Brand Name
Strensiq
Generic Name
Asfotase
View Brand Information FDA approval date: October 23, 2015
Classification: Tissue-nonspecific Alkaline Phosphatase
Form: Solution
What is Strensiq (Asfotase)?
STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia . STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia .
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Related Clinical Trials
A Prospective Observational Sub-Study of the Global Hypophosphatasia Registry to Describe the Potential Risk of Immune-Mediated Loss of Pharmacological Effect of Asfotase Alfa in Participants With Hypophosphatasia
Summary: In this prospective observational sub-study, participants with pediatric-onset hypophosphatasia (HPP) (perinatal/infantile- or juvenile-onset) of any age will be followed for a minimum of 5 years at sites in the United States and potentially 1 or 2 other countries.
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Brand Information
STRENSIQ (ASFOTASE ALFA)
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue STRENSIQ and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur
1INDICATIONS AND USAGE
STRENSIQ
2DOSAGE FORMS AND STRENGTHS
STRENSIQ is a 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-dose vials
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are described below and elsewhere in the labeling:
- Hypersensitivity Reactions
- Lipodystrophy
- Ectopic Calcifications
- Possible Immune-Mediated Clinical Effects
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to STRENSIQ in 99 patients with perinatal/infantile- or juvenile onset HPP (age 1 day to 58 years) treated with STRENSIQ, most for more than 2 years (range 1 day to 312 weeks [78 months]): 51 patients received at least 96 weeks (24 months) of treatment and 39 patients received 168 weeks (42 months) or more of treatment
4.2Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of the antibodies in the studies described below with the incidence of antibodies in other studies or to other asfotase alfa products may be misleading.
During clinical trials, anti-asfotase alfa antibodies have been detected in patients receiving treatment with STRENSIQ using an electrochemiluminescent (ECL) immunoassay. Antibody positive samples were tested to determine the presence of neutralizing antibodies based on in vitro inhibition of the catalytic activity of STRENSIQ.
Among STRENSIQ-treated patients with hypophosphatasia (HPP) in clinical studies who had post-baseline antibody data available, 97/109 (89%) tested positive for anti-asfotase alfa antibodies at some time point during STRENSIQ treatment. Among those 97 patients, 55 (57%) also tested positive for neutralizing antibodies at some time point during STRENSIQ treatment. No correlation was observed between the anti-asfotase alfa antibody titers and the neutralizing antibody (% inhibition) values. Formation of anti-asfotase alfa antibody resulted in a reduced systemic exposure of asfotase alfa
4.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of STRENSIQ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Some STRENSIQ-treated patients with initial therapeutic response to STRENSIQ subsequently developed worsening in disease-associated laboratory and radiographic biomarkers (some in association with neutralizing antibodies) suggesting possible immune-mediated effects on STRENSIQ's pharmacologic action resulting in disease progression
5DESCRIPTION
Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa 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 TNSALP, the human immunoglobulin G
STRENSIQ (asfotase alfa) injection 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-dose 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.
6HOW SUPPLIED/STORAGE AND HANDLING
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-dose vials in a carton of one (1) or twelve (12) vials at the following strengths:
7PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Advise patients or caregivers of the following:
8INSTRUCTIONS FOR USE STRENSIQ®[stren' sik] (asfotase alfa) injection, for subcutaneous use vial
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 treatment.
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
- 1 or 2 STRENSIQ vial(s).
- 1 or 2 sterile disposable 1 mL syringes for injection with 25 to 29 gauge (G), ½ inch needles.
- 2 alcohol wipes
- 1 gauze or cotton ball
- a clean flat surface, like a table
- 1 sharps container for throwing away used needles and syringes. See
Storing your STRENSIQ dose:
- Store STRENSIQ in the original carton in the refrigerator between 36°F to 46°F (2°C to 8°C) until you are ready to use it.
- Do not freeze your STRENSIQ vials. Do not use STRENSIQ if it has been frozen.
- Do not shake your STRENSIQ vials.
- Protect STRENSIQ from light until you are ready to use it.
- Do not use STRENSIQ after the expiration date printed on the carton.
- STRENSIQ vials are for 1 time use only. Throw away any unused STRENSIQ left in the vial.
Preparing your STRENSIQ dose and giving your STRENSIQ injection:
- Prepare a clean flat surface, like a table or counter top.
- Remove the unopened STRENSIQ vial(s) out of the refrigerator and allow it to sit at room temperature for at least 15 to 30 minutes. Injecting STRENSIQ when cold can make the injection feel uncomfortable.
- Gather all the supplies you will need to give your STRENSIQ injection.
- Wash your hands with soap and water.
- Utilize STRENSIQ within 3 hours after removing it from the refrigerator.
- Inject STRENSIQ exactly as your healthcare provider has shown you.
Disposing of used needles and syringes:
- Put your used needles in a FDA-cleared sharps disposal container right away after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
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.
Approved: 6/2020
© 2020 Alexion Pharmaceuticals, Inc.
Printed in USA
9PRINCIPAL DISPLAY PANEL - 18 mg/0.45 mL Vial Carton
NDC 25682-010-12
STRENSIQ
18 mg/0.45 mL
For Subcutaneous Use Only.
Single Use Only. Discard Unused Portion.
10PRINCIPAL DISPLAY PANEL - 28 mg/0.7 mL Vial Carton
NDC 25682-013-12
STRENSIQ
28 mg/0.7 mL
For Subcutaneous Use Only.
Single Use Only. Discard Unused Portion.
11PRINCIPAL DISPLAY PANEL - 40 mg/mL Vial Carton
NDC 25682-016-12
STRENSIQ
40 mg/mL
For Subcutaneous Use Only.
Single Use Only. Discard Unused Portion.
12PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Vial Carton
NDC 25682-019-12
STRENSIQ
80 mg/0.8 mL
For Subcutaneous Use Only.
For patients 40 kg and greater.
Single Use Only. Discard Unused Portion.
