ZINBRYTA Solution for injection Ref.[8979] Active ingredients: Daclizumab

Treatment should be initiated by a physician experienced in the management of multiple sclerosis.

Posology

The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month.

In case a dose is missed and it is within 2 weeks of the missed dose, patients should be instructed to inject without delay their missed dose and then remain on their original monthly dosing schedule.

If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule.

Only one dose should be administered at a time to make up for a missed dose.

Special populations

Elderly population

There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta. It has not been determined whether these patients respond differently compared with younger patients.

Renal impairment

Daclizumab beta has not been studied in patients with renal impairment. As renal excretion is not a major route of elimination, no dose adjustments are considered necessary (see section 5.2).

Hepatic impairment

Daclizumab beta has not been studied in patients with hepatic impairment. Zinbryta is contraindicated in patients with pre-existing hepatic impairment (see sections 4.3 and 4.4).

Paediatric population

The safety and efficacy of Zinbryta in children and adolescents below 18 years have not been established. No data are available.

Method of administration

Zinbryta is for subcutaneous use.

It is recommended that patients should be trained in the proper technique for self-administering subcutaneous injection using the pre-filled syringe/pre-filled pen. The usual sites for subcutaneous injection include the thigh, abdomen, and back of the upper arm.

Zinbryta is provided with the needle pre-attached. Pre-filled syringes/Pre-filled pens contain a single dose only and should be discarded after use.

Precautions to be taken before handling or administering the medicinal product

Once removed from the refrigerator, Zinbryta should be allowed to warm to room temperature (20°C-30°C) (about 30 minutes) prior to injection. External heat sources such as hot water must not be used to warm Zinbryta.

This medicinal product should not be used if:

• the syringe/pen is cracked or broken
• the solution is cloudy or you can see particles floating in it
• the solution is any other colour than colourless to slightly yellow
• the pen has been dropped or is visibly damaged.

Reported experience with overdose is limited. The safety of doses above 300 mg administered subcutaneously and 400 mg intravenously have not been evaluated. Doses up to this level were well tolerated with no evidence of acute toxicity. Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab beta in MS patients.

Management

In case of overdose, patients may require medical attention and appropriate supportive treatment should be given.

Shelf life: 3 years.

Zinbryta can be stored at room temperature (up to 30°C) in the original pack for 30 days.

Do not place Zinbryta back into the refrigerator after warming to room temperature.

If Zinbryta has been outside of the refrigerator for more than a total of 30 days or if you are not sure how long Zinbryta has been at room temperature, it should be discarded.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original package in order to protect from light.

For additional information on storage at room temperature, see section 6.3.

Pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield containing 1 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.

Pack sizes:

• Pack containing one 150 mg pre-filled syringe.
• 3 month multipack containing three 150 mg pre-filled syringes (3 boxes containing 1 syringe each).

A pre-filled syringe of Zinbryta is contained within a spring-powered pen injector called Zinbryta Pen. The syringe inside the pen is a pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield, containing 1 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.

Pack sizes:

• Pack containing one 150 mg pre-filled pen.
• 3 month multipack containing three 150 mg pre-filled pens (3 boxes containing 1 pen each).

Not all pack sizes may be marketed

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