Active Ingredient: Peginterferon beta-1a
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Subcutaneous, 63 micrograms peginterferon beta-1a, one dose, over the duration of 14 days. Afterwards, subcutaneous, 94 micrograms peginterferon beta-1a, one dose, over the duration of 14 days. Afterwards, subcutaneous, 125 micrograms peginterferon beta-1a, once every 14 days.
Regimen B: Intramuscular, 63 micrograms peginterferon beta-1a, one dose, over the duration of 14 days. Afterwards, intramuscular, 94 micrograms peginterferon beta-1a, one dose, over the duration of 14 days. Afterwards, intramuscular, 125 micrograms peginterferon beta-1a, once every 14 days.
The recommended dose is 125 micrograms injected SC or IM every 2 weeks (14 days).
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).
An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).
Table 1a. Titration schedule at initiation via SC route:
| 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)
An administration dose pack contains the full 125 microgram dose in 1 pre-filled syringe.
The 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 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:
| Dose | Time* | Amount (micrograms) | Titration clip |
|---|---|---|---|
| Dose 1 | Day 0 | 63 | Yellow |
| Dose 2 | Day 14 | 94 | Purple |
| Dose 3 | Day 28 | 125 (full dose) | No clips needed |
* 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.
If a dose is missed, it should be administered as soon as possible.
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.
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