Drug Detail:Plegridy (Peginterferon beta-1a [ peg-in-ter-fear-on-bay-ta-- 1a ])
Generic Name: PEGINTERFERON BETA-1A 125ug in 0.5mL
Dosage Form: subcutaneous injection
Drug Class: Interferons
Dosing Information
PLEGRIDY may only be administered subcutaneously (SC) or intramuscularly (IM).
Recommended Maintenance Dosage
After initial titration (see Table 1 and Table 2), the recommended dosage of PLEGRIDY is 125 micrograms injected every 14 days.
Treatment Initiation
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 analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY.
Switching between the subcutaneous and intramuscular routes of administration and vice versa has not been studied. It is not expected that dose titration should be repeated to ameliorate flu-like symptoms if switching between subcutaneous and intramuscular routes of administration, or vice versa based upon bioequivalence demonstrated between the two routes of administration.
Subcutaneous Administration of PLEGRIDY
Patients using PLEGRIDY for the first time should start treatment with 63 micrograms on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 1). A PLEGRIDY Starter Pack is available containing two prefilled pens or syringes: 63 micrograms (dose 1) and 94 micrograms (dose 2).
| Dose | Timea | Amount (micrograms) | Color of Pen or Syringe Label |
|---|---|---|---|
|
a Dosed every 14 days |
|||
| Dose 1 | On day 1 | 63 | Orange |
| Dose 2 | On day 15 | 94 | Blue |
| Dose 3 | On day 29 and every 14 days thereafter | 125 (full dose) | Grey |
Intramuscular Administration of PLEGRIDY
For patients using PLEGRIDY injected intramuscularly for the first time, PLEGRIDY should be titrated using the PLEGRIDY Titration Kit designed for use with the prefilled syringe. The PLEGRIDY Titration Kit is supplied separately and contains two titration devices to be used only with PLEGRIDY prefilled syringes for intramuscular use.
Patients should start treatment with 63 micrograms (yellow clip) on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms (purple clip), reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 2).
| Dose | Timea | Amount (micrograms) | Titration Clip |
|---|---|---|---|
|
a Dosed every 14 days |
|||
| Dose 1 | On day 1 | 63 | Yellow |
| Dose 2 | On day 15 | 94 | Purple |
| Dose 3 | On day 29 and every 14 days thereafter | 125 (full dose) | No Clips Needed |
Important Administration Instructions (All Dosage Forms)
Healthcare professionals should train patients in the proper technique for self-administering subcutaneous injections using the prefilled pen or syringe or intramuscular injections using the prefilled syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Advise patients and caregivers to rotate injection sites with each administration to minimize the likelihood of severe injection site reactions, including necrosis or localized infection [see Warnings and Precautions (5.4)].
Once removed from the refrigerator, PLEGRIDY should be allowed to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm PLEGRIDY.
Each PLEGRIDY pen and syringe for subcutaneous injection is provided with the needle pre-attached. PLEGRIDY prefilled syringe for intramuscular injection is supplied as a prefilled syringe with a separate needle. Both intramuscular and subcutaneous prefilled syringes and subcutaneously administered prefilled pens are for one-time use in one patient only and should be discarded after use.
