STRENSIQ is a prescription medicine used to treat perinatal/infantile- and juvenile-onset hypophosphatasia (HPP), a rare genetic disorder that affects bone and tooth development due to a deficiency of the enzyme tissue-nonspecific alkaline phosphatase (TNSALP).
Asfotase Alfa
Generic Name/API:ASFOTASE ALFA
Packaging:Each carton contains 12 single use vials.
Storage:Store at 2°C to 8°C.
Dosage:For dosage information, please check the General Information section.
Strength:Injection available in 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL, or 80 mg/0.8 mL solution in single-dose vials
Indication:Strensiq is indicated for the treatment of patients with perinatal/infantile and juvenile onset hypophosphatasia (HPP). Hypophosphatasia is a rare genetic condition characterized by impaired bone and tooth mineralization caused by a deficiency of tissue-nonspecific alkaline phosphatase (TNSALP).
STRENSIQ (asfotase alfa) is the first and only enzyme replacement therapy approved for the treatment of perinatal/infantile- and juvenile-onset hypophosphatasia (HPP), a rare genetic disorder affecting bone and tooth mineralization. It works by replacing the deficient tissue-nonspecific alkaline phosphatase (TNSALP), targeting the root cause of the disease.
DOSAGE:
The recommended dosage regimen for the following
Dosage for Perinatal/infantile patients is 6 mg/kg per week administered subcutaneously either as
- 2 mg/kg three times per week,
- 1 mg/kg six times per week.
Dosage for Juvenile-Onset HPP is 6 mg/kg per week administered subcutaneously either as
- 2 mg/kg three times per week,
- 1 mg/kg six times per week.
STRENGTH:
- Injection available in 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL, or 80 mg/0.8 mL solution in single-dose vials
ADVERSE REACTIONS:
The following are the adverse reactions for Strensiq:
- Hypersensitivity Reactions
- Lipodystrophy
- Ectopic Calcifications
- Possible Immune-Mediated Clinical Effects
STORAGE: Store Strensiq injection at 2°C to 8°C. Do not freeze or shake. Protect from light.
Hypersensitivity Reactions Including Anaphylaxis:
STRENSIQ may cause life-threatening hypersensitivity reactions, including anaphylaxis, which can occur anytime during treatment. Symptoms include breathing difficulty, nausea, facial swelling, dizziness, rash, and itching. Start treatment under medical supervision with emergency support available. Discontinue immediately if a severe reaction occurs and treat appropriately. Re-administration should be cautious, with close monitoring. Patients should be informed of symptoms and advised to seek immediate medical care if needed.
Lipodystrophy:
Localized lipodystrophy, such as lipoatrophy and lipohypertrophy, has been reported at injection sites after several months of STRENSIQ treatment in clinical trials. Patients should be advised to use proper injection technique and rotate injection sites regularly.
Ectopic Calcifications:
Patients with HPP are at increased risk for ectopic calcifications, including in the eyes (conjunctival and corneal) and kidneys (nephrocalcinosis, nephrolithiasis), as reported during STRENSIQ clinical trials. It is unclear whether these events are related to the disease or the treatment, and no associated vision or kidney function changes were reported. Baseline and periodic ophthalmologic exams and renal ultrasounds are recommended to monitor for calcifications and assess vision and kidney function.
Possible Immune-Mediated Clinical Effects:
Most patients treated with STRENSIQ developed anti-asfotase alfa and neutralizing antibodies, leading to decreased systemic exposure to asfotase alfa.
FAQ
Who can take STRENSIQ?
STRENSIQ is approved for use in patients of all ages with perinatal/infantile- or juvenile-onset HPP. It is not approved for adult-onset HPP unless symptoms began during childhood.
How is STRENSIQ administered?
STRENSIQ is given as a subcutaneous injection (under the skin), typically 3 to 6 times per week depending on the prescribed dose and patient’s needs.
Can STRENSIQ improve quality of life?
Yes, clinical studies have shown that STRENSIQ can improve physical function, bone growth, and overall health in children and adults with pediatric-onset HPP, contributing to better daily functioning and quality of life.
What are the key criteria for selecting a supplier?
While selecting a supplier, we essentially ensure that the supplier holds a valid Good Distribution Practice (GDP) and possess valid operating license. These credentials confirm that the supplier’s adherence to International standards for the proper distribution of medicinal products.
What is the price of Strensiq (asfotase alfa) in India?
The cost of Strensiq (Asfotase Alfa) in India varies, as it is not approved locally and must be imported. Factors such as international currency exchange rates (USD/EUR), import duties, and supplier availability influence the final price. For the latest pricing and order details, please contact 24/7 QualityMeds.
How to buy Strensiq (Asfotase Alfa) in India?
To buy Strensiq (Asfotase Alfa) in India at a genuine price, contact 24/7 QualityMeds. We assist you in importing this medication legally and at the best possible cost.
