1 Name of Medicine
Asfotase alfa rch.
2 Qualitative and Quantitative Composition
Strensiq is supplied as a single-use vial containing 40 or 100 mg/mL of asfotase alfa rch.
Asfotase alfa rch is a human recombinant tissue nonspecific alkaline phosphatase (TNSALP)-Fc-deca-aspartate fusion protein with enzymatic activity, produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
For the full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Solution for injection. Strensiq is a sterile, preservative-free, non-pyrogenic, clear, slightly opalescent or opalescent, colourless to slightly yellow aqueous solution; few small translucent or white particles may be present. For subcutaneous injection.
4 Clinical Particulars
4.9 Overdose
The maximum dose of Strensiq used in clinical trials is 28 mg/kg/week. No dose related toxicity or change in the safety profile has been observed in clinical studies to date; therefore no overdose level has been determined.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
5 Pharmacological Properties
5.3 Preclinical Safety Data
Genotoxicity. No studies have been conducted to assess the genotoxic potential of asfotase alfa rch.
Carcinogenicity. No studies have been conducted to assess the carcinogenic potential of asfotase alfa rch.
6 Pharmaceutical Particulars
6.7 Physicochemical Properties
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSASFOTA.gif CAS number. CAS registry number: 1174277-80-5.
7 Medicine Schedule (Poisons Standard)
Schedule 4 - Prescription Only Medicine.
Summary Table of Changes
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/STRENSST.gif
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