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Poteligeo Injection Dosage

Generic name: mogamulizumab 4mg in 1mL
Dosage form: injection

Medically reviewed by Drugs.com. Last updated on Jul 12, 2019.

Recommended Dosage

The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.

Administer POTELIGEO within 2 days of the scheduled dose. If a dose is missed, administer the next 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 POTELIGEO infusion.

Dose Modifications for Toxicity

Dermatologic Toxicity

  • Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (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 may be 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 [see Warnings and Precautions (5.2)].
  • Temporarily interrupt the infusion of POTELIGEO for mild to severe (Grades 1 to 3) infusion reactions 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 and acetaminophen) for subsequent POTELIGEO infusions.

Preparation and Administration

Preparation

  • Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution. Discard the vial if cloudiness, discoloration, or particulates are observed.
  • Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight.
  • Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP. The final concentration 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 a sterile, 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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