Bortezomib Glenmark: Uses, Dosage & Side Effects
A proteasome inhibitor used in the treatment of multiple myeloma and mantle cell lymphoma, available as a ready-to-use solution for subcutaneous or intravenous injection
Bortezomib Glenmark is a proteasome inhibitor containing the active substance bortezomib, used primarily in the treatment of multiple myeloma and mantle cell lymphoma. It works by blocking the 26S proteasome, a critical enzyme complex responsible for degrading regulatory proteins within cells. This disruption of protein homeostasis leads to cancer cell death. Bortezomib Glenmark is a generic version of the original brand Velcade and is supplied as a ready-to-use 2.5 mg/ml solution for subcutaneous or intravenous injection. It is administered in hospital or clinic settings by healthcare professionals and requires a prescription.
Quick Facts: Bortezomib Glenmark
Key Takeaways
- Bortezomib Glenmark is a proteasome inhibitor that disrupts protein degradation in cancer cells, leading to cell cycle arrest and apoptosis. It is primarily used for multiple myeloma and mantle cell lymphoma.
- It is supplied as a ready-to-use 2.5 mg/ml solution for injection, administered subcutaneously (preferred) or intravenously by healthcare professionals in a clinical setting.
- Peripheral neuropathy and thrombocytopenia are among the most significant side effects; subcutaneous administration reduces neuropathy risk compared to the intravenous route.
- Antiviral prophylaxis (e.g., acyclovir) is mandatory during treatment to prevent herpes zoster reactivation, which occurs in approximately 13% of patients without prophylaxis.
- Regular blood count monitoring is essential, as bortezomib causes cyclical thrombocytopenia with platelet nadirs typically occurring around day 11 of each treatment cycle and recovering by the start of the next cycle.
What Is Bortezomib Glenmark and What Is It Used For?
Bortezomib Glenmark contains the active substance bortezomib, a dipeptide boronic acid that functions as a selective and reversible inhibitor of the 26S proteasome. The proteasome is a large, barrel-shaped protein complex present in all eukaryotic cells that serves as the cell’s primary machinery for degrading ubiquitin-tagged proteins. These proteins regulate a wide range of critical cellular processes including cell cycle progression, apoptosis (programmed cell death), transcription factor activation, DNA repair, and immune surveillance.
By inhibiting the proteasome, bortezomib disrupts multiple interconnected signaling pathways that cancer cells rely on for survival and proliferation. One of the most important of these is the nuclear factor kappa B (NF-κB) pathway. Under normal conditions, NF-κB is kept inactive in the cytoplasm by inhibitor proteins (IκB). The proteasome degrades IκB, allowing NF-κB to enter the nucleus and activate genes that promote cell survival, growth, and resistance to apoptosis. By preventing IκB degradation, bortezomib effectively suppresses NF-κB activity, making cancer cells more susceptible to programmed cell death.
Multiple myeloma cells are particularly vulnerable to proteasome inhibition for several reasons. As plasma cell-derived cancers, myeloma cells produce extremely large quantities of immunoglobulin proteins. This places an enormous burden on the cell’s protein quality control machinery, including the proteasome. When the proteasome is inhibited, misfolded and unneeded proteins accumulate within the cell, triggering a stress response known as the unfolded protein response (UPR). If the UPR becomes overwhelming and the cell cannot restore protein homeostasis, it initiates apoptosis. This inherent sensitivity of myeloma cells to proteasome inhibition is a key reason why bortezomib has proven so effective in treating this disease.
Bortezomib Glenmark is a generic version of the original brand-name product Velcade, manufactured by Glenmark Pharmaceuticals. As a generic medicine approved by the European Medicines Agency (EMA), it has been demonstrated to be bioequivalent to the reference product, meaning it contains the same active substance, has the same pharmaceutical form, and produces equivalent blood levels when administered at the same dose. It is supplied as a ready-to-use solution for injection at a concentration of 2.5 mg/ml, which offers the advantage of not requiring reconstitution before administration.
Bortezomib Glenmark is approved for the following indications, which are based on the extensive clinical trial programme conducted with the reference product:
- Multiple myeloma (previously untreated): In combination with melphalan and prednisone (VMP regimen) for adult patients who are not eligible for high-dose chemotherapy with bone marrow transplantation. It may also be used with dexamethasone (VD), or with thalidomide and dexamethasone (VTD), or with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) in various clinical settings.
