Bortezomib Ever Pharma
Generic Name
Bortezomib
Manufacturer
Ever Pharma GmbH
Country
Austria
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
bortezomib ever pharma 35 mg injection | ৳ 14,000.00 | N/A |
Description
Overview of the medicine
Bortezomib is an antineoplastic agent belonging to the class of proteasome inhibitors. It is used in the treatment of multiple myeloma and mantle cell lymphoma. It works by blocking the proteasome, a cellular complex that breaks down unneeded or damaged proteins, leading to the accumulation of proteins and cell death in cancer cells.
Uses & Indications
Dosage
Adults
Typically 1.3 mg/m² as a bolus IV or SC injection twice weekly for 2 weeks (Days 1, 4, 8, 11) followed by a 10-day rest period (Days 12-21). This 21-day period constitutes one treatment cycle. For some regimens, weekly dosing for 4 weeks followed by a rest period may be used.
Elderly
No specific dose adjustment required based on age alone, but caution with comorbidities.
Renal_impairment
No dose adjustment required for mild to moderate renal impairment. For severe renal impairment or dialysis, consult specific guidelines as dosage modifications might be considered.
How to Take
For subcutaneous (SC) administration: Inject into the thigh or abdomen. Rotate injection sites. For intravenous (IV) administration: Administer as a 3-5 second bolus injection into a peripheral or central vein. Do NOT administer intrathecally. Reconstitute lyophilized powder with 0.9% Sodium Chloride Injection.
Mechanism of Action
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins, a process critical for maintaining cellular homeostasis. Inhibition of the proteasome prevents the breakdown of key regulatory proteins, including pro-apoptotic factors, leading to their accumulation and subsequent induction of apoptosis in cancer cells.
Pharmacokinetics
Onset
Varies, typically within days to weeks of treatment initiation.
Excretion
Excreted primarily via feces (approx. 50-62%) and urine (approx. 21-25%).
Half life
Terminal half-life ranges from 9 to 15 hours.
Absorption
Rapidly absorbed after subcutaneous (SC) administration with peak plasma concentration at 30 minutes to 120 minutes. Bioavailability of SC route is comparable to IV.
Metabolism
Primarily hepatic, via cytochrome P450 enzymes (CYP3A4, CYP2C19, CYP1A2) and non-CYP dependent deboronation.
Side Effects
Contraindications
- Hypersensitivity to Bortezomib, boron, or mannitol
- Patients with acute diffuse infiltrative pulmonary and pericardial disease
Drug Interactions
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease bortezomib exposure, potentially reducing efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase bortezomib exposure, requiring caution.
Other neurotoxic agents (e.g., thalidomide, vinca alkaloids)
Increased risk of peripheral neuropathy.
Hypoglycemic agents (e.g., insulin, oral hypoglycemic agents)
Monitor blood glucose levels carefully as bortezomib can cause hyperglycemia or hypoglycemia.
Storage
Store intact vials at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light. Store reconstituted solution at room temperature or refrigerated, protect from light.
Overdose
No specific antidote for bortezomib overdose. Management involves general supportive measures to treat symptoms and close monitoring of vital signs. Patients may require hospitalization and appropriate medical intervention.
Pregnancy & Lactation
Pregnancy Category D. Can cause fetal harm. Avoid use during pregnancy. Advise women of childbearing potential to use effective contraception during treatment and for a specified period after. It is unknown if bortezomib is excreted in human milk; avoid breastfeeding during treatment and for 2 months after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months when stored as recommended. Reconstituted solution stable for 8 hours at 25°C or 24 hours at 2-8°C.
Availability
Hospitals, specialized oncology pharmacies
Approval Status
Approved by regulatory authorities (e.g., FDA, EMA)
Patent Status
Generics available, original patent expired
Clinical Trials
Bortezomib was approved based on pivotal trials such as APEX (for relapsed multiple myeloma) and VISTA (for newly diagnosed multiple myeloma). Ongoing trials explore new combinations and indications.
Lab Monitoring
- Complete Blood Count (CBC) with differential, including platelet count (before each dose)
- Liver function tests (LFTs)
- Renal function tests
- Blood glucose (especially for diabetic patients)
Doctor Notes
- Administer under the supervision of a physician experienced in the use of antineoplastic agents.
- Closely monitor for signs of peripheral neuropathy and adjust dose as necessary.
- Prophylactic antiviral agents may be considered to prevent herpes zoster reactivation.
Patient Guidelines
- Report any numbness, tingling, or pain in hands or feet immediately.
- Stay well-hydrated.
- Avoid driving or operating heavy machinery if experiencing dizziness or blurred vision.
- Report any signs of infection (fever, chills) immediately.
- Discuss any planned vaccinations with your doctor.
Missed Dose Advice
If a Bortezomib dose is missed, it should not be administered. The next scheduled dose should be administered as planned. There should be at least 72 hours between consecutive doses.
Driving Precautions
Bortezomib may cause fatigue, dizziness, or blurred vision. Patients should be advised to avoid driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Maintain a balanced diet.
- Engage in light exercise if tolerated, consult doctor.
- Avoid alcohol or limit consumption due to potential liver effects.
- Manage stress effectively.
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International brand names for this medicine
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