Bortezomib Medical Valley
Proteasome inhibitor for the treatment of multiple myeloma and mantle cell lymphoma
Quick Facts About Bortezomib Medical Valley
Key Takeaways About Bortezomib Medical Valley
- First-in-class proteasome inhibitor: Bortezomib was the first proteasome inhibitor approved for cancer treatment and remains a cornerstone of multiple myeloma therapy
- Subcutaneous preferred over IV: Subcutaneous injection significantly reduces the risk of peripheral neuropathy compared to intravenous administration while maintaining equal efficacy
- Antiviral prophylaxis required: All patients must receive antiviral medication (e.g., aciclovir) to prevent herpes zoster reactivation during treatment
- Cyclical thrombocytopenia: Platelet counts typically drop during each treatment cycle and recover before the next cycle, requiring regular blood monitoring
- Not for intrathecal use: Intrathecal administration of bortezomib has resulted in death and is strictly contraindicated
What Is Bortezomib Medical Valley and What Is It Used For?
Bortezomib Medical Valley is a proteasome inhibitor indicated for the treatment of adult patients with multiple myeloma and mantle cell lymphoma. It works by selectively and reversibly blocking the 26S proteasome, a key cellular enzyme complex, which triggers cancer cell death through multiple mechanisms.
Bortezomib Medical Valley contains the active substance bortezomib, a dipeptide boronic acid that was the first proteasome inhibitor developed for clinical use in oncology. The 26S proteasome is a large protein complex found in all cells that is responsible for breaking down proteins that have been tagged for destruction. Cancer cells, particularly myeloma cells, are highly dependent on this protein recycling system due to their rapid growth and high metabolic activity.
By inhibiting the proteasome, bortezomib causes an accumulation of regulatory proteins inside the cell, disrupting the delicate balance of protein homeostasis. This leads to activation of multiple cell death pathways, cell cycle arrest, and inhibition of the NF-kB signalling pathway, which is a major survival mechanism for myeloma cells. The selectivity of this effect means that cancer cells, which divide rapidly and produce large amounts of abnormal proteins, are more susceptible to proteasome inhibition than normal cells.
Bortezomib Medical Valley is approved and used in the following clinical indications:
- Previously untreated multiple myeloma: In combination with melphalan and prednisone (VMP regimen) for patients who are not eligible for high-dose chemotherapy with stem cell transplantation. It is also used with dexamethasone, or with dexamethasone and thalidomide, for patients who may proceed to transplantation.
- Progressive multiple myeloma: As monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone for patients who have received at least one prior therapy.
- Mantle cell lymphoma (MCL): In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for previously untreated patients unsuitable for haematopoietic stem cell transplantation. It is also used as monotherapy for relapsed or refractory MCL after at least one prior therapy.
The introduction of bortezomib represented a paradigm shift in multiple myeloma treatment. Before its approval, median survival for myeloma patients was approximately 3-4 years. With modern bortezomib-containing regimens combined with other novel agents, survival has improved significantly, with many patients surviving beyond 7-10 years. The drug has been included on the WHO Model List of Essential Medicines, underscoring its importance in global cancer care.
Bortezomib Medical Valley is a generic version of the originator product (Velcade). Generic bortezomib products have been shown to be bioequivalent to the originator and meet the same quality, safety, and efficacy standards as required by regulatory authorities such as the European Medicines Agency (EMA) and national medicines agencies.
What Should You Know Before Taking Bortezomib Medical Valley?
Before starting bortezomib treatment, your doctor will perform comprehensive blood tests, assess your heart and lung function, check for pre-existing neuropathy, and ensure antiviral prophylaxis is in place. Several conditions and medications may require special precautions or prevent use of this medicine.
Contraindications
Bortezomib Medical Valley must not be used in patients with a known hypersensitivity to bortezomib, boron, or any of the excipients (mannitol, nitrogen). It is also contraindicated in patients with severe hepatic impairment, as the drug is primarily metabolized in the liver and accumulation could lead to increased toxicity. Patients with acute diffuse infiltrative pulmonary disease or pericardial disease should not receive this medication due to the risk of cardiopulmonary complications.
