Check Drug InteractionsCheck known drug interactions.
Check Drug InteractionsDosage & Administration
Perinatal/Infantile-Onset HPP (
The recommended dosage regimen of STRENSIQ for the treatment of perinatal/infantile-onset HPP is 6 mg/kg per week administered subcutaneously as either:
The dose of STRENSIQ may be increased for lack of efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings) up to 9 mg/kg per week administered subcutaneously as 3 mg/kg three times per week.
)
Juvenile-Onset HPP (
The recommended dosage regimen of STRENSIQ for the treatment of juvenile-onset HPP is 6 mg/kg per week administered subcutaneously as either:
)
Preparation and Weight-Based Dosing (
Caution:
Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg because the systemic exposure of asfotase alfa 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 Dosage Forms and Strengths (3), Clinical Pharmacology (12.3)]
.| Body Weight (kg)Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg [see Clinical Pharmacology (12.3)] . | Dose to Inject | Volume to Inject | Vial Configuration |
|---|---|---|---|
| 3 | 6 mg | 0.15 mL | 18 mg/0.45 mL |
| 4 | 8 mg | 0.2 mL | 18 mg/0.45 mL |
| 5 | 10 mg | 0.25 mL | 18 mg/0.45 mL |
| 6 | 12 mg | 0.3 mL | 18 mg/0.45 mL |
| 7 | 14 mg | 0.35 mL | 18 mg/0.45 mL |
| 8 | 16 mg | 0.4 mL | 18 mg/0.45 mL |
| 9 | 18 mg | 0.45 mL | 18 mg/0.45 mL |
| 10 | 20 mg | 0.5 mL | 28 mg/0.7 mL |
| 15 | 30 mg | 0.75 mL | 40 mg/1 mL |
| 20 | 40 mg | 1 mL | 40 mg/1 mL |
| 25 | 50 mg | 1.25 mL | Two 28 mg/0.7 mL vials |
| 30 | 60 mg | 1.5 mL | Two 40 mg/1 mL vials |
| 35 | 70 mg | 1.75 mL | Two 40 mg/1 mL vials |
| 40 | 80 mg | 0.8 mL | 80 mg/0.8 mL |
| 50 | 100 mg | 1 mL | Two 80 mg/0.8 mL vials |
| 60 | 120 mg | 1.2 mLWhen preparing a volume for injection greater than 1 mL, split the volume equally between two syringes, and administer two injections. When administering the two injections, use two separate injection sites. | Two 80 mg/0.8 mL vials |
| 70 | 140 mg | 1.4 mL | Two 80 mg/0.8 mL vials |
| 80 | 160 mg | 1.6 mL | Two 80 mg/0.8 mL vials |
| Body Weight (kg)Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg [see Clinical Pharmacology (12.3)] . | Dose to Inject | Volume to Inject | Vial Configuration |
|---|---|---|---|
| 3 | 3 mg | 0.08 mL | 18 mg/0.45 mL |
| 4 | 4 mg | 0.1 mL | 18 mg/0.45 mL |
| 5 | 5 mg | 0.13 mL | 18 mg/0.45 mL |
| 6 | 6 mg | 0.15 mL | 18 mg/0.45 mL |
| 7 | 7 mg | 0.18 mL | 18 mg/0.45 mL |
| 8 | 8 mg | 0.2 mL | 18 mg/0.45 mL |
| 9 | 9 mg | 0.23 mL | 18 mg/0.45 mL |
| 10 | 10 mg | 0.25 mL | 18 mg/0.45 mL |
| 15 | 15 mg | 0.38 mL | 18 mg/0.45 mL |
| 20 | 20 mg | 0.5 mL | 28 mg/0.7 mL |
| 25 | 25 mg | 0.63 mL | 28 mg/0.7 mL |
| 30 | 30 mg | 0.75 mL | 40 mg/1 mL |
| 35 | 35 mg | 0.88 mL | 40 mg/1 mL |
| 40 | 40 mg | 1 mL | 40 mg/1 mL |
| 50 | 50 mg | 0.5 mL | 80 mg/0.8 mL |
| 60 | 60 mg | 0.6 mL | 80 mg/0.8 mL |
| 70 | 70 mg | 0.7 mL | 80 mg/0.8 mL |
| 80 | 80 mg | 0.8 mL | 80 mg/0.8 mL |
| 90 | 90 mg | 0.9 mL | Two 80 mg/0.8 mL vials |
| 100 | 100 mg | 1 mL | Two 80 mg/0.8 mL vials |
| Body Weight (kg)Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg [see Clinical Pharmacology (12.3)] . | Dose to Inject | Volume to Inject | Vial Configuration |
|---|---|---|---|
| 3 | 9 mg | 0.23 mL | 18 mg/0.45 mL |
| 4 | 12 mg | 0.3 mL | 18 mg/0.45 mL |
| 5 | 15 mg | 0.38 mL | 18 mg/0.45 mL |
| 6 | 18 mg | 0.45 mL | 18 mg/0.45 mL |
| 7 | 21 mg | 0.53 mL | 28 mg/0.7 mL |
| 8 | 24 mg | 0.6 mL | 28 mg/0.7 mL |
| 9 | 27 mg | 0.68 mL | 28 mg/0.7 mL |
| 10 | 30 mg | 0.75 mL | 40 mg/1 mL |
| 15 | 45 mg | 1.13 mLWhen preparing a volume for injection greater than 1 mL, split the volume equally between two syringes, and administer two injections. When administering the two injections, use two separate injection sites. | Two 28 mg/0.7 mL vials |
| 20 | 60 mg | 1.5 mL | Two 40 mg/1 mL vials |
| 25 | 75 mg | 1.88 mL | Two 40 mg/1 mL vials |
):
Administration (
STRENSIQ is for subcutaneous injection only.
):
PrescriberAI is currently offline. Try again later.
By using PrescriberAI, you agree to the AI Terms of Use.
This AI tool offers medical information for informational purposes only and is not a substitute for professional medical judgment or advice.
