HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed
to use POTELIGEO safely and effectively. See fullprescribing information for POTELIGEO.
POTELIGEO®(mogamulizumab-kpkc)injection, forintravenous 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 ofadult patients with relapsed or refractory mycosis fungoides orSézary syndrome after at least one prior systemic therapy [1].
DOSAGE AND ADMINISTRATION
1 mg/kg as an intravenous infusion over at least 60 minutes ondays 1, 8, 15, and 22 of the first 28-day cycle and on days 1and 15 of each subsequent cycle [2].
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dosevial [3].
CONTRAINDICATIONS
None [4].
WARNINGS AND PRECAUTIONS
Dermatologic Toxicity: Temporarily interruptPOTELIGEO for moderate or severe skin rashes.
Permanently discontinue POTELIGEO for life-threateningrash [5.1].
Infusion Reactions: Temporarily interrupt POTELIGEOfor any infusion reaction. Permanently discontinuePOTELIGEO for any life-threatening infusion reaction[5.2].
Infections: Monitor and treat promptly [5.3].
Autoimmune Complications: Interrupt or permanentlydiscontinue 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-relatedmortality has occurred. [5.5].
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥20% ofpatients) were rash, infusion related reactions, fatigue,diarrhea, musculoskeletal pain, and upper respiratory tractinfection [6.1].
To report SUSPECTED ADVERSE REACTIONS, contactKyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATIONand FDA- approved patient labeling.
Revised: 08/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Dose Modification for Toxicity
2.3 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Dermatologic Toxicity
5.2 Infusion Reactions
5.3 Infections
5.4 Autoimmune Complications
5.5 Complications of Allogeneic HSCT after
POTELIGEO
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Postmarketing Safety Information
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.2Pharmacodynamics
12.3Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing
information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGEPOTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosisfungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended do |
