bortezomib injection 3.5 MG VIAL Principal Display Panel (bortezomib for injection) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Label

NDC 0409-1700-01

Bortezomib
for Injection

3.5 mg/vial

DISCARD UNUSED PORTION

FOR INTRAVENOUS OR
SUBCUTANEOUS USE

SINGLE USE VIAL

Rx ONLY
Hospira

PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Label

PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Carton

NDC 0409-1700-01

Bortezomib
for Injection

3.5 mg/vial

Reconstitution Information

SUBCUTANEOUS
INJECTION ONLY

Add 1.4 mL
0.9% Sodium
Chloride

To make 2.5 mg / mL
final concentration

INTRAVENOUS
INJECTION ONLY

Add 3.5 mL
0.9% Sodium
Chloride

To make 1 mg / mL
final concentration

Rx ONLY

Hospira

PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Carton

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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 3.5 MG VIAL Quick Finder

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Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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 3.5 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 for injection treatment causes a peripheral neuropathy that is predominantly sensory; however, cases...

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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 for Injection

Strong CYP3A4...

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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

"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 10 mL vials containing 3.5 mg of bortezomib 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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To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.