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

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Clinical trial results of Strensiq® treatment of patients with hypophosphatasia were demonstrated over both the short- and long-term.

Lab values

Mean alkaline phosphatase levels varied across populations studied in Strensiq clinical trials and increased typically well above the upper limit of normal.8

Survival

In patients with perinatal/infantile-onset hypophosphatasia, Strensiq improved survival and invasive ventilation-free survival at 1 year (week 48) vs historical controls.1,a

Skeletal

74% (50/68) of patients with perinatal/infantile-onset hypophosphatasia and 100% (8/8) of patients with juvenile-onset hypophosphatasia achieved substantial or complete healing of hypophosphatasia-related rickets at the mean time interval of 24 months and by month 54 of treatment, respectively.1,8,b

Growth

Strensiq gradually increased height and weight z scores over the course of treatment in patients with perinatal/infantile- and juvenile-onset hypophosphatasia.1,c

Movement

Strensiq improved mobility and gait in patients with juvenile-onset hypophosphatasia. 100% (6/6) of patients with juvenile-onset hypophosphatasia had percent-predicted 6MWT values within the normal range for age-, sex-, and height-matched peers at 48 months after starting treatment.1,d

aOverall and invasive ventilation-free survival were assessed in Studies 1 and 2.
bAs measured by a score of ≥2 on the RGI-C scale in Studies 1, 2, and 3.
cGrowth was assessed in Studies 1, 2, and 3 using height and weight z scores.
dMobility and gait assessments were conducted in Study 3 using 6MWT and MPOMA-G.

Indication

STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP)1

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.