Usual Adult Dose for Mycosis Fungoides

1 mg/kg IV over at least 60 minutes 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

Comments:

• Administer premedication with diphenhydramine and acetaminophen for the first infusion.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dose Modifications for Dermatologic Toxicity:

• If mild (Grade 1) rash occurs, consider topical corticosteroids.
• If moderate or severe (Grade 2 or 3) rash occurs, interrupt therapy and administer at least 2 weeks of topical corticosteroids; if rash improves to Grade 1 or less, therapy may be resumed.
• Permanently discontinue therapy for life-threatening (Grade 4) rash or for Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If SJS or TEN is suspected, discontinue therapy, and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less.

• If an infusion reaction occurs, administer premedication (i.e., diphenhydramine and acetaminophen) for subsequent infusions.
• Temporarily interrupt the infusion for mild to severe (Grades 1 to 3) infusion

• Permanently discontinue therapy for a life-threatening (Grade 4) infusion reaction.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Premedicate patients with diphenhydramine and acetaminophen for the first infusion.
• Administer 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 subcutaneously or by rapid IV administration.
• Administer infusion solution over at least 60 minutes through an IV line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter.
• Do not mix this drug with other drugs.
• Do not coadminister other drugs through the same IV line.

• Store unused vials under refrigeration at 2C to 8C (36F to 46F) in original package to protect from light until time of use.
• Do not freeze.
• Do not shake.
• After preparation, infuse the solution immediately, or store under refrigeration at 2C to 8C (36F to 46F) for no more than 24 hours from the time of infusion preparation.

• Visually inspect drug product solution for particulate matter and discoloration prior to administration. The solution should be clear to slightly colorless opalescent. Discard the vial if cloudiness, discoloration, or particulates are observed.
• Calculate the dose (mg/kg) and number of vials needed to prepare the solution based on patient weight.
• Aseptically withdraw the required dose into the syringe and transfer into an IV bag containing 0.9% sodium chloride injection. The final concentration of the diluted solution should be between 0.1 mg/mL to 3 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.

• Compatible with 0.9% sodium chloride injection.

• Read the patient information leaflet.

Frequently asked questions

• What is Poteligeo used to treat?