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bortezomib injection 1 MG and 2.5 MG VIAL (bortezomib for injection)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

bortezomib injection 1 MG and 2.5 MG VIAL Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Multiple Myeloma

Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma.

...
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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Guidelines

Bortezomib for Injection is for intravenous or subcutaneous use only. Do not administer Bortezomib for...

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3 DOSAGE FORMS AND STRENGTHS

For injection: Each single-dose vial of Bortezomib for Injection contains 1 mg or 2.5 mg of bortezomib as a sterile lyophilized white to off-white powder for reconstitution and withdrawal of the...

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4 CONTRAINDICATIONS

Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions...

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5 WARNINGS AND PRECAUTIONS

5.1 Peripheral Neuropathy

Bortezomib treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are also discussed in other sections of the labeling:

  • Peripheral Neuropathy [see ...
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7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Bortezomib

Strong CYP3A4 Inducers...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on its mechanism...

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10 OVERDOSAGE

There is no known specific antidote for Bortezomib for Injection overdosage. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which...

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11 DESCRIPTION

Bortezomib for Injection, a proteasome inhibitor, is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with bortezomib.

Bortezomib...

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14 CLINICAL STUDIES

14.1 Multiple Myeloma

Randomized, Open-Label Clinical Study in Patients...

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15 REFERENCES

  1. "OSHA Hazardous Drugs" (refer to antineoplastic weblinks including OSHA Technical Manual). OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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16 HOW SUPPLIED/STORAGE AND HANDLING

Bortezomib for Injection is supplied as individually cartoned 5 mL or 10 mL vials containing 1 mg or 2.5 mg of bortezomib, respectively, as a white to off-white cake or powder.

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17 PATIENT COUNSELING INFORMATION

Discuss the following with patients prior to treatment with Bortezomib for Injection:

Peripheral...

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Manufactured by:
Gland Pharma Limited; Visakhapatnam,
Andhra Pradesh 530049 India

Manufactured for:
Hospira, Inc., Lake Forest, IL 60045 USA

...

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