se of POTELIGEO is 1 mg/kg administered as an intravenous infusionover at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then ondays 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptabletoxicity.
Administer POTELIGEO within 2 days of the scheduled dose. If a dose is missed, administer thenext dose as soon as possible and resume dosing schedule.
Do not administer POTELIGEO subcutaneously or by rapid intravenous administration.
Recommended Premedications
Administer premedication with diphenhydramine and acetaminophen for the first POTELIGEOinfusion.
2.2 Dose Modifications for Toxicity
Dermatologic Toxicity
Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any StevensJohnsonsyndrome (SJS) or toxic epidermal necrolysis (TEN) [see Warnings and Precautions(5.1)].
If SJS or TEN is suspected, stop POTELIGEO and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less.
If moderate or severe (Grades 2 or 3) rash occurs, interrupt POTELIGEO and administer at least 2 weeks of topical corticosteroids. If rash improves to Grade 1 or less, POTELIGEO maybe resumed [see Warnings and Precautions (5.1)].
If mild (Grade 1) rash occurs, consider topical corticosteroids.
Infusion Reactions
Permanently discontinue POTELIGEO for a life-threatening (Grade 4) infusion reaction [seeWarnings and Precautions (5.2)].
Temporarily interrupt the infusion of POTELIGEO for mild to severe (Grades 1 to 3) infusionreactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If reaction recurs and is unmanageable, discontinue infusion.[see Warnings and Precautions (5.2)].
If an infusion reaction occurs, administer premedication (such as diphenhydramine andacetaminophen) for subsequent POTELIGEO infusions.
2.3 Preparation and Administration
Preparation
Visually inspect drug product solution for particulate matter and discoloration prior toadministration. POTELIGEO is a clear to slightly opalescent colorless solution. Discard thevial if cloudiness, discoloration, or particulates are observed.
Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare theinfusion solution based on patient weight.
Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer intoan intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP. The finalconcentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Mix diluted solution by gentle inversion. Do not shake.
Discard any unused portion left in the vial.
The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion
bags.
Administration
Administer infusion solution over at least 60 minutes through an intravenous line containing asterile, low protein binding, 0.22 micron (or equivalent) in-line filter.
Do not mix POTELIGEO with other drugs.
Do not co-administer other drugs through the same intravenous line.
Storage of Diluted Solution
After preparation, infuse the POTELIGEO solution immediately, or store under refrigeration at
2°C to 8°C (36°F to 46°F) for no more than 4 hours from the time of infusion preparation.
Do not freeze. Do not shake.
3 DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/5 mL (4 mg/mL) as a clear to slightly opalescent colorless solution |