- Multiple myeloma (progressive disease): As monotherapy or in combination with dexamethasone or with pegylated liposomal doxorubicin and dexamethasone for adult patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.
- Multiple myeloma (induction therapy): In combination with dexamethasone, or with dexamethasone and thalidomide, for adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with bone marrow transplantation.
- Mantle cell lymphoma (previously untreated): In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) for adult patients who are not suitable for bone marrow transplantation.
Multiple myeloma is a cancer of the plasma cells, a type of white blood cell that normally produces antibodies to fight infections. In myeloma, abnormal plasma cells accumulate in the bone marrow, crowd out healthy blood cells, and produce large amounts of a single type of abnormal antibody protein (M-protein or paraprotein). This leads to bone destruction, kidney damage, anemia, and increased susceptibility to infections. Multiple myeloma accounts for approximately 10% of all hematological malignancies and affects around 176,000 people worldwide each year.
Mantle cell lymphoma is a relatively rare and typically aggressive subtype of B-cell non-Hodgkin lymphoma. It arises from B-lymphocytes in the mantle zone of lymph node follicles and is characterized by the overexpression of cyclin D1 due to a specific chromosomal translocation t(11;14). Despite advances in treatment, mantle cell lymphoma remains challenging to cure, and most patients eventually experience relapse. Bortezomib-containing regimens have significantly improved outcomes for many of these patients.
Bortezomib Glenmark is a generic version of Velcade that has been approved by the EMA after demonstrating bioequivalence to the reference product. Generic medicines undergo rigorous regulatory assessment to ensure they meet the same standards of quality, safety, and efficacy as the original. The ready-to-use solution formulation eliminates the reconstitution step required with some other bortezomib products, reducing preparation time and the risk of dosing errors.
What Should You Know Before Taking Bortezomib Glenmark?
Contraindications
There are specific clinical situations in which Bortezomib Glenmark must not be administered. Understanding these absolute contraindications is essential before initiating treatment.
- Hypersensitivity: Do not receive Bortezomib Glenmark if you have a known allergy to bortezomib, boron, or any of the excipients in the formulation. Hypersensitivity reactions including anaphylaxis have been reported.
- Acute diffuse infiltrative pulmonary disease: Bortezomib must not be given to patients with acute diffuse infiltrative pulmonary or pericardial disease, as cases of acute respiratory failure and pulmonary hypertension have been reported in this population.
- When given in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP): The contraindications of each of these additional agents must also be considered before starting treatment.
Warnings and Precautions
Bortezomib causes characteristic cyclical thrombocytopenia (low platelet counts). Platelet counts typically reach their lowest point (nadir) around day 11 of each 21-day treatment cycle and usually recover to baseline by the start of the next cycle. Complete blood counts including platelet counts should be monitored before each dose. Dose modifications or treatment delays may be necessary if platelet counts are critically low. Patients with baseline platelet counts below 70,000/µL before starting treatment may be at higher risk.
Before and during treatment with Bortezomib Glenmark, your doctor should be informed about the following conditions and will monitor you for potential complications:
- Peripheral neuropathy: This is one of the most significant dose-limiting toxicities of bortezomib. Patients may experience new or worsening numbness, tingling, burning, pain, or weakness in the hands and feet. Pre-existing peripheral neuropathy (including that caused by prior therapies such as thalidomide or vincristine) may worsen during treatment. Subcutaneous administration significantly reduces the incidence and severity of peripheral neuropathy compared to the intravenous route. Your doctor will regularly assess neurological function and may modify the dose, change the administration schedule, or discontinue treatment based on the severity of neuropathy.
- Hypotension: Orthostatic hypotension (a drop in blood pressure upon standing) is common during bortezomib treatment and may cause dizziness, light-headedness, or fainting. Patients taking antihypertensive medications may be particularly susceptible. Adequate hydration is important, and dose adjustments of blood pressure medications may be necessary.
- Cardiac disorders: Cases of new onset or worsening congestive heart failure, decreased left ventricular ejection fraction, and QT interval prolongation have been reported. Patients with pre-existing cardiac risk factors or heart disease require careful monitoring throughout treatment.
- Pulmonary disorders: Rare cases of acute respiratory distress syndrome (ARDS), pneumonitis, interstitial lung disease, and pulmonary infiltrates (not related to infection) have been reported, some with fatal outcomes. New or worsening pulmonary symptoms require immediate medical evaluation.