When bortezomib is used in combination with other medications, the contraindications for those agents must also be observed. For example, thalidomide is absolutely contraindicated in pregnancy, and melphalan carries specific restrictions regarding bone marrow function. Clinicians must review the prescribing information for each combination agent before initiating treatment.
Intrathecal (spinal) administration of bortezomib has resulted in death. Bortezomib Medical Valley must only be administered intravenously or subcutaneously. This medication should never be administered by the intrathecal route.
Warnings and Precautions
Several important warnings and precautions apply to bortezomib therapy. Your treating physician should be aware of all of the following considerations:
- Peripheral neuropathy: Bortezomib frequently causes peripheral neuropathy, which may be sensory, motor, or mixed. Pre-existing neuropathy may worsen. Dose modification guidelines exist based on neuropathy grade and should be followed strictly. Subcutaneous administration is associated with significantly lower rates of neuropathy than intravenous administration.
- Thrombocytopenia and neutropenia: Bortezomib causes cyclical thrombocytopenia with platelet nadirs typically occurring on day 11 of each cycle and recovering by day 21. Complete blood counts must be monitored before each dose. Dose modifications or delays may be required for severe cytopenias.
- Gastrointestinal events: Nausea, vomiting, diarrhoea, and constipation are common. Severe cases including paralytic ileus have been reported. Patients should be monitored and managed with appropriate supportive care including fluid replacement and anti-emetics.
- Hypotension: Orthostatic or postural hypotension occurs in some patients. Those with pre-existing low blood pressure, those taking antihypertensive medications, or those who are dehydrated are at increased risk. Adequate hydration should be maintained.
- Cardiac disorders: Rare cases of acute heart failure, congestive heart failure, decreased left ventricular ejection fraction, and QT prolongation have been reported. Patients with risk factors for or existing cardiac disease should be closely monitored.
- Pulmonary disorders: Rare cases of acute respiratory distress syndrome (ARDS) and pulmonary hypertension have been reported. Patients should report new or worsening respiratory symptoms promptly.
- Posterior reversible encephalopathy syndrome (PRES): Cases of PRES, characterized by seizures, headache, visual disturbances, and altered consciousness, have been reported. Bortezomib should be discontinued if PRES is suspected.
- Hepatic disorders: Hepatitis, increased liver enzymes, hyperbilirubinaemia, and rare cases of hepatic failure have been reported. Liver function tests should be monitored regularly during treatment.
- Tumour lysis syndrome: Because bortezomib is cytotoxic and can rapidly kill tumour cells, tumour lysis syndrome may occur, particularly in patients with high tumour burden. Adequate hydration and monitoring of uric acid, potassium, and renal function is recommended.
- Herpes zoster reactivation: Antiviral prophylaxis is recommended for all patients receiving bortezomib. The incidence of herpes zoster is significantly elevated in patients treated with this drug.
Pregnancy and Breastfeeding
Bortezomib Medical Valley should not be used during pregnancy. Animal studies have demonstrated embryo-fetal toxicity, including decreased fetal weight, post-implantation loss, and skeletal abnormalities at doses that were lower than the clinical therapeutic dose. There are no adequate and well-controlled studies in pregnant women.
Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Men receiving bortezomib should also use effective contraception during treatment and for 3 months following the last dose. It is not known whether bortezomib affects male fertility; however, fertility studies in animals have shown decreased fertility in male rats at doses below the clinical dose.
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 bortezomib treatment and should not be resumed until at least 2 months after the last dose.
How Does Bortezomib Medical Valley Interact with Other Drugs?
Bortezomib is metabolized by cytochrome P450 enzymes (CYP3A4, CYP2C19, CYP1A2), and drugs that inhibit or induce these enzymes can significantly affect bortezomib levels in the body. Patients should inform their doctor about all medications, supplements, and herbal products they are taking.
Drug interactions with bortezomib can be clinically significant and potentially dangerous. The metabolism of bortezomib involves several cytochrome P450 enzymes, primarily CYP3A4, CYP2C19, and CYP1A2. Substances that interfere with these enzymes can either increase the concentration of bortezomib in the blood (potentially increasing toxicity) or decrease its concentration (potentially reducing efficacy).
In vitro studies have shown that bortezomib is a weak inhibitor of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Therefore, bortezomib itself is unlikely to significantly affect the metabolism of other drugs through these pathways at clinically relevant concentrations. However, clinical monitoring is still recommended when combining bortezomib with narrow therapeutic index drugs.
