Zegomib 3.5 mg injection is used to treat multiple myeloma (blood plasma cell cancer) in patients with or without a prior history of treatment, and mantle cell lymphoma.
Zegomib 3.5 mg interferes with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by Zegomib 3.5 mg, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.
Zegomib 3.5 mg is to be given only by or under the supervision of your doctor.
Zegomib 3.5 mg indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Zegomib 3.5 mg® (Zegomib 3.5 mg) for Injection is indicated for the treatment of patients with multiple myeloma.
Mantle Cell Lymphoma
Zegomib 3.5 mg (Zegomib 3.5 mg) for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.
How should I use Zegomib 3.5 mg?
Use Zegomib 3.5 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Drinking extra fluids while you are taking Zegomib 3.5 mg is recommended. Check with your doctor for instructions.
Zegomib 3.5 mg is given as an injection into a vein or under the skin at your doctor's office, hospital, or clinic. Zegomib 3.5 mg is not intended to be injected into the spinal cord. Contact your health care provider if you have any questions.
It is very important that each dose is given at the scheduled time. If you miss a dose of Zegomib 3.5 mg, contact your doctor right away to establish a new dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Zegomib 3.5 mg.
Uses of Zegomib 3.5 mg in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Mantle cell lymphoma: Treatment of mantle cell lymphoma in adults.
Multiple myeloma: Treatment of multiple myeloma in adults.
Off Label Uses
Antibody-mediated rejection in cardiac transplantation (treatment)
Based on the American Heart Association's Scientific Statement for Antibody-Mediated Rejection in Cardiac Transplantation, Zegomib 3.5 mg, in combination with other immune therapies, may be a reasonable agent for the secondary treatment of patients with antibody-mediated rejection (AMR) of the cardiac allograft. There are currently no large randomized trials evaluating treatments for AMR in cardiac transplantation; recommendations are based on consensus.
Data from a small single-center, single-agent phase II trial suggest that Zegomib 3.5 mg may be beneficial for the treatment of relapsed/refractory cutaneous T-cell lymphomas such as mycosis fungoides may be beneficial for treatment of Waldenström macroglobulinemia.
Based on recommendations from the Eighth International Workshop on Waldenström Macroglobulinemia, Zegomib 3.5 mg therapy is recommended in patients with Waldenström macroglobulinemia with high IgM levels, symptomatic hyperviscosity, cryoglobulinemia, cold agglutinemia, renal impairment, or in patients where chemotherapy with alkylators or nucleoside analog should be avoided.
Zegomib 3.5 mg description
Zegomib 3.5 mg (originally PS-341 and marketed as Zegomib 3.5 mg by Millennium Pharmaceuticals) is the first therapeutic proteasome inhibitor to be tested in humans. The boron atom within Zegomib 3.5 mg catalytically binds the active site of the 26S proteasome with high affinity and specificity, thereby resulting in cell cycle arrest and apoptosis. In normal cells, the proteasome is involved in degradation of ubiquitylated proteins that have been tagged for destruction because they are damaged or unneeded by the cell. However, in cancerous cells, proteasome activity degrades pro-apoptotic proteins such as p53 that would normally result in programmed cell death of the dysfunctional cells. Proteasome inhibitors such as Zegomib 3.5 mg interrupt this process, resulting in destruction of cancerous cells. Zegomib 3.5 mg is approved in the U.S. for treating relapsed multiple myeloma and mantle cell lymphoma. In multiple myeloma, complete clinical responses have been obtained in patients with otherwise refractory or rapidly advancing disease.
Zegomib 3.5 mg dosage
Previously Untreated Multiple Myeloma: Zegomib 3.5 mg is administered as a 3-5 sec bolus IV injection in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 8. 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 hrs should elapse between consecutive doses of Zegomib 3.5 mg.
Dose Modification Guidelines for Combination Therapy with Zegomib 3.5 mg, 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 ≥70 x 109/L and the ANC should be ≥1 x 109/L; nonhematological toxicities should have resolved to Grade 1 or baseline.
For information concerning melphalan and prednisone, see manufacturer's prescribing information.
Relapsed Multiple Myeloma and Mantle Cell Lymphoma: Zegomib 3.5 mg (1.3 mg/m2/dose) is administered as a 3-5 sec bolus IV injection 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 >8 cycles, Zegomib 3.5 mg may be administered on the standard schedule or on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22) followed by a 13-day rest period (days 23-35). At least 72
hrs should elapse between consecutive doses of Zegomib 3.5 mg.
Dose Modification Guidelines for Relapsed Multiple Myeloma and Mantle Cell Lymphoma: Zegomib 3.5 mg therapy should be withheld at the onset of any Grade 3 non-hematological or Grade 4 hematological toxicities excluding neuropathy discussed as follows. 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 the management of patients who experience Zegomib 3.5 mg-related neuropathic pain and/or peripheral neuropathy. Patients with preexisting severe neuropathy should be treated with Zegomib 3.5 mg only after careful risk-benefit assessment.
Renal Impairment: The pharmacokinetics of Zegomib 3.5 mg is not influenced by the degree of renal impairment.
