BORTEZOMIB 3.5 mg/1
BORTEZOMIB · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Eugia US LLC
BORTEZOMIB is a injection, powder, lyophilized, for solution containing bortezomib at 3.5 mg/1, taken intravenous. Manufactured by Eugia US LLC.
Key Facts
- Brand Name
- BORTEZOMIB
- Generic Name
- BORTEZOMIB
- NDC Code (Product)
55150-337- Manufacturer
- Eugia US LLC
- Strength
- 3.5 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA212825
- Drug Class
- Proteasome Inhibitor [EPC]
- Marketing Start
- 05/02/2022
Recall History
Millennium Pharmaceuticals Inc.
Defective Container: Confirmed reports of loose vial crimps.
Infusion Options, Inc.
Lack of Assurance of Sterility
Dr. Reddy's Laboratories, Inc.
Failed stability specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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 ) 1.1 Multiple Myeloma Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma.
Dosage & Administration
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/m 2 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 ) 2.1 Important Dosing Guidelines Bortezomib for injection is for intravenous or subcutaneous use only. Do not administer bortezomib for injection by any other route. Because each route of administration has a different reconstituted concentration, use caution when calculating the volume to be administered. The recommended starting dose of bortezomib for injection is 1.3 mg/m 2 . Bortezomib for injection is administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL [se…
Contraindications
4 CONTRAINDICATIONS Bortezomib is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions [see Adverse Reactions ( 6.1 )]. Bortezomib is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib. • Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. ( 4 ) • Contraindicated for intrathecal administration. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use. ( 7.1 ) • Strong CYP3A4 Inducers: Avoid concomitant use. (7.3) 7.1 Effects of Other Drugs on Bortezomib Strong CYP3A4 Inducers Coadministration with a strong CYP3A4 inducer decreases the exposure of bortezomib [see Clinical Pharmacology ( 12.3 )] which may decrease bortezomib efficacy. Avoid coadministration with strong CYP3A4 inducers. Strong CYP3A4 Inhibitors Coadministration with a strong CYP3A4 inhibitor increases the exposure of bortezomib [see Clinical Pharmacology ( 12.3 )] which may increase the risk of bortezomib toxicities. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors. 7.2 Drugs Without Clinically Significant Interactions with Bortezomib No clinically significant drug interactions have been observed when bortezomib was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology ( 12.3 )].
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: • Peripheral Neuropathy [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Cardiac Toxicity [see Warnings and Precautions ( 5.3 )] • Pulmonary Toxicity [see Warnings and Precautions ( 5.4 )] • Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions ( 5.5 )] • Gastrointestinal Toxicity [see Warnings and Precautions ( 5.6 )] • Thrombocytopenia/Neutropenia [see Warnings and Precautions ( 5.7 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.8 )] • Hepatic Toxicity [see Warnings and Precautions ( 5.9 )] • Thrombotic Microangiopathy [see Warnings and Precautions ( 5.10 )] 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 Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinic…
Frequently Asked Questions
What is BORTEZOMIB used for?
BORTEZOMIB contains BORTEZOMIB. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is BORTEZOMIB a controlled substance?
BORTEZOMIB is not classified as a controlled substance by the DEA.
What is the generic name for BORTEZOMIB?
The generic name for BORTEZOMIB is BORTEZOMIB. There are 9 other brand versions of BORTEZOMIB.
What is the NDC code for BORTEZOMIB 3.5 mg/1?
The NDC (National Drug Code) for BORTEZOMIB 3.5 mg/1 is 55150-337, listed by Eugia US LLC.