Zegomib 3.5 mg Dosage

sponsored
Is this medication very expensive?

Dosage of Zegomib 3.5 mg in details

infoThe dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
sponsored

General Dosing Guidelines

The recommended starting dose of Zegomib 3.5 mg is 1.3 mg/m2. Zegomib 3.5 mg may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL.

​Zegomib 3.5 mg retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with Zegomib 3.5 mg and who have relapsed at least 6 months after completing prior Zegomib 3.5 mg treatment. Treatment may be started at the last tolerated dose.

When administered intravenously, Zegomib 3.5 mg is administered as a 3 to 5 second bolus intravenous injection. Zegomib 3.5 mg is for intravenous or subcutaneous use only. Zegomib 3.5 mg should not be administered by any other route.

Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.

Dosage in Previously Untreated Multiple Myeloma

Zegomib 3.5 mg is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 1. In Cycles 1-4, Zegomib 3.5 mg is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, Zegomib 3.5 mg is administered once weekly (days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Zegomib 3.5 mg.

Table 1: Dosage Regimen for Patients with Previously Untreated Multiple Myeloma
Twice Weekly Zegomib 3.5 mg (Cycles 1-4)
Week 1 2 3 4 5 6
Zegomib 3.5 mg

(1.3 mg/m2)

Day

1

-- -- Day

4

Day

8

Day

11

rest

period

Day

22

Day

25

Day

29

Day

32

rest

period

Melphalan(9 mg/m2)

Prednisone(60 mg/m2)

Day

1

Day

2

Day

3

Day

4

-- -- rest

period

-- -- -- -- rest

period

Once Weekly Zegomib 3.5 mg (Cycles 5-9 when used in combination with Melphalan and Prednisone)
Week 1 2 3 4 5 6
Zegomib 3.5 mg

(1.3 mg/m2)

Day

1

-- -- Day

8

rest

period

Day

22

Day

29

rest

period

Melphalan(9 mg/m2)

Prednisone(60 mg/m2)

Day

1

Day

2

Day

3

Day

4

-- -- rest

period

-- -- -- -- rest

period

Dose Modification Guidelines for Zegomib 3.5 mg When Given in Combination with Melphalan and Prednisone

Prior to initiating any cycle of therapy with Zegomib 3.5 mg in combination with melphalan and prednisone:

  • Platelet count should be at least 70 × 109/L and the absolute neutrophil count (ANC) should be at least 1.0 × 109/L
  • Non-hematological toxicities should have resolved to Grade 1 or baseline
Table 2: Dose Modifications during Cycles of Combination Zegomib 3.5 mg, Melphalan and Prednisone Therapy
Toxicity Dose modification or delay
For information concerning melphalan and prednisone, see manufacturer's prescribing information.
Hematological toxicity during a cycle:

If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle

Consider reduction of the melphalan dose by 25% in the next cycle
If platelet count is not above 30 × 109/L or ANC is not above 0.75 × 109/L on a Zegomib 3.5 mg dosing day (other than day 1) Withhold Zegomib 3.5 mg dose
If several Zegomib 3.5 mg doses in consecutive cycles are withheld due to toxicity Reduce Zegomib 3.5 mg dose 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 3.5 mg therapy until symptoms of toxicity have resolved to Grade 1 or baseline. Then, Zegomib 3.5 mg 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). For Zegomib 3.5 mg-related neuropathic pain and/or peripheral neuropathy, hold or modify Zegomib 3.5 mg as outlined in Table 5.

Dose modifications guidelines for peripheral neuropathy are provided.

Dosage in Previously Untreated Mantle Cell Lymphoma

​Zegomib 3.5 mg (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone (VcR-CAP) for six 3-week treatment cycles as shown in Table 3. Zegomib 3.5 mg is administered first followed by rituximab. Zegomib 3.5 mg is administered twice weekly for two weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period on Days 12-21. For patients with a response first documented at cycle 6, two additional VcR-CAP cycles are recommended. At least 72 hours should elapse between consecutive doses of Zegomib 3.5 mg.

