Generic Name: Bortezomib Brand Name(s): .

Uses

What is Bortezomib used for?

Bortezomib is commonly used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma). It works by slowing or stopping the growth of cancer cells.

How should I take Bortezomib?

This medication is given by injection into a vein or under the skin by a health care professional. If you are receiving this medication under the skin, make sure that the injection site is changed each time to lessen injury under the skin. The dosage is based on your body size, medical condition, laboratory tests, and response to treatment.

To prevent dehydration, it is important to drink plenty of fluids while you are being treated with this drug. Consult your doctor or pharmacist if you have any questions.

How do I store Bortezomib?

Bortezomib for Injection contains no antimicrobial preservative. Administer reconstituted Bortezomib for Injection within 8 hours of preparation. When reconstituted as directed, Bortezomib for Injection may be stored at 25°C (77°F). 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 8 hours in a syringe; however, total storage time for the reconstituted material must not exceed 8 hours when exposed to normal indoor lighting.

Stability: Unopened vials of Bortezomib are stable until the date indicated on the package when stored in the original package protected from light.

If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Precautions & warnings

What should I know before using Bortezomib?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: nerve problems (such as peripheral neuropathy), liver disease, kidney disease, loss of too much body water (dehydration), heart disease (such as heart failure), bleeding/blood disorders, current/recent infections, diabetes.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Bortezomib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should have a pregnancy test before starting this medication. You should not become pregnant while using bortezomib. Bortezomib may harm an unborn baby. Males and females using this drug should ask about reliable forms of birth control during treatment and for 2 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 months after stopping this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Bortezomib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Bortezomib. This Bortezomib is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Bortezomib?

Dizziness, lightheadedness, nausea, vomiting, loss of appetite, diarrhea, constipation, tiredness, weakness, or pain/redness at the injection site may occur. Nausea, vomiting, and diarrhea can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, and diarrhea. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Bortezomib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

Tell your doctor right away if you have any serious side effects, including: tingling/numbness/pain/burning feeling of arms/legs, fainting, swelling ankles/feet, severe headache, mental/mood changes (such as confusion), severe stomach/abdominal pain, signs of liver disease (such as yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: chest pain, trouble breathing, vision changes, seizures, weakness on one side of the body, trouble speaking.

This medication can decrease blood cells, which can cause anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (such as sore throat that doesn’t go away, fever, chills), unusual tiredness, pale skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Bortezomib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Bortezomib?

Other medications can affect the removal of bortezomib from your body, which may affect how bortezomib works. Examples include rifamycins (such as rifabutin), St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Bortezomib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Bortezomib?

Bortezomib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Bortezomib?

Bortezomib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Bortezomib.

What is the dose of Bortezomib for an adult?

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 bortezomib.

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

Comments:

-At least 72 hours should elapse between consecutive doses of bortezomib.

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:

-Bortezomib 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 bortezomib.

-Patients with multiple myeloma who have previously responded to treatment with bortezomib (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 BORTEZOMIB, MELPHALAN AND PREDNISONE:

Prior to initiating any cycle of therapy with bortezomib 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 bortezomib dosing day (other than day 1), then the bortezomib dose should be withheld.

-If several bortezomib doses in consecutive cycles are withheld due to toxicity, the bortezomib 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: Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 1 or baseline. Then, bortezomib 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 BORTEZOMIB 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 bortezomib 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

Bortezomib 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 bortezomib 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 bortezomib has been withheld, the toxicity does not resolve, discontinue bortezomib. 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 bortezomib 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 bortezomib therapy until symptoms of the toxicity have resolved to Grade 2 or better. Then, bortezomib 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:

-Bortezomib 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, bortezomib 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 bortezomib only after a careful risk/benefit assessment.

DOSE MODIFICATION GUIDELINES FOR ALL PATIENTS ON BORTEZOMIB:

For patients who experience bortezomib 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 bortezomib to 1 mg/m2.

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

-Grade 4 (permanent sensory loss that interferes with function) – discontinue bortezomib.

What is the dose of Bortezomib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Bortezomib available?

Bortezomib is available in the following dosage forms and strengths:

  • Injectable powder for injection

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Bortezomib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 11, 2018 | Last Modified: January 11, 2018

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