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STRENSIQ is a brand name for Asfotase Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Strensiq® (asfotase alfa) is indicated for: Enzyme replacement therapy for patients with confirmed diagnosis of pediatric-onset hypophopatasia (HPP) Treatment with Strensiq should be initiated by a physician with experience in the management of patients with metabolic bone disorders. 1.1 Pediatrics Pediatrics (0-18…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment The recommended dosage regimen of Strensiq is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered six times per week.
The maximum volume of subcutaneous injection is 1 mL per injection. 3 Reconstitution Strensiq is a ready to use, human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca- aspartate fusion protein for subcutaneous administration.
Therefore, Strensiq should not be reconstituted. 4 Administration Strensiq should not be administered intravenously or intramuscularly. Strensiq should be administered as subcutaneous injections. The maximum volume of medication per injection should not exceed 1 mL per single injection site.
If more than 1 mL is required, multiple injections may be administered at the same time at different injection sites. Draft_08APR2021 Alexion STRENSIQ® (asfotase alfa) Page 5 of 33 Injection sites should be rotated and carefully monitored for signs of potential reactions including lipodystrophy.
Strensiq should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
For administration of Strensiq, please read the following instructions carefully :
Each vial is for single use and should only be punctured once. Strensiq liquid should look clear to slightly yellow and may have a few small translucent or white particles in it. Do not use if the liquid is discoloured or contains any lumps or large particles in it and get a new vial.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
How to inject Strensiq:
Wash your hands thoroughly with soap and water. 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).
Upon removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum (see Section 11 Storage, Stability and Disposal). Remove the protective cap from the Strensiq vial. Withdraw the correct dose of Strensiq into the syringe.
5 years]). 35 patient years (PYs) of exposure in patients who received weekly doses ≥ 6 mg/kg (N=109/112 patients). Overall, the most common adverse reactions reported were injection site reactions (74%). The majority of injection site reactions resolved within a week.
One patient withdrew from the trial due to injection site hypersensitivity. 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. ] Tabulated list of adverse reactions Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% in clinical trials following subcutaneous injection of Strensiq.
Table 2:
Adverse Reactions Reported in at Least 1% of HPP Patients Enrolled in Strensiq Clinical Trials MedDRA System Organ Class Adverse Reaction Category or Term Frequency N=112 (n %) General disorders and administration site conditions Injection site Reactions (ISRs)a 83 (74%) Immune system disorders Hypersensitivity reactionsb 22 (20%) Renal and urinary disorders Nephrolithiasis 8 (7%) Metabolism and nutrition Hypocalcemia 8 (7%) Skin and Subcutaneous Tissue Disorders Skin discolouration 5 (4%) aPreferred terms considered as ISRs are presented in section below.
bPreferred terms considered as hypersensitivity reactions are presented in section below .
Description of selected adverse reactions Injection site reactions (ISRs):
3% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients. Craniosynostosis can lead to increased intracranial pressure. Periodic monitoring (including fundoscopy for signs of papilledema) and prompt intervention for increased intracranial pressure is recommended in patients with HPP below 5 years of age.
In asfotase alfa clinical studies, adverse events of craniosynostosis (associated with increase of intracranial pressure) including worsening of pre-existing craniosynostosis and occurrence of Arnold- Chiari malformation, have been reported in hypophosphatasia patients <5 years of age.
There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis. Ectopic Calcification Patients with HPP are at increased risk for developing ectopic calcifications. 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.
Events of ectopic calcification, including ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis, have been reported in the clinical trial experience with Strensiq. 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 resulting from the occurrence of ectopic calcifications. Hypersensitivity Hypersensitivity reactions have been reported in patients treated with Strensiq, including signs and symptoms consistent with anaphylaxis.
Symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness. The reactions have occurred within minutes after subcutaneous administration of Strensiq and can occur in patients on treatment for more than one year.
Strensiq is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Section 5 Dosage Forms, Strengths, Composition and Packaging.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The use of two different gauge needles is recommended, a larger bore needle for withdrawal of the medication, and a smaller bore needle for the injection. Strensiq is injected under the skin (subcutaneously) of your stomach-area (abdomen), upper arms, upper legs, or buttocks.
It is important to rotate Strensiq injection sites. Do not administer injections in areas that are reddened, inflamed or swollen. Determine the injection site then, using a 60-70% alcohol-based solution (isopropyl alcohol or ethanol) on a single use or cotton-wool ball, clean the site.
NOTE:
Do not use any areas in which you feel lumps, firm knots, or pain. Draft_08APR2021 Alexion STRENSIQ® (asfotase alfa) Page 6 of 33 Gently pinch the skin of the chosen injection area between your thumb and index finger. Subcutaneously administer the prescribed dose to the injection site.
Holding the syringe like a pencil or a dart, insert the needle into the raised skin so it is at an angle of between 45° and 90° to the skin surface. For patients who have little subcutaneous fat or thin skin, a 45° angle may be preferable.
While continuing to hold the skin, push the syringe plunger to inject the medication slowly and steadily all the way until you can no longer push down on the plunger. Remove the needle, release the skin fold and gently place a piece of cotton wool or gauze over the injection site for a few seconds.
