lete response; NE=not estimable; PR=partial response
16 HOW SUPPLIED/STORAGE AND HANDLING
POTELIGEO (mogamulizumab-kpkc) injection is a sterile, preservative-free, clear to slightlyopalescent colorless solution supplied in a carton containing one 20 mg/5 mL (4 mg/mL), singledoseglass 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 fromlight until time of use. Do not freeze. Do not shake.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the risk of the following adverse reactions that may require additionaltreatment and/or withholding or discontinuation of POTELIGEO including:
Dermatological Toxicity: Advise patients to contact their healthcare provider immediately fornew or worsening skin rash [see Warnings and Precautions (5.1)]. Advise patients that therash can happen at any time while receiving POTELIGEO.
Infusion Reactions: Advise patients to contact their healthcare provider immediately for signsor symptoms of infusion reactions [see Warnings and Precautions (5.2)].
Infections: Advise patients to contact their health care provider for fever or other evidence ofinfection [see Warnings and Precautions (5.3)].
Autoimmune Complications: Advise patients to notify their healthcare provider of any historyof autoimmune disease [see Warnings and Precautions (5.4)].
Complications of Allogeneic HSCT after POTELIGEO: Advise patients of potential risk ofpost-transplant complications [see Warnings and Precautions (5.5)].
Females of Reproductive Potential: Advise use of effective contraception during treatmentwith POTELIGEO and for at least 3 months following the last dose of POTELIGEO [see Usein Specific Populations (8.3)].
POTELIGEO®
(mogamulizumab-kpkc)
Manufactured by:
Kyowa Kirin, Inc.
Bedminster, NJ 07921 |
