Asfotase Alfa — Membership Pricing

Other medications in Metabolic

• Cerliponase Alfa
• Eliglustat
• Inotersen
• Miglustat
• Nitisinone
• Patisiran
• Sapropterin
• Tafamidis

About Asfotase Alfa

Asfotase alfa is a vital enzyme replacement therapy for individuals living with hypophosphatasia (HPP), a rare genetic disorder. This critical medication can dramatically improve quality of life, but its cost can be a significant barrier. TheDrugClub is dedicated to helping our members access essential treatments like asfotase alfa, potentially offering substantial savings on this high-value medication.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Asfotase Alfa is approved for (FDA label)

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 )

Source: Read the full FDA label on DailyMed. Label effective date: December 12, 2025.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Asfotase Alfa (FDA label)

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. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. ( 5.1 ) If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue STRENSIQ and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 )

Source: FDA prescribing information (DailyMed). Set ID: 3387574f-5eaa-4501-a71d-4cbfbd563031. SPL document ID: 404d99e5-991e-4353-bb9f-29dfa00a43b3. Label effective date: December 12, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Asfotase Alfa (FDA label)

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 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. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 3387574f-5eaa-4501-a71d-4cbfbd563031. SPL document ID: 404d99e5-991e-4353-bb9f-29dfa00a43b3. Label effective date: December 12, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Asfotase Alfa (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 3387574f-5eaa-4501-a71d-4cbfbd563031. SPL document ID: 404d99e5-991e-4353-bb9f-29dfa00a43b3. Label effective date: December 12, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Asfotase Alfa (FDA label)

None. None. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 3387574f-5eaa-4501-a71d-4cbfbd563031. SPL document ID: 404d99e5-991e-4353-bb9f-29dfa00a43b3. Label effective date: December 12, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Asfotase Alfa (FDA label)

Lipodystrophy: Localized reactions were reported after several months of treatment; follow proper injection technique and rotate injection sites. ( 5.2 ) Ectopic Calcifications (eye and kidneys): Monitor using ophthalmologic examinations and renal ultrasounds at baseline and periodically during treatment. ( 5.3 ) Possible Immune-Mediated Clinical Effects: Evaluate patients for antibody formation if clinically indicated. ( 5.4 ) 5.1 Hypersensitivity Reactions Including Anaphylaxis 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.

Source: FDA prescribing information (DailyMed). Set ID: 3387574f-5eaa-4501-a71d-4cbfbd563031. SPL document ID: 404d99e5-991e-4353-bb9f-29dfa00a43b3. Label effective date: December 12, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Asfotase Alfa (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 3387574f-5eaa-4501-a71d-4cbfbd563031. SPL document ID: 404d99e5-991e-4353-bb9f-29dfa00a43b3. Label effective date: December 12, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.