• Dosage of Zegomib in details
• Zegomib interactions
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Dosage of Zegomib in details

Zegomib 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:

• Lymphoma
• Multiple Myeloma

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

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 Zegomib.

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

Comments:

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

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:

-Zegomib 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 Zegomib.

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

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

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

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

-Zegomib 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, Zegomib 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 Zegomib only after a careful risk/benefit assessment.

DOSE MODIFICATION GUIDELINES FOR ALL PATIENTS ON Zegomib:

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

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

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

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 Zegomib 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 Zegomib

• Side Effects
• During Pregnancy
• Dosage Information
• Drug Interactions
• Support Group
• En Espanol
• 3 Reviews - Add your own review/rating

Consumer resources

• Zegomib
• Zegomib

  Intravenous (Advanced Reading)

• Other brands: Velcade

Professional resources

• Zegomib (AHFS Monograph)
• Zegomib (Wolters Kluwer)

Related treatment guides

• Lymphoma
• Mantle Cell Lymphoma
• Multiple Myeloma

What other drugs will affect Zegomib?

Many drugs can interact with Zegomib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zegomib. Give a list of all your medicines to any healthcare provider who treats you.

Zegomib interactions

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 Zegomib. Management: Patients should avoid taking vitamin C supplements and vitamin C-containing multivitamins during their Zegomib 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 Zegomib. Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Zegomib. 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 Zegomib. 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 Zegomib. Specifically, the vitamin C (ascorbic acid) found in many multivitamins may impair the clinical effects of Zegomib. Management: Patients should avoid taking extra vitamin C supplements and vitamin C-containing multivitamins during their Zegomib 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 Zegomib. Management: Patients should avoid taking extra vitamin C supplements and vitamin C-containing multivitamins with Zegomib. 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 Zegomib. Specifically, vitamin C may decrease Zegomib therapeutic effects. Management: Patients should avoid taking extra vitamin C supplements and vitamin C-containing multivitamins during their Zegomib 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 Zegomib. Avoid combination

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

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. FDA/SPL Indexing Data. "69G8BD63PP: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Antineoplastic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology