Mycosis fungoides (MF)

Active Ingredient: Mogamulizumab

Indication for Mogamulizumab

Population group: only adults (18 - 65 years old)

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

For this indication, competent medicine agencies globally authorize below treatments:

1 mg/kg once every 7 days

Route of admnistration

Intravenous

Defined daily dose

1 - 1 mg per kg of body weight

Dosage regimen

From 1 To 1 mg per kg of body weight once every 7 day(s)

Detailed description

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.

Mogamulizumab 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 mogamulizumab infusion. If an infusion reaction occurs, administer pre-medication for subsequent mogamulizumab 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.

Mogamulizumab should be permanently discontinued for a life-threatening (Grade 4) rash.

Infusion-related reactions

The infusion of mogamulizumab 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.

Mogamulizumab should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction.

Dosage considerations

It should be administered by intravenous infusion only, over at least 60 minutes.

Active ingredient

Mogamulizumab

Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells.

Read more about Mogamulizumab

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