- Posterior reversible encephalopathy syndrome (PRES): This rare but serious neurological condition may present with seizures, hypertension, headache, lethargy, confusion, blindness, or other visual and neurological disturbances. Brain imaging (MRI) is required for confirmation. Treatment must be discontinued if PRES is suspected.
- Hepatotoxicity: Cases of hepatitis, elevated liver enzymes, hyperbilirubinemia, and hepatic failure (some fatal) have been reported. Patients with impaired hepatic function should be treated with caution and at reduced doses. Liver function should be monitored regularly.
- Tumor lysis syndrome (TLS): Rapid tumor destruction can lead to metabolic complications including hyperkalemia, hyperphosphatemia, hyperuricemia, and hypocalcemia. Patients with high tumor burden are at greatest risk. Adequate hydration and monitoring of electrolytes are essential.
- Herpes zoster reactivation: Bortezomib treatment significantly increases the risk of herpes zoster (shingles) reactivation. Without prophylaxis, approximately 13% of patients develop herpes zoster. Antiviral prophylaxis with acyclovir or valacyclovir should be started before beginning bortezomib and continued throughout treatment and for at least 90 days after completing therapy.
- Gastrointestinal toxicity: Nausea, vomiting, diarrhea, and constipation are common. Ileus (bowel obstruction) has been reported in rare cases. Patients should maintain adequate fluid intake and report severe gastrointestinal symptoms promptly.
- Immune-mediated thrombocytopenia: In rare cases, bortezomib-associated thrombocytopenia may have an immune-mediated component that does not respond to the expected cyclical recovery pattern. Persistent thrombocytopenia warrants further investigation.
Pregnancy and Breastfeeding
Bortezomib should not be used during pregnancy as it may harm the developing fetus. Animal studies have shown embryo-fetal toxicity including reduced fetal weight and skeletal malformations. Women of childbearing potential must use effective contraception during treatment and for 3 months after the last dose. Men must also use effective contraception during treatment and for 3 months after the final dose.
If you become pregnant during treatment with bortezomib, or if your partner becomes pregnant, inform your doctor immediately. The potential risks to the fetus should be discussed, and appropriate counseling provided.
It is not known whether bortezomib or its metabolites are excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding must be discontinued during treatment with Bortezomib Glenmark. Discuss with your doctor when it is safe to resume breastfeeding after completing treatment.
Bortezomib may impair fertility in both men and women. Animal studies have shown effects on both male and female reproductive organs. Patients who wish to have children should discuss fertility preservation options with their doctor before starting treatment.
How Does Bortezomib Glenmark Interact with Other Drugs?
Drug interactions with bortezomib are clinically important and can significantly affect both the safety and effectiveness of treatment. Bortezomib undergoes oxidative deboronation primarily via cytochrome P450 enzymes CYP3A4, CYP2C19, and CYP1A2. Medications that modulate the activity of these enzymes can alter bortezomib plasma concentrations. Additionally, bortezomib itself may affect the metabolism or pharmacodynamics of co-administered drugs. It is essential to inform your healthcare team about all prescription medications, over-the-counter drugs, herbal supplements, and dietary products you are taking.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Ketoconazole and other strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, clarithromycin) | Increased bortezomib exposure (AUC increased by approximately 35% with ketoconazole) | Close monitoring for toxicity required; dose reduction may be necessary |
| Rifampicin and other strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, St. John’s Wort) | Decreased bortezomib exposure (AUC decreased by approximately 45% with rifampicin) | Combination not recommended; significant reduction in efficacy expected |
| Oral antidiabetic agents (e.g., metformin, sulfonylureas, insulin) | Hypo- or hyperglycemia reported in diabetic patients receiving bortezomib | Close blood glucose monitoring required; dose adjustments of antidiabetics may be needed |
| Oral anticoagulants (e.g., warfarin) | Altered INR values; increased or decreased anticoagulant effect | Frequent INR monitoring required; dose adjustments of anticoagulant may be necessary |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, verapamil) | Possible moderate increase in bortezomib exposure | Use with caution; monitor for increased side effects |
| Dexamethasone (commonly co-administered) | Both CYP3A4 substrate and weak inducer; no clinically significant pharmacokinetic interaction | Standard combination; no dose adjustment required for the interaction |
| Melphalan and prednisone (VMP regimen) | No significant pharmacokinetic interaction; additive myelosuppressive effects | Approved combination; blood count monitoring is essential |
| Antihypertensive agents | Additive hypotensive effect with bortezomib-induced orthostatic hypotension | Blood pressure monitoring; consider dose reduction of antihypertensives |
In vitro studies indicate that bortezomib is a weak inhibitor of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. However, at clinically relevant concentrations, significant inhibition of these enzymes is not expected. Nonetheless, when bortezomib is combined with narrow therapeutic index drugs metabolized by CYP2C19 (e.g., phenytoin) or CYP2C9 (e.g., warfarin), patients should be carefully monitored for any changes in the efficacy or toxicity of these medications.