Physicians and healthcare professionals should exercise their expertise and discretion when interpreting and applying the provided information to specific clinical situations.
Strensiq Prescribing Information
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
[see ]
.Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including STRENSIQ. 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 have been observed more than 1 year after treatment initiation. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, erythema, rash, pruritus and oral hypoesthesia
[see Adverse Reactions (6.1)]
.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. 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. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.
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 [see Warnings and Precautions (5.1)] .WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning.
| 7/2024 |
Dosage and Administration (Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures [see Warnings and Precautions (5.1)]. | 7/2024 |
Warnings and Precautions (Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including STRENSIQ. 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 have been observed more than 1 year after treatment initiation. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, erythema, rash, pruritus and oral hypoesthesia [see Adverse Reactions (6.1)] .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. 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. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur. | 7/2024 |
STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
Perinatal/Infantile-Onset HPP (
The recommended dosage regimen of STRENSIQ for the treatment of perinatal/infantile-onset HPP is 6 mg/kg per week administered subcutaneously as either:
- 2 mg/kg three times per week, or
- 1 mg/kg six times per week. Injection site reactions may limit the tolerability of the six times per week regimen[see Adverse Reactions (6.1)].
The dose of STRENSIQ may be increased for lack of efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings) up to 9 mg/kg per week administered subcutaneously as 3 mg/kg three times per week.
)
- 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 (
The recommended dosage regimen of STRENSIQ for the treatment of juvenile-onset HPP is 6 mg/kg per week administered subcutaneously as either:
- 2 mg/kg three times per week, or
- 1 mg/kg six times per week. Injection site reactions may limit the tolerability of the six times per week regimen[see Adverse Reactions (6.1)].
)
- 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 (
Caution:
Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg because the systemic exposure of asfotase alfa 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 Dosage Forms and Strengths (3), Clinical Pharmacology (12.3)]
.1.000000000000000e+00 Determine the total weekly volume needed for the prescribed dosage based on the patient's weight and recommended dosage. Follow these steps to determine the patient dose.Total weekly dose (mg) = patient's weight (kg) × prescribed dose (mg/kg/week) Total injection volume (mL) per week = Total dose (mg/week) divided by the STRENSIQ concentration (40 mg/mL or 100 mg/mL). Note product concentrations are: 40 mg/mL (vial strengths 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL) or 100 mg/mL (vial strength 80 mg/0.8 mL). Round total injection volume to the nearest hundredth of a mL Total number of vials per week = Total injection volume divided by vial volume (mL)
2.000000000000000e+00 Determine the number of injection days per week (three or six per week).3.000000000000000e+00 Determine dose per injection day. Patient weights should be rounded to the nearest kilogram when determining dose. Use the following tables for guidance, for patients administering 2 mg/kg three times per week (Table 1), 1 mg/kg six times per week (Table 2) and for dose escalations to 3 mg/kg three times per week, recommended only for patients with perinatal/infantile-onset HPP[see Dosage and Administration (2.2)](Table 3).
