Strensiq or asfotase alfa is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
HPP is caused by a deficiency in TNSALP enzyme activity, leading to elevations in several substrates, like inorganic pyrophosphate (PPi). TNSALP is a metalloenzyme that catalyzes the hydrolysis of phosphomonoesters with the 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 asfotase alfa treatment reduces the enzyme substrate levels.
There are no available data on asfotase alfa use in pregnant women to inform a drug-associated risk, presence of asfotase alfa in human milk, the effects on the breastfed infant, or the effects on milk production. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for asfotase alfa and any potential adverse effects on the breastfed infant from asfotase alfa or from the underlying maternal condition. Safety and effectiveness of asfotase alfa for the treatment of perinatal/infantile- and juvenile-onset HPP have been established in pediatric patients. There is no information available to determine whether geriatric patients differ in terms of adverse reactions and response, as compared to younger patients. Asfotase alfa is for subcutaneous injection only.
The following are the most adverse reactions reported in patients undergoing treatment (incidence rates being gretaer than 10%) with asfotase alfa: hypersensitivity reactions, lipodystrophy, ectopic calcifications, and possible immune-mediated clinical effects
Pricing and Availability
Asfotase alfa is not currently registered in India and is therefore not available through regular pharmacies or standard distribution channels.
As this is a prescription-only medication, a price quotation for asfotase alfa is shared only after reviewing valid medical documents and a doctor’s prescription. For the most up-to-date pricing and supply details, patients may contact our support team.
The price of asfotase alfa in India may differ based on factors such as market demand, supplier access, import regulations, and availability from international manufacturers. The total cost may also depend on shipping charges, origin country, documentation fees, and currency exchange rates.
Pricing may be affected by local taxes (GST) and any revisions in company or distributor pricing policies.
We assist patients in India with the safe and lawful access through import asfotase alfa through the Named Patient Supply (NPS) program, ensuring compliance with all import regulations. Our services include document verification, import coordination, and doorstep delivery of the medicine.
Patient Access
Since asfotase alfa is not approved for commercial sale in India, it can be obtained only through the Named Patient Import Program (NPIP).
We help patients obtain unregistered medicines under the NPS route, maintaining full adherence to applicable legal and regulatory standards.
Strensiq or asfotase alfa is available as injection: 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL, or 80 mg/0.8 mL solution in single-dose vials with each carton containing 1 or 12 vials.
Import Procedure
- Medicine Request Submission: Patients or caregivers can begin by submitting a request, along with their doctor’s prescription and treatment information.
- Filing Form 12A: A completed Form 12A and a valid prescription from a Registered Medical Practitioner (RMP) must be submitted.
- Verification Process: All documents are carefully reviewed to confirm the patient’s eligibility to import the medicine for personal medical use.
- Regulatory Approval: Once approval is received from the Drugs Controller General (India), the import procedure is initiated in accordance with the approved prescription.
- Medicine Procurement: Our procurement specialists connect with licensed international suppliers to source the medicine at the best possible rate while ensuring authenticity and quality.
- Product Delivery: Following approval and shipment, logistics are handled to ensure timely, safe, and compliant delivery of the medicine to the patient’s address in India.
Documents Required
To import asfotase alfa into India, patients must provide the following:
- A valid prescription indicating the medicine name, dosage, duration, and diagnosis.
- Recent medical history and diagnostic reports (preferably from the last three months).
- Government-issued ID proof and proof of residence.
- Import permit (if required).
Orders are confirmed only after the submission and verification of all necessary documents. Once the import authorization is granted, shipment of asfotase alfa is arranged by a licensed global supplier typically from the USA, Canada, Europe, or Australia.
This process ensures that patients in India can legally and securely access and buy asfotase alfa in India. We coordinate with reliable international sources, maintain pricing transparency, and ensure all deliveries are pharmacist-verified and fully compliant with import regulations.
For the best pricing, authentic sourcing, and priority assistance, connect with 247QualityMeds.com today. Our team ensures a safe and easy buying process.