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

Adults and Adolescents 12 to less than 18 years of age

The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction to 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.

In patients with a body weight less than 40 kg, a starting dose of 150 mg lanadelumab every 2 weeks may also be considered. In patients who are stably attack free on treatment, a dose reduction to 150 mg lanadelumab every 4 weeks may be considered.

Children 2 to less than 12 years of age

The recommended dose of lanadelumab for children 2 to less than 12 years of age is based on body weight (see table below).

Patients with a body weight of 20 to less than 40 kg who are stably attack free may continue with the same dose when reaching 12 years of age.

Table 1. Recommended dose in children 2 to less than 12 years of age:

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 or caregiver should be instructed to administer the dose as soon as possible. The subsequent dosing schedule may need adjustment according to the intended dosing frequency to ensure:

• at least 10 days between doses for patients on every 2 weeks dosing regimen,
• at least 17 days between doses for patients on every 3 weeks dosing regimen,
• at least 24 days between doses for patients on every 4 weeks dosing regimen.

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 2 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 or 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.

For adults and adolescents (12 to less than 18 years of age), TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.

For children (2 to less than 12 years of age), TAKHZYRO should only be administered by a caregiver after training on subcutaneous 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.

TAKHZYRO 150 mg and 300 mg solution for injection in pre-filled syringe: 2 years.

TAKHZYRO 300 mg solution for injection in vial: 2 years.

The injection 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.

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.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Keep the solution (pre-filled syringe or vial) in the outer carton in order to protect from light.

The solution (pre-filled syringe or vial) 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.

When one pre-filled syringe from a multi-pack is removed from refrigeration, return the remaining pre-filled syringes to the refrigerator until future use when needed.

For storage conditions after first opening of the product in vial, see section 6.3.

TAKHZYRO 150 mg solution for injection in pre-filled syringe:

1 ml of solution in pre-filed syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.

TAKHZYRO 300 mg solution for injection in pre-filled syringe:

2 ml of solution in pre-filled syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.

TAKHZYRO 300 mg solution for injection in vial:

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.

Each pack also contains the following items:

• Empty 3 ml syringe
• 18G vial access needle
• 27G x 13 mm injection needle

Not all pack sizes may be marketed.

Lanadelumab is provided in single use pre-filled syringes and vials.

Before use, TAKHZYRO solution 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

TAKHZYRO 150 mg solution for injection in pre-filled syringe:

After removing the single use pre-filled syringe from the refrigerator, wait 15 minutes before injecting to allow the solution to reach room temperature. Caregiver should inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

TAKHZYRO 300 mg solution for injection in pre-filled syringe:

After removing the single use pre-filled syringe from the refrigerator, wait 15 minutes before injecting to allow the solution to reach room temperature. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

Each pre-filled syringe is for single use only. Discard the pre-filled syringe after injection is completed.

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.

TAKHZYRO 300 mg solution for injection in vial:

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 subcutaneous injection. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

Discard the vial with any unused contents.