POLIVY Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Genentech, Inc.

Λέξεις κλειδιά

50242-103 50242-105

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1. Indications and Usage

POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, ...

2. Dosage and Administration

2.1 Recommended Dosage The recommended dose of POLIVY is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Administer ...

3. Dosage Forms and Strengths

For Injection: 30 mg/vial or 140 mg/vial of polatuzumab vedotin-piiq as a white to grayish-white lyophilized powder in a single-dose vial for reconstitution and further dilution.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Peripheral Neuropathy POLIVY can cause peripheral neuropathy, including severe cases. Peripheral neuropathy occurs as early as the first cycle of treatment and is a cumulative effect [see Adverse ...

6. Adverse Reactions

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Peripheral Neuropathy [see Warnings and Precautions (5.1)] Infusion-Related ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

6.2. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

7. Drug Interactions

7.1 Effects of Other Drugs on POLIVY Strong CYP3A Inhibitors Concomitant use with a strong CYP3A4 inhibitor may increase unconjugated MMAE AUC [see Clinical Pharmacology (12.3)], which may increase ...

8.1. Pregnancy

Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], POLIVY can cause fetal harm. There are no available data in pregnant women to ...

8.2. Lactation

Risk Summary There is no information regarding the presence of polatuzumab vedotin-piiq in human milk, the effects on the breastfed child, or milk production. Because of the potential for serious adverse ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating POLIVY [see Use in Specific Populations (8.1)]. Contraception Females POLIVY can cause embryo-fetal ...

8.4. Pediatric Use

Safety and effectiveness of POLIVY have not been established in pediatric patients.

8.5. Geriatric Use

Among 173 patients treated with POLIVY in Study GO29365, 95 (55%) were ≥65 years of age. Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged <65 (53%). ...

8.6. Hepatic Impairment

Avoid the administration of POLIVY in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 × ULN). Patients with moderate or severe hepatic impairment are likely to have increased ...

11. Description

Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate (ADC) consisting of three components: 1) the humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b; 2) the ...

12.1. Mechanism of Action

Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the antibody via a ...

12.2. Pharmacodynamics

Over polatuzumab vedotin-piiq dosages of 0.1 to 2.4 mg/kg (0.06 to 1.33 times the approved recommended dosage), a higher exposure was associated with higher incidence of some adverse reactions (e.g., ≥ ...

12.3. Pharmacokinetics

The exposure parameters of antibody-conjugated MMAE (acMMAE) and unconjugated MMAE (the cytotoxic component of polatuzumab vedotin-piiq) are summarized in Table 7. The plasma exposure of acMMAE and unconjugated ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies in animals have not been performed with polatuzumab vedotin-piiq or MMAE. MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic ...

14. Clinical Studies

14.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma The efficacy of POLIVY was evaluated in Study GO29365 (NCT02257567), an open-label, multicenter clinical trial that included a cohort of 80 patients ...

15. References

1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16.1. How Supplied

POLIVY (polatuzumab vedotin-piiq) for injection is a preservative-free, white to grayish-white lyophilized powder, which has a cake-like appearance. POLIVY is supplied as: Carton Contents NDC One 30 ...

16.2. Storage and Handling

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not use beyond the expiration date shown on the carton. Do not freeze. Do not shake. POLIVY is a cytotoxic drug. ...

17. Patient Counseling Information

Peripheral Neuropathy Advise patients that POLIVY can cause peripheral neuropathy. Advise patients to report to their healthcare provider any numbness or tingling of the hands or feet or any muscle weakness ...