Velcade 3.5mg Uses

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What is Velcade 3.5mg?

Velcade 3.5mg injection is used to treat multiple myeloma (blood plasma cell cancer) in patients with or without a prior history of treatment, and mantle cell lymphoma.

Velcade 3.5mg interferes with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by Velcade 3.5mg, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Velcade 3.5mg is to be given only by or under the supervision of your doctor.

Velcade 3.5mg indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Multiple Myeloma

Velcade 3.5mg for Injection is indicated for the treatment of patients with multiple myeloma.

Mantle Cell Lymphoma

Velcade 3.5mg for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

How should I use Velcade 3.5mg?

Use Velcade 3.5mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Velcade 3.5mg.

Uses of Velcade 3.5mg in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Mantle cell lymphoma: Treatment of mantle cell lymphoma in adults.

Multiple myeloma: Treatment of multiple myeloma in adults.

Off Label Uses

Antibody-mediated rejection in cardiac transplantation (treatment)

Based on the American Heart Association's Scientific Statement for Antibody-Mediated Rejection in Cardiac Transplantation, Velcade 3.5mg, in combination with other immune therapies, may be a reasonable agent for the secondary treatment of patients with antibody-mediated rejection (AMR) of the cardiac allograft. There are currently no large randomized trials evaluating treatments for AMR in cardiac transplantation; recommendations are based on consensus.

Cutaneous T-cell lymphomas (mycosis fungoides), relapsed/refractory

Data from a small single-center, single-agent phase II trial suggest that Velcade 3.5mg may be beneficial for the treatment of relapsed/refractory cutaneous T-cell lymphomas such as mycosis fungoides may be beneficial for treatment of Waldenström macroglobulinemia.

Based on recommendations from the Eighth International Workshop on Waldenström Macroglobulinemia, Velcade 3.5mg therapy is recommended in patients with Waldenström macroglobulinemia with high IgM levels, symptomatic hyperviscosity, cryoglobulinemia, cold agglutinemia, renal impairment, or in patients where chemotherapy with alkylators or nucleoside analog should be avoided.

Velcade 3.5mg description

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Velcade 3.5mg (originally PS-341 and marketed as Velcade by Millennium Pharmaceuticals) is the first therapeutic proteasome inhibitor to be tested in humans. The boron atom within Velcade 3.5mg catalytically binds the active site of the 26S proteasome with high affinity and specificity, thereby resulting in cell cycle arrest and apoptosis. In normal cells, the proteasome is involved in degradation of ubiquitylated proteins that have been tagged for destruction because they are damaged or unneeded by the cell. However, in cancerous cells, proteasome activity degrades pro-apoptotic proteins such as p53 that would normally result in programmed cell death of the dysfunctional cells. Proteasome inhibitors such as Velcade 3.5mg interrupt this process, resulting in destruction of cancerous cells. Velcade 3.5mg is approved in the U.S. for treating relapsed multiple myeloma and mantle cell lymphoma. In multiple myeloma, complete clinical responses have been obtained in patients with otherwise refractory or rapidly advancing disease.

Velcade 3.5mg dosage

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Velcade 3.5mg Dosage

Applies to the following strength(s): 3.5 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Lymphoma

DOSAGE IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA:

1.3 mg/m2 as a bolus IV injection twice weekly in combination with IV rituximab, cyclophosphamide, doxorubicin, and oral prednisone for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21)

Comments:

-The three week period is considered a treatment cycle.

-A minimum of 72 hours should elapse between consecutive doses of Velcade 3.5mg.

-For patients with a response first documented at cycle 6, two additional cycles (for a total of 8 cycles) are recommended.

FOR USE IN THE TREATMENT OF RELAPSED MANTLE CELL LYMPHOMA:

-Usual dose: 1.3 mg/m2 as a bolus IV injection or subcutaneously twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21). Therapy extending beyond 8 cycles may be administered by the standard schedule or may be given once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest (days 23 through 35).

Uses: For the treatment of mantle cell lymphoma

Usual Adult Dose for Multiple Myeloma

FOR USE IN THE TREATMENT OF PREVIOUSLY UNTREATED MULTIPLE MYELOMA:

-Usual dose: 1.3 mg/m2 administered as a 3 to 5 second bolus IV injection or subcutaneously in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles:

-In cycles 1 through 4, Velcade 3.5mg is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32). In cycles 5 through 9, Velcade 3.5mg is administered once weekly (days 1, 8, 22, and 29).

Comments:

-At least 72 hours should elapse between consecutive doses of Velcade 3.5mg.

FOR USE IN THE TREATMENT OF RELAPSED MULTIPLE MYELOMA:

-Usual dose: 1.3 mg/m2 as a bolus intravenous injection or subcutaneously twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21). Therapy extending beyond 8 cycles may be administered by the standard schedule or may be given once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest (days 23 through 35).

Comments:

-Velcade 3.5mg may be administered alone or in combination with dexamethasone.

