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Asfotase Alfa (Strensiq)

Trade Name : STRENSIQ

Alexion Pharmaceuticals, Inc.

SOLUTION

Strength 18 mg/.45mL

ASFOTASE ALFA Tissue-nonspecific Alkaline Phosphatase [EPC],Alkaline Phosphatase [CS]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Asfotase Alfa (Strensiq) which is also known as STRENSIQ and Manufactured by Alexion Pharmaceuticals, Inc.. It is available in strength of 18 mg/.45mL per ml. Read more

Asfotase Alfa (Strensiq) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • STRENSIQ is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
  • STRENSIQu00ae is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). ()
  • Perinatal/Infantile-Onset HPP ()
  • Juvenile-Onset HPP ()
  • Preparation and Weight-Based Dosing ():
  • Administration ():
  • STRENSIQ is supplied as a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow aqueous solution; few small translucent or white particles may be present. The product 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-use vials. ()
  • None.
  • None. ()
  • No data
  • Hypersensitivity Reactions:
  • Lipodystrophy:
  • Ectopic Calcifications (eye and kidneys):
  • The following adverse reactions are described below and elsewhere in the labeling:
  • Most common adverse reactions (u2265 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions. ()n n n
  • No data
  • Drug Interference with Laboratory Tests:
  • Serum Alkaline Phosphatase
  • No data
  • STRENSIQ is a formulation of asfotase alfa, which is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP), the human immunoglobulin G Fc domain and a deca-aspartate peptide used as a bone targeting domain. The two polypeptide chains are covalently linked by two disulfide bonds.
  • STRENSIQ is a tissue nonspecific alkaline phosphatase produced by recombinant DNA technology in a Chinese hamster ovary cell line. TNSALP is a metallo-enzyme that catalyzes the hydrolysis of phosphomonoesters with release of inorganic phosphate and alcohol. Asfotase alfa has a specific activity of 620 to 1250 units/mg. One activity unit is defined as the amount of asfotase alfa required to form 1 u00b5mol of p-nitrophenol from pNPP per minute at 37u00b0C.
  • STRENSIQ (asfotase alfa) is a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow, with few small translucent or white particles, aqueous solution for subcutaneous administration. STRENSIQ is supplied in glass single-use vials containing asfotase alfa; dibasic sodium phosphate, heptahydrate; monobasic sodium phosphate, monohydrate; and sodium chloride at a pH between 7.2 and 7.6. Table 5 describes the content of STRENSIQ vial presentations.
  • No data
  • Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with asfotase alfa. Asfotase alfa at intravenous doses up to 50 mg/kg/day administered daily in pregnant rats (approximately 21 times the human AUC of 65486 ng.h/mL at 2 mg/kg dose administered three times weekly for a 50 kg individual) was found to have no adverse effect on fertility and reproductive performance of male and female rats.
  • No data
  • STRENSIQ is supplied as a sterile, nonpyrogenic, preservative free, clear, slightly opalescent or opalescent, colorless to slightly yellow aqueous solution; a few small translucent or white particles may be present. The product is available as single-use vials in a carton of one (1) or twelve (12) vials at the following strengths:
  • STRENSIQ vials must be stored in the original carton until the time of use under refrigerated conditions at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) and protected from light.
  • Once removed from refrigeration, STRENSIQ should be administered within 1 hour.
  • Do not use beyond the expiration date stamped on the carton.
  • DO NOT FREEZE OR SHAKE.
  • Vials are single-use only. Discard any unused product.
  • Advise the patient to read the FDA-approved patient labeling (Patient Labeling and Instructions for Use).
  • Advise patients or caregivers of the following:
  • STRENSIQ is manufactured by:
  • Alexion Pharmaceuticals, Inc.New Haven, CT 06510 USAU.S. License Number: 1743
  • 1-888-765-4747 (phone)
  • No data
  • Read this Instructions for Use before you start using STRENSIQ and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatmentn
  • Do not share your syringes or needles with anyone else. You may give an infection to them or get an infection from them.
  • Supplies needed to give your STRENSIQ injection (See ):
  • Preparing your STRENSIQ dose:
  • Giving your STRENSIQ injection:
  • Disposing of used needles and syringes:
  • How should I store STRENSIQ?
  • Keep STRENSIQ and all medicines, needles and syringes out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Alexion Pharmaceuticals, Inc.New Haven, CT 06510 USAU.S. License Number: 17431-888-765-4747 (phone)
  • Approved: 10/2016
  • NDC 25682-010-12n n
  • STRENSIQn (asfotase alfa)
  • 18 mg/0.45 mL
  • For Subcutaneous Use Only.
  • Single Use Only. Discard Unused Portion.
  • NDC 25682-013-12n n
  • STRENSIQn (asfotase alfa)
  • 28 mg/0.7 mL
  • For Subcutaneous Use Only.
  • Single Use Only. Discard Unused Portion.
  • NDC 25682-016-12n n
  • STRENSIQn (asfotase alfa)
  • 40 mg/mL
  • For Subcutaneous Use Only.
  • Single Use Only. Discard Unused Portion.
  • NDC 25682-019-12n n
  • STRENSIQn (asfotase alfa)
  • 80 mg/0.8 mL
  • For Subcutaneous Use Only.
  • For patients 40 kg and greater.
  • Single Use Only. Discard Unused Portion.

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