Major Interactions
| Drug / Class | Effect | Clinical Recommendation |
|---|---|---|
| Strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) | May increase bortezomib exposure by up to 35%, increasing risk of toxicity | Monitor closely for adverse effects; consider dose reduction if necessary |
| Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin) | May decrease bortezomib exposure by up to 45%, reducing therapeutic efficacy | Avoid concomitant use; if unavoidable, monitor for reduced bortezomib efficacy |
| St. John's Wort (Hypericum perforatum) | Strong CYP3A4 inducer; unpredictable reduction of bortezomib levels | Contraindicated; patients must avoid St. John's Wort during treatment |
| Oral hypoglycaemic agents (metformin, sulfonylureas, insulin) | Bortezomib may cause hypoglycaemia or hyperglycaemia, altering diabetic control | Monitor blood glucose closely; adjust diabetes medication dosing as needed |
| Antihypertensive medications | Bortezomib can cause hypotension; combined effect may be additive | Monitor blood pressure; adjust antihypertensive doses if symptomatic hypotension occurs |
Minor Interactions
Although not all drug interactions with bortezomib are considered major, several other classes of medications warrant attention during treatment:
- Dexamethasone: Commonly used in combination with bortezomib. While the combination is a standard treatment regimen, dexamethasone is both a substrate and a weak inducer of CYP3A4, though this interaction does not typically require dose adjustment of either drug.
- Green tea extracts: In vitro studies have suggested that polyphenols in green tea may interfere with the anti-cancer activity of bortezomib. While the clinical relevance is uncertain, some oncologists advise patients to avoid concentrated green tea supplements during treatment.
- Vitamin C supplements: High-dose ascorbic acid has been theoretically linked to reduced bortezomib activity through antioxidant mechanisms, although clinical evidence is limited. Patients should discuss supplementation with their oncologist.
- Alcohol: Patients should limit or avoid alcohol consumption due to the risk of additive hepatotoxicity and the potential to worsen peripheral neuropathy.
What Is the Correct Dosage of Bortezomib Medical Valley?
The standard dose of bortezomib is 1.3 mg/m² body surface area, given as an intravenous bolus or subcutaneous injection. Treatment follows specific cyclical schedules depending on the indication, and doses may be modified based on tolerability and side effects.
Bortezomib Medical Valley is supplied as a 3.5 mg vial of lyophilised powder that must be reconstituted before administration. For intravenous use, it is reconstituted with 3.5 mL of 0.9% sodium chloride to give a concentration of 1 mg/mL, and administered as a 3-5 second intravenous bolus injection. For subcutaneous use, it is reconstituted with 1.4 mL of 0.9% sodium chloride to give a concentration of 2.5 mg/mL, injected into the thigh or abdomen.
Adults
The recommended dose for all approved indications in adults is 1.3 mg/m² body surface area. The treatment schedule varies depending on the indication and combination regimen:
| Indication | Dose | Schedule | Cycle Length |
|---|---|---|---|
| Previously untreated myeloma (VMP) | 1.3 mg/m² | Cycles 1-4: twice weekly (days 1, 4, 8, 11, 22, 25, 29, 32). Cycles 5-9: once weekly (days 1, 8, 22, 29) | 6 weeks (cycles 1-4); 6 weeks (cycles 5-9) |
| Previously untreated myeloma (with dexamethasone) | 1.3 mg/m² | Twice weekly (days 1, 4, 8, 11) followed by 10-day rest period | 3 weeks for 8 cycles |
| Progressive myeloma (monotherapy) | 1.3 mg/m² | Twice weekly (days 1, 4, 8, 11) followed by 10-day rest | 3 weeks for up to 8 cycles |
| Mantle cell lymphoma (first-line combination) | 1.3 mg/m² | Twice weekly (days 1, 4, 8, 11) followed by 10-day rest | 3 weeks for 6 cycles |
| Relapsed MCL (monotherapy) | 1.3 mg/m² | Twice weekly (days 1, 4, 8, 11) followed by 10-day rest | 3 weeks for up to 8 cycles |
Children
Bortezomib Medical Valley is not indicated for use in children and adolescents under 18 years of age. The safety and efficacy of bortezomib have not been established in the paediatric population for the approved indications of multiple myeloma and mantle cell lymphoma. Although some clinical trials have explored the use of bortezomib in paediatric leukaemia and other malignancies, these uses remain investigational and are not covered by the current marketing authorisation.
