Bortezomib

Bortezomib is a prescription medication used for the treatment of mantle cell lymphoma and multiple myeloma.

• Bortezomib is available under the following different brand names: Velcade

Adult dosage

Injection, lyophilized powder for reconstitution

• 3.5mg/vial

Mantle Cell Lymphoma

Adult dosage

Previously untreated MCL

• 1.3 mg/m²/dose IV twice weekly for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12 to 21) for six 3-week cycles; may continue for 8 cycles if the response is first seen at cycle 6
• Give with rituximab 375 mg/m² IV, cyclophosphamide 750 mg/m² IV, and doxorubicin 50 mg/m² IV on day 1, plus prednisone 100 mg/m² IV on days 1-5

Relapsed MCL

• 1.3 mg/m²/dose IV/SC twice weekly for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12 to 21)
• Therapy extending beyond 8 cycles: Give a standard schedule

Multiple Myeloma

Adult dosage

• Previously untreated multiple myeloma
• Administer in combination with prednisone and melphalan as part of 6 weeks treatment cycles for 9 cycles
• Cycles 1-4 (twice weekly): 1.3 mg/m² IV/SC on Days 1, 4, 8, 11, 22, 25, 29, and 32  
• Cycles 5-9 (once weekly): 1.3 mg/m² IV/SC on Days 1, 8, 22, and 29

Relapsed multiple myeloma

• 1.3 mg/m²/dose IV/SC twice weekly for 2 weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21)
• Therapy extending beyond 8 cycles: Standard schedule or maintenance schedule of once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (Days 23 to 35)

Retreatment

• Administer twice weekly for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12 to 21)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Bortezomib include:

• numbness or tingly feeling,
• loss of appetite,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• fever,
• chills,
• cold or flu symptoms,
• rash, and
• tiredness.

Serious side effects of Bortezomib include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe headache,
• buzzing in the ears,
• vision problems,
• weakness,
• confusion,
• thinking problems,
• seizure,
• new or worsening nerve problems (numbness, burning, weakness, or tingly feeling),
• lightheadedness,
• severe or ongoing nausea,
• vomiting,
• diarrhea,
• constipation,
• fever,
• shortness of breath,
• feeling very thirsty or hot,
• unable to urinate,
• heavy sweating,
• hot and dry skin,
• tiredness,
• flu-like symptoms,
• mouth sores,
• skin sores,
• easy bruising,
• unusual bleeding,
• pale skin,
• cold hands and feet,
• right-sided stomach pain,
• yellowing of the skin or eyes (jaundice),
• swelling in the lower legs,
• rapid weight gain,
• cough with mucus,
• fast heart rate,
• sleep problems,
• muscle cramps,
• fluttering in the chest,
• decreased urination, and
• tingling around the mouth

Rare side effects of Bortezomib include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Bortezomib has severe interactions with the following drugs:
  • eliglustat
  • green tea
• Bortezomib has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • enzalutamide
  • fedratinib
  • fexinidazole
  • idelalisib
  • ivosidenib
  • lonafarnib
  • mefloquine
  • palifermin
  • ropeginterferon alfa 2b
  • selinexor
  • tucatinib
  • voxelotor
• Bortezomib has moderate interactions with at least 110 other drugs.
• Bortezomib has minor interactions with the following drugs:
  • amitriptyline
  • escitalopram
  • griseofulvin
  • lansoprazole
  • miconazole vaginal
  • rabeprazole
  • ruxolitinib
  • ruxolitinib topical
  • topiramate
  • voriconazole

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to any component or boron or mannitol; intrathecal administration

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bortezomib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bortezomib?”

Cautions

• Cases, sometimes fatal, of thrombotic microangiopathy (eg, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome [TTP/HUS]), have been reported in the postmarketing setting
• Monitor for signs and symptoms of TTP/HUS; if the diagnosis is suspected, stop treatment and evaluate; if diagnosis of TTP/HUS excluded, consider restarting therapy; safety of reinitiating therapy in patients previously experiencing TTP/HUS not known
• Use caution in hepatic impairment (reduce starting dose); monitor hepatic enzymes during treatment High tumor load (risk of tumor lysis syndrome); closely monitor patients with high tumor burden
• Posterior reversible encephalopathy syndrome, PRES (formerly RPLS); safety of reinitiating therapy in patients previously experiencing PRES is not known
• Associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically resolves before initiation of the subsequent cycle; monitor CBCs regularly throughout treatment
• Hypotension (postural, orthostatic, and hypotension NOS) observed throughout therapy; management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics
• Nausea, diarrhea, constipation, and vomiting may require the use of antiemetic and antidiarrheal medications or fluid replacement
• Women should avoid becoming pregnant while on therapy; advise pregnant women of potential embryo-fetal harm (see Pregnancy)
• Associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering before initiation of the subsequent cycle
• Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred
• Acute respiratory distress syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration have occurred
• Peripheral neuropathy
  • The treatment causes peripheral neuropathy (predominantly sensory); however, cases of severe sensory and motor peripheral neuropathy have been reported
  • Pre-existing symptoms (eg, numbness, pain, or burning in feet or hands) and/or signs of peripheral neuropathy may worsen during treatment
  • Consider starting SC treatment for patients with preexisting or at high risk of peripheral neuropathy
  • New or worsening peripheral neuropathy may require a decreased dose or altered dose schedule (see Dosage Modification)

Pregnancy and Lactation

• Based on the mechanism of action and findings in animals, therapy can cause fetal harm when administered to a pregnant woman; there are no studies in pregnant women to inform drug-associated risks; therapy caused embryo-fetal lethality in rabbits at doses lower than the clinical dose; advise pregnant women of the potential risk to the fetus
• Verify pregnancy status of females of reproductive potential before initiating treatment
• Contraception
  • Females: Use effective contraception during treatment and for 7 months after the last dose
  • Males: Males with female partners of reproductive potential should use effective contraception during treatment and for 4 months after the last dose
• Infertility
  • Based on the mechanism of action and findings in animals, the drug may affect either male or female fertility.
• Lactation
  • There are no data on the presence of bortezomib or metabolites in human milk, the effects of the drug on the breastfed infant, or on milk production
  • Many drugs are excreted in human milk and the potential for serious adverse reactions in breastfed infants from therapy is unknown
  • Advise nursing women not to breastfeed during treatment and for 2 months after treatment