Description and Brand Names

US Brand Name

1. Advate
2. Adynovate
3. Afstyla
4. Altuviiio
5. Eloctate
6. Esperoct
7. Helixate FS
8. Hemofil-M
9. HyateC
10. Jivi
11. Koate DVI
12. Obizur

Descriptions

Antihemophilic factor (AHF) injection is used to treat, control, prevent, and decrease the frequency of bleeding episodes, and prevent bleeding during surgery in patients with hemophilia A (congenital Factor VIII deficiency).

Antihemophilic factor (AHF) is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often.

Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

There are several different types of AHF. They are made from human blood or artificially by a man-made process (recombinant). AHF made from human blood has been treated and is not likely to contain harmful viruses, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made AHF products do not contain these viruses.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of antihemophilic factor injection in children.

No information is available on the relationship of age to the effects of Hemofil® M in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of Advate®, Adynovate®, Eloctate™, Kogenate® FS, Kovaltry®, Novoeight®, Xyntha®, or Xyntha® Solofuse® in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related medical problems, which may require caution and an adjustment in the dose for patients receiving these medicines.

No information is available on the relationship of age to the effects of Hemofil® M in geriatric patients.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to hamster or mouse proteins, history of or
• von Willebrand disease (blood clotting disorder)—Should not be used in patients with these conditions.

• Heart or blood vessel disease—Use with caution. May make these conditions worse.

Precautions

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.

Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

The stopper of the bottle (vial) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

1. Fever

Less common or rare

1. Changes in facial skin color
2. chest tightness
3. chills
4. fast or irregular breathing
5. nausea
6. puffiness or swelling of the eyelids or around the eyes
7. sensation of burning, warmth, heat, numbness, tightness, or tingling
8. skin rash, hives, or itching
9. trouble breathing
10. unusual tiredness or weakness

Incidence not known

1. Bluish color of the fingernails, lips, skin, palms, or nail beds
2. blurred vision
3. chest pain or discomfort
4. confusion
5. cough
6. deep or fast breathing with dizziness
7. difficult or labored breathing
8. difficulty with swallowing
9. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
10. fast, pounding, or irregular heartbeat or pulse
11. noisy breathing
12. numbness of the feet, hands, and around the mouth
13. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
14. slow or irregular heartbeat
15. sweating
16. swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. Headache

Less common

1. Burning, stinging, or swelling at the injection site
2. diarrhea
3. dizziness or lightheadedness
4. dry mouth or bad taste in the mouth
5. lack or loss of strength
6. nosebleed
7. redness of the face
8. vomiting

Rare

1. Change in taste
2. loss of taste

Incidence not known

1. Feeling of warmth
2. increased sweating
3. irritability
4. muscle or bone pain
5. redness of the eye
6. redness of the face, neck, arms, and occasionally, upper chest
7. redness of the skin
8. stomach pain
9. trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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