Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: ADYNOVATE is distributed in New Zealand by: Takeda New Zealand Limited, Level 10, 21 Queen Street, Auckland 1010, New Zealand, Phone 0508 169 077, www.takeda.com/en-au
ADYNOVATE 250 IU powder for injection with diluent.
ADYNOVATE 500 IU powder for injection with diluent.
ADYNOVATE 750 IU powder for injection with diluent.
ADYNOVATE 1000 IU powder for injection with diluent.
ADYNOVATE 1500 IU powder for injection with diluent.
ADYNOVATE 2000 IU powder for injection with diluent.
ADYNOVATE 3000 IU powder for injection with diluent.
| Pharmaceutical Form |
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Powder for intravenous injection with diluent. ADYNOVATE is formulated as a sterile, non-pyrogenic, white to off-white, lyophilised powder, for intravenous injection after reconstitution with water for injections. For appearance after reconstitution, see sections 4.2 and 6.6. |
Rurioctocog alfa pegol.
ADYNOVATE [rurioctocog alfa pegol, Recombinant Coagulation Factor VIII (rch), PEGylated] is supplied in single-use vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 or 3000 International Units (IU) per vial for reconstitution with 5 mL or 2 mL sterile water for injections.
The 5 mL diluent of water for injections is available for ADYNOVATE 250, 500, 750, 1000, 1500, 2000, or 3000 IU.
The 2 mL diluent of water for injections is available for ADYNOVATE 250, 500, 750, 1000 or 1500 IU.
Excipient(s) with known effect: Each vial of ADYNOVATE contains 0.45 mmol (10 mg) sodium, see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
For the full list of excipients, see section 6.1.
ADYNOVATE [rurioctocog alfa pegol, Recombinant Coagulation Factor VIII (rch), PEGylated] is a full-length form of human coagulation factor VIII (parent molecule: ADVATE [octocog alfa, Recombinant Human Factor VIII (rch)] with an extended half-life. ADYNOVATE is comprised of 2,332 amino acids [molecular weight (MW) 280kDa] covalently conjugated with a polyethylene glycol (PEG) reagent (MW 20kDa). The therapeutic activity of ADYNOVATE is derived from ADVATE, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line. The ADVATE molecule is then covalently conjugated with the PEG reagent, which targets lysine residues. The PEG moiety is conjugated to the ADVATE molecule to increase the plasma half-life through the reduction of the LRP-1 receptor-mediated clearance of the factor VIII molecule.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor VIII |
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
| List of Excipients |
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Calcium chloride dihydrate The amounts of the inactive ingredients are constant in all strengths. |
Each pack contains a powder vial and a vial containing 2mL or 5mL diluent (both type I glass closed with chlorobutyl rubber stoppers). The product is supplied in either one of the following configurations:
Not all pack sizes may be marketed.
ADYNOVATE is distributed in New Zealand by: Takeda New Zealand Limited, Level 10, 21 Queen Street, Auckland 1010, New Zealand, Phone 0508 169 077, www.takeda.com/en-au
Date of publication in the New Zealand Gazette of consent to distribute the medicine:
ADYNOVATE 250 IU, 500 IU, 1000 IU, 2000 IU: 20 December 2018
ADYNOVATE 750 IU, 1500 IU, 3000 IU: 5 August 2021
| Drug | Countries | |
|---|---|---|
| ADYNOVATE | Brazil, Canada, Japan, New Zealand, Turkey |
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