Drug Action
Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase that promotes mineralisation of the skeleton.
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Drug reference
Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase that promotes mineralisation of the skeleton.
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Paediatric-onset hypophosphatasia (initiated by a specialist) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 2 mg/kg 3 times a week, alternatively 1 mg/kg 6 times a week, dosing frequency depends on body- weight—consult product literature for further information
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Hypersensitivity reactions CAUTIONS, FURTHER INFORMATION ▶Hypersensitivity reactions Reactions, including signs and symptoms consistent with anaphylaxis, have occurred within minutes of administration and can occur in patients on treatment for more than one year; if these reactions occur, manufacturer advises immediate discontinuation of treatment and initiation of appropriate medical treatment. For information on re-administration, consult product literature.
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NICE decisions ▶Asfotase alfa for treating paediatric-onset hypophosphatasia (August 2017) NICE HST6 Asfotase alfa is recommended as an option for treating paediatric-onset hypophosphatasia only: . for people who meet the criteria for treatment within the managed access arrangement (see section 4.18 of the guidance), and . for the duration of this arrangement and in line with the other conditions it specifies, and . when the manufacturer provides asfotase alfa with the confidential commercial terms agreed with NHS England. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/HST6
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▶Common or very common Bruising tendency. chills. cutis laxa. fever. headache. hypersensitivity. irritability. lipohypertrophy. myalgia. nausea. oral hypoaesthesia. pain. skin reactions. vasodilation SIDE-EFFECTS, FURTHER INFORMATION Injection-site reactions including hypertrophy, induration, skin discolouration, and cellulitis may occur, particularly in patients receiving treatment 6 times a week. Manufacturer advises rotation of injection sites to manage these reactions; interrupt treatment if severe reactions occur and administer appropriate medical therapy.
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid—no information available.
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▶Manufacturer advises monitor serum parathyroid hormone and calcium concentrations—supplements of calcium and oral vitamin D may be required. ▶Manufacturer advises periodic ophthalmological examination and renal ultrasounds.
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Manufacturer advises max. 1 mL per injection site; administer multiple injections if more than 1 mL is required—consult product literature. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8 °C).
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Strensiq (Alexion Pharma UK Ltd) A Asfotase alfa 40 mg per 1 ml Strensiq 18mg/0.45ml solution for injection vials | 12 vial P £12,700.80 (Hospital only) Strensiq 28mg/0.7ml solution for injection vials | 12 vial P £19,756.80 (Hospital only) Strensiq 40mg/1ml solution for injection vials | 12 vial P £28,224.00 (Hospital only) Asfotase alfa 100 mg per 1 ml Strensiq 80mg/0.8ml solution for injection vials | 12 vial P £56,448.00 (Hospital only) 2.8 Mucopolysaccharidosis ENZYMES
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Injection guides The manufacturer has produced injection guides for patients and carers to support training given by health care professionals.
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2 mg/kg 3 times a week, alternatively 1 mg/kg
First-line fragment. Read the complete Indications and Dose section above.
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