| Body Weight (kg)Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg [see Clinical Pharmacology (12.3)] . | Dose to Inject | Volume to Inject | Vial Configuration |
|---|---|---|---|
| 3 | 6 mg | 0.15 mL | 18 mg/0.45 mL |
| 4 | 8 mg | 0.2 mL | 18 mg/0.45 mL |
| 5 | 10 mg | 0.25 mL | 18 mg/0.45 mL |
| 6 | 12 mg | 0.3 mL | 18 mg/0.45 mL |
| 7 | 14 mg | 0.35 mL | 18 mg/0.45 mL |
| 8 | 16 mg | 0.4 mL | 18 mg/0.45 mL |
| 9 | 18 mg | 0.45 mL | 18 mg/0.45 mL |
| 10 | 20 mg | 0.5 mL | 28 mg/0.7 mL |
| 15 | 30 mg | 0.75 mL | 40 mg/1 mL |
| 20 | 40 mg | 1 mL | 40 mg/1 mL |
| 25 | 50 mg | 1.25 mL | Two 28 mg/0.7 mL vials |
| 30 | 60 mg | 1.5 mL | Two 40 mg/1 mL vials |
| 35 | 70 mg | 1.75 mL | Two 40 mg/1 mL vials |
| 40 | 80 mg | 0.8 mL | 80 mg/0.8 mL |
| 50 | 100 mg | 1 mL | Two 80 mg/0.8 mL vials |
| 60 | 120 mg | 1.2 mLWhen preparing a volume for injection greater than 1 mL, split the volume equally between two syringes, and administer two injections. When administering the two injections, use two separate injection sites. | Two 80 mg/0.8 mL vials |
| 70 | 140 mg | 1.4 mL | Two 80 mg/0.8 mL vials |
| 80 | 160 mg | 1.6 mL | Two 80 mg/0.8 mL vials |
| Body Weight (kg)Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg [see Clinical Pharmacology (12.3)] . | Dose to Inject | Volume to Inject | Vial Configuration |
|---|---|---|---|
| 3 | 3 mg | 0.08 mL | 18 mg/0.45 mL |
| 4 | 4 mg | 0.1 mL | 18 mg/0.45 mL |
| 5 | 5 mg | 0.13 mL | 18 mg/0.45 mL |
| 6 | 6 mg | 0.15 mL | 18 mg/0.45 mL |
| 7 | 7 mg | 0.18 mL | 18 mg/0.45 mL |
| 8 | 8 mg | 0.2 mL | 18 mg/0.45 mL |
| 9 | 9 mg | 0.23 mL | 18 mg/0.45 mL |
| 10 | 10 mg | 0.25 mL | 18 mg/0.45 mL |
| 15 | 15 mg | 0.38 mL | 18 mg/0.45 mL |
| 20 | 20 mg | 0.5 mL | 28 mg/0.7 mL |
| 25 | 25 mg | 0.63 mL | 28 mg/0.7 mL |
| 30 | 30 mg | 0.75 mL | 40 mg/1 mL |
| 35 | 35 mg | 0.88 mL | 40 mg/1 mL |
| 40 | 40 mg | 1 mL | 40 mg/1 mL |
| 50 | 50 mg | 0.5 mL | 80 mg/0.8 mL |
| 60 | 60 mg | 0.6 mL | 80 mg/0.8 mL |
| 70 | 70 mg | 0.7 mL | 80 mg/0.8 mL |
| 80 | 80 mg | 0.8 mL | 80 mg/0.8 mL |
| 90 | 90 mg | 0.9 mL | Two 80 mg/0.8 mL vials |
| 100 | 100 mg | 1 mL | Two 80 mg/0.8 mL vials |
| Body Weight (kg)Do not use the 80 mg/0.8 mL vial of STRENSIQ in pediatric patients weighing less than 40 kg [see Clinical Pharmacology (12.3)] . | Dose to Inject | Volume to Inject | Vial Configuration |
|---|---|---|---|
| 3 | 9 mg | 0.23 mL | 18 mg/0.45 mL |
| 4 | 12 mg | 0.3 mL | 18 mg/0.45 mL |
| 5 | 15 mg | 0.38 mL | 18 mg/0.45 mL |
| 6 | 18 mg | 0.45 mL | 18 mg/0.45 mL |
| 7 | 21 mg | 0.53 mL | 28 mg/0.7 mL |
| 8 | 24 mg | 0.6 mL | 28 mg/0.7 mL |
| 9 | 27 mg | 0.68 mL | 28 mg/0.7 mL |
| 10 | 30 mg | 0.75 mL | 40 mg/1 mL |
| 15 | 45 mg | 1.13 mLWhen preparing a volume for injection greater than 1 mL, split the volume equally between two syringes, and administer two injections. When administering the two injections, use two separate injection sites. | Two 28 mg/0.7 mL vials |
| 20 | 60 mg | 1.5 mL | Two 40 mg/1 mL vials |
| 25 | 75 mg | 1.88 mL | Two 40 mg/1 mL vials |
4.000000000000000e+00 Take the unopened STRENSIQ vial(s) out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.