Table 3: Dosage Regimen for Patients with Previously Untreated Mantle Cell Lymphoma
​Twice Weekly Zegomib 3.5 mg (Six 3-Week Cycles)*
​Week 1 2 3
*
Dosing may continue for 2 more cycles (for a total of 8 cycles) if response is first seen at cycle 6.
​Zegomib 3.5 mg

(1.3 mg/m2)

Day

1

-- -- Day

4

-- Day

8

Day

11

rest

period

​Rituximab (375 mg/m2)

Cyclophosphamide (750 mg/m2)

Doxorubicin (50 mg/m2)

Day

1

-- -- -- -- rest

period

​Prednisone (100 mg/m2) Day

1

Day

2

Day

3

Day

4

Day

5

-- -- rest

period

Dose Modification Guidelines for Zegomib 3.5 mg When Given in Combination with Rituximab, Cyclophosphamide, Doxorubicin and Prednisone

​Prior to the first day of each cycle (other than Cycle 1):

  • ​Platelet count should be at least 100 × 109/L and absolute neutrophil count (ANC) should be at least 1.5 × 109/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

​Interrupt Zegomib 3.5 mg treatment at the onset of any Grade 3 hematologic or non-hematological toxicities, excluding neuropathy. For dose adjustments, see Table 4 below.

Table 4: Dose Modifications on Days 4, 8, and 11 during Cycles of Combination Zegomib 3.5 mg, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone Therapy
​Toxicity Dose modification or delay
​Hematological toxicity
  • ​Grade 3 or higher neutropenia, or a platelet count not at or above 25 × 109/L
Withhold Zegomib 3.5 mg therapy for up to 2 weeks until the patient has an ANC at or above 0.75 × 109/L and a platelet count at or above 25 × 109/L.
  • If, after Zegomib 3.5 mg has been withheld, the toxicity does not resolve, discontinue Zegomib 3.5 mg.
  • If toxicity resolves such that the patient has an ANC at or above 0.75 × 109/L and a platelet count at or above 25 × 109/L, Zegomib 3.5 mg 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 3.5 mg therapy until symptoms of the toxicity have resolved to Grade 2 or better. Then, Zegomib 3.5 mg 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).

For Zegomib 3.5 mg-related neuropathic pain and/or peripheral neuropathy, hold or modify Zegomib 3.5 mg as outlined in Table 5.

​For information concerning rituximab, cyclophosphamide, doxorubicin and prednisone, see manufacturer's prescribing information.

Dosage and Dose Modifications for Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma

Zegomib 3.5 mg (1.3 mg/m2/dose) is administered twice weekly for 2 weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21). For extended therapy of more than 8 cycles, Zegomib 3.5 mg may be administered on the standard schedule or, for relapsed multiple myeloma, on a 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). At least 72 hours should elapse between consecutive doses of Zegomib 3.5 mg.

​Patients with multiple myeloma who have previously responded to treatment with Zegomib 3.5 mg (either alone or in combination) and who have relapsed at least 6 months after their prior Zegomib 3.5 mg therapy may be started on Zegomib 3.5 mg at the last tolerated dose. Retreated patients are administered Zegomib 3.5 mg twice weekly (Days 1, 4, 8, and 11) every three weeks for a maximum of 8 cycles. At least 72 hours should elapse between consecutive doses of Zegomib 3.5 mg. Zegomib 3.5 mg may be administered either as a single agent or in combination with dexamethasone.

Zegomib 3.5 mg therapy should be withheld at the onset of any Grade 3 non-hematological or Grade 4 hematological toxicities excluding neuropathy as discussed below. Once the symptoms of the toxicity have resolved, Zegomib 3.5 mg therapy may be reinitiated at a 25% reduced dose (1.3 mg/m2/dose reduced to 1 mg/m2/dose; 1 mg/m2/dose reduced to 0.7 mg/m2/dose).

For dose modifications guidelines for peripheral neuropathy see section 2.7.

Dose Modifications for Peripheral Neuropathy

Starting Zegomib 3.5 mg subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients with pre-existing severe neuropathy should be treated with Zegomib 3.5 mg only after careful risk-benefit assessment.

Patients experiencing new or worsening peripheral neuropathy during Zegomib 3.5 mg therapy may require a decrease in the dose and/or a less dose-intense schedule.

For dose or schedule modification guidelines for patients who experience Zegomib 3.5 mg-related neuropathic pain and/or peripheral neuropathy see Table 5.

Table 5: Recommended Dose Modification for Zegomib 3.5 mg related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy
Severity of Peripheral Neuropathy Signs and Symptoms* Modification of Dose and Regimen
*
Grading based on NCI Common Terminology Criteria CTCAE v4.0
Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money etc;
Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden
Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) without pain or loss of function No action
Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)†) Reduce Zegomib 3.5 mg to 1 mg/m2
Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL ‡) Withhold Zegomib 3.5 mg therapy until toxicity resolves. When toxicity resolves reinitiate with a reduced dose of Zegomib 3.5 mg at 0.7 mg/m2 once per week.
Grade 4 (life-threatening consequences; urgent intervention indicated) Discontinue Zegomib 3.5 mg

Dosage in Patients with Hepatic Impairment

Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated per the recommended Zegomib 3.5 mg dose. Patients with moderate or severe hepatic impairment should be started on Zegomib 3.5 mg at a reduced dose of 0.7 mg/m2 per injection during the first cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerance.

Table 6: Recommended Starting Dose Modification for Zegomib 3.5 mg in Patients with Hepatic Impairment
Bilirubin Level SGOT (AST) Levels Modification of Starting Dose
Abbreviations: SGOT = serum glutamic oxaloacetic transaminase;

AST = aspartate aminotransferase; ULN = upper limit of the normal range.

Mild Less than or equal to 1.0x ULN More than ULN None
More than 1.0x–1.5x ULN Any None
Moderate More than 1.5x–3x ULN Any Reduce Zegomib 3.5 mg to 0.7 mg/m2 in the first cycle. Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Severe More than 3x ULN Any

Administration Precautions

The drug quantity contained in one vial (3.5 mg) may exceed the usual dose required. Caution should be used in calculating the dose to prevent overdose.

When administered subcutaneously, sites for each injection (thigh or abdomen) should be rotated. New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, erythematous, or indurated.

If local injection site reactions occur following Zegomib 3.5 mg administration subcutaneously, a less concentrated Zegomib 3.5 mg solution (1 mg/mL instead of 2.5 mg/mL) may be administered subcutaneously. Alternatively, the intravenous route of administration should be considered.

Zegomib 3.5 mg is an antineoplastic. Procedures for proper handling and disposal should be considered.

Reconstitution/Preparation for

Intravenous and Subcutaneous Administration

Proper aseptic technique should be used. Reconstitute only with 0.9% sodium chloride. The reconstituted product should be a clear and colorless solution.

Different volumes of 0.9% sodium chloride are used to reconstitute the product for the different routes of administration. The reconstituted concentration of Zegomib 3.5 mg for subcutaneous administration (2.5 mg/mL) is greater than the reconstituted concentration of Zegomib 3.5 mg for intravenous administration (1 mg/mL). Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.

For each 3.5 mg single-use vial of Zegomib 3.5 mg reconstitute with the following volume of 0.9% sodium chloride based on route of administration (Table 7):

Table 7: Reconstitution Volumes and Final Concentration for

Intravenous and Subcutaneous Administration

Route of administration Zegomib 3.5 mg

(mg/vial)

Diluent

(0.9% Sodium Chloride)

Final Zegomib 3.5 mg concentration (mg/mL)

Intravenous

3.5 mg 3.5 mL 1 mg/mL
Subcutaneous 3.5 mg 1.4 mL 2.5 mg/mL

Dose must be individualized to prevent overdosage. After determining patient body surface area (BSA) in square meters, use the following equations to calculate the total volume (mL) of reconstituted Zegomib 3.5 mg to be administered:

  • Intravenous Administration [1 mg/mL concentration]

  • Subcutaneous Administration [2.5 mg/mL concentration]

Stickers that indicate the route of administration are provided with each Zegomib 3.5 mg vial. These stickers should be placed directly on the syringe of Zegomib 3.5 mg once Zegomib 3.5 mg is prepared to help alert practitioners of the correct route of administration for Zegomib 3.5 mg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If any discoloration or particulate matter is observed, the reconstituted product should not be used.