This will help seal the punctured tissue and prevent any leakage. Do not rub the injection site after injection. Place bandage onto the injection site and properly dispose of the needle. 5 Missed Dose In case of a missed dose, resume the regular schedule as soon as possible.
2 Recommended Dose and Dose Adjustment). Draft_08APR2021 Alexion STRENSIQ® (asfotase alfa) Page 7 of 33
ISRs (including injection site atrophy, abscess, erythema, discoloration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, hematoma, inflammation, urticaria, calcification, warmth, hemorrhage, cellulitis, scar, mass, extravasation, exfoliation and vesicles) are the most common adverse reactions, observed in approximately 74% of the patients in the clinical studies.
Two patients experienced ISRs that led to reductions of their Strensiq dose. The frequency of ISRs was higher in patients with juvenile-onset HPP and in patients who received injections 6 times/week (compared to 3 times/week). Hypersensitivity Hypersensitivity reactions (including irritability, pyrexia, rash, pruritus, chills, erythema, nausea, vomiting, flushing, oral hypoesthesia, hypersensitivity, headache, tachycardia and cough) have been observed in approximately 22/112 (20%) of the patients in the clinical studies.
A few case reports of signs and symptoms associated with anaphylaxis were received where the patient experienced difficulty breathing, choking sensation, periorbital edema and/or dizziness. Draft_08APR2021 Alexion STRENSIQ® (asfotase alfa) Page 14 of 33 Immunogenicity No trends in adverse events based on antibody status were observed in clinical trials.
Some patients confirmed positive for antidrug antibodies experienced injection site reactions (ISRs) and/or hypersensitivity, however there was no consistent trend in the frequency of these reactions over time noted between ADA ever positive and ADA always negative patients.
Data from post-marketing cases suggests that the development of antibodies may affect clinical efficacy (see Section 7 Warnings & Precautions, subsection Immune). 1 Clinical Trial Adverse Reactions – Pediatrics Refer to Table 2 above.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Apart from the laboratory abnormalities included in Section 8 Adverse Reactions, there were no abnormal hematology or clinical chemistry values considered as adverse drug reactions following Strensiq administration.
5 Post-Market Adverse Reactions Cases from the post-approval setting suggest that development of inhibitory antibodies may be associated with a decreased clinical response.
Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, erythema, rash, pruritus, and oral hypoesthesia. If a severe hypersensitivity reaction occurs, discontinue Strensiq treatment and initiate appropriate medical treatment.
The current medical standards for emergency treatment should be observed. Consider the risks and benefits of re-administering Strensiq to individual patients following a severe reaction taking other factors into account that may contribute to the risk of a hypersensitivity reaction, such as concurrent infection and/ or use of antibiotics.
If the decision is made to re-administer the product, the re-challenge should be made under medical supervision and consideration may be given to use of appropriate pre-medication. Patients should be monitored for recurrence of signs and Draft_08APR2021 Alexion STRENSIQ® (asfotase alfa) Page 9 of 33 symptoms of a severe hypersensitivity reaction.
Severe or potentially life-threatening hypersensitivity is a contraindication to re-challenge, if hypersensitivity is not controllable. Infections and Infestations In asfotase alfa clinical studies, the majority of adverse events related to infections and infestations were respiratory infections including pneumonia, upper respiratory tract infection and nasopharyngitis.
They occurred primarily in patients in the infantile-onset HPP subgroup and were usually experienced by patients <2 years of age. These types of events were not unexpected, particularly in patients with more severe manifestations of HPP.
Injection Site Reactions Administration of Strensiq may result in local injection site reactions (ISRs), (including, but not limited to, erythema, rash, discolouration, pruritus, pain, papule, nodule, atrophy), defined as any related adverse event occurring during injection or until the end of the injection day.
These have been generally assessed as non-serious, mild to moderate in severity and self-limiting. In the clinical trial setting, the majority of patients who experienced an injection site reaction had the first occurrence within the first 12 weeks of treatment with asfotase alfa, and some patients continued to experience injection site reactions until 1 or more years after initiating asfotase alfa dosing.
Injection sites should be rotated among different body areas to minimize these reactions. Injection sites with unresolved reactions should not be used for injections again until the reaction subsides. Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered.
Lipodystrophy Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with Strensiq in clinical trials (see Section 8 Adverse Reactions). 4 Administration).
Serum Parathyroid Hormone and Calcium Serum parathyroid hormone concentration may increase in patients with HPP receiving Strensiq, most notably during the first 12 weeks of treatment. It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with Strensiq.
2 Clinical Trial Adverse Reactions). Treatment Discontinuation Possible Risk of Hypercalcemia upon Discontinuation of Strensiq Patients with HPP are known to experience hypercalcemia as well as seizures as a result of their underlying disease.
While serum calcium in patients with HPP who discontinue Strensiq has not been Draft_08APR2021 Alexion STRENSIQ® (asfotase alfa) Page 10 of 33 systemically studied, patients should be advised and monitored for the re-emergence of their HPP symptoms, including […]