Takhzyro Dosage/Direction for Use

This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE).
Posology: The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
TAKHZYRO is not intended for treatment of acute HAE attacks (see Precautions).
Missed doses: If a dose of TAKHZYRO is missed, the patient should be instructed to administer the dose as soon as possible ensuring at least 10 days between doses.
Special populations: Elderly: Age is not expected to affect exposure to lanadelumab. No dose adjustment is required for patients above 65 years of age (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No studies have been conducted in patients with hepatic impairment. Hepatic impairment is not expected to affect exposure to lanadelumab. No dose adjustment is required in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No studies have been conducted in patients with severe renal impairment. Renal impairment is not expected to affect exposure to lanadelumab or the safety profile. No dose adjustment is required in patients with renal impairment. (See Pharmacology: Pharmacokinetics under Actions.)
Paediatric population: The safety and efficacy of TAKHZYRO in children aged less than 12 years have not been established. No data are available.
Method of administration: TAKHZYRO is intended for subcutaneous (SC) administration only.
Each TAKHZYRO unit (pre-filled syringe) is intended for single use only (see Special precautions for disposal and other handling under Cautions for Usage).
The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms (see Pharmacology: Pharmacokinetics under Actions). Rotation of the injection site is recommended.
TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.