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Learn more about Strensiq® (asfotase alfa) and HPP.

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References

1. Strensiq® Prescribing Information. Alexion Pharmaceuticals, Inc. 2016.

2. Scott LJ. Asfotase alfa: A review in Paediatric-Onset Hypophosphatasia. Drugs. 2016;76(2):255-262.

3. Rockman-Greenberg C. Hypophosphatasia. Pediatr Endocrinol Rev. 2013;10(suppl 2):380-388.

4. Whyte MP. Hypophosphatasia: nature’s window on alkaline phosphatase function in humans. In: Bilezikian JP, Raisz LG, Martin TJ, eds. Principles of Bone Biology. Vol 1. 3rd ed. San Diego, CA: Academic Press; 2008:1573-1598.

5. Greenberg CR, Taylor CL, Haworth JC, et al. A homoallelic Gly317 → Asp mutation in ALPL causes the perinatal (lethal) form of hypophosphatasia in Canadian Mennonites. Genomics. 1993;17(1):215-217.

6. Whyte MP, Rockman-Greenberg C, Ozono K, et al. Asfotase alfa treatment improves survival for perinatal and infantile hypophosphatasia. J Clin Endrocrinol Metab. 2016;101(1):334-342.

7. Seshia SS, Derbyshire G, Haworth JC, Hoogstraten J. Myopathy with hypophosphatasia. Arch Dis Child. 1990:65(1):130-131.

8. Taketani T, Onigata K, Kobayashi H, Mushimoto Y, Fukuda S, Yamaguchi S. Clinical and genetic aspects of hypophosphatasia in Japanese patients. Arc Dis Child. 2014;99(3):211-215.

9. Data on file, Alexion Pharmaceuticals.

10. Whyte MP, Greenberg CR, Salman N, et al. Enzyme-replacement therapy in life-threatening hypophosphatasia. N Engl J Med. 2012;366(10):904-913.

11. Whyte MP, Madson KL, Phillips D, et al. Asfotase alfa therapy for children with hypophosphatasia. JCI Insight. 2016;1(9):e85971.

12. McDonald CM, Henricson EK, Abresch RT, et al; for PTC124-GD-007-DMD Study Group. The 6-minute walk test and other clinical endpoints in Duchenne muscular dystrophy: reliability, concurrent validity, and minimal clinically important differences from a multicenter study. Muscle Nerve. 2013;48(3):357-368.

13. Tomazos I, Moseley S, Sawyer EK, Iloeje U. Determination of the minimal clinically important difference in the six-minute walk test for patients with hypophosphatasia. Paper presented at: 55th Annual ESPE Meeting; September 10-12, 2016; Paris, France.

14. Whyte MP, Simmons JH, Bishop N, et al. for Study 003-08 Investigators. Asfotase alfa: sustained efficacy and tolerability in infants and young children with life-threatening hypophosphatasia. Poster presented at: 2014 Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting; May 3-6, 2014; Vancouver, BC.

15. Whyte MP, Greenberg CR, Salman NJ, et al. Enzyme-replacement therapy in life-threatening hypophosphatasia [supplementary appendix]. N Engl J Med. 2012;366(10):S1-S47.

16. Whyte MP, Madson KL, Phillips D, et al. Asfotase alfa therapy for children with hypophosphatasia [supplementary appendix]. JCI Insight. 2016;1(9):S1-S33.

17. Kishnani P, Gayron M, Denker AE, Watsky E, Rockman-Greenberg CR. Biochemical and physical function outcomes in adults with pediatric-onset hypophosphatasia treated with asfotase alfa for up to 3 years: interim results from a Phase 2 study. Paper presented at: The Joint Annual Scientific Meeting of Endocrine Society of Australia & the Society for Reproductive Biology & ANZ Bone & Mineral Society. August 21-24, 2016; Queensland, Australia.

18. Bruininks RH, Bruininks BD. BOT-2. Pearson website. http://images.pearsonclinical.com/images/Assets/BOT-2/BOT-2_Complete_Form_Sample_Report.pdf. Updated October 22, 2013. Accessed January 29, 2016.


Indication

STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP)

Important Safety Information

  • Hypersensitivity reactions, including anaphylaxis, have been reported in STRENSIQ-treated patients. Signs and symptoms consistent with anaphylaxis included difficulty breathing, choking sensation, nausea, periorbital edema, and dizziness. These reactions have occurred within minutes after subcutaneous administration of STRENSIQ and can occur in patients on treatment for more than one year. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus and oral hypoesthesia. If a severe hypersensitivity reaction occurs, discontinue STRENSIQ treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering STRENSIQ to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
  • Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ. Advise patients to follow proper injection technique and to rotate injection sites.
  • Patients with HPP are at increased risk for developing ectopic calcifications. In clinical trials, 14 cases (14%) of ectopic calcification of the eye including the cornea and conjunctiva, and the kidneys (nephrocalcinosis) were reported. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported. Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with STRENSIQ to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function.
  • The most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions.