Drug Detail:Takhzyro (Lanadelumab-flyo [ lan-a-del-ue-mab ])
Generic Name: lanadelumab 300mg in 2mL
Dosage Form: injection, solution
Drug Class: Hereditary angioedema agents
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.
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.
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.
