Posology : מינונים

4.2   Posology and method of administration

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

Efficacy of Plegridy has been demonstrated over placebo. Direct comparative data for Plegridy versus non-pegylated interferon beta or data on efficacy of Plegridy after switching from a non- pegylated interferon beta are not available. This should be considered when switching patients between pegylated and non-pegylated interferons. Please refer also to section 5.1.

Posology

The recommended dose of Plegridy is 125 micrograms injected subcutaneously every 2 weeks (14 days).
Treatment initiation

It is generally recommended that patients start 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 1). An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).

Table 1: Titration schedule at initiation
Dose             Time*                    Amount (micrograms)              Syringe label Dose 1           Day 0                            63                         Orange Dose 2           Day 14                           94                           Blue Dose 3           Day 28                     125 (full dose)                    Grey *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 Plegridy within 7 days of each other.

Special populations

Elderly population
The safety and efficacy of Plegridy 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

Plegridy has not been studied in patients with hepatic impairment (see section 4.4).
Paediatric population

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

Method of administration

Plegridy is for subcutaneous use.
It is recommended that a healthcare professional trains patients in the proper technique for self-administering subcutaneous injections using the pre-filled pen or syringe. Patients should be advised to rotate sites for subcutaneous injections. The usual sites for subcutaneous injections include abdomen, arm, and thigh.

Pre-filled syringes/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 Plegridy.

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 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.