-The three week period is considered a treatment cycle.

-A minimum of 72 hours should elapse between consecutive doses of Velcade 3.5mg.

-Patients with multiple myeloma who have previously responded to treatment with Velcade 3.5mg (either alone or in combination) and who have relapsed at least 6 months after their prior therapy may be started on the last tolerated dose.

Use: For the treatment of multiple myeloma (who had previously responded to treatment with this drug and who have relapsed at least 6 months after completing treatment)

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Moderate to severe hepatic impairment (bilirubin levels greater than 1.5 times the upper limit of normal range [ULN]): Starting doses should be reduced to 0.7 mg/m2 in the first cycle. Dose escalation to 1 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered in subsequent cycles based on patient tolerability.

Dose Adjustments

DOSE MODIFICATION GUIDELINES FOR COMBINATION THERAPY WITH Velcade 3.5mg, MELPHALAN AND PREDNISONE:

Prior to initiating any cycle of therapy with Velcade 3.5mg in combination with melphalan and prednisone:

-Platelet count should be greater than or equal to 70 x 10^9/L and the ANC should be greater than or equal to 1.0 x 10^9/L.

-Non-hematological toxicities should have resolved to grade 1 or baseline.

Hematological toxicity during a cycle:

-If prolonged grade 4 neutropenia, thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle, then reduction of the melphalan dose by 25% in the next cycle should be considered.

-If the platelet count is less than or equal to 30 x 10^9/L or ANC less than or equal to 0.75 x 10^9/L on a Velcade 3.5mg dosing day (other than day 1), then the Velcade 3.5mg dose should be withheld.

-If several Velcade 3.5mg doses in consecutive cycles are withheld due to toxicity, the Velcade 3.5mg dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2)

-Nonhematological toxicities greater than or equal to grade 3: Velcade 3.5mg therapy should be withheld until symptoms of the toxicity have resolved to grade 1 or baseline. Then, Velcade 3.5mg may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).

DOSE MODIFICATION GUIDELINES FOR Velcade 3.5mg WHEN GIVEN IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE:

Prior to the first day of each cycle (other than Cycle 1) of therapy with Velcade 3.5mg in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone:

-Platelet count should be at least 100 x 10^9/L and absolute neutrophil count (ANC) should be at least 1.5 x 10^9/L

-Hemoglobin should be at least 8 g/dL (at least 4.96 mmol/L)

-Non-hematologic toxicity should have recovered to Grade 1 or baseline

Velcade 3.5mg therapy should be interrupted at the onset of any Grade 3 hematologic or non-hematological toxicities, excluding neuropathy.

Hematological toxicity during a cycle:

-Grade 3 or higher neutropenia, or a platelet count not at or above 25 x 10^9/L:

Withhold Velcade 3.5mg therapy for up to 2 weeks until the patient has an ANC at or above 0.75 x 10^9/L and a platelet count at or above 25 x 10^9/L. If, after Velcade 3.5mg has been withheld, the toxicity does not resolve, discontinue Velcade 3.5mg. If toxicity resolves such that the patient has an ANC at or above 0.75 x 10^9/L and a platelet count at or above 25 x 10^9/L, the Velcade 3.5mg dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2)

-Grade 3 or higher non-hematological toxicities: Withhold Velcade 3.5mg therapy until symptoms of the toxicity have resolved to Grade 2 or better. Then, Velcade 3.5mg may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).

DOSE MODIFICATION GUIDELINES FOR RELAPSED MULTIPLE MYELOMA AND MANTLE CELL LYMPHOMA:

-Velcade 3.5mg should be withheld at the onset of any grade 3 nonhematologic or grade 4 toxicities excluding neuropathy. Once the symptoms of the toxicity have been resolved, Velcade 3.5mg therapy may be reinitiated at a 25% reduced dose (1.3 mg/m2 is reduced to 1 mg/m2, 1 mg/m2 is reduced to 0.7 mg/m2).

-Patients with preexisting severe neuropathy should be treated with Velcade 3.5mg only after a careful risk/benefit assessment.

DOSE MODIFICATION GUIDELINES FOR ALL PATIENTS ON Velcade 3.5mg:

For patients who experience Velcade 3.5mg related neuropathic pain and/or peripheral sensory neuropathy the following modifications in the dose or regimen is recommended:

-Grade 1 (paresthesias and/or loss of reflexes) without pain or loss of function - no action is required.

-Grade 1 with pain or Grade 2 (interfering with function but not with activities of daily living) - reduce the dose of Velcade 3.5mg to 1 mg/m2.

-Grade 2 with pain or Grade 3 (interfering with activities of daily living) - withhold Velcade 3.5mg therapy until toxicity resolves. Once the toxicity resolves, reinitiate therapy with a reduced dose of Velcade 3.5mg at 0.7 mg/m2 and change the frequency to once a week.

-Grade 4 (permanent sensory loss that interferes with function) - discontinue Velcade 3.5mg.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Consult WARNINGS section for additional precautions.