Do not warm STRENSIQ in any other way (for example, do not warm it in a microwave or in hot water).5.000000000000000e+00 Inspect the solution in the vial(s) for particulate matter and discoloration. STRENSIQ is supplied as a clear, slightly opalescent or opalescent, colorless to slightly yellow aqueous solution; a few small translucent or white particles may be present. Discard any vial(s) not consistent with this appearance.6.000000000000000e+00 Assemble injection supplies. Administer STRENSIQ using sterile disposable 1 mL syringes and ½ inch injection needles, between 25 to 29 gauge are recommended. The use of two different gauge needles is recommended, a larger bore needle (e.g. 25 gauge) for withdrawal of the medication, and a smaller bore needle (e.g. 29 gauge) for the injection. For doses greater than 1 mL, the injection volume should be split equally between two 1 mL syringes. Always use a new syringe and needle for each injection.7.000000000000000e+00 Remove vial cap, aseptically prepare the vial and insert the syringe into the vial to withdraw the prescribed dose for administration. Do not shake.8.000000000000000e+00 Remove any air bubbles in the syringe and verify the correct dose.9.000000000000000e+00 STRENSIQ vials are for one time use only. Discard any unused product.
):
- 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 (
STRENSIQ is for subcutaneous injection only.
- When administering two injections, use two separate injection sites.
- Administer STRENSIQ within 3 hours upon removal of the vial(s) from refrigeration.
- Rotate the injection from among the following sites to reduce the risk of lipodystrophy: abdominal area, thigh, deltoid, or buttocks[see Warnings and Precautions (5.2), Adverse Reactions (6.1)].
- Do NOT administer injections in areas that are reddened, inflamed, or swollen.
- Inject STRENSIQ subcutaneously into the determined site and properly dispose of the syringe and the needle.
):
- For subcutaneous injection only.
- Rotate injection sites. Do not administer to areas that are reddened, inflamed or swollen.
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
Risk Summary
There are no available data on STRENSIQ use in pregnant women to inform a drug associated risk. In animal reproduction studies, asfotase alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose
(see )
.Data
Animal Data
Asfotase alfa administered during the period of organogenesis to rats (from gestation Day 6 to Day 19 post-partum) and rabbits (on gestation days 7 to 19) at intravenous doses up to 50 mg/kg/day, approximately 21 and 24 times the human AUC of 65486 ng.h/mL at 2 mg/kg dose administered three times weekly for a 50 kg individual, respectively did not cause any adverse effects on embryofetal development. A pre- and post-natal development study in pregnant rats showed no evidence of adverse effects on pre- and post-natal development at intravenous doses (from Day 6 of gestation to Day 19 postpartum) of asfotase alfa up to 50 mg/kg/day approximately 21 times the human AUC of 65486 ng.h/mL at 2 mg/kg dose administered three times weekly for a 50 kg individual.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available