STRENSIQ 28 mg/.7mL
ASFOTASE ALFA · SOLUTION · Alexion Pharmaceuticals, Inc.
STRENSIQ is a solution containing asfotase alfa at 28 mg/.7mL, taken subcutaneous. Manufactured by Alexion Pharmaceuticals, Inc..
Key Facts
- Brand Name
- STRENSIQ
- Generic Name
- ASFOTASE ALFA
- NDC Code (Product)
25682-013- Manufacturer
- Alexion Pharmaceuticals, Inc.
- Strength
- 28 mg/.7mL
- Dosage Form
- SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125513
- Drug Class
- Tissue-nonspecific Alkaline Phosphatase [EPC]
- Marketing Start
- 10/23/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Perinatal/Infantile-Onset HPP ( 2.2 ) Recommended dosage regimen is 2 mg/kg administered subcutaneously three times per week, or 1 mg/kg administered six times per week. Injection site reactions may limit the tolerability of the six times per week regimen. The dose may be increased to 3 mg/kg three times per week for insufficient efficacy. Juvenile-Onset HPP ( 2.3 ) Recommended dosage regimen is 2 mg/kg administered subcutaneously three times per week, or 1 mg/kg administered six times per week. Injection site reactions may limit the tolerability of the six times per week regimen. Preparation and Weight-Based Dosing ( 2.4 ): Caution: Do not use the 80 mg/0.8 mL vial in pediatric patients weighing less than 40 kg because the systemic asfotase alfa exposure achieved with the 80 mg/0.8 mL vial (higher concentration) is lower than that achieved with the other strength vials (lower concentration). A lower exposure may not be adequate for this subgroup of patients. See full prescribing information for tables of weight-based dosing by treatment regimen. Administration ( 2.5 ): For subcutaneous injection only. Rotate injection sites. Do not administer to areas t…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drug Interference with Laboratory Tests: Alkaline Phosphatase (ALP) is used as a detection reagent in many laboratory tests and the presence of asfotase alfa in clinical laboratory samples could result in erroneous test results. Inform laboratory personnel and discuss use of an alternative testing platform for patients on treatment. ( 7.1 ) Serum Alkaline Phosphatase : Serum ALP measurements are expected to be elevated during treatment and may be unreliable for clinical decision making. ( 7.1 ) 7.1 Drug Interference with Laboratory Tests Laboratory Tests Utilizing Alkaline Phosphatase as a Detection Reagent Studies have shown that there is analytical interference between asfotase alfa and laboratory tests that utilize an alkaline phosphatase (ALP)-conjugated test system, rendering erroneous test results in patients treated with STRENSIQ. ALP-conjugated test systems are utilized to measure substances such as hormones, bacterial antigens and antibodies. Therefore, it is recommended that laboratory assays which do not have ALP-conjugate technology be used when testing samples from patients who are receiving STRENSIQ. To avoid erroneous test results for patients tre…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Lipodystrophy [see Warnings and Precautions (5.2) ] Ectopic Calcifications [see Warnings and Precautions (5.3) ] Possible Immune-Mediated Clinical Effects [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 a…
Frequently Asked Questions
What is STRENSIQ used for?
STRENSIQ contains ASFOTASE ALFA. It is a solution taken subcutaneous. Consult your doctor for specific uses.
Is STRENSIQ a controlled substance?
STRENSIQ is not classified as a controlled substance by the DEA.
What is the generic name for STRENSIQ?
The generic name for STRENSIQ is ASFOTASE ALFA. There are no other listed brand versions of ASFOTASE ALFA.
What is the NDC code for STRENSIQ 28 mg/.7mL?
The NDC (National Drug Code) for STRENSIQ 28 mg/.7mL is 25682-013, listed by Alexion Pharmaceuticals, Inc..
Other STRENSIQ Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)