Bortezomib (Page 10 of 10)

15 REFERENCES

1. “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual). OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

Bortezomib for Injection is supplied as individually cartoned 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder.

NDC 72205-183-01

3.5 mg single-dose vial

Unopened vials may be stored at controlled room temperature 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Retain in original package to protect from light.

Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact¹.

17 PATIENT COUNSELING INFORMATION

Discuss the following with patients prior to treatment with bortezomib for injection:

Peripheral Neuropathy
Advise patients to report the development or worsening of sensory and motor peripheral neuropathy to their healthcare provider [see Warnings and Precautions (5.1)].
Hypotension
Advise patients to drink adequate fluids to avoid dehydration and to report symptoms of hypotension to their healthcare provider [see Warnings and Precautions (5.2)].
Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps.
Cardiac Toxicity
Advise patients to report signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3)].
Pulmonary Toxicity
Advise patients to report symptoms of ARDS, pulmonary hypertension, pneumonitis, and pneumonia immediately to their healthcare provider [see Warnings and Precautions (5.4)].
Posterior Reversible Encephalopathy Syndrome (PRES)
Advise patients to seek immediate medical attention for signs or symptoms of PRES [see Warnings and Precautions (5.5)].
Gastrointestinal Toxicity
Advise patients to report symptoms of gastrointestinal toxicity to their healthcare provider and to drink adequate fluids to avoid dehydration. Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps [see Warnings and Precautions (5.6)].
Thrombocytopenia/Neutropenia
Advise patients to report signs or symptoms of bleeding or infection immediately to their healthcare provider [see Warnings and Precautions (5.7)].

Tumor Lysis Syndrome
Advise patients of the risk of tumor lysis syndrome and to drink adequate fluids to avoid dehydration [see Warnings and Precautions (5.8)].
Hepatic Toxicity
Advise patients to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions (5.9)].
Thrombotic Microangiopathy
Advise patients to seek immediate medical attention if any signs or symptoms of thrombotic microangiopathy occur [see Warnings and Precautions (5.10)].
Ability to Drive or Operate Machinery or Impairment of Mental Ability
Bortezomib may cause fatigue, dizziness, syncope, orthostatic/postural hypotension. Advise patients not to drive or operate machinery if they experience any of these symptoms [see Warnings and Precautions (5.2, 5.5)].
Embryo-Fetal Toxicity
Advise females of the potential risk to the fetus and to use effective contraception during treatment with bortezomib and for seven months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with bortezomib and for four months following the last dose. Instruct patients to report pregnancy to their physicians immediately if they or their female partner becomes pregnant during treatment or within seven months following last dose [see Warnings and Precautions (5.11)].
Lactation
Advise women not to breastfeed while receiving bortezomib and for two months after last dose [see Use in Specific Populations (8.2)].
Concomitant Medications
Advise patients to speak with their physicians about any other medication they are currently taking.
Diabetic Patients
Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level.
Dermal
Advise patients to contact their physicians if they experience rash, severe injection site reactions [ see Dosage and Administration (2.9)],or skin pain. Discuss with patients the option for antiviral prophylaxis for herpes virus infection [see Adverse Reactions (6.1)].
Other
Instruct patients to contact their physicians if they develop an increase in blood pressure, bleeding,fever, constipation, or decreased appetite.

Manufactured by:

MSN Laboratories Private Limited

Telangana – 509 228,

INDIA

Distributed by:

Novadoz Pharmaceuticals LLC
Piscataway, NJ 08854-3714

Issued on:
April 2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bortezomib-Carton-ouside-Label

Bortezomib-Vial-Label

Bortezomib-intravenous-sticker-label

Bortezomib-subcutaneous-sticker-label

BORTEZOMIB bortezomib injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-183 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORTEZOMIB (BORTEZOMIB) BORTEZOMIB 3.5 mg in 3.5 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 35 mg in 3.5 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72205-183-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 3.5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (72205-183-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209622 07/26/2022

Labeler — Novadoz Pharmaceuticals LLC (081109687)

Establishment
Name	Address	ID/FEI	Operations
MSN LABORATORIES PRIVATE LIMITED		650786952	ANALYSIS (72205-183), MANUFACTURE (72205-183)

Revised: 07/2022 Novadoz Pharmaceuticals LLC