It is particularly important to note the interaction between bortezomib and oral hypoglycemic agents in patients with diabetes mellitus. Cases of both hypoglycemia and hyperglycemia have been reported during bortezomib treatment. The mechanism is not fully elucidated but may involve bortezomib’s effects on insulin receptor signaling and glucose metabolism. Diabetic patients should monitor their blood glucose levels more frequently during treatment, and dose adjustments of their antidiabetic medications may be required.
What Is the Correct Dosage of Bortezomib Glenmark?
Bortezomib Glenmark must be prescribed and administered by a physician experienced in the use of anticancer chemotherapy. The dose is calculated based on the patient’s body surface area (BSA), which takes into account both height and weight. The standard dose across most treatment regimens is 1.3 mg/m² BSA. The maximum single dose should not exceed 1.3 mg/m² in any regimen.
Adults
Multiple Myeloma – VMP Regimen (Bortezomib + Melphalan + Prednisone)
Indication: Previously untreated multiple myeloma in patients not eligible for transplantation
Dose: 1.3 mg/m² subcutaneously or intravenously
Cycles 1–4: Days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle (twice weekly for 4 weeks, rest, then twice weekly for 4 weeks)
Cycles 5–9: Days 1, 8, 22, and 29 of a 42-day cycle (once weekly)
Duration: Up to 9 cycles (approximately 54 weeks)
Multiple Myeloma – Monotherapy or with Dexamethasone (Relapsed/Refractory)
Indication: Progressive multiple myeloma after at least one prior therapy
Dose: 1.3 mg/m² subcutaneously or intravenously
Schedule: Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period (days 12–21)
Duration: A maximum of 8 cycles is recommended for monotherapy. Patients may receive up to 8 additional cycles when combined with dexamethasone.
Multiple Myeloma – Induction Before Transplantation
Indication: Induction therapy in transplant-eligible patients
Dose: 1.3 mg/m² subcutaneously or intravenously
With Dexamethasone: Days 1, 4, 8, and 11 of a 21-day cycle for 4 cycles
With Dexamethasone + Thalidomide (VTD): Days 1, 4, 8, and 11 of a 21-day cycle for 4 cycles before and 2 cycles after transplantation
Mantle Cell Lymphoma – VR-CAP Regimen
Indication: Previously untreated mantle cell lymphoma not eligible for transplantation
Dose: 1.3 mg/m² subcutaneously or intravenously on days 1, 4, 8, and 11 of a 21-day cycle
Duration: 6 cycles, with potential for 2 additional cycles (total up to 8 cycles)
Combined with rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV on day 1, doxorubicin 50 mg/m² IV on day 1, and prednisone 100 mg/m² orally on days 1–5.
Children
The safety and efficacy of Bortezomib Glenmark in children and adolescents under 18 years of age have not been established. There are no data available for pediatric use, and it is not indicated for use in this population.
Elderly
No overall differences in the safety or effectiveness of bortezomib have been observed between elderly patients (65 years and older) and younger adults in clinical trials. However, elderly patients may be more susceptible to certain side effects, particularly peripheral neuropathy, gastrointestinal toxicity, and cardiac complications. No specific dose adjustment is required solely based on age, but careful clinical monitoring is recommended, and dose modifications should be implemented promptly if significant toxicities develop.
For patients with hepatic impairment, dose reduction is recommended. Patients with mild hepatic impairment (bilirubin ≤1.0 × ULN) do not require adjustment. Those with moderate (bilirubin 1.5–3 × ULN) or severe (bilirubin >3 × ULN) impairment should start at a reduced dose of 0.7 mg/m² in the first cycle, with subsequent dose escalation to 1.0 mg/m² or further reduction to 0.5 mg/m² based on tolerability.