Therefore, dosing adjustments of Zegomib 3.5 mg are not necessary for patients with renal insufficiency. Since dialysis may reduce Zegomib 3.5 mg concentrations, the drug should be administered after the dialysis procedure.
Hepatic Impairment: Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated with 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/injection during the 1st cycle and a subsequent dose escalation to 1 mg/m2, or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerance.
Children 2-16 years: The safety and effectiveness of Zegomib 3.5 mg in children has not been established.
Administration: Zegomib 3.5 mg is administered as a 3-5 sec IV bolus injection through a peripheral or central IV catheter followed by a flush with 0.9% sodium chloride solution for injection.
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.
Summary of Clinical Trials of Zegomib 3.5 mg IV in Patients with Relapsed/Refractory Multiple Myeloma: The safety and efficacy of Zegomib 3.5 mg were evaluated in 3 studies at the recommended dose of 1.3 mg/m2. These included a phase 3 randomized, comparative study versus dexamethasone of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy (M34101-039); a phase 2 single arm, open-label, multicenter study of 202 patients who had received at least 2 prior therapies and demonstrated disease progression on their most recent therapy (M34100-025); and a phase 2 dose-response clinical study in relapsed multiple myeloma for patients who had progressed or relapsed on or after 1st line therapy with Zegomib 3.5 mg 1 mg/m2 or 1.3 mg/m2 (M34100-024).
Summary of Clinical Trials of Zegomib 3.5 mg IV versus SC in Patients with Relapsed Multiple Myeloma: The safety and efficacy of Zegomib 3.5 mg SC were evaluated in 1 phase 3 study at the recommended dose of 1.3 mg/m2. This was a randomized, comparative study of Zegomib 3.5 mg IV versus SC in 222 patients with relapsed multiple myeloma.
Although in general, safety data were similar for the IV and SC treatment groups, the following table highlights differences larger than 10% in the overall incidence of adverse drug reactions between the 2 treatment arms.
Patients who received Zegomib 3.5 mg SC compared to IV administration had 13% lower overall incidence of treatment-emergent adverse drug reactions that were grade 3 or higher in toxicity (57% vs 70%, respectively) and a 5% lower incidence of discontinuation of Zegomib 3.5 mg (22% vs 27%). The overall incidence of diarrhea (24% for the SC arm vs 36% for the IV arm), gastrointestinal and abdominal pain (6% for the SC arm vs 19% for the IV arm), asthenic conditions (27% for SC arm vs 39% for IV arm), upper respiratory tract infections (14% SC arm vs 26% IV arm) and peripheral neuropathy NEC (38% SC arm vs 53% IV arm) were 12-15% lower in the SC group than the IV group. In addition, the incidence of peripheral neuropathies that were grade ≥3 in toxicity was 10% lower (6% for SC vs 16% for IV) and the discontinuation rate due to peripheral neuropathies was 8% lower for the SC group (5%) as compared to the IV group (12%).
Six percent (6%) of patients were reported to have had an adverse local reaction to SC administration, mostly redness. Only 2 (1%) subjects were reported as having severe reactions. These severe local reactions were 1 case of pruritus and 1 case of redness. These reactions seldom led to dose modifications and all resolved in a median of 6 days.
Summary of Clinical Trials in Patients with Previously Untreated Multiple Myeloma: Table 19 describes safety data from 340 patients with previously untreated multiple myeloma who received Zegomib 3.5 mg IV (1.3 mg/m2) in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) in a prospective phase 3 study.
Herpes Zoster Virus Reactivation:
Physicians should consider using antiviral prophylaxis in patients being treated with Zegomib 3.5 mg. In the phase 3 study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with VcMP compared with MP (14% vs 4%, respectively). Antiviral prophylaxis was administered to 26% of the patients in the VcMP arm. The incidence of herpes zoster among patients in the VcMP treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Patients with Mantle Cell Lymphoma: Safety data for patients with mantle cell lymphoma were evaluated in a phase 2 study, which included 155 patients treated with Zegomib 3.5 mg at the recommended dose of 1.3 mg/m2. The safety profile of Zegomib 3.5 mg in these patients was similar to that observed in patients with multiple myeloma. Notable differences between the 2 patient populations were that thrombocytopenia, neutropenia, anemia, nausea, vomiting and pyrexia were reported more often in the patients with multiple myeloma than in those with mantle cell lymphoma; whereas peripheral neuropathy, rash and pruritis were higher among patients with mantle cell lymphoma compared to patients with multiple myeloma.
Post-Marketing Experience: Clinically significant adverse drug reactions are listed as follows if they have not been reported in the previous texts.
The frequencies provided as follows reflect reporting rates of adverse drug reactions from the worldwide post-marketing experience with Zegomib 3.5 mg. The frequencies provided reflect reporting rates and precise estimates of incidence cannot be made. These adverse drug reactions are ranked by frequency, using the following convention: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000, including isolated reports).
Do not use Zegomib 3.5 mg if you are pregnant. It could harm the unborn baby.
Zegomib 3.5 mg can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
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.
Avoid becoming dehydrated if you have any vomiting or diarrhea. Symptoms of dehydration include dizziness, dry mouth, fainting, or hot and dry skin. Talk with your doctor about how best to keep yourself hydrated.
This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
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).
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