Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

ADVATE is intended for intravenous administration (infusion into a vein). It is given to you under close supervision of your doctor who is experienced in the care of patients with haemophilia A. Dosage will vary depending on your condition and your body weight. Always use ADVATE exactly as your doctor has told you. You should check with your doctor if you are not sure.

Dosage for prophylaxis of bleeding

If you are using ADVATE to prevent bleeding (prophylaxis), your doctor will calculate the dose for you. He/she will do this according to your particular needs. The usual dose will be between 20 to 40 IU of octocog alfa per kilogramme of body weight, administered at intervals of 2 to 3 days. However, in some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.

If you have the impression that the effect of ADVATE is insufficient, talk to your doctor.

Dosage for treatment of bleeding

If you are receiving ADVATE for treatment of bleeding, your doctor will calculate the dose for you. He/she will do this according to your particular needs using the formula below:

Contra Indications

Special Precautions

When allergic reactions occur:

• There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADVATE. You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness. These symptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.

• If any of these symptoms occur, stop the injection/infusion immediately and contact your doctor. Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment.

Interactions

No interactions of ADVATE with other medicinal products are known. Pregnancy and lactatio: Based on the rare occurrence of haemophilia A in women, experience regarding the use of ADVATE during pregnancy is not available.

Animal reproduction studies have not been conducted with ADVATE. Therefore, the benefit of using ADVATE during pregnancy must be judged against the risk for the mother and baby and should be used only if clearly needed. Based on the lack of experience regarding the use of ADVATE during lactation, breast-feeding should be discontinued.

Adverse Reactions

Like all medicines, ADVATE can cause side effects, although not everybody gets them.

• The following side effects were commonly observed during the clinical studies with ADVATE (more than 1 in 100 patients and less than 1 in 10 patients): dizziness, headache and fever. The other side effects were uncommonly observed (more than 1 in 1000 patients and less than 1 in 100 patients): itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, laryngitis, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, increase in enzymes that track liver function, decrease in haematocrit and pain in the upper abdomen or lower chest. The following uncommon side effects have been observed during surgery (more than 1 in 1000 patients and less than 1 in 100 patients): catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative haematoma. Most of these events were reported once and did not re-occur upon further exposure to ADVATE. Only headache (5 patients), fever, dizziness (3 patients each), itching and diarrhea (2 patients each) were reported by more than 1 patient.

• Since the drug has been on the market, there have been rare reports of severe and potentially life threatening reactions (anaphylaxis) and other allergic reactions. You should be aware of the early symptoms of allergic reactions such as rash, hives, wheals and generalised itching, swelling of
the lips or tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness. Thesesymptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.

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