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ANDEMBRY®

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Product Information

Indications: ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients 12 years and older.

Contraindications: None

Dosing:

  • Recommended Dosage: Initial loading dose of 400 mg (two 200 mg injections) administered subcutaneously followed by maintenance dose of 200 mg once monthly.
  • Subcutaneous use.
  • Patients may self-administer.

Administration: Subcutaneous use.

ANDEMBRY is intended for self-administration or administration by a caregiver. The patient or caregiver should be trained and assessed in subcutaneous (SC) injection technique by a healthcare professional prior to administration of ANDEMBRY by patient and/or caregiver.

ANDEMBRY injection is provided as a single-dose prefilled autoinjector or single-dose prefilled syringe with needle safety device.

ANDEMBRY should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ANDEMBRY is a slightly opalescent to clear, brownish-yellow to yellow solution.

Prior to administration, remove ANDEMBRY from the refrigerator and allow to sit for 30 minutes at room temperature before use.

Using aseptic technique, inject ANDEMBRY subcutaneously into the upper arm, thigh or belly (abdomen) ensuring to stay 1 inch (2 cm) away from the belly button.

Discard the used ANDEMBRY into a sharps disposal container (closed puncture-resistant container).

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