Dialysis

Because dialysis may reduce Velcade 3.5mg concentrations, the drug should be administered after the dialysis procedure.

Other Comments

The manufacturer product information should be consulted for current reconstitution, dilution and administration recommendations.

More about Velcade 3.5mg

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Velcade 3.5mg interactions

See also:
What other drugs will affect Velcade 3.5mg?

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Ascorbic Acid: May diminish the therapeutic effect of Velcade 3.5mg. Management: Patients should avoid taking vitamin C supplements and vitamin C-containing multivitamins during their Velcade 3.5mg therapy. It is probably unnecessary to advise patients to avoid foods/beverages that contain vitamin C (e.g., citrus fruits, etc.). Consider therapy modification

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

CYP2C19 Inducers (Moderate): May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Velcade 3.5mg. Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Velcade 3.5mg. Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Green Tea: May diminish the antineoplastic effect of Velcade 3.5mg. Avoid combination

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Multivitamins/Fluoride (with ADE): May diminish the therapeutic effect of Velcade 3.5mg. Specifically, the vitamin C (ascorbic acid) found in many multivitamins may impair the clinical effects of Velcade 3.5mg. Management: Patients should avoid taking extra vitamin C supplements and vitamin C-containing multivitamins during their Velcade 3.5mg therapy. It is likely unnecessary, though, to advise patients to avoid dietary sources of vitamin C. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May diminish the therapeutic effect of Velcade 3.5mg. Management: Patients should avoid taking extra vitamin C supplements and vitamin C-containing multivitamins with Velcade 3.5mg. It is probably unnecessary to restrict or limit vitamin C-containing foods/beverages. Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May diminish the therapeutic effect of Velcade 3.5mg. Specifically, vitamin C may decrease Velcade 3.5mg therapeutic effects. Management: Patients should avoid taking extra vitamin C supplements and vitamin C-containing multivitamins during their Velcade 3.5mg therapy. It is likely unnecessary, though, to advise patients to avoid dietary sources of vitamin C. Consider therapy modification

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

St John's Wort: May decrease the serum concentration of Velcade 3.5mg. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Velcade 3.5mg side effects

See also:
What are the possible side effects of Velcade 3.5mg?

The following adverse reactions are also discussed in other sections of the labeling:

Clinical Trials Safety Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Summary of Clinical Trial in Patients with Previously Untreated Multiple Myeloma

Table 7 describes safety data from 340 patients with previously untreated multiple myeloma who received Velcade 3.5mg (1.3 mg/m2) administered intravenously in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) in a prospective randomized study.

The safety profile of Velcade 3.5mg in combination with melphalan/prednisone is consistent with the known safety profiles of both Velcade 3.5mg and melphalan/prednisone.

Table 7: Most Commonly Reported Adverse Reactions (≥ 10% in the Velcade 3.5mg, Melphalan and Prednisone arm) with Grades 3 and ≥ 4 Intensity in the Previously Untreated Multiple Myeloma Study

a Represents High Level Term Peripheral Neuropathies NEC

Velcade 3.5mg, Melphalan and

Prednisone

(n=340)

Melphalan and Prednisone

(n=337)

Toxicity Grade, n (%) Toxicity Grade, n (%)
System Organ Class

Preferred Term

Total n (%) 3 ≥ 4 Total n (%) 3 ≥ 4
Blood and lymphatic system disorders
Thrombocytopenia 164 (48) 60 (18) 57 (17) 140 (42) 48 (14) 39 (12)
Neutropenia 160 (47) 101 (30) 33 (10) 143 (42) 77 (23) 42 (12)
Anemia 109 (32) 41 (12) 4 (1) 156 (46) 61 (18) 18 (5)
Leukopenia 108 (32) 64 (19) 8 (2) 93 (28) 53 (16) 11 (3)
Lymphopenia 78 (23) 46 (14) 17 (5) 51 (15) 26 (8) 7 (2)
Gastrointestinal disorders
Nausea 134 (39) 10 (3) 0 70 (21) 1 (< 1) 0
Diarrhea 119 (35) 19 (6) 2 (1) 20 (6) 1 (< 1) 0
Vomiting 87 (26) 13 (4) 0 41 (12) 2 (1) 0
Constipation 77 (23) 2 (1) 0 14 (4) 0 0
Abdominal Pain Upper 34 (10) 1 (< 1) 0 20 (6) 0 0
Nervous system disorders
Peripheral Neuropathya 156 (46) 42 (12) 2 (1) 4 (1) 0 0
Neuralgia 117 (34) 27 (8) 2 (1) 1 (< 1) 0 0
Paresthesia 42 (12) 6 (2) 0 4 (1) 0 0
General disorders and administration site
conditions
Fatigue 85 (25) 19 (6) 2 (1) 48 (14) 4 (1) 0
Asthenia 54 (16) 18 (5) 0 23 (7) 3 (1) 0
Pyrexia 53 (16) 4 (1) 0 19 (6) 1 (< 1) 1 (< 1)
Infections and infestations
Herpes Zoster 39 (11) 11 (3) 0 9 (3) 4 (1) 0
Metabolism and nutrition disorders
Anorexia 64 (19) 6 (2) 0 19 (6) 0 0
Skin and subcutaneous tissue disorders
Rash 38 (11) 2 (1) 0 7 (2) 0 0
Psychiatric disorders
Insomnia 35 (10) 1 (< 1) 0 21 (6) 0 0

Relapsed Multiple Myeloma Randomized Study of Velcade 3.5mg versus Dexamethasone

The safety data described below and in Table 8 reflect exposure to either Velcade 3.5mg (n=331) or dexamethasone (n=332) in a study of patients with relapsed multiple myeloma. Velcade 3.5mg was administered intravenously at doses of 1.3 mg/m2 twice weekly for 2 out of 3 weeks (21-day cycle). After eight 21-day cycles patients continued therapy for three 35-day cycles on a weekly schedule. Duration of treatment was up to 11 cycles (9 months) with a median duration of 6 cycles (4.1 months). For inclusion in the trial, patients must have had measurable disease and 1 to 3 prior therapies. There was no upper age limit for entry. Creatinine clearance could be as low as 20 mL/min and bilirubin levels as high as 1.5 times the upper limit of normal. The overall frequency of adverse reactions was similar in men and women, and in patients < 65 and ≥ 65 years of age. Most patients were Caucasian.

Among the 331 Velcade 3.5mg-treated patients, the most commonly reported (> 20%) adverse reactions overall were nausea (52%), diarrhea (52%), fatigue (39%), peripheral neuropathies (35%), thrombocytopenia (33%), constipation (30%), vomiting (29%), and anorexia (21%). The most commonly reported (> 20%) adverse reaction reported among the 332 patients in the dexamethasone group was fatigue (25%). Eight percent (8%) of patients in the Velcade 3.5mg-treated arm experienced a Grade 4 adverse reaction; the most common reactions were thrombocytopenia (4%) and neutropenia (2%). Nine percent (9%) of dexamethasone-treated patients experienced a Grade 4 adverse reaction. All individual dexamethasone-related Grade 4 adverse reactions were less than 1%.

Serious Adverse Reactions and Adverse Reactions Leading to Treatment Discontinuation in the Relapsed Multiple Myeloma Study of Velcade 3.5mg versus Dexamethasone

Serious adverse reactions are defined as any reaction that results in death, is life-threatening, requires

hospitalization or prolongs a current hospitalization, results in a significant disability, or is deemed to be an important medical event. A total of 80 (24%) patients from the Velcade 3.5mg treatment arm experienced a serious adverse reaction during the study, as did 83 (25%) dexamethasone-treated patients. The most commonly reported serious adverse reactions in the Velcade 3.5mg treatment arm were diarrhea (3%), dehydration, herpes zoster, pyrexia, nausea, vomiting, dyspnea, and thrombocytopenia (2% each). In the dexamethasone treatment group, the most commonly reported serious adverse reactions were pneumonia (4%), hyperglycemia (3%), pyrexia, and psychotic disorder (2% each).

A total of 145 patients, including 84 (25%) of 331 patients in the Velcade 3.5mg treatment group and 61 (18%) of

332 patients in the dexamethasone treatment group were discontinued from treatment due to adverse reactions. Among the 331 Velcade 3.5mg-treated patients, the most commonly reported adverse reaction leading to discontinuation was peripheral neuropathy (8%). Among the 332 patients in the dexamethasone group, the most commonly reported adverse reactions leading to treatment discontinuation were psychotic disorder and hyperglycemia (2% each).

Four deaths were considered to be Velcade 3.5mg-related in this relapsed multiple myeloma study: 1 case each of cardiogenic shock, respiratory insufficiency, congestive heart failure and cardiac arrest. Four deaths were considered dexamethasone-related: 2 cases of sepsis, 1 case of bacterial meningitis, and 1 case of sudden death at home.

Most Commonly Reported Adverse Reactions in the Relapsed Multiple Myeloma Study of Velcade 3.5mg versus Dexamethasone

The most common adverse reactions from the relapsed multiple myeloma study are shown in Table 8. All adverse reactions with incidence ≥ 10% in the Velcade 3.5mg arm are included.

Table 8: Most Commonly Reported Adverse Reactions (≥ 10% in Velcade 3.5mg arm), with Grades 3 and 4 Intensity in the Relapsed Multiple Myeloma Study of Velcade 3.5mg versus Dexamethasone (N=663)

a Represents High Level Term Peripheral Neuropathies NEC

Preferred Term

All

Velcade 3.5mg

(N=331)

Grade 3

Grade 4

All

Dexamethasone

(N=332)

Grade 3

Grade 4

Adverse Reactions 324 (98) 193 (58) 28 (8) 297 (89) 110 (33) 29 (9)
Nausea 172 (52) 8 (2) 0 31 (9) 0 0
Diarrhea NOS 171 (52) 22 (7) 0 36 (11) 2 (< 1) 0
Fatigue 130 (39) 15 (5) 0 82 (25) 8 (2) 0
Peripheral neuropathiesa 115 (35) 23 (7) 2 (< 1) 14 (4) 0 1 (< 1)
Thrombocytopenia 109 (33) 80 (24) 12 (4) 11 (3) 5 (2) 1 (< 1)
Constipation 99 (30) 6 (2) 0 27 (8) 1 (< 1) 0
Vomiting NOS 96 (29) 8 (2) 0 10 (3) 1 (< 1) 0
Anorexia 68 (21) 8 (2) 0 8 (2) 1 (< 1) 0
Pyrexia 66 (20) 2 (< 1) 0 21 (6) 3 (< 1) 1 (< 1)
Paresthesia 64 (19) 5 (2) 0 24 (7) 0 0
Anemia NOS 63 (19) 20 (6) 1 (< 1) 21 (6) 8 (2) 0
Headache NOS 62 (19) 3 (< 1) 0 23 (7) 1 (< 1) 0
Neutropenia 58 (18) 37 (11) 8 (2) 1 (< 1) 1 (< 1) 0
Rash NOS 43 (13) 3 (< 1) 0 7 (2) 0 0
Appetite decreased NOS 36 (11) 0 0 12 (4) 0 0
Dyspnea NOS 35 (11) 11 (3) 1 (< 1) 37 (11) 7 (2) 1 (< 1)
Abdominal pain NOS 35 (11) 5 (2) 0 7 (2) 0 0
Weakness 34 (10) 10 (3) 0 28 (8) 8 (2) 0

Safety Experience from the Phase 2 Open-Label Extension Study in Relapsed Multiple Myeloma

In the phase 2 extension study of 63 patients, no new cumulative or new long-term toxicities were observed with prolonged Velcade 3.5mg treatment. These patients were treated for a total of 5.3 to 23 months, including time on Velcade 3.5mg in the prior Velcade 3.5mg study.

Integrated Summary of Safety (Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma)

Safety data from phase 2 and 3 studies of single agent Velcade 3.5mg 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1,163 patients with previously-treated multiple myeloma (N=1,008) and previously-treated mantle cell lymphoma (N=155) were integrated and tabulated. This analysis does not include data from the Phase 3 Open-Label Study of Velcade 3.5mg subcutaneous versus intravenous in relapsed multiple myeloma. In the integrated studies, the safety profile of Velcade 3.5mg was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported (> 20%) adverse reactions were nausea (49%), diarrhea (46%), asthenic conditions including fatigue (41%) and weakness (11%), peripheral neuropathies (38%), thrombocytopenia (32%), vomiting (28%), constipation (25%), and pyrexia (21%). Eleven percent (11%) of patients experienced at least 1 episode of ≥ Grade 4 toxicity, most commonly thrombocytopenia (4%) and neutropenia (2%).

In the Phase 2 relapsed multiple myeloma clinical trials of Velcade 3.5mg administered intravenously, local skin irritation was reported in 5% of patients, but extravasation of Velcade 3.5mg was not associated with tissue damage.

Serious Adverse Reactions and Adverse Reactions Leading to Treatment Discontinuation in the Integrated Summary of Safety

A total of 26% of patients experienced a serious adverse reaction during the studies. The most commonly reported serious adverse reactions included diarrhea, vomiting and pyrexia (3% each), nausea, dehydration, and thrombocytopenia (2% each) and pneumonia, dyspnea, peripheral neuropathies, and herpes zoster (1% each).

Adverse reactions leading to discontinuation occurred in 22% of patients. The reasons for discontinuation included peripheral neuropathy (8%), and fatigue, thrombocytopenia, and diarrhea (2% each).

In total, 2% of the patients died and the cause of death was considered by the investigator to be possibly related to study drug: including reports of cardiac arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis.

Most Commonly Reported Adverse Reactions in the Integrated Summary of Safety

The most common adverse reactions are shown in Table 9. All adverse reactions occurring at ≥ 10% are included. In the absence of a randomized comparator arm, it is often not possible to distinguish between adverse events that are drug-caused and those that reflect the patient's underlying disease. Please see the discussion of specific adverse reactions that follows.

