Molecule
Asfotase alfa is a tissue-nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). It is available as injection for subcutaneous use. MedsAcross supplies Asfotase alfa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
Source: US FDA prescribing information
HPP is caused by a deficiency in TNSALP enzyme activity, which leads to elevations in several TNSALP substrates, including inorganic pyrophosphate (PPi). TNSALP is a metallo-enzyme that catalyzes the hydrolysis of phosphomonoesters with release of inorganic phosphate and alcohol. Elevated extracellular levels of PPi block hydroxyapatite crystal growth which inhibits bone mineralization and causes an accumulation of unmineralized bone matrix which manifests as rickets and bone deformation in infants and children and as osteomalacia (softening of bones) once growth plates close, along with muscle weakness. Replacement of the TNSALP enzyme upon STRENSIQ treatment reduces the enzyme substrate levels.
Source: US FDA prescribing information
Perinatal/Infantile-Onset HPP. Recommended dosage regimen is 2 mg/kg administered subcutaneously three times per week, or 1 mg/kg administered six times per week. Injection site reactions may limit the tolerability of the six times per week regimen. The dose may be increased to 3 mg/kg three times per week for insufficient efficacy. Juvenile-Onset HPP. Preparation and Weight-Based Dosing: Caution: Do not use the 80 mg/0.8 mL vial in pediatric patients weighing less than 40 kg because the systemic asfotase alfa exposure achieved with the 80 mg/0.8 mL vial (higher concentration) is lower than that achieved with the other strength vials (lower concentration). A lower exposure may not be adequate for this subgroup of patients. See full prescribing information for tables of weight-based dosing by treatment regimen. Administration: For subcutaneous injection only. Rotate injection sites.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (hypersensitivity reactions including anaphylaxis): Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. Lipodystrophy: Localized reactions were reported after several months of treatment, follow proper injection technique and rotate injection sites. Ectopic Calcifications (eye and kidneys): Monitor using ophthalmologic examinations and renal ultrasounds at baseline and periodically during treatment. Possible Immune-Mediated Clinical Effects: Evaluate patients for antibody formation if clinically indicated.
Source: US FDA prescribing information
The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions Lipodystrophy Ectopic Calcifications Possible Immune-Mediated Clinical Effects Most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions.
Source: US FDA prescribing information
Drug Interference with Laboratory Tests: Alkaline Phosphatase (ALP) is used as a detection reagent in many laboratory tests and the presence of asfotase alfa in clinical laboratory samples could result in erroneous test results. Inform laboratory personnel and discuss use of an alternative testing platform for patients on treatment. Serum Alkaline Phosphatase: Serum ALP measurements are expected to be elevated during treatment and may be unreliable for clinical decision making.
Source: US FDA prescribing information
STRENSIQ vials must be stored in the original carton until the time of use under refrigerated conditions at 2°C to 8°C (36°F to 46°F) and protected from light. Once removed from refrigeration, STRENSIQ should be administered within 3 hours. DO NOT FREEZE OR SHAKE.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Asfotase alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Strensiq 18 mg/0.45 mL injectionSubcutaneous Cold chain | Alexion Pharmaceuticals | US FDA | Available on request |
| Strensiq 28 mg/0.7 mL injectionSubcutaneous Cold chain | Alexion Pharmaceuticals | US FDA | Available on request |
| Strensiq 40 mg/1 mL injectionSubcutaneous Cold chain | Alexion Pharmaceuticals | US FDA | Available on request |
| Strensiq 80 mg/0.8 mL injectionSubcutaneous Cold chain | Alexion Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 4 presentations of Asfotase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Asfotase alfa, including Strensiq.
Yes. The US FDA first approved Asfotase alfa on 23 October 2015, according to Drugs@FDA.
Yes. Asfotase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Asfotase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Asfotase alfa is classified under ATC code A16AB13 (Asfotase alfa).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.