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MedsAcross

Molecule

Mogamulizumab

Antibodies
Available on requestBiologicOrphanCold chainOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Mogamulizumab is a chemokine receptor type 4 interaction indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. MedsAcross supplies Mogamulizumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Antibodies, Chemokine Receptor Type 4 Interaction, Monoclonal Antibody, Chemokine Receptor Type 4 Interactions
ATC classification
L01FX09 Mogamulizumab · Cancer medicines (antineoplastics), subgroup L01F, subgroup L01FX
US FDA first approval
8 August 2018
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII YI437801BERxCUI 2054068CAS 1159266-37-1DrugBank DB12498Q6890447

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

Source: US FDA prescribing information

How it works

Mogamulizumab-kpkc is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells. CCR4 is expressed on the surface of some T-cell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells.

Source: US FDA prescribing information

Dosing overview

1 mg/kg as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle.

Source: US FDA prescribing information

Warnings and precautions

Dermatologic Toxicity: Temporarily interrupt POTELIGEO for moderate or severe skin rashes. Permanently discontinue POTELIGEO for life-threatening rash. Infusion Reactions: Temporarily interrupt POTELIGEO for any infusion reaction. Permanently discontinue POTELIGEO for any life-threatening infusion reaction. Infections: Monitor and treat promptly. Autoimmune Complications: Interrupt or permanently discontinue POTELIGEO as appropriate. Complications of Allogeneic HSCT after POTELIGEO: Monitor for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD. Transplant-related mortality has occurred.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Dermatologic Toxicity. Infusion Reactions. Infections. Autoimmune Complications. Complications of Allogeneic HSCT after POTELIGEO. The most common adverse reactions (reported in ≥20% of patients) are rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.

Source: US FDA prescribing information

Storage

Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original package to protect from light until time of use. Do not freeze. Do not shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Mogamulizumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Poteligeo 20 mg/5 mL injectionIntravenous Cold chainKyowa KirinUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 8 August 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Mogamulizumab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Mogamulizumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Mogamulizumab have?

The catalogue lists 1 brand names for Mogamulizumab, including Poteligeo.

Is Mogamulizumab approved by the US FDA?

Yes. The US FDA first approved Mogamulizumab on 8 August 2018, according to Drugs@FDA.

Is Mogamulizumab authorised in the European Union?

Yes. Mogamulizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Mogamulizumab need cold chain shipping?

At least one listed presentation of Mogamulizumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Mogamulizumab in?

Mogamulizumab is classified under ATC code L01FX09 (Mogamulizumab).

References

  1. POTELIGEO prescribing information (Kyowa Kirin). U.S. National Library of Medicine, DailyMed. Retrieved 2 March 2026
  2. Poteligeo: European public assessment report (EPAR). European Medicines Agency. Retrieved 20 October 2026

Request Mogamulizumab for export supply

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