Table 9: Most Commonly Reported (≥ 10% Overall) Adverse Reactions in Integrated Analyses of Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma Studies using the 1.3 mg/m2 Dose (N=1,163)

a Represents High Level Term Peripheral Neuropathies NEC

All Patients Multiple Myeloma Mantle Cell Lymphoma
(N=1,163)

(N=1,008) (N=155)
Preferred Term All ≥ Grade 3 All ≥ Grade 3 All ≥ Grade 3
Nausea 567 (49) 36 (3) 511 (51) 32 (3) 56 (36) 4 (3)
Diarrhea NOS 530 (46) 83 (7) 470 (47) 72 (7) 60 (39) 11 (7)
Fatigue 477 (41) 86 (7) 396 (39) 71 (7) 81 (52) 15 (10)
Peripheral neuropathiesa 443 (38) 129 (11) 359 (36) 110 (11) 84 (54) 19 (12)
Thrombocytopenia 369 (32) 295 (25) 344 (34) 283 (28) 25 (16) 12 (8)
Vomiting NOS 321 (28) 44 (4) 286 (28) 40 (4) 35 (23) 4 (3)
Constipation 296 (25) 17 (1) 244 (24) 14 (1) 52 (34) 3 (2)
Pyrexia 249 (21) 16 (1) 233 (23) 15 (1) 16 (10) 1 (< 1)
Anorexia 227 (20) 19 (2) 205 (20) 16 (2) 22 (14) 3 (2)
Anemia NOS 209 (18) 65 (6) 190 (19) 63 (6) 19 (12) 2 (1)
Headache NOS 175 (15) 8 (< 1) 160 (16) 8 (< 1) 15 (10) 0
Neutropenia 172 (15) 121 (10) 164 (16) 117 (12) 8 (5) 4 (3)
Rash NOS 156 (13) 8 (< 1) 120 (12) 4 (< 1) 36 (23) 4 (3)
Paresthesia 147 (13) 9 (< 1) 136 (13) 8 (< 1) 11 (7) 1 (< 1)
Dizziness (excl vertigo) 129 (11) 13 (1) 101 (10) 9 (< 1) 28 (18) 4 (3)
Weakness 124 (11) 31 (3) 106 (11) 28 (3) 18 (12) 3 (2)

Description of Selected Adverse Reactions from the Integrated Phase 2 and 3 Relapsed Multiple Myeloma and Phase 2 Relapsed Mantle Cell Lymphoma Studies

Gastrointestinal Toxicity

A total of 75% of patients experienced at least one gastrointestinal disorder. The most common gastrointestinal disorders included nausea, diarrhea, constipation, vomiting, and appetite decreased. Other gastrointestinal disorders included dyspepsia and dysgeusia. Grade 3 adverse reactions occurred in 14% of patients; ≥ Grade 4 adverse reactions were ≤ 1%. Gastrointestinal adverse reactions were considered serious in 7% of patients. Four percent (4%) of patients discontinued due to a gastrointestinal adverse reaction. Nausea was reported more often in patients with multiple myeloma (51%) compared to patients with mantle cell lymphoma (36%).

Thrombocytopenia

Across the studies, Velcade 3.5mg-associated thrombocytopenia was characterized by a decrease in platelet count during the dosing period (days 1 to 11) and a return toward baseline during the 10-day rest period during each treatment cycle. Overall, thrombocytopenia was reported in 32% of patients. Thrombocytopenia was Grade 3 in 22%, ≥ Grade 4 in 4%, and serious in 2% of patients, and the reaction resulted in Velcade 3.5mg discontinuation in 2% of patients. Thrombocytopenia was reported more often in patients with multiple myeloma (34%) compared to patients with mantle cell lymphoma (16%). The incidence of ≥ Grade 3 thrombocytopenia also was higher in patients with multiple myeloma (28%) compared to patients with mantle cell lymphoma (8%).

Peripheral Neuropathy

Overall, peripheral neuropathies occurred in 38% of patients. Peripheral neuropathy was Grade 3 for 11% of patients and ≥ Grade 4 for < 1% of patients. Eight percent (8%) of patients discontinued Velcade 3.5mg due to peripheral neuropathy. The incidence of peripheral neuropathy was higher among patients with mantle cell lymphoma (54%) compared to patients with multiple myeloma (36%).

In the Velcade 3.5mg versus dexamethasone phase 3 relapsed multiple myeloma study, among the 62 Velcade 3.5mg-treated patients who experienced ≥ Grade 2 peripheral neuropathy and had dose adjustments, 48% had improved or resolved with a median of 3.8 months from first onset.

In the phase 2 relapsed multiple myeloma studies, among the 30 patients who experienced Grade 2 peripheral neuropathy resulting in discontinuation or who experienced ≥ Grade 3 peripheral neuropathy, 73% reported improvement or resolution with a median time of 47 days to improvement of one Grade or more from the last dose of Velcade 3.5mg.

Hypotension

The incidence of hypotension (postural, orthostatic and hypotension NOS) was 8% in patients treated with Velcade 3.5mg. Hypotension was Grade 1 or 2 in the majority of patients and Grade 3 in 2% and ≥ Grade 4 in

< 1%. Two percent (2%) of patients had hypotension reported as a serious adverse reaction, and 1% discontinued due to hypotension. The incidence of hypotension was similar in patients with multiple myeloma (8%) and those with mantle cell lymphoma (9%). In addition, < 1% of patients experienced hypotension associated with a syncopal reaction.

Neutropenia

Neutrophil counts decreased during the Velcade 3.5mg dosing period (days 1 to 11) and returned toward baseline during the 10-day rest period during each treatment cycle. Overall, neutropenia occurred in 15% of patients and was Grade 3 in 8% of patients and ≥ Grade 4 in 2%. Neutropenia was reported as a serious adverse reaction in < 1% of patients and < 1% of patients discontinued due to neutropenia. The incidence of neutropenia was higher in patients with multiple myeloma (16%) compared to patients with mantle cell lymphoma (5%). The incidence of ≥ Grade 3 neutropenia also was higher in patients with multiple myeloma (12%) compared to patients with mantle cell lymphoma (3%).

Asthenic conditions (Fatigue, Malaise, Weakness, Asthenia)

Asthenic conditions were reported in 54% of patients. Fatigue was reported as Grade 3 in 7% and ≥ Grade 4 in < 1% of patients. Asthenia was reported as Grade 3 in 2% and ≥ Grade 4 in < 1% of patients. Two percent (2%) of patients discontinued treatment due to fatigue and < 1% due to weakness and asthenia. Asthenic conditions were reported in 53% of patients with multiple myeloma and 59% of patients with mantle cell lymphoma.

Pyrexia

Pyrexia (> 38ºC) was reported as an adverse reaction for 21% of patients. The reaction was Grade 3 in 1% and ≥ Grade 4 in < 1%. Pyrexia was reported as a serious adverse reaction in 3% of patients and led to Velcade 3.5mg discontinuation in < 1% of patients. The incidence of pyrexia was higher among patients with multiple myeloma (23%) compared to patients with mantle cell lymphoma (10%). The incidence of ≥ Grade 3 pyrexia was 1% in patients with multiple myeloma and < 1% in patients with mantle cell lymphoma.

Herpes Virus Infection

Consider using antiviral prophylaxis in subjects being treated with Velcade 3.5mg. In the randomized studies in

previously untreated and relapsed multiple myeloma, herpes zoster reactivation was more common in subjects treated with Velcade 3.5mg (ranging between 6 to 11%) than in the control groups (3 to 4%). Herpes simplex was seen in 1 to 3% in subjects treated with Velcade 3.5mg and 1 to 3% in the control groups. In the previously untreated multiple myeloma study, herpes zoster virus reactivation in the Velcade 3.5mg, melphalan and prednisone arm was less common in subjects receiving prophylactic antiviral therapy (3%) than in subjects who did not receive prophylactic antiviral therapy (17%).

Additional Adverse Reactions from Clinical Studies

The following clinically important serious adverse reactions that are not described above have been reported in clinical trials in patients treated with Velcade 3.5mg administered as monotherapy or in combination with other chemotherapeutics. These studies were conducted in patients with hematological malignancies and in solid tumors.

Blood and lymphatic system disorders: Anemia, disseminated intravascular coagulation, febrile neutropenia, lymphopenia, leukopenia

Cardiac disorders: Angina pectoris, atrial fibrillation aggravated, atrial flutter, bradycardia, sinus arrest, cardiac amyloidosis, complete atrioventricular block, myocardial ischemia, myocardial infarction, pericarditis, pericardial effusion, Torsades de pointes, ventricular tachycardia

Ear and labyrinth disorders: Hearing impaired, vertigo

Eye disorders: Diplopia and blurred vision, conjunctival infection, irritation

Gastrointestinal disorders: Abdominal pain, ascites, dysphagia, fecal impaction, gastroenteritis, gastritis hemorrhagic, hematemesis, hemorrhagic duodenitis, ileus paralytic, large intestinal obstruction, paralytic intestinal obstruction, peritonitis, small intestinal obstruction, large intestinal perforation, stomatitis, melena, pancreatitis acute, oral mucosal petechiae, gastroesophageal reflux

General disorders and administration site conditions: Chills, edema, edema peripheral, injection site erythema, neuralgia, injection site pain, irritation, malaise, phlebitis

Hepatobiliary disorders: Cholestasis, hepatic hemorrhage, hyperbilirubinemia, portal vein thrombosis, hepatitis, liver failure

Immune system disorders: Anaphylactic reaction, drug hypersensitivity, immune complex mediated hypersensitivity, angioedema, laryngeal edema

Infections and infestations: Aspergillosis, bacteremia, bronchitis, urinary tract infection, herpes viral infection, listeriosis, nasopharyngitis, pneumonia, respiratory tract infection, septic shock, toxoplasmosis, oral candidiasis, sinusitis, catheter-related infection

Injury, poisoning and procedural complications: Catheter-related complication, skeletal fracture, subdural hematoma

Investigations: Weight decreased

Metabolism and nutrition disorders: Dehydration, hypocalcemia, hyperuricemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia

Musculoskeletal and connective tissue disorders: Arthralgia, back pain, bone pain, myalgia, pain in extremity

Nervous system disorders: Ataxia, coma, dizziness, dysarthria, dysesthesia, dysautonomia, encephalopathy, cranial palsy, grand mal convulsion, headache, hemorrhagic stroke, motor dysfunction, neuralgia, spinal cord compression, paralysis, postherpetic neuralgia, transient ischemic attack

Psychiatric disorders: Agitation, anxiety, confusion, insomnia, mental status change, psychotic disorder, suicidal ideation

Renal and urinary disorders: Calculus renal, bilateral hydronephrosis, bladder spasm, hematuria, hemorrhagic cystitis, urinary incontinence, urinary retention, renal failure (acute and chronic), glomerular nephritis proliferative

Respiratory, thoracic and mediastinal disorders: Acute respiratory distress syndrome, aspiration pneumonia, atelectasis, chronic obstructive airways disease exacerbated, cough, dysphagia, dyspnea, dyspnea exertional, epistaxis, hemoptysis, hypoxia, lung infiltration, pleural effusion, pneumonitis, respiratory distress, pulmonary hypertension

Skin and subcutaneous tissue disorders: Urticaria, face edema, rash (which may be pruritic), leukocytoclastic vasculitis, pruritus

Vascular disorders: Cerebrovascular accident, cerebral hemorrhage, deep venous thrombosis, hypertension, peripheral embolism, pulmonary embolism, pulmonary hypertension

Postmarketing Experience

The following adverse reactions have been identified from the worldwide postmarketing experience with Velcade 3.5mg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Cardiac disorders: Cardiac tamponade

Ear and labyrinth disorders: Deafness bilateral

Eye disorders: Optic neuropathy, blindness Gastrointestinal disorders: Ischemic colitis

Infections and infestations: Progressive multifocal leukoencephalopathy (PML), ophthalmic herpes, herpes meningoencephalitis

Nervous system disorders: Posterior reversible encephalopathy syndrome (PRES, formerly RPLS)

Respiratory, thoracic and mediastinal disorders: Acute diffuse infiltrative pulmonary disease

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), acute febrile neutrophilic dermatosis (Sweet's syndrome)

Velcade 3.5mg contraindications

See also:
What is the most important information I should know about Velcade 3.5mg?

Velcade 3.5mg for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to Velcade 3.5mg, boron, boric acid or glycine. Reactions have included anaphylactic reactions.

Velcade 3.5mg for Injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of Velcade 3.5mg.

Active ingredient matches for Velcade 3.5mg:

Bortezomib in Austria, Germany, Luxembourg, Oman, Switzerland, Uruguay.


List of Velcade 3.5mg substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
2 mg x 1's (Celon (Vivilon))$ 177.78
3.5 mg x 1's (Celon (Vivilon))$ 238.10
Mibor 2mg INJ / 1 (Celon (Vivilon))$ 177.78
Mibor 3.5mg INJ / 1 (Celon (Vivilon))$ 238.10
Mibor 2mg INJ / 1 (Celon (Vivilon))$ 177.78
Mibor 3.5mg INJ / 1 (Celon (Vivilon))$ 238.10
Injectable; Injection; Bortezomib 3.5 mg
2 mg x 1's (Dr. Reddy's)
3.5 mg x 1's (Dr. Reddy's)
Myezom 2mg VIAL / 1 (Dr. Reddy's)
Myezom 3.5mg VIAL / 1 (Dr. Reddy's)
MYEZOM 2MG INJECTION 1 vial / 1 injection each (Dr. Reddy's)$ 208.33
MYEZOM 3.5MG INJECTION 1 vial / 1 injection each (Dr. Reddy's)$ 294.00
Myezom 2mg VIAL / 1 (Dr. Reddy's)
Myezom 3.5mg VIAL / 1 (Dr. Reddy's)
Myezom 2mg Injection (Dr. Reddy's)$ 208.33
Myezom 3.5mg Injection (Dr. Reddy's)$ 294.00
Mylosome 2mg Injection (Fresenius Kabi India Pvt Ltd)$ 190.19
Onbort 2 mg Injection (Neon Laboratories Ltd)$ 0.25
Onbort 3.5 mg Injection (Neon Laboratories Ltd)$ 0.27
Ortez 2mg POWD / 1 (Zuventus)$ 198.41
Ortez 3.5mg POWD / 1 (Zuventus)$ 238.10
ORTEZ 2MG INJECTION 1 vial / 1 injection each (Zuventus)$ 201.53
Ortez 2mg Injection (Zuventus)$ 201.53
PROTEOZ 2MG INJECTION 1 vial / 1 injection each (Zydus Cadila)$ 183.22
TAZENTA 2MG INJECTION 1 vial / 1 injection each (Biocon)$ 208.17
VELTIP 2MG INJECTION 1 vial / 1 injection each (Pfizer Ltd)$ 246.14
ZOMIBET 2MG INJECTION 1 vial / 1 injection each (Sun Pharma Laboratories Ltd)$ 193.65

References

  1. DailyMed. "BORTEZOMIB: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Bortezomib". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Bortezomib". http://www.drugbank.ca/drugs/DB00188 (accessed September 17, 2018).

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