Adynovate

Adynovate

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Rurioctocog α pegol (recombinant human coagulation factor VIII)
Indications/Uses
Treatment, control & prophylaxis of bleeding episodes; peri-op management in childn & adults w/ hemophilia A. Not indicated in von Willebrand's disease.
Dosage/Direction for Use
Early hemarthrosis, mild muscle or oral bleeding 20-40 IU/dL or 10-20 IU/kg every 12-24 hr until bleeding is resolved. Muscle bleeding, moderate oral cavity bleeding, definite hemarthroses, known trauma 30-60 IU/dL or 15-30 IU/kg every 12-24 hr until bleeding is resolved. Significant GI, CNS, intracranial, intra-abdominal & intrathoracic bleeding, retropharyngeal or retroperitoneal spaces or iliopsoas sheath bleeding, fractures, head trauma 60-100 IU/dL or 30-50 IU/kg every 8-24 hr until bleeding is resolved. Minor surgery including tooth extraction 30-60 IU/dL or 30-50 IU/kg 1 hr before surgery, repeat after 24 hr if necessary until bleeding is resolved. Major pre- & post-op surgery eg, intracranial, intra-abdominal or intrathoracic surgery, joint replacement surgery 80-100 IU/dL or 40-60 IU/kg 1 hr before surgery, repeat every 8-24 hr (6-24 hr for childn <12 yr) until adequate wound healing. Routine prophylaxis Adult & adolescent ≥12 yr 40-50 IU/kg twice wkly, childn <12 yr 55 IU/kg twice wkly. Max: 70 IU/kg. Adjust dose & dosing intervals based on patient's clinical response.
Contraindications
Prior anaphylactic reaction to Adynovate, parent molecule (Advate), mouse or hamster protein, or tris, mannitol, trehalose, glutathione &/or polysorbate 80.
Special Precautions
Discontinue use if hypersensitivity reactions occur. Neutralizing Ab; previously-untreated patients. Monitor for development of factor VIII inhibitors. Immunogenicity. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Headache, diarrhea, rash, nausea, dizziness, urticaria.
MIMS Class
Haemostatics
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
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Adynovate powd for inj 1,000 IU
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Adynovate powd for inj 1,500 IU
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Adynovate powd for inj 2,000 IU
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Adynovate powd for inj 250 IU
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Adynovate powd for inj 3,000 IU
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Adynovate powd for inj 500 IU
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Adynovate powd for inj 750 IU
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1's
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