S
Concomitant use of strong CYP3A inhibitors or inducers has the potential toaffect the exposure to unconjugated monomethyl auristatin E (MMAE). (7.1)
USE IN SPECIFIC POPULATIONS
Hepatic impairment has the potential to increase exposure to MMAE.Monitor patients for adverse reactions. (8.6)
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 06/2019
----------------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Management of Adverse Reactions
2.3 Recommended Prophylactic Medications
2.4 Instructions for Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Peripheral Neuropathy
5.2 Infusion-Related Reactions
5.3 Myelosuppression
5.4 Serious and Opportunistic Infections
5.5 Progressive Multifocal Leukoencephalopathy (PML)
5.6 Tumor Lysis Syndrome
5.7 Hepatotoxicity
5.8 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on POLIVY
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
8.6 Hepatic Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are notlisted.
----------------------------------------------------------------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
POLIVY in combination with bendamustine and a rituximab product is indicated for thetreatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL),not otherwise specified, after at least two prior therapies.
Accelerated approval was granted for this indication based on complete response rate [seeClinical Studies (14.1)].
Continued approval for this indication may be contingent uponverification and description of clinical benefit in a confirmatory trial.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of POLIVY is 1.8 mg/kg administered as an intravenous infusion every21 days for 6 cycles in combination with bendamustine and rituximab product. AdministerPOLIVY, bendamustine, and rituximab product in any order on Day 1 of each cycle. Therecommended dose of bendamustine is 90 mg/m2
/day on Day 1 and 2 when administered withPOLIVY and a rituximab product. The recommended dose of rituximab product is 375 mg/m2intravenously on Day 1 of each cycle.
If not already premedicated, administer an antihistamine and antipyretic at least 30 minutes priorto POLIVY.
Administer the initial dose of
