bortezomib injection 1 MG and 2.5 MG VIAL Highlights

(bortezomib for injection)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BORTEZOMIB FOR INJECTION safely and effectively. See full prescribing information for BORTEZOMIB FOR INJECTION.

BORTEZOMIB for injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2003

RECENT MAJOR CHANGES

Indications and Usage, Mantle Cell Lymphoma (1.2), Removed phrase “who have received at least 1 prior therapy”

12/2022

Dosage and Administration (2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 2.10)

12/2022

Warnings and Precautions, Thrombocytopenia/Neutropenia (5.7)

12/2022

INDICATIONS AND USAGE

Bortezomib for Injection is a proteasome inhibitor indicated for:

•
Treatment of adult patients with multiple myeloma. (1.1)
•
Treatment of adult patients with mantle cell lymphoma. (1.2)

DOSAGE AND ADMINISTRATION

•
For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration; Exercise caution when calculating the volume to be administered. (2.1, 2.10)
•
The recommended starting dose of Bortezomib for Injection is 1.3 mg/m2 administered either as a 3 to 5 second bolus intravenous injection or subcutaneous injection. (2.2, 2.4, 2.6)
•
Retreatment for multiple myeloma: May retreat starting at the last tolerated dose. (2.6)
•
Hepatic Impairment: Use a lower starting dose for patients with moderate or severe hepatic impairment. (2.8)
•
Dose must be individualized to prevent overdose. (2.10)

DOSAGE FORMS AND STRENGTHS

For injection: 1 mg or 2.5 mg of bortezomib as a lyophilized powder in a single-dose vial for reconstitution and withdrawal of the appropriate individual patient dose. (3)

CONTRAINDICATIONS

•
Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. (4)
•
Contraindicated for intrathecal administration. (4)

WARNINGS AND PRECAUTIONS

•
Peripheral Neuropathy: Manage with dose modification or discontinuation. (2.7) Patients with pre-existing severe neuropathy should be treated with Bortezomib for Injection only after careful risk-benefit assessment. (2.7, 5.1)
•
Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. (5.2)
•
Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease. (5.3)
•
Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib for Injection therapy. (5.4)
•
Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib for Injection if suspected. (5.5)
•
Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. (5.6)
•
Thrombocytopenia/Neutropenia: Monitor complete blood counts regularly throughout treatment. (5.7)
•
Tumor Lysis Syndrome: Closely monitor patients with high tumor burden. (5.8)
•
Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib for Injection therapy to assess reversibility. (5.9)
•
Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Bortezomib for Injection if suspected. (5.10)
•
Embryo-Fetal Toxicity: Bortezomib for Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.11)

ADVERSE REACTIONS

Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use. (7.1)
•
Strong CYP3A4 Inducers: Avoid concomitant use. (7.1)

USE IN SPECIFIC POPULATIONS

Patients with diabetes may require close monitoring of blood glucose and adjustment of antidiabetic medication. (8.8)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2022

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BORTEZOMIB FOR INJECTION safely and effectively. See full prescribing information for BORTEZOMIB FOR INJECTION.

BORTEZOMIB for injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2003

RECENT MAJOR CHANGES

Indications and Usage, Mantle Cell Lymphoma (1.2), Removed phrase “who have received at least 1 prior therapy”

12/2022

Dosage and Administration (2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 2.10)

12/2022

Warnings and Precautions, Thrombocytopenia/Neutropenia (5.7)

12/2022

INDICATIONS AND USAGE

Bortezomib for Injection is a proteasome inhibitor indicated for:

•
Treatment of adult patients with multiple myeloma. (1.1)
•
Treatment of adult patients with mantle cell lymphoma. (1.2)

DOSAGE AND ADMINISTRATION

•
For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration; Exercise caution when calculating the volume to be administered. (2.1, 2.10)
•
The recommended starting dose of Bortezomib for Injection is 1.3 mg/m2 administered either as a 3 to 5 second bolus intravenous injection or subcutaneous injection. (2.2, 2.4, 2.6)
•
Retreatment for multiple myeloma: May retreat starting at the last tolerated dose. (2.6)
•
Hepatic Impairment: Use a lower starting dose for patients with moderate or severe hepatic impairment. (2.8)
•
Dose must be individualized to prevent overdose. (2.10)

DOSAGE FORMS AND STRENGTHS

For injection: 1 mg or 2.5 mg of bortezomib as a lyophilized powder in a single-dose vial for reconstitution and withdrawal of the appropriate individual patient dose. (3)

CONTRAINDICATIONS

•
Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. (4)
•
Contraindicated for intrathecal administration. (4)

WARNINGS AND PRECAUTIONS

•
Peripheral Neuropathy: Manage with dose modification or discontinuation. (2.7) Patients with pre-existing severe neuropathy should be treated with Bortezomib for Injection only after careful risk-benefit assessment. (2.7, 5.1)
•
Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. (5.2)
•
Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease. (5.3)
•
Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib for Injection therapy. (5.4)
•
Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib for Injection if suspected. (5.5)
•
Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. (5.6)
•
Thrombocytopenia/Neutropenia: Monitor complete blood counts regularly throughout treatment. (5.7)
•
Tumor Lysis Syndrome: Closely monitor patients with high tumor burden. (5.8)
•
Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib for Injection therapy to assess reversibility. (5.9)
•
Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Bortezomib for Injection if suspected. (5.10)
•
Embryo-Fetal Toxicity: Bortezomib for Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.11)

ADVERSE REACTIONS

Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use. (7.1)
•
Strong CYP3A4 Inducers: Avoid concomitant use. (7.1)

USE IN SPECIFIC POPULATIONS

Patients with diabetes may require close monitoring of blood glucose and adjustment of antidiabetic medication. (8.8)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2022
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