Bortezomib

Brand name: Velcade
Dosage form: Single-dose vial lyophilized powder for reconstitution (3.5 mg)
Drug class: Proteasome inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 8, 2024.

What is bortezomib?

Bortezomib (Velcade) is used to treat multiple myeloma (MM) and mantle cell lymphoma (MCL) in adults. Bortezomib injection is a proteasome inhibitor, a type of targeted cancer drug, it is not chemotherapy. Bortezomib mechanism of action (MOA) is it blocks enzymes (proteasomes), which usually break down proteins inside cancer cells. This causes proteins to build up inside cancer cells, and the cancer cells die. 

Bortezomib is given as an injection under the skin (subcutaneous injection) or into a vein (intravenous injection) weekly or twice weekly.  Bortezomib may be used alone or in combination with other medicines, including rituximab, cyclophosphamide, doxorubicin, melphalan, prednisone, or dexamethasone.

Multiple myeloma is a type of cancer of the bone marrow, and mantle cell lymphoma is a fast-growing cancer that begins in the cells of the immune system. Bortezomib can be used to treat relapsed multiple myeloma, untreated multiple myeloma, relapsed mantel cell lymphoma and untreated mantel cell lymphoma,

Bortezomib injection received FDA approval on May 13, 2003. Bortezomib brand name is Velcade.

Bortezomib side effects

Common bortezomib side effects may include:

• numbness, burning pain, or tingly feeling;
• loss of appetite, nausea, vomiting;
• diarrhea, constipation;
• fever, chills, cold or flu symptoms;
• low blood cell counts;
• skin rash; or
• feeling tired.

Serious bortezomib side effects

Get emergency medical help if you have signs of an allergic reaction to bortezomib, including hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Bortezomib may cause a serious side effect of brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Bortezomib can cause the side effect of life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Bortezomib may cause other serious side effects. Call your doctor at once if you have:

• headache, confusion, thinking problems, weakness, vision loss, seizure, a light-headed feeling, like you might pass out;
• pain, bruising, swelling, or irritation where the medicine was injected;
• severe or ongoing nausea, vomiting, diarrhea, constipation, stomach pain;
• fever with shortness of breath or trouble breathing;
• dehydration - dizziness, confusion, feeling very thirsty, less urination;
• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• heart problems - swelling, rapid weight gain, feeling short of breath; or
• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Carvykti, Tecvayli, prednisone, methotrexate, dexamethasone, Decadron, cyclophosphamide

Warnings

Velcade may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Velcade can lower blood cells that help your body fight infections and help your blood clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding or signs of infection (fever, chills, body aches).

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not be treated with this medicine if you are allergic to bortezomib, or to mannitol, or boron.

To make sure bortezomib is safe for you, tell your doctor if you have ever had:

• numbness, tingling, or burning pain in your hands or feet;
• high or low blood pressure;
• heart disease, congestive heart failure;
• headache, confusion, thinking problems, weakness, vision loss, seizure;
• a low level of platelets or low white or red blood cell counts;
• skin rash or herpes zoster (also called shingles);
• lung disease or breathing problems;
• diabetes;
• if you are dehydrated;
• liver disease; or
• kidney disease (or if you are on dialysis).

Pregnancy

Bortezomib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

How is bortezomib given?

Bortezomib injection is given into a vein (intravenous injection) or under your skin (subcutaneous injection). A healthcare provider will give you this injection.

You may be given medication to prevent nausea or vomiting while you are receiving Velcade. As part of your treatment plan, you may be given Velcade drug with other medications.

You may need frequent medical tests, and your cancer treatments may be delayed based on the results.

Bortezomib Dosing information

Usual Adult Bortezomib Dose for Multiple Myeloma

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 is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32). In cycles 5 through 9, Velcade is administered once weekly (days 1, 8, 22, and 29).
Comments:
At least 72 hours should elapse between consecutive doses of Velcade.

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 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.
Patients with multiple myeloma who have previously responded to treatment with Velcade (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)

Usual Adult Bortezomib Dose for Mantle Cell Lymphoma

Treatment in previously untreated Mantle Cell Lymphoma:
Usual dose: 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.
For patients with a response first documented at cycle 6, two additional cycles (for a total of 8 cycles) are recommended.

Treatment of relapsed Mantel 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).

Vecade injection is available as a single-dose vial contains 3.5 mg of bortezomib as lyophilized powder for reconstitution and withdrawal of the appropriate individual patient dose.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Velcade injection.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid while receiving this medicine?

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What other drugs will affect bortezomib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can interact with bortezomib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Velcade Package Insert

Review the Velcade Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Ingredients

Velcade Active ingredient: bortezomib
Velcade Inactive ingredients: mannitol, USP.

Storage

Unopened vials
Unopened vials may be stored at a controlled room temperature of 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). Keep the vial in its original package to protect it from light.

Reconstituted Velcade
Velcade contains no antimicrobial preservatives.
Reconstituted Velcade should be administered within eight hours of preparation.
When reconstituted as directed, Velcade may be stored at 25ºC (77ºF).
The reconstituted material may be stored in the original vial and/or the syringe prior to administration.
The product may be stored for up to eight hours in a syringe; however, the total storage time for the reconstituted material must not exceed eight hours when exposed to normal indoor lighting.

Manufacturer

Velcade is manufactured by Takeda Pharmaceuticals America, Inc. , Lexington, MA 02421.

Frequently asked questions

• Ninlaro vs Velcade, which is better?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer