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

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Strensiq® improved growth in patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP) vs untreated historical controls.1

Perinatal/infantile-onset hypophosphatasia

On average, height and weight as measured by z scores improved over time in patients with perinatal/infantile-onset hypophosphatasia treated with Strensiq®.1

Heighta,b,c

Weighta,b,c

aGrowth was assessed in patients with perinatal/infantile-onset hypophosphatasia in Studies 1, 2, and 3 using change in height and weight z scores.1
bPatients enrolled in Studies 1 and 2 ranged from 1 day to 6.5 years of age.1
cPatients enrolled in Study 3 ranged from 6 to 12 years of age.1
dThe mean time interval between baseline and last assessment was 21 months (range, 1 to 72 months).1
eThe mean time interval between baseline and last assessment was 56 months (range, 53 to 60 months).1

Juvenile-onset hypophosphatasia

On average, height and weight as measured by z scores improved over time in patients with juvenile-onset hypophosphatasia treated with Strensiq®.1

Heightf

Weightf

fGrowth was assessed in patients 6 to 12 years of age with juvenile-onset hypophosphatasia in Study 3 using change in height and weight z scores and was compared with a cohort of untreated historical controls.1
gThe mean time interval between baseline and last assessment was 55 months (range, 53 to 60 months).1
hThe mean time interval between baseline and last assessment was 61 months (range, 19 to 109 months).1

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.