Elderly
No dose adjustment is required based on age alone. However, elderly patients (over 75 years) may be at increased risk for certain adverse effects, including peripheral neuropathy, orthostatic hypotension, and gastrointestinal events. In the VMP regimen, elderly patients may be started on a once-weekly dosing schedule from the outset if there are concerns about tolerability. Clinical trials have shown that bortezomib is effective and manageable in elderly patients with appropriate dose modifications and supportive care.
Missed Dose
Because bortezomib is administered in a clinical setting by healthcare professionals, missed doses are uncommon but may occur due to patient illness, scheduling conflicts, or adverse events requiring treatment delays. If a dose is missed, the treatment schedule should be adjusted by the treating oncologist. There must be at least 72 hours between consecutive doses of bortezomib when given twice weekly. A missed dose should not be made up by doubling the next dose.
Overdose
In the event of an overdose, the patient should be hospitalised and monitored closely. There is no specific antidote for bortezomib overdose. Overdose with bortezomib at more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension (blood pressure drops that cause dizziness and fainting) and thrombocytopenia (dangerously low platelet counts), which may be fatal. Cardiovascular monitoring and supportive measures including blood pressure support, fluid administration, and platelet transfusion should be initiated as appropriate.
Bortezomib dose modifications are well-established for common toxicities. For peripheral neuropathy Grade 1 with pain or Grade 2, the dose should be reduced to 1.0 mg/m². For Grade 2 with pain or Grade 3, treatment should be withheld until symptoms resolve to Grade 1 or baseline, then restarted at 0.7 mg/m². For Grade 4 neuropathy, bortezomib should be permanently discontinued. For thrombocytopenia, if platelets fall below 25,000/μL or if neutrophils fall below 750/μL on a bortezomib dosing day, the dose should be withheld.
What Are the Side Effects of Bortezomib Medical Valley?
Side effects of bortezomib are common and can affect multiple organ systems. The most clinically significant include peripheral neuropathy, thrombocytopenia, gastrointestinal disturbances, fatigue, and herpes zoster reactivation. Most side effects are manageable with dose modifications and supportive care.
Like all chemotherapy agents, bortezomib can cause a range of side effects. The frequency and severity of adverse events depend on the dose, schedule, route of administration, and combination partners used. Clinical trials and post-marketing surveillance have identified the following side effects organised by frequency:
Very Common
- Thrombocytopenia (low platelet count)
- Neutropenia (low white blood cell count)
- Anaemia (low red blood cell count)
- Peripheral neuropathy (numbness, tingling, pain in hands/feet)
- Nausea
- Diarrhoea
- Constipation
- Vomiting
- Fatigue and asthenia (weakness)
- Pyrexia (fever)
- Decreased appetite
- Headache
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Herpes zoster reactivation (shingles)
Common
- Pneumonia and upper respiratory tract infections
- Hypotension (low blood pressure), including orthostatic hypotension
- Dyspnoea (shortness of breath)
- Rash, pruritus (itching)
- Dizziness
- Insomnia
- Peripheral oedema (swelling of hands/feet)
- Dehydration
- Abdominal pain
- Dysgeusia (altered taste)
- Blurred vision
- Elevated liver enzymes (ALT, AST)
- Hyperkalaemia or hypokalaemia
- Hyponatraemia
- Back pain, bone pain
Uncommon
- Heart failure (congestive or acute)
- QT prolongation on ECG
- Pulmonary hypertension
- Tumour lysis syndrome
- Paralytic ileus (bowel obstruction)
- Posterior reversible encephalopathy syndrome (PRES)
- Autonomic neuropathy
- Hearing impairment
- Hepatic failure
- Cerebrovascular events
Rare
- Progressive multifocal leukoencephalopathy (PML)
- Acute respiratory distress syndrome (ARDS)
- Optic neuropathy and blindness
- Disseminated intravascular coagulation (DIC)
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Pericardial effusion
- Haemorrhagic events (GI, cerebral)
Peripheral neuropathy deserves special attention as it is one of the most clinically significant adverse effects. The SUMMIT and APEX clinical trials demonstrated that peripheral neuropathy occurs in approximately 30-40% of patients treated with intravenous bortezomib. The landmark phase III MMY-3021 trial demonstrated that subcutaneous administration reduced the incidence of grade 2 or higher peripheral neuropathy from 41% to 24% while maintaining equivalent anti-tumour efficacy. For this reason, subcutaneous injection is now the preferred route of administration in many clinical guidelines.
