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Bortezomib
Overview
What is Bortezomib?
Bortezomib for injection is an antineoplastic agent available for intravenous injection. Each single-dose vial contains 3.5 mg of bortezomib, 10.5 mg boric acid, 25 mg glycine as a sterile lyophilized powder.
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 of bortezomib is 384.24 and its molecular formula is CHBNO.
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.
What does Bortezomib look like?
What are the available doses of Bortezomib?
For injection: Single-dose vial contains 3.5 mg of bortezomib as lyophilized powder for reconstitution. ()
What should I talk to my health care provider before I take Bortezomib?
How should I use Bortezomib?
Bortezomib for Injection is indicated for the treatment of patients with multiple myeloma.
Bortezomib for Injection is for intravenous use only. Do not administer Bortezomib for Injectionby any other route.
The recommended starting dose of bortezomib for injection is 1.3 mg/m. Bortezomib may be administered intravenously at a concentration of 1 mg/mL .
When administered intravenously, bortezomib is administered as a 3 to 5 second bolus intravenous injection.
What interacts with Bortezomib?
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What are the warnings of Bortezomib?
Sorry No Records found
What are the precautions of Bortezomib?
Sorry No Records found
What are the side effects of Bortezomib?
Sorry No records found
What should I look out for while using Bortezomib?
Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, boric acid or glycine. Reactions have included anaphylactic reactions .
Bortezomib for Injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.
What might happen if I take too much Bortezomib?
There is no known specific antidote for bortezomib 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 () and thrombocytopenia (). 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 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 Bortezomib?
Bortezomib for injection is supplied in a 10 mL vial containing 3.5 mg of bortezomib as a white to off-white cake or powder in a single-dose vial for reconstitution (after reconstitution the solution is clear and colorless). Unopened vials may be stored at 20°C to 25ºC (68°F to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. The vial stopper is not made with natural rubber latex. Follow guidelines for handling and disposal for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact. () Bortezomib for injection is supplied in a 10 mL vial containing 3.5 mg of bortezomib as a white to off-white cake or powder in a single-dose vial for reconstitution (after reconstitution the solution is clear and colorless). Unopened vials may be stored at 20°C to 25ºC (68°F to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. The vial stopper is not made with natural rubber latex. Follow guidelines for handling and disposal for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact. () Bortezomib for injection is supplied in a 10 mL vial containing 3.5 mg of bortezomib as a white to off-white cake or powder in a single-dose vial for reconstitution (after reconstitution the solution is clear and colorless). Unopened vials may be stored at 20°C to 25ºC (68°F to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. The vial stopper is not made with natural rubber latex. Follow guidelines for handling and disposal for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact. () Bortezomib for injection is supplied in a 10 mL vial containing 3.5 mg of bortezomib as a white to off-white cake or powder in a single-dose vial for reconstitution (after reconstitution the solution is clear and colorless). Unopened vials may be stored at 20°C to 25ºC (68°F to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. The vial stopper is not made with natural rubber latex. Follow guidelines for handling and disposal for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact. ()
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
Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, boric acid or glycine. Reactions have included anaphylactic reactions .Bortezomib for Injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, ACE inhibitors, disopyramide, fluoxetine, clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving Glyburide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Glyburide, the patient should be observed closely for loss of control.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known.
A possible interaction between glyburide and fluoroquinolone antibiotics has been reported resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism for this interaction is not known.
Possible interactions between glyburide and coumarin derivatives have been reported that may either potentiate or weaken the effects of coumarin derivatives. The mechanism of these interactions is not known.
Rifampin may worsen glucose control of glyburide because rifampin can significantly induce metabolic isozymes of glyburide such as CYP2C9 and 3A4.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Glyburide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving Glyburide, the patient should be observed closely for hypoglycemia.
An increased incidence of elevated liver enzymes was observed in patients receiving glyburide concomitantly with bosentan. Therefore this combination should not be used. (See .)
Glyburide may increase cyclosporine plasma concentration and potentially lead to its increased toxicity. Monitoring and dosage adjustment of cyclosporine are therefore recommended when both drugs are coadministered.
Bortezomib 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 bortezomib. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness.
Patients experiencing new or worsening peripheral neuropathy during bortezomib therapy may require a decrease in the dose and/or a less dose-intense schedule . In the bortezomib 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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Interactions
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