When factoring dosing and administration into treatment choice for your patients, it’s good to have options. To help meet the needs of your patients, PLEGRIDY offers1:
Subcutaneous (SC) administration using the PLEGRIDY SC Pen or PLEGRIDY SC prefilled syringe
Intramuscular (IM) administration using the PLEGRIDY IM prefilled syringe
SC prefilled syringe arrives prefilled with 1 dose of PLEGRIDY in solution
29-gauge, 0.5-inch needle is preattached to the syringe
Injection sites are abdomen, back of upper arm, or thigh
An open-label, crossover study analyzed findings from 130 healthy volunteers to assess the bioequivalence of single doses of 125 mcg of PLEGRIDY administered as an SC and IM injection.
The primary endpoint of the study was the assessment of bioequivalence based on pharmacokinetics of PLEGRIDY administered subcutaneously and intramuscularly. The pharmacokinetics of 125 mcg single dose of PLEGRIDY administered subcutaneously and intramuscularly were similar.
IM prefilled syringe arrives prefilled with 1 dose of PLEGRIDY in solution
The tip of the cap of the PLEGRIDY IM prefilled syringe is made of natural rubber latex which may cause allergic reactions
23-gauge, 1.25-inch needle is included with the syringe but is not pre-attached
Injection site is the thigh; patients may alternate between left and right thigh
PLEGRIDY should be titrated at the start of treatment to help reduce flu-like symptoms that occur at the beginning of treatment.
The recommended full dose of PLEGRIDY is 125 mcg by SC or IM injection 1 time every 14 days.
PLEGRIDY is titrated at doses of 63 mcg (dose 1, day 1) and 94 mcg (dose 2, day 15) prior to receiving the full dose (125 mcg).
Switching between the SC and IM routes of administration and vice versa has not been studied. It is not expected that dose titration should be repeated based upon bioequivalence demonstrated between the 2 routes of administration.
A PLEGRIDY Starter Pack is available for PLEGRIDY SC Pen and PLEGRIDY SC prefilled syringe containing the first 3 doses. Starter Pack devices are color-coded to help the patient select the right dose.
PLEGRIDY SC Pen Starter Pack1,5
PLEGRIDY SC Prefilled Syringe Starter Pack1,6
The PLEGRIDY Titration Kit comes with 2 titration clips to help ensure the right dose is delivered the first 2 times patients use the IM prefilled syringe. The IM prefilled syringe snaps into the titration clip, which has a collar to ensure the right dose is delivered. The clips are color-coded to help the patient select the right clip for each of the first 2 injections. The yellow clip (for dose 1) allows a delivered dose of 63 mcg of PLEGRIDY, and the purple clip (for dose 2) allows a delivered dose of 94 mcg of PLEGRIDY. The PLEGRIDY Titration Kit does not include PLEGRIDY and is intended for use with the PLEGRIDY IM Prefilled Syringe Administration Pack.
PLEGRIDY IM Titration Kit
Titration clip collar
PLEGRIDY is for subcutaneous or intramuscular use only
Recommended dose for both routes of administration: 125 mcg every 14 days
PLEGRIDY dose should be titrated, starting with 63 mcg on day 1, 94 mcg on day 15, and 125 mcg (full dose) on day 29
For subcutaneous administration, the usual injection sites are the abdomen, back of the upper arm, and thigh
For intramuscular administration, alternate injections between the left and right thigh
Patients should be advised to rotate areas of injection with each dose to minimize the likelihood of injection site reactions
Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms
Store PLEGRIDY in the original carton to protect it from light
Keep PLEGRIDY in the refrigerator between 36°F to 46°F (2°C to 8°C)
After removing PLEGRIDY from the refrigerator, allow it to warm to room temperature for about 30 minutes. Do not use external heat sources, such as hot water, to warm PLEGRIDY
Do not freeze PLEGRIDY. Discard PLEGRIDY in an FDA-cleared sharps container if it freezes
If refrigeration is unavailable, such as during travel, PLEGRIDY may be stored at room temperature up to 25°C (77°F) for a period up to 30 days. PLEGRIDY can be removed from and returned to a refrigerator, if necessary