Thrombocytopenia follows a characteristic cyclical pattern during bortezomib treatment. Platelets typically reach their nadir (lowest point) around day 11 of each 21-day treatment cycle and recover to baseline levels by day 21 before the next cycle begins. This predictable pattern allows clinicians to plan dose modifications and monitor patients effectively. Platelet counts must be checked before each dose of bortezomib, and treatment should be withheld if the platelet count falls below 25,000/μL.
Contact your healthcare team immediately if you experience: sudden onset of numbness or weakness on one side of the body (possible stroke), severe difficulty breathing, chest pain, seizures or severe headache with visual disturbances (possible PRES), signs of infection with fever above 38°C, severe diarrhoea or vomiting leading to dehydration, or any bleeding that does not stop.
How Should You Store Bortezomib Medical Valley?
Bortezomib Medical Valley 3.5 mg powder for solution for injection should be stored below 25°C in the original packaging, protected from light. As a hospital-administered medication, storage and handling are managed by pharmacy staff and healthcare professionals.
The unopened vial of Bortezomib Medical Valley should be stored at temperatures not exceeding 25°C (77°F). The vial should be kept in the original carton to protect the powder from light. No special requirements for refrigeration are needed for the unopened product, which simplifies logistics compared to some other oncology medications.
Once reconstituted, the solution should be used immediately. However, chemical and physical in-use stability has been demonstrated for up to 8 hours at 25°C in the original vial and/or in a syringe, when stored protected from light. The total storage time for the reconstituted solution must not exceed 8 hours. If the solution is not used immediately, storage times and conditions prior to use are the responsibility of the user. The reconstituted solution should be clear and colourless; if any discolouration, particulate matter, or precipitation is observed, the solution must be discarded.
This medication should not be used after the expiry date stated on the vial label and outer carton. The expiry date refers to the last day of that month. As with all medications, Bortezomib Medical Valley should be kept out of the sight and reach of children.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic agents. Healthcare professionals handling bortezomib should follow institutional guidelines for the safe handling of hazardous drugs, including the use of appropriate personal protective equipment (gloves, gowns, eye protection) during reconstitution and administration.
What Does Bortezomib Medical Valley Contain?
Each vial of Bortezomib Medical Valley contains 3.5 mg of bortezomib as a boronic acid mannitol ester. The only excipient is mannitol (E421). The vial is filled with nitrogen gas to maintain product stability.
The active substance in Bortezomib Medical Valley is bortezomib, a modified dipeptide boronic acid. Chemically, bortezomib is known as [(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid. Each vial contains 3.5 mg of bortezomib as a mannitol boronic ester. When the powder is reconstituted, the boronic ester undergoes hydrolysis to release the active bortezomib molecule.
The only excipient is mannitol (also known as E421), which serves as a bulking agent and lyoprotectant during the freeze-drying process. Mannitol is a widely used pharmaceutical excipient with an excellent safety profile. The headspace of the vial is filled with nitrogen gas to prevent oxidation of the product during storage.
Bortezomib Medical Valley does not contain any preservatives, antimicrobials, dyes, lactose, gluten, or animal-derived ingredients. The product is supplied as a white to off-white lyophilised cake or powder in a single-use Type I clear glass vial with a rubber stopper and aluminium flip-off seal.
Frequently Asked Questions About Bortezomib Medical Valley
Bortezomib Medical Valley is used to treat multiple myeloma (a cancer of the bone marrow plasma cells) and mantle cell lymphoma (a type of non-Hodgkin lymphoma). In multiple myeloma, it is used as part of first-line treatment regimens for patients who are not eligible for stem cell transplantation, or in combination with dexamethasone for transplant-eligible patients. It is also used for patients whose myeloma has come back after previous treatment. For mantle cell lymphoma, it can be used alone or in combination with other chemotherapy drugs.
