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Safety
Information
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Strensiq® promoted substantial improvements in hypophosphatasia (HPP)-related rickets in patients with perinatal/infantile- and juvenile-onset hypophosphatasia.1

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  4. Skeletal Improvement
 

RGI-C scale

Hypophosphatasia-related rickets was assessed using the RGI-C scale.1,14

 
 

Radiographic Global Impression of Change (RGI-C) Scale1,14

 
 

 

RGI-C evaluates change in paired radiographs of the chest and bilateral wrists and knees1,14

Scores measure change from baseline at prespecified time points14

 
 
 

Radiographic examples

 
 
An example of substantial healing of hypophosphatasia-related rickets10,15,a

There were insufficient data to determine the effect of Strensiq on fractures in patients with perinatal/infantile- and juvenile-onset hypophosphatasia1

aHypophosphatasia-related rickets was assessed in patients with perinatal/infantile-onset hypophosphatasia in Studies 1, 2, and 3 using the RGI-C scale.1
bRadiographs are from a patient in Study 1.10
 
 
Example of a responder showing substantial healing of hypophosphatasia-related rickets10,15,a

aRadiographs are from a patient in Study 1.10
 
 
 

Results in juvenile-onset hypophosphatasia

100% (8/8) of patients with juvenile-onset hypophosphatasia treated with Strensiq® had substantial or complete healing of hypophosphatasia-related rickets.1,a

 
 

Patients with substantial or complete healing of hypophosphatasia-related rickets1,a

 
 
 
 
 
Example of a responder showing substantial healing of hypophosphatasia-related rickets10,15,a

aRadiographs are from a patient in Study 3.16
 

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.
                                                                                       
 

Additional information on trial design and endpoints

 
 
 

Information on growth improvement

 
 

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