Stability: Unopened vials of Zegomib 3.5 mg are stable until the date indicated on the package when stored in the original package protected from light.

Zegomib 3.5 mg contains no antimicrobial preservative. Reconstituted Zegomib 3.5 mg should be administered within 8 hours of preparation. When reconstituted as directed, Zegomib 3.5 mg 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.

What other drugs will affect Zegomib 3.5 mg?

Many drugs can interact with Zegomib 3.5 mg. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Zegomib 3.5 mg, especially:

  • dexamethasone;
  • rifabutin, rifampin, rifapentine;
  • St. John's wort;
  • an antibiotic--clarithromycin, erythromycin, telithromycin;
  • an antifungal medication--clotrimazole, itraconazole, ketoconazole, voriconazole;
  • an antidepressant--nefazodone, paroxetine, sertraline;
  • a barbiturate--amobarbital, butabarbital, mephobarbital, secobarbital, phenobarbital;
  • diabetes medicine you take by mouth (your dose may need to be adjusted when your Zegomib 3.5 mg treatment starts);
  • HIV/AIDS medicine--atazanavir, delavirdine, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, saquinavir, ritonavir;
  • medicines to treat narcolepsy--armodafinil, modafinil; or
  • seizure medicine--carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone.

This list is not complete and many other drugs can interact with Zegomib 3.5 mg. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Zegomib 3.5 mg interactions

infoInteractions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Zegomib 3.5 mg, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
sponsored

In vitro and animal ex vivo studies indicate that Zegomib 3.5 mg is a weak inhibitor of cytochrome P-450 (CYP450) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4. Based on the limited contribution (7%) of CYP2D6 to the metabolism of Zegomib 3.5 mg, the CYP2D6 poor metabolizer phenotype is not expected to affect the overall disposition of Zegomib 3.5 mg.

A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of Zegomib 3.5 mg, showed a Zegomib 3.5 mg AUC mean increase of 35%, based on data from 12 patients. Therefore, patients should be closely monitored when given Zegomib 3.5 mg in combination with potent CYP3A4 inhibitors (eg, ketoconazole, ritonavir).

In a drug-drug interaction study assessing the effect of omeprazole, a potent inhibitor of CYP2C19, on the pharmacokinetics of Zegomib 3.5 mg, there was no significant effect on the pharmacokinetics of Zegomib 3.5 mg based on data from 17 patients.

A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of Zegomib 3.5 mg showed a mean Zegomib 3.5 mg AUC reduction of 45% based on data from 6 patients. The concomitant use of Zegomib 3.5 mg with strong CYP3A4 inducers is, therefore, not recommended, as efficacy may be reduced. Examples of CYP3A4 inducers are rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s wort. In the same drug-drug interaction study, the effect of dexamethasone, a weaker CYP3A4 inducer, was assessed. There was no significant effect on Zegomib 3.5 mg pharmacokinetics based on data from 7 patients.

A drug-drug interaction study assessing the effect of melphalan-prednisone on Zegomib 3.5 mg showed a 17% increase in mean Zegomib 3.5 mg AUC based on data from 21 patients. This is not considered clinically relevant.

During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving Zegomib 3.5 mg treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Patients should be cautioned about the use of concomitant medications that may be associated with peripheral neuropathy (eg, amiodarone, antivirals, isoniazid, nitrofurantoin or statins) or with a decrease in blood pressure.

Drug-Laboratory Test Interactions: None known.

Incompatibilities: Zegomib 3.5 mg must not be mixed with other medicinal products except those mentioned in Caution for Usage: Instructions for Use, Handling and Disposal.


sponsored

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).

Reviews

The results of a survey conducted on ndrugs.com for Zegomib 3.5 mg are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Zegomib 3.5 mg. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported frequency of use

No survey data has been collected yet


Consumer reported doses

No survey data has been collected yet


Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 9 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2020 ndrugs.com All Rights Reserved