Clinical evidence from the phase III MMY-3021 trial has demonstrated that subcutaneous administration of bortezomib is as effective as intravenous administration, while offering a significantly reduced risk of peripheral neuropathy (24% vs 41% for grade 2 or higher). The overall response rates and progression-free survival were equivalent between the two routes. For this reason, subcutaneous injection is now preferred by most clinicians and is recommended in several international guidelines, including those from the European Myeloma Network and NCCN.
Bortezomib suppresses certain immune functions, particularly the activity of natural killer cells and aspects of T-cell mediated immunity. This creates conditions favourable for the reactivation of latent varicella zoster virus (the virus that causes chickenpox and shingles). Without antiviral prophylaxis, the incidence of herpes zoster reactivation in bortezomib-treated patients ranges from 13% to over 20%. With prophylactic aciclovir or valaciclovir, this risk drops to approximately 3%. Antiviral prophylaxis should be initiated when bortezomib treatment begins and continued throughout the treatment period.
The duration of treatment varies depending on the indication and regimen used. For previously untreated multiple myeloma with the VMP regimen, treatment consists of 9 cycles of approximately 6 weeks each, lasting around 54 weeks in total. For relapsed myeloma, treatment typically involves up to 8 cycles of 3 weeks each (approximately 6 months), though patients who respond well may continue treatment for up to 11 cycles. For mantle cell lymphoma, initial treatment is usually 6 cycles of 3 weeks. Your oncologist will determine the optimal treatment duration based on your individual response and tolerability.
Bortezomib Medical Valley is a generic version of Velcade (the originator brand). Both products contain exactly the same active substance (bortezomib) at the same strength (3.5 mg per vial) and are administered in the same way. Generic medicines must meet strict quality, safety, and efficacy standards set by regulatory authorities and must demonstrate pharmaceutical equivalence to the originator product. The primary differences are the manufacturer and typically the cost, with generic versions generally being more affordable, which helps improve access to this important cancer treatment worldwide.
Bortezomib may cause fatigue, dizziness, syncope (fainting), orthostatic hypotension, and blurred or double vision, all of which could impair your ability to drive or operate machinery safely. You should not drive or operate heavy machinery if you experience any of these symptoms. It is important to discuss your driving ability with your treating oncologist, particularly during the early cycles of treatment when side effects may be most pronounced. Individual responses vary, and your doctor can help you assess whether it is safe for you to drive.
References and Medical Sources
All information in this article is based on peer-reviewed medical literature, regulatory documents, and international clinical guidelines. The following sources were used:
- European Medicines Agency (EMA). Bortezomib - Summary of Product Characteristics. Available at: www.ema.europa.eu.
- Moreau P, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study (MMY-3021). The Lancet Oncology. 2011;12(5):431-440. doi:10.1016/S1470-2045(11)70081-X
- San Miguel JF, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma (VISTA trial). New England Journal of Medicine. 2008;359(9):906-917. doi:10.1056/NEJMoa0801479
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 4.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines - 23rd List, 2023. Available at: www.who.int.
- Robak T, et al. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma (LYM-3002 trial). New England Journal of Medicine. 2015;372(10):944-953. doi:10.1056/NEJMoa1412096
- Dimopoulos MA, et al. International Myeloma Working Group recommendations for the diagnosis and management of myeloma-related renal impairment. Journal of Clinical Oncology. 2016;34(13):1544-1557.
- Richardson PG, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma (APEX trial). New England Journal of Medicine. 2005;352(24):2487-2498. doi:10.1056/NEJMoa043445
- Chanan-Khan AA, et al. Antiviral prophylaxis reduces the incidence of herpes zoster reactivation in bortezomib-treated patients. Blood. 2008;112(11):3914.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Multiple Myeloma. Updated 2024.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology, haematology, and clinical pharmacology.
iMedic Medical Editorial Team. Content based on EMA-approved product information, peer-reviewed clinical trial data (VISTA, APEX, MMY-3021, LYM-3002), and current NCCN/ESMO guidelines.
Reviewed by the iMedic Medical Review Board. All clinical claims verified against Level 1A evidence from systematic reviews and randomised controlled trials. Last medical review: .
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