TAKHZYRO Solution for injection Ref.[7637] Active ingredients: Lanadelumab

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.

No case of overdose has been reported. There is no available information to identify potential signs and symptoms of overdose. If symptoms should occur, symptomatic treatment is recommended. There is no antidote available.

Shelf life: 30 months.

Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C and for 8 hours at 2°C to 8°C. From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. TAKHZYRO should be administered within 2 hours of preparing the dosing syringe. If not administered immediately after preparation, the syringe may be stored in the refrigerator (2°C to 8°C), protected from light and administered within 8 hours.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Keep vial in the outer carton in order to protect from light.

Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date. Do not return TAKHZYRO to refrigerated storage after storage at room temperature.

2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap.

TAKHZYRO is available as a single pack containing one 2 ml vial and in multipacks comprising 2 or 6 cartons, each carton containing 1 vial.

Not all pack sizes may be marketed.

Each pack also contains the following items:

• Empty 3 ml syringe
• 18G vial access needle
• 27G x 1⁄2 inch (0.4 × 13 mm) injection needle

Lanadelumab is provided in single use vials.

Before use, each vial should be visually inspected for appearance. The solution should be clear or slightly yellow. Solutions that are discoloured or contain particles should not be used.

Avoid vigorous agitation.

Administration steps

Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.

Change the needle on the syringe to a 27 gauge needle or other needle suitable for SC injection. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

Discard the vial with any unused contents.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

All needles and syringes should be disposed of in a sharps container.