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Asfotase Alfa Dosage

Applies to the following strength(s): 18 mg/0.45 mL ; 28 mg/ 0.7 mL ; 40 mg/mL ; 80 mg/0.8 mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Hypophosphatasia

Usual dose: 2 mg/kg subcutaneously 3 times per week OR 1 mg/kg subcutaneously 6 times per week
Maximum dose: 9 mg/kg per week

Comments:
-For patients with perinatal/infantile-onset hypophosphatasia (HPP), an increase to 3 mg/kg three times per week may be necessary for insufficient efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings).
-Injection site reactions may limit the tolerability of the 6 times per week dosing regimens.

Use: For the treatment of patients with perinatal/infantile and juvenile onset HPP.

Usual Pediatric Dose for Hypophosphatasia

Usual dose: 2 mg/kg subcutaneously 3 times per week OR 1 mg/kg subcutaneously 6 times per week
Maximum dose: 9 mg/kg per week

Comments:
-For patients with perinatal/infantile-onset hypophosphatasia (HPP), an increase to 3 mg/kg three times per week may be necessary for insufficient efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings).
-Injection site reactions may limit the tolerability of the 6 times per week dosing regimens.

Use: For the treatment of patients with perinatal/infantile and juvenile onset HPP.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

For patients weighing less than 40 kg: Do not use the 80 mg/0.8 mL vial because the systemic exposure is lower than that achieved with the lower strength vials.

Precautions

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer subcutaneously into the abdominal area, thigh, or deltoid
-Always use a new syringe and needle; do not share syringes or needles
-Rotate injection sites to reduce risk of lipodystrophy; do not administer into reddened, inflamed, or swollen areas

Storage requirements:
-Store in the refrigerator [2C to 8C (36F to 46F)] in the original carton until time of use; protect from light
-Once removed from refrigerator, use within 1 hour
-Do not freeze or shake vial; single-use only

Reconstitution/preparation techniques:
-Administer dose within 1 hour of removing vial from the refrigerator.
-Do not use 80 mg/0.8 mL vial in patients weighing less than 40 kg.
-For injection volumes greater than 1 mL, split dose equally between 2 injections and use 2 separate injection sites.
-Vial should be clear, slightly opalescent or opalescent, colorless to slightly yellow aqueous solution; few small translucent or white particles may be present; discard vials not consistent with this description.
-Manufacturer product labeling may be consulted for weight-based dosing tables.

General:
-Hypophosphatasia (HPP) Registry: A voluntary registry has been established to better understand the HPP population and to monitor and evaluate the long-term treatment effects of this drug; information can be found at www.hppregistry.com.
-In clinical trials, anti-drug antibodies were detected; no correlation between anti-drug antibody titer and percent inhibition was observed. The formation of anti-drug antibody resulted in a reduction in systemic exposure.

Monitoring:
-Signs and symptoms of hypersensitivity reactions
-Signs and symptoms of lipodystrophy

Patient advice:
-Patients or caregivers should be instructed on preparation, storage, and administration of this drug; proper injection technique and site rotation are necessary to avoid injection site reactions.
-Patients or caregivers should be instructed on proper disposal of needles and syringes; with each dose, a new syringe and needle should be used and needles and syringes should never be shared.
-If signs or symptoms of an allergic reaction occur, patients should seek immediate medical advice.
-Tell your health care provider if you notice skin thickening or pits at injection sites.

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