POTELIGEO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/5ML [SIN17252P]

Product Info

POTELIGEO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/5ML

[SIN17252P]

Indication

4.1. Therapeutic indications

POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

Dosing

4.2. Posology and method of administration

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Paediatric population

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

Elderly

No dose adjustment is required in elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3. Contraindication

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.