Takhzyro

TAKHZYRO^® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.

• Adult and pediatric patients 12 years of age and older: administer 300 mg every 2 weeks by the patient or caregiver. Dosing interval every 4 weeks may be considered in some patients. (
  2.1 Recommended Dosage for Adult and Pediatric Patients 12 Years of Age and Older

  The recommended starting dosage in adult and pediatric patients 12 years of age and older is 300 mg administered subcutaneously every 2 weeks (q2wks). A dosing interval of 300 mg every 4 weeks (q4wks) is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.
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• Pediatric patients 6 to less than 12 years of age: administer 150 mg every 2 weeks by a healthcare provider or caregiver. Dosing interval every 4 weeks may be considered in some patients. (
  2.2 Recommended Dosage for Pediatric Patients 2 to Less Than 12 Years of Age

  Pediatric Patients 6 to Less Than 12 Years of Age

  The recommended starting dosage in pediatric patients 6 to less than 12 years of age is 150 mg administered subcutaneously q2wks. A dosing interval of 150 mg q4wks may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

  Pediatric Patients 2 to Less Than 6 Years of Age

  The recommended dosage in pediatric patients 2 to less than 6 years of age is 150 mg administered subcutaneously q4wks.
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• Pediatric patients 2 to less than 6 years of age: administer 150 mg every 4 weeks by a healthcare provider or caregiver. (
  2.2 Recommended Dosage for Pediatric Patients 2 to Less Than 12 Years of Age

  Pediatric Patients 6 to Less Than 12 Years of Age

  The recommended starting dosage in pediatric patients 6 to less than 12 years of age is 150 mg administered subcutaneously q2wks. A dosing interval of 150 mg q4wks may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

  Pediatric Patients 2 to Less Than 6 Years of Age

  The recommended dosage in pediatric patients 2 to less than 6 years of age is 150 mg administered subcutaneously q4wks.
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• See Full Prescribing Information for Administration Instructions. (
  2.3 Preparation and Administration Instructions

  TAKHZYRO is administered subcutaneously only.

  TAKHZYRO is intended for administration by a healthcare provider, patient or caregiver.

  The patient or caregiver should be trained in subcutaneous injection technique by a healthcare professional.

  • Adult and pediatric patients 12 years of age and older: TAKHZYRO may be administered by the patient or caregiver.
  • Pediatric patients 2 to less than 12 years of age: TAKHZYRO should be administered by a healthcare provider or caregiver.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use TAKHZYRO if the solution appears discolored or contains visible particles. TAKHZYRO is a clear to slightly opalescent, colorless to slightly yellow solution.

  Administration Instructions for Single-Dose Prefilled Syringes

  Instruct patients and/or caregiver on proper use of the TAKHZYRO prefilled syringe and assess that they are well trained in subcutaneous injection technique prior to administration by patient and/or caregiver.

  Avoid vigorous agitation of the prefilled syringe.

  Take the TAKHZYRO prefilled syringe out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature.

  Using aseptic technique, inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm.

  Discard any unused portion of drug remaining in the prefilled syringe.

  For detailed instructions on the preparation and administration of TAKHZYRO see Instructions for Use for either single-dose 1 mL prefilled syringe or single-dose 2 mL prefilled syringe.

  Administration Instructions for Single-Dose Vial

  TAKHZYRO vial is provided as a ready-to-use solution that does not require additional reconstitution or dilution for administration.

  Instruct patients and/or caregivers on proper use of TAKHZYRO from a vial and assess that they are well trained in subcutaneous injection technique prior to administration by patient and/or caregiver.

  Avoid vigorous agitation of the vial.

  Take the TAKHZYRO vial out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature.

  Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial using an 18-gauge needle. Change the needle on the syringe to a 27-gauge, ½-inch needle or other needle suitable for subcutaneous injection. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm. In clinical studies, the majority of patients self-administered TAKHZYRO over 10 to 60 seconds.

  TAKHZYRO should be administered within 2 hours of preparing the dosing syringe. After the dosing syringe is prepared, it can be refrigerated at 36°F to 46°F (2°C to 8°C) and must be used within 8 hours.

  Discard any unused portions of drug remaining in the vial and dosing syringe.

  For detailed instructions on the preparation and administration of TAKHZYRO see single-dose vial Instructions for Use.
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TAKHZYRO is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution available in the following presentations.

• Injection: 150 mg/1 mL (150 mg/mL) solution in a single-dose prefilled syringe
• Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose prefilled syringe
• Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose vial

There are no available data on TAKHZYRO use in pregnant women to inform any drug associated risks. Monoclonal antibodies such as lanadelumab-flyo are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. An enhanced pre-and postnatal development (ePPND) study conducted in pregnant monkeys at doses resulting in exposures of up to 33 times the exposure achieved (on an AUC basis) at the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. 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.

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. (