Missed Dose
If a dose of Bortezomib Glenmark is missed during a scheduled treatment cycle, your doctor will determine the best course of action. In general, if a dose is missed, it should be administered as soon as possible, provided that at least 72 hours have elapsed since the last dose. The treatment schedule should then be adjusted accordingly to maintain appropriate dosing intervals. It is important not to double the dose to make up for a missed one.
Overdose
There is no specific antidote for bortezomib overdose. Cases of fatal cardiac and respiratory failure have been reported following overdose with more than twice the recommended dose. In the event of an overdose, vital signs should be closely monitored, and supportive care should be provided. Particular attention should be paid to maintaining blood pressure and body temperature. Monitoring of blood counts, electrolytes, and liver function is essential, and any complications should be managed with appropriate supportive therapy.
What Are the Side Effects of Bortezomib Glenmark?
Like all medicines, Bortezomib Glenmark can cause side effects, although not everybody experiences them. Some of these side effects may be serious and require immediate medical attention. The following overview summarizes the known adverse reactions by frequency category, based on data from clinical trials and post-marketing surveillance with bortezomib.
The side effect profile of bortezomib is well characterized through years of clinical use. Many side effects are dose-dependent and can be managed through dose modifications, supportive care, and prophylactic measures. Your healthcare team will monitor you closely throughout treatment and will implement dose adjustments or treatment interruptions as needed.
Very Common
May affect more than 1 in 10 people
- Nausea and vomiting
- Diarrhea
- Constipation
- Fatigue and general weakness (asthenia)
- Peripheral neuropathy (numbness, tingling, burning, or pain in hands/feet)
- Thrombocytopenia (low platelet count)
- Neutropenia (low white blood cell count)
- Anemia (low red blood cell count)
- Decreased appetite
- Fever (pyrexia)
- Herpes zoster (shingles) reactivation
- Headache
- Upper respiratory tract infection
- Injection site reactions (subcutaneous route: redness, swelling, itching)
Common
May affect up to 1 in 10 people
- Pneumonia and other lower respiratory tract infections
- Herpes simplex reactivation
- Orthostatic hypotension (dizziness upon standing)
- Hypotension (low blood pressure)
- Rash, itching (pruritus)
- Muscle and joint pain (myalgia, arthralgia)
- Abdominal pain
- Dehydration
- Insomnia
- Dizziness
- Peripheral edema (swelling of limbs)
- Dysgeusia (altered sense of taste)
- Blurred vision
- Dyspnea (shortness of breath)
- Elevated liver enzymes (ALT, AST)
Uncommon
May affect up to 1 in 100 people
- Tumor lysis syndrome
- Heart failure, pericardial effusion
- Pulmonary hypertension
- Posterior reversible encephalopathy syndrome (PRES)
- Autonomic neuropathy (affecting involuntary body functions)
- Ileus (bowel obstruction)
- Hepatitis and hepatotoxicity
- Disseminated herpes zoster
- Sepsis and septic shock
- Encephalopathy
Rare
May affect up to 1 in 1,000 people
- Progressive multifocal leukoencephalopathy (PML)
- Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
- Acute respiratory distress syndrome (ARDS)
- Cranial nerve palsies
- Optic neuropathy and blindness
- Immune complex-mediated hypersensitivity (type III)
- Ischemic colitis
- Acute febrile neutrophilic dermatosis (Sweet syndrome)
Not Known
Frequency cannot be estimated from available data
- Hearing loss, deafness
- Gastrointestinal hemorrhage
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Reactivation of hepatitis B virus
Contact your doctor or seek emergency medical care immediately if you experience any of the following: severe numbness or weakness in your limbs; difficulty breathing or chest pain; severe abdominal pain; unusual bleeding or bruising; high fever with low blood counts; signs of infection (chills, body aches); severe skin reactions (widespread rash with blistering); sudden changes in vision; seizures; or confusion and altered consciousness.
The peripheral neuropathy associated with bortezomib deserves particular attention. In clinical trials, peripheral neuropathy of any grade occurred in approximately 30–40% of patients receiving intravenous bortezomib, with severe (grade 3 or higher) neuropathy occurring in about 12–14% of patients. The landmark VISTA trial comparing VMP with MP demonstrated that subcutaneous administration reduced the overall incidence of peripheral neuropathy to approximately 24%, with severe neuropathy occurring in only 6% of patients. For this reason, subcutaneous administration is now the preferred route.
