POTELIGEO- mogamulizumab-kpkc injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

mogamulizumab (UNII: YI437801BE) (mogamulizumab - UNII:YI437801BE)

Available from:

Kyowa Kirin, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None. Risk Summary There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC (see Data ). In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. The es

Product summary:

POTELIGEO (mogamulizumab-kpkc) injection is a sterile, preservative-free, clear to slightly opalescent colorless solution supplied in a carton containing one 20 mg/5 mL (4 mg/mL), single-dose glass vial (NDC 42747-761-01). 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

POTELIGEO- MOGAMULIZUMAB-KPKC INJECTION
KYOWA KIRIN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTELIGEO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR POTELIGEO.
POTELIGEO (MOGAMULIZUMAB-KPKC) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
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 (1).
DOSAGE AND ADMINISTRATION
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 (2).
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Dermatologic Toxicity: Temporarily interrupt POTELIGEO for moderate or
severe skin rashes.
Permanently discontinue POTELIGEO for life-threatening rash (5.1).
Infusion Reactions: Temporarily interrupt POTELIGEO for any infusion
reaction. Permanently discontinue
POTELIGEO for any life-threatening infusion reaction (5.2).
Infections: Monitor and treat promptly (5.3).
Autoimmune Complications: Interrupt or permanently discontinue
POTELIGEO as appropriate (5.4).
Complications of Allogeneic HSCT after POTELIGEO: Monitor for severe
acute graft-versus-host disease
(GVHD) and steroid-refractory GVHD. Transplant-related mortality has
occurred (5.5).
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥20% of patients) are
rash, infusion related reactions,
fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract
infection (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT KYOWA KIRIN, INC. AT
1-844-768-3544 OR
FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2023
FULL PRESCRIBING INFO