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VELCADE
Overview
What is VELCADE?
VELCADE for Injection contains bortezomib which 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-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid.
Bortezomib has the following chemical structure:
The molecular weight is 384.24. The molecular formula is CHBNOThe 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-use 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.
What does VELCADE look like?
What are the available doses of VELCADE?
For injection: Each single-use 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 .
What should I talk to my health care provider before I take VELCADE?
How should I use VELCADE?
VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma.
VELCADE is for intravenous or subcutaneous use only. VELCADE should not be administered by any other route.
Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.
The recommended starting dose of VELCADE is 1.3 mg/m. VELCADE may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL []
VELCADE retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with VELCADE and who have relapsed at least 6 months after completing prior VELCADE treatment. Treatment may be started at the last tolerated dose [].
When administered intravenously, VELCADE is administered as a 3 to 5 second bolus intravenous injection.
What interacts with VELCADE?
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What are the warnings of VELCADE?
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What are the precautions of VELCADE?
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What are the side effects of VELCADE?
Sorry No records found
What should I look out for while using VELCADE?
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.
What might happen if I take too much VELCADE?
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 2 times the recommended clinical dose on a mg/m basis were associated with increases in heart rate, decreases in contractility, hypotension, and death. In dog studies, a slight increase in the corrected QT interval was observed at doses resulting in death. In monkeys, doses of 3.0 mg/m and greater (approximately twice the recommended clinical dose) resulted in hypotension starting at 1 hour post-administration, with progression to death in 12 to 14 hours following drug administration.
How should I store and handle VELCADE?
RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.VELCADE (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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling cascades within the cell. This disruption of normal homeostatic mechanisms can lead to cell death. Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types . Bortezomib causes a delay in tumor growth in nonclinical tumor models, including multiple myeloma.
Non-Clinical Toxicology
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.
The drug interaction data described in this section were obtained from controlled clinical trials and studies involving otherwise healthy adults with epilepsy.
VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous versus intravenous the incidence of Grade ≥ 2 peripheral neuropathy was 24% for subcutaneous and 39% for intravenous. Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy.
Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule [ ]. In the VELCADE versus dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥ Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies [ ]. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.
The following adverse reactions are also discussed in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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