMT 750 µg glycine/IU FVIIIC; NMT 1.0 U heparin/mL; 10 - 40 mmol histidine/L; NMT 0.1 mg imidazole/mL; 50 - 200 mmol arginine/L; NMT 1.0 µg polyethylene glycol and polysorbate 80/IU FVIII:C; NMT 10 mEq sodium/vial; and NMT 0.1 µg TNBP/IU FVIIIC.

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...

Read All Potential Side Effects and See Pictures of Alphanate »

What are the precautions when taking antihemophilic factor (Alphanate)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Alphanate »

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...

Read All Potential Side Effects and See Pictures of Alphanate »

What are the precautions when taking antihemophilic factor (Alphanate)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Alphanate »

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...

Read All Potential Side Effects and See Pictures of Alphanate »

What are the precautions when taking antihemophilic factor (Alphanate)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Alphanate »


Alphanate Consumer (continued)

SIDE EFFECTS: Flushing of the face, nausea, vomiting, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, chills, and headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of anemia (e.g., tiredness, low energy, pale skin color, shortness of breath), new or worsening bleeding/bruising.

This medication is made from human blood. There is a very small chance that you may get infections from this medication (e.g., viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of hepatitis or other infection, including fever, persistent sore throat, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details.

Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral infections such as hepatitis). It is recommended that you get the appropriate vaccinations (e.g., for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent virus infections. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


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)?
  • What are the possible side effects of antihemophilic factor (factor VIII)?
  • What is the most important information I should know about antihemophilic factor (factor VIII)?
  • What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?
  • How should I use antihemophilic factor (factor VIII)?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using antihemophilic factor (factor VIII)?
  • What other drugs will affect antihemophilic factor (factor VIII)?
  • Where can I get more information?

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.

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.

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