Generic Name
Bortezomib
Brand Names
Velcade, Boruzu
FDA approval date: May 13, 2003
Classification: Proteasome Inhibitor
Form: Injection
What is Velcade (Bortezomib)?
Bortezomib for injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma.
Approved To Treat
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Brand Information
VELCADE (bortezomib)
1DOSAGE FORMS AND STRENGTHS
For injection: Each single-dose vial of VELCADE contains 3.5 mg of bortezomib as a sterile lyophilized white to off-white powder for reconstitution and withdrawal of the appropriate individual patient dose
2CONTRAINDICATIONS
VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions
VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are also discussed in other sections of the labeling:
- Peripheral Neuropathy
- Hypotension
- Cardiac Toxicity
- Pulmonary Toxicity
- Posterior Reversible Encephalopathy Syndrome (PRES)
- Gastrointestinal Toxicity
- Thrombocytopenia/Neutropenia
- Tumor Lysis Syndrome
- Hepatic Toxicity
- Thrombotic Microangiopathy
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
3.2Postmarketing Experience
The following adverse reactions have been identified from the worldwide postmarketing experience with VELCADE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Cardiac Disorders: Cardiac tamponade
Ear and Labyrinth Disorders: Deafness bilateral
Eye Disorders: Optic neuropathy, blindness, chalazion/blepharitis
Gastrointestinal Disorders: Ischemic colitis
Infections and Infestations: Progressive multifocal leukoencephalopathy (PML), ophthalmic herpes, herpes meningoencephalitis
Nervous System Disorders: Posterior reversible encephalopathy syndrome (PRES, formerly RPLS), Guillain-Barré syndrome, demyelinating polyneuropathy
Respiratory, Thoracic and Mediastinal Disorders: Acute diffuse infiltrative pulmonary disease
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), acute febrile neutrophilic dermatosis (Sweet's syndrome)
4OVERDOSAGE
There is no known specific antidote for VELCADE overdosage. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which were associated with the acute onset of symptomatic hypotension (5.2) and thrombocytopenia (5.7). In the event of an overdosage, the patient's vital signs should be monitored and appropriate supportive care given.
Studies in monkeys and dogs showed that intravenous bortezomib doses as low as two times the recommended clinical dose on a mg/m
5DESCRIPTION
VELCADE
Bortezomib has the following chemical structure:
The molecular weight is 384.24. The molecular formula is C19H25BN4O4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5.
VELCADE is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine.
6REFERENCES
1. "OSHA Hazardous Drugs" (refer to antineoplastic weblinks including OSHA Technical Manual).
7HOW SUPPLIED/STORAGE AND HANDLING
VELCADE
NDC 63020-049-01
8PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to treatment with VELCADE:
9PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Label
NDC 63020-049-01
VELCADE®
3.5 mg/vial
SINGLE-DOSE VIAL
FOR INTRAVENOUS OR SUBCUTANEOUS USE
10PRINCIPAL DISPLAY PANEL - 3.5 mg Vial Carton
See
NDC 63020-049-01
VELCADE®
3.5 mg/vial
SINGLE-DOSE VIAL – DISCARD UNUSED PORTION
FOR INTRAVENOUS OR SUBCUTANEOUS USE
Takeda
