TAKHZYRO 300 mg solution for injection
1. Name of the medicinal product
TAKHZYRO 300 mg solution for injection
2. Qualitative and quantitative composition
One vial contains 300 mg of lanadelumab* in 2 mL solution.
*Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
The solution is colourless to slightly yellow, appearing either clear or slightly opalescent.
The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
4.2 Posology and method of administration
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 section 4.4)
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 section 5.2).
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 section 5.2).
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 section 5.2).
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 vial is intended for single use only (see section 6.6).
The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms (see section 5.2). 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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
General
TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualiz |
