Boruzu

Pronunciation: bore-roo-zoo
Generic name: bortezomib
Dosage form: injection for subcutaneous or intravenous use
Drug class: Proteasome inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 10, 2024.

What is Boruzu?

Boruzu (bortezomib) is a ready-to-use injectable cancer medicine that may be used to treat multiple myeloma (MM) or mantle cell lymphoma (MCL) in adults.

Boruzu is a targeted treatment for cancer and is not chemotherapy. The mechanism of action of Boruzu involves blocking the effects of proteasomes, which are enzymes involved in the breakdown of damaged or unwanted proteins. This causes these damaged proteins to build up to toxic levels inside the cancer cells, killing the cells. Myeloma cells produce more proteins than normal cells and rely on proteasomes which makes them much more sensitive to Boruzu. Boruzu belongs to a class of medicines known as proteasome inhibitors.

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

Boruzu (bortezomib) received FDA approval on September 5, 2024. Boruzu is the first ready-to-use bortezomib product and reduces the compounding steps typically required for the administration of Velcade, another bortezomib product.

Boruzu side effects

The most common side effects of Boruzu are:

• weakness
• fatigue or tiredness
• diarrhea
• nausea or vomiting
• constipation
• tingling in the hands and feet
• fever
• low blood cell counts
• low blood pressure
• psychiatric conditions
• weight loss and decreased appetite
• nerve pain
• a skin rash.

Serious side effects and warnings

Boruzu may cause the following serious side effects.

Peripheral neuropathy (problems with the nerves outside of your brain and spinal cord). If you already have numbness, pain, or burning in your hands or feet, these symptoms might get worse during treatment with Boruzu. Talk to your healthcare provider if you develop painful or uncomfortable burning, tingling, or prickling sensations, or 
muscle weakness

Low blood pressure. Boruzu may lower blood pressure, causing dizziness or fainting. Stay hydrated and inform your doctor if you're on blood pressure medication. Avoid driving or operating machinery if you feel dizzy. Your doctor may adjust other medications as needed.

Heart failure. Boruzu may worsen preexisting heart failure and cause heart failure to develop, especially in those with risk factors. Tell your healthcare provider immediately if you develop shortness of breath or swelling in your hands or feet.

Lung problems. Tell your healthcare provider immediately if you develop any new or worsening lung symptoms, such as difficulty breathing, or a persistent cough.

Low blood cell counts. Boruzu can lower blood cell counts, potentially causing anemia, fatigue, increased infection risk, and bleeding. Your healthcare provider will monitor your blood and may provide treatments to boost cell counts and manage these side effects if needed. Call your doctor if you have unusual bruising or bleeding or signs of infection (fever, chills, body aches).

Gastrointestinal disturbances. Digestive issues such as diarrhea, constipation, nausea, and vomiting are common with Boruzu. Stay hydrated and eat a balanced diet. Your doctor can prescribe medications to manage these side effects if they become troublesome.

Posterior Reversible Encephalopathy Syndrome (PRES). Boruzu can cause a serious brain condition called PRES. Symptoms include seizures, headaches, and vision problems. If you experience these while taking Bortezomib, stop the medication and seek medical help immediately. 

Tumor lysis syndrome (TLS). Boruzu can cause TLS which is a condition that occurs when cancer cells die rapidly, releasing their contents into the bloodstream. Patients with a large amount of cancer cells before treatment are at higher risk.

Liver problems. Liver damage has been reported in some patients receiving bortezomib injections, such as Boruzu. Especially those with other health conditions or taking multiple medications. Tell your healthcare provider immediately if you develop symptoms such as abdominal pain, yellow skin or whites of the eyes, or excessive tiredness.

Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). TTP/HUS is a serious blood clotting disorder reported in some patients receiving bortezomib injections, such as Boruzu. Tell your healthcare provider immediately if you develop symptoms such as fever, fatigue, confusion, and shortness of breath. 

Boruzu may harm an unborn baby. Females of childbearing potential may need to use effective contraception when taking Boruzu.

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

Boruzu 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.

Before taking this medicine

You should not be treated with Boruzu if you are allergic to bortezomib or mannitol.

To make sure Boruzu 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, the active ingredient in Boruzu, 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 can 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 Boruzu given?

Boruzu injection is given under your skin (subcutaneous injection) or into a vein (intravenous injection) by a healthcare provider.

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

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

Boruzu dosing information

See the Boruzu Prescribing Information for full bortezomib dosing information.

Usual adult Boruzu dosage for 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, Boruzu is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32).
• In cycles 5 through 9, Boruzu is administered once weekly (days 1, 8, 22, and 29).

Comments:
At least 72 hours should elapse between consecutive doses of Boruzu.

Usual adult Boruzu dosage for 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:
Boruzu 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 Boruzu.
Patients with multiple myeloma who have previously responded to treatment with Boruzu (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 Boruzu dosage for Mantle Cell Lymphoma

Boruzu 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 Boruzu.
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 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).

Related/similar drugs

Carvykti, Abecma, Tecvayli, prednisone, methotrexate, dexamethasone, Decadron, Revlimid, cyclophosphamide, lenalidomide

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while receiving Boruzu?

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 Boruzu?

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 Boruzu. 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.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original package to protect from light.

Boruzu is a cytotoxic drug. Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact.

Boruzu ingredients

Active ingredient: bortezomib 3.5 mg/ 1.4 mL (1 mL contains bortezomib 2.5 mg)

Inactive ingredients: mannitol, sodium chloride for isotonicity, water for injection.

Supplied as a carton containing one single-dose vial.

Who makes Boruzu?

Amenal Oncology Private Limited makes Boruzu for Shilpa Medicare Limited.

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