HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
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 1 MG and 2.5 MG VIAL (bortezomib for injection)
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 1 MG and 2.5 MG VIAL Quick Finder
Highlights
Indications and Usage
...
1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma.
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Guidelines
Bortezomib for Injection is for intravenous or subcutaneous use only. Do not administer Bortezomib for...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
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...
Did you find an answer to your question?
Yes
No
Contraindications
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...
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Peripheral Neuropathy
Bortezomib treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are also discussed in other sections of the labeling:
- •
- Peripheral Neuropathy [see Warnings...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Bortezomib
Strong CYP3A4 Inducers...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its...
Did you find an answer to your question?
Yes
No
Overdosage
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...
Did you find an answer to your question?
Yes
No
Description
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...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
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...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with bortezomib.
Bortezomib...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
14.1 Multiple Myeloma
Randomized, Open-Label Clinical Study in Patients...
Did you find an answer to your question?
Yes
No
References
15 REFERENCES
- 1.
- "OSHA Hazardous Drugs" (refer to antineoplastic weblinks including OSHA Technical Manual). OSHA.http://www.osha.gov/...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
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.
...
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to treatment with Bortezomib for Injection:
...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Report Adverse Event
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:
*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.
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.
(800)-332-1088.