The thrombocytopenia caused by bortezomib follows a characteristic cyclical pattern that distinguishes it from the bone marrow suppression seen with conventional chemotherapy. Platelet counts typically decrease during the first 11 days of each 21-day treatment cycle, reach a nadir around day 11, and then recover during the 10-day rest period before the next cycle. This predictable pattern allows for appropriate monitoring and dose management. In the clinical trials, grade 3 thrombocytopenia (platelet count 25,000–50,000/µL) occurred in approximately 24–30% of patients, while grade 4 thrombocytopenia (below 25,000/µL) occurred in about 3–5% of patients.
Gastrointestinal side effects, particularly nausea, vomiting, diarrhea, and constipation, are among the most frequently reported adverse reactions. These symptoms can often be managed effectively with supportive medications such as antiemetics (e.g., ondansetron), loperamide for diarrhea, and laxatives for constipation. Maintaining adequate hydration and nutrition is important throughout treatment.
How Should You Store Bortezomib Glenmark?
Proper storage of Bortezomib Glenmark is essential to maintain the potency and safety of the medication. As this is a hospital-administered product, storage conditions are typically managed by the healthcare facility’s pharmacy department. However, understanding the storage requirements helps ensure optimal treatment quality.
The following storage conditions apply to unopened vials of Bortezomib Glenmark:
- Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
- Freezing: Do not freeze the product. If accidental freezing occurs, the solution may still be used if the product is refrigerator thawed to 2°C–8°C. Check for precipitation or discoloration before use.
- Light protection: Keep the vial in the original outer carton to protect from light.
- Shelf life: Follow the expiry date printed on the carton and vial label. Do not use the medicine after the expiry date.
Once the vial has been opened, the solution should be used immediately or within the timeframe specified in the product information, as preservative-free formulations have limited microbiological stability after opening. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the healthcare professional.
Before administration, the solution should be visually inspected for particulate matter and discoloration. The solution should be clear and colorless to slightly yellow. Do not use the solution if it is discolored, cloudy, or contains visible particles.
As with all medicines, keep Bortezomib Glenmark out of the sight and reach of children. Do not dispose of unused medicines via household waste or wastewater. Healthcare professionals should follow local regulations for the safe disposal of cytotoxic agents.
What Does Bortezomib Glenmark Contain?
Understanding the composition of Bortezomib Glenmark is important for healthcare professionals preparing and administering the medication, as well as for identifying potential allergens. The complete composition is as follows:
Active Substance
The active ingredient is bortezomib. Each milliliter of solution contains 2.5 mg of bortezomib. Bortezomib is a modified dipeptidyl boronic acid (pyrazinylcarbonyl-phenylalanyl-leucyl boronic acid) with the molecular formula C19H25BN4O4 and a molecular weight of 384.24 g/mol. The boron atom in the molecule is critical for its mechanism of action, as it forms a reversible covalent bond with the threonine residue in the active site of the proteasome’s catalytic subunit.
Excipients (Inactive Ingredients)
- Mannitol: A sugar alcohol used as a bulking agent and to provide isotonicity to the solution.
- Citric acid monohydrate: Used as a buffering agent to maintain the appropriate pH of the solution.
- Sodium citrate dihydrate: A buffering agent that works in conjunction with citric acid to maintain pH stability.
- Water for injections: The solvent used to prepare the injectable solution.
Bortezomib Glenmark is supplied as a clear, colorless to slightly yellow solution in a glass vial. The ready-to-use solution formulation distinguishes it from lyophilized (freeze-dried) bortezomib products that require reconstitution before use. This offers practical advantages in the clinical setting, as it reduces preparation time, minimizes the risk of dosing errors associated with reconstitution, and eliminates potential issues with incomplete dissolution of the lyophilized powder.
The solution contains sodium. Each vial contains a small amount of sodium from the sodium citrate excipient. Patients on a strict sodium-restricted diet should be informed of this content, although the amount per dose is negligibly small and unlikely to be clinically significant.
The glass vial has a rubber stopper closure. Patients or healthcare professionals with known latex allergies should check with the manufacturer regarding the stopper material, as some rubber stoppers may contain natural rubber latex derivatives.
Frequently Asked Questions About Bortezomib Glenmark
Bortezomib Glenmark is a proteasome inhibitor used to treat multiple myeloma (a cancer of the bone marrow plasma cells) and mantle cell lymphoma (a type of non-Hodgkin lymphoma). It may be used alone or in combination with other chemotherapy agents such as melphalan, prednisone, dexamethasone, rituximab, or cyclophosphamide, depending on the stage and prior treatment history of the disease. It is approved for both newly diagnosed and relapsed or refractory disease in adult patients.
