POTELIGEO Concentrate for solution for infusion Ref.[7600] Active ingredients: Mogamulizumab

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and should only be administered by healthcare professionals in an environment where resuscitation equipment is available.

Posology

The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes. Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.

POTELIGEO should be administered within 2 days of the scheduled day. If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days.

Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion. If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions.

Dose modification

Dermatologic reactions

Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious.

In the event of a rash (drug related) with severity of Grade 2 or 3 (moderate or severe), treatment with mogamulizumab must be interrupted and the rash should be treated appropriately until rash improves to Grade 1 or less (mild severity), at which time mogamulizumab treatment may be resumed.

POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) rash (see section 4.4).

Infusion-related reactions

The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated. The infusion rate should be reduced by at least 50% when re-starting the infusion after symptoms resolve. If reaction recurs, discontinuing the infusion should be considered (see section 4.4).

POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4).

Special populations

Paediatric population

The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established. No data are available.

Elderly

No dose adjustment is required in elderly patients (see section 5.2).

Renal impairment

Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild to severe renal impairment (see section 5.2).

Hepatic impairment

Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment. POTELIGEO has not been studied in patients with severe hepatic impairment (see section 5.2).

Method of administration

POTELIGEO is for intravenous use. It should be administered by intravenous infusion only, over at least 60 minutes. See above recommendations in case of infusion-related reaction.

For instructions on the dilution of the medicinal product before administration, see section 6.6.

There is no information on overdose with mogamulizumab. In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required.

Shelf life

Unopened vial: 3 years

After opening: POTELIGEO does not contain a preservative. Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).

After preparation of infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.

These time limits include storage of the infusion solution in the infusion bag through the duration of infusion. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 4 hours at 2°C-8°C provided that dilution has taken place under controlled and validated aseptic conditions.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

5 mL solution in a 10 mL glass vial (type I glass) with a rubber stopper, an aluminium seal and a polypropylene flip-off cap.

Pack of 1 vial.

Preparation:

• Visually inspect the medicinal product for particulate matter and discolouration prior to administration. POTELIGEO is a clear to slightly opalescent, colourless solution. Discard the vial if cloudiness, discolouration or particulates are observed.
• Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2). Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an infusion bag containing 9mg per ml (0.9%) sodium chloride solution for injection. Mix diluted solution by gentle inversion. Do not shake. The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
• Each vial is for single use only. Discard any unused portion left in the vial in accordance with local requirements.

Administration:

• The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
• Do not mix POTELIGEO with, or administer as an infusion with, other medicinal products.
• POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous 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.