PLEGRIDY Solution for injection Ref.[7696] Active ingredients: Peginterferon beta-1a

Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.

Plegridy may be administered subcutaneously (SC) using a single-use pre-filled pen or pre-filled syringe or intramuscularly (IM) using a single use pre-filled syringe.

Efficacy of peginterferon beta-1a administered subcutaneously has been demonstrated over placebo. Direct comparative data for peginterferon beta-1a versus non-pegylated interferon beta or data on efficacy of peginterferon beta-1a after switching from a non-pegylated interferon beta are not available. This should be considered when switching patients between pegylated and non-pegylated interferons (see section 5.1).

Posology

The recommended dose of Plegridy is 125 micrograms injected SC or IM every 2 weeks (14 days).

Treatment initiation

It is generally recommended that patients start SC or IM treatment with 63 micrograms at dose 1 (on day 0), increasing to 94 micrograms at dose 2 (on day 14), reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 2 weeks (14 days) thereafter (see Table 1a for SC use or Table 1b for IM use).

Subcutaneous route

An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).

Table 1a. Titration schedule at initiation via SC route:

^* Dosed every 2 weeks (14 days)

Intramuscular route

An administration dose pack contains the full 125 microgram dose in 1 pre-filled syringe.

The Plegridy titration clips, designed for use with the pre-filled syringe are intended to limit the dose that is administered to 63 micrograms (dose 1 (½ dose), yellow titration clip) and 94 micrograms (dose 2 (¾ dose), purple titration clip), for day 0 and day 14 respectively. Each Plegridy titration clip should be used once, and then discarded along with any remaining medicinal product. Patients should use the full dose of 125 micrograms (no clip required) from day 28 onwards (dosing every 14 days).

Table 1b. Titration schedule at initiation via IM route:

^* Dosed every 2 weeks (14 days)

Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of anti-inflammatory, analgesic and/or antipyretic treatments may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment (see section 4.8).

If a dose is missed, it should be administered as soon as possible.

• If 7 days or more to the next planned dose: Patients should administer their missed dose immediately. Treatment can then continue with the next scheduled dose as planned.
• If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. A patient should not administer two doses of peginterferon beta-1a within 7 days of each other.

Special populations

Elderly population

The safety and efficacy of peginterferon beta-1a in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.

Renal impairment

No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease (see sections 4.4 and 5.2).

Hepatic impairment

Peginterferon beta-1a has not been studied in patients with hepatic impairment (see section 4.4).

Paediatric population

The safety and efficacy of peginterferon beta-1a in children and adolescents aged 0 to 18 years have not been established in multiple sclerosis. No data are available.

Method of administration

It is recommended that a healthcare professional trains patients in the proper technique for self-administering SC injections using the SC pre-filled syringe/pre-filled pen or IM injections using the IM pre-filled syringes as appropriate. Patients should be advised to rotate sites for SC or IM injections every two weeks. The usual sites for subcutaneous injections include abdomen, arm, and thigh. The usual site for intramuscular injection is the thigh.

Each Plegridy pre-filled pen/syringe for SC is provided with the needle pre-attached. Plegridy prefilled syringe for IM use is supplied as a prefilled syringe with a separate needle for IM use.

Both IM and SC pre-filled syringes and SC pre-filled pens are for single use only and should be discarded after use.

Precautions to be taken before handling or administering the medicinal product

Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (up to 25°C) for about 30 minutes prior to injection. External heat sources such as hot water must not be used to warm the medicinal product.

Plegridy pre-filled syringe must not be used if the liquid is coloured, cloudy, or contains floating particles. The liquid in the syringe must be clear and colourless.

Plegridy pre-filled pen must not be used unless the green stripes are visible in the pen injection status window. Plegridy pre-filled pen must not be used if the liquid is coloured, cloudy, or contains floating particles. The liquid in the medicinal product window must be clear and colourless.

In case of over-dose, patients may be hospitalized for observation and appropriate supportive treatment should be given.

3 years.

Plegridy can be stored at room temperature (up to 25°C) for up to 30 days as long as it is stored away from light. If Plegridy is at room temperature for a total of 30 days, it should be used or discarded. If it is not clear if Plegridy has been stored at room temperature 30 days or more, it should be discarded.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

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

See section 6.3 for additional information on storage at room temperature.

Pre-filled syringe / pre-filled pen (subcutaneous)

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

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

Pack sizes

The Plegridy initiation pack contains 1x 63 micrograms pre-filled syringe (orange labelled syringe, 1^st dose) and 1x 94 micrograms pre-filled syringe (blue labelled syringe, 2^nd dose) in sealed plastic trays.

The Plegridy Pen initiation pack contains 1x 63 micrograms pre-filled pen (orange labelled pen, 1^st dose) and 1x 94 micrograms pre-filled pen (blue labelled pen, 2^nd dose) in a protective plastic tray.

Box of two or six 125 microgram pre-filled syringes (grey labelled syringes) in sealed plastic trays.

Box of two 125 microgram pre-filled pens (grey labelled pens) in a protective plastic tray.

Multipacks containing 6 (3 packs of 2) 125 microgram pre-filled pens (grey labelled pens). The pack contains 3 inner cartons. Each inner carton contains 2 pens in a protective plastic tray.

Not all pack sizes may be marketed.

Pre-filled syringe (intramuscular):

1 mL pre-filled Luer-Lok syringe made of glass (Type I) with a bromobutyl rubber stopper containing 0.5 mL of solution and supplied with a 23 gauge, 1.25 inch needle. A single pre-filled syringe contains 0.5 mL of solution of Plegridy containing 125 micrograms of peginterferon beta-1a.

Box of two or six 125 microgram pre-filled syringes in sealed plastic trays.

Not all pack sizes may be marketed.

Plegridy prefilled syringes (for IM and SC administration) and pen (for SC administration) are for single-use only.

Before use check the dosage form to be used. It should not have any cracks or damage and the solution should be clear, colourless and not have any particles in it.

Once removed from the refrigerator, the Plegridy pre-filled syringe or pen to be used should be allowed to warm to room temperature (15°C to 30°C) for about 30 minutes.

Do not use external heat sources such as hot water to warm the Plegridy pre-filled syringe or pen Titration of Plegridy doses for patients initiating treatment is described in section 4.2.

Pre-filled syringe / pre-filled pen (subcutaneous): Patients initiating treatment with Plegridy via SC administration should use initiation packs.

Pre-filled syringe (intramuscular): Patients initiating treatment with Plegridy via IM administration should use Plegridy Titration clips which may be attached to the syringe to limit the dose.

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