Bortezomib Glenmark is a generic version of Velcade, containing the same active ingredient (bortezomib) and approved for the same indications. The main difference is that Bortezomib Glenmark is supplied as a ready-to-use solution for injection (2.5 mg/ml), whereas the original Velcade was initially available only as a lyophilized powder requiring reconstitution. Generic medicines must demonstrate bioequivalence to the reference product and meet the same regulatory standards for quality, safety, and efficacy.
The subcutaneous route of administration is generally preferred because clinical studies have shown it significantly reduces the incidence and severity of peripheral neuropathy compared to intravenous injection. The landmark phase III trial by Moreau et al. (2011) demonstrated that the overall rate of peripheral neuropathy was 24% with subcutaneous versus 41% with intravenous administration, while the efficacy (response rates and progression-free survival) remained equivalent between the two routes. Subcutaneous injection also offers greater convenience and shorter administration time.
The duration of treatment varies depending on the specific regimen and indication. For previously untreated multiple myeloma with the VMP regimen, treatment consists of up to 9 cycles over approximately 54 weeks. For relapsed disease as monotherapy, a maximum of 8 cycles is recommended. Induction therapy before transplantation typically involves 4 cycles. For mantle cell lymphoma with VR-CAP, 6 to 8 cycles are given. Your doctor will determine the optimal duration based on your response and tolerability.
Some herbal supplements can interact with bortezomib and affect its safety or efficacy. In particular, St. John’s Wort (Hypericum perforatum) is a strong CYP3A4 inducer that can significantly reduce bortezomib levels in the blood, potentially making the treatment less effective. Green tea extracts containing epigallocatechin gallate (EGCG) have also been shown in laboratory studies to potentially interfere with bortezomib’s mechanism of action. Always inform your doctor about any herbal supplements, vitamins, or dietary products you are taking or considering.
Bortezomib suppresses certain aspects of the immune system, particularly T-cell mediated immunity, which is the body’s primary defense against viral infections. This increases the risk of herpes zoster (shingles) reactivation from the dormant varicella-zoster virus that remains in nerve cells after childhood chickenpox. Clinical studies showed that without antiviral prophylaxis, approximately 13% of patients developed herpes zoster during bortezomib treatment. Antiviral medications such as acyclovir or valacyclovir effectively prevent this complication and are recommended throughout treatment and for at least 90 days after the last dose.
References
- European Medicines Agency (EMA). Bortezomib Glenmark – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Velcade (bortezomib) for injection – Prescribing Information. Available at: www.accessdata.fda.gov. Accessed January 2026.
- San Miguel JF, Schlag R, Khuageva NK, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008;359(9):906-917. doi:10.1056/NEJMoa0801479 (VISTA trial).
- Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12(5):431-440. doi:10.1016/S1470-2045(11)70081-X.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 1.2025. Available at: www.nccn.org.
- Dimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines. Ann Oncol. 2021;32(3):309-322. doi:10.1016/j.annonc.2020.11.014.
- Robak T, Huang H, Jin J, et al. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015;372(10):944-953. doi:10.1056/NEJMoa1412096 (LYM-3002 trial).
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. 2023. Available at: www.who.int.
- Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003;348(26):2609-2617. doi:10.1056/NEJMoa030288.
- Chanan-Khan AA, Sonneveld P, Schuster MW, et al. Analysis of herpes zoster events among bortezomib-treated patients in the phase III APEX study. J Clin Oncol. 2008;26(29):4784-4790. doi:10.1200/JCO.2007.14.9641.
Medical Editorial Team
Medical Content
iMedic Medical Editorial Team – Specialists in Oncology, Hematology, and Clinical Pharmacology
Medical Review
iMedic Medical Review Board – Independent panel following EMA, FDA, NCCN, and ESMO guidelines
Evidence Standard
Level 1A – Based on systematic reviews and randomized controlled trials (VISTA, LYM-3002, Moreau et al.)
Last Reviewed
January 12, 2026 – Updated to reflect current EMA SmPC, FDA label, NCCN and ESMO guidelines
All content on iMedic is written and reviewed by qualified medical professionals. We follow international evidence-based guidelines and the GRADE framework for assessing the quality of medical evidence. Our editorial process ensures independence from pharmaceutical industry funding. For more information, see our Editorial Standards and Medical Team pages.