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Drug Details

ADVATE Solution for Injection

• Drug Class Description
  Antihaemorrhagics: Blood coagulation Factor VIII
• Generic Name
  Octocog Alfa
• Presentation
  ADVATE 250 IU, ADVATE 500 IU, ADVATE 1000 IU, ADVATE 1500 IU, ADVATE 2000 IU, ADVATE 3000 IU powder and solvent for solution for injection. Octocog alfa (recombinant human coagulation Factor VIII produced by recombinant DNA technology in Chinese Hamster Ovary cells) 250 IU/vial. Octocog alfa 250 IU per 5 ml after reconstitution. The concentration after reconstitution is 50 IU/ml. Octocog alfa (recombinant human coagulation Factor VIII produced by recombinant DNA technology in Chinese Hamster Ovary cells) 500 IU/vial. Octocog alfa 500 IU per 5 ml after reconstitution. The concentration after reconstitution is 100 IU/ml. Octocog alfa (recombinant human coagulation Factor VIII produced by recombinant DNA technology in Chinese Hamster Ovary cells) 1000 IU/vial. Octocog alfa 1000 IU per 5 ml after reconstitution. The concentration after reconstitution is 200 IU/ml. Octocog alfa (recombinant human coagulation Factor VIII produced by recombinant DNA technology in Chinese Hamster Ovary cells) 1500 IU/vial. Octocog alfa 1500 IU per 5 ml after reconstitution. The concentration after reconstitution is 300 IU/ml. Octocog alfa (recombinant human coagulation Factor VIII produced by recombinant DNA technology in Chinese Hamster Ovary cells) 2000 IU/vial. Octocog alfa 2000 IU per 5 ml after reconstitution. The concentration after reconstitution is 400 IU/ml. Octocog alfa (recombinant human coagulation Factor VIII produced by recombinant DNA technology in Chinese Hamster Ovary cells) 3000 IU/vial. Octocog alfa 3000 IU per 5 ml after reconstitution. The concentration after reconstitution is 600 IU/ml. The potency (IU) is determined using the chromogenic assay against an in-house standard that is referenced to the WHO standard. The specific activity is approximately 4,000-10,000 IU/mg protein. Prepared without the addition of any (exogenous) human-or animal-derived protein in the cell culture process, purification or final formulation. Excipients: Sodium chloride: 90 mmol
• Description
  Powder and solvent for solution for injection. White to off-white friable powder. After reconstitution, the solution has a pH of between 6.7 and 7.3.
• Indications
  Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor VIII deficiency) see Dosage. ADVATE does not contain von Willebrand Factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand’s disease.
• 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:

  Required IU = body weight (kilogramme) x desired Factor VIII rise (% of normal) x 0.5

   

• Contra Indications
  Hypersensitivity to the active substance or to any of the excipients or to mouse or hamster proteins.
• 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 Drug 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. 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.