How do you administer this medicine?
What is Neomib?
Neomib 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.
Neomib 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 Neomib, 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.
Neomib is to be given only by or under the supervision of your doctor.
Neomib® (Neomib) for Injection is indicated for the treatment of patients with multiple myeloma.
Mantle Cell Lymphoma
Neomib (Neomib) 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 Neomib?
Use Neomib as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Drinking extra fluids while you are taking Neomib is recommended. Check with your doctor for instructions.
- Neomib is given as an injection into a vein or under the skin at your doctor's office, hospital, or clinic. Neomib 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 Neomib, 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 Neomib.
Uses of Neomib in details
Neomib is used to treat certain types of cancer such as multiple myeloma (a cancer of the cells of the immune system in the bone marrow) and mantle cell lymphoma (a cancer of the cells of the immune system affecting the lymph nodes).
Neomib (originally PS-341 and marketed as Neomib by Millennium Pharmaceuticals) is the first therapeutic proteasome inhibitor to be tested in humans. The boron atom within Neomib 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 Neomib interrupt this process, resulting in destruction of cancerous cells. Neomib 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.
Previously Untreated Multiple Myeloma: Neomib 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, Neomib is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In cycles 5-9, Neomib is administered once weekly (days 1, 8, 22 and 29). At least 72 hrs should elapse between consecutive doses of Neomib.
Dose Modification Guidelines for Combination Therapy with Neomib, Melphalan and Prednisone: Prior to initiating any cycle of therapy with Neomib 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: Neomib (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, Neomib 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 Neomib.
Dose Modification Guidelines for Relapsed Multiple Myeloma and Mantle Cell Lymphoma: Neomib 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, Neomib 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 Neomib-related neuropathic pain and/or peripheral neuropathy. Patients with preexisting severe neuropathy should be treated with Neomib only after careful risk-benefit assessment.
Renal Impairment: The pharmacokinetics of Neomib is not influenced by the degree of renal impairment.
Therefore, dosing adjustments of Neomib are not necessary for patients with renal insufficiency. Since dialysis may reduce Neomib 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 Neomib dose. Patients with moderate or severe hepatic impairment should be started on Neomib 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 Neomib in children has not been established.
Administration: Neomib 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.
What other drugs will affect Neomib?
In vitro and animal ex vivo studies indicate that Neomib 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 Neomib, the CYP2D6 poor metabolizer phenotype is not expected to affect the overall disposition of Neomib.
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of Neomib, showed a Neomib AUC mean increase of 35%, based on data from 12 patients. Therefore, patients should be closely monitored when given Neomib 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 Neomib, there was no significant effect on the pharmacokinetics of Neomib based on data from 17 patients.
A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of Neomib showed a mean Neomib AUC reduction of 45% based on data from 6 patients. The concomitant use of Neomib 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 Neomib pharmacokinetics based on data from 7 patients.
A drug-drug interaction study assessing the effect of melphalan-prednisone on Neomib showed a 17% increase in mean Neomib 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 Neomib 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: Neomib must not be mixed with other medicinal products except those mentioned in Caution for Usage: Instructions for Use, Handling and Disposal.
Neomib side effects
Summary of Clinical Trials of Neomib IV in Patients with Relapsed/Refractory Multiple Myeloma: The safety and efficacy of Neomib 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 Neomib 1 mg/m2 or 1.3 mg/m2 (M34100-024).
Summary of Clinical Trials of Neomib IV versus SC in Patients with Relapsed Multiple Myeloma: The safety and efficacy of Neomib SC were evaluated in 1 phase 3 study at the recommended dose of 1.3 mg/m2. This was a randomized, comparative study of Neomib 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 Neomib 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 Neomib (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 Neomib 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:
Herpes Zoster Virus Reactivation:Physicians should consider using antiviral prophylaxis in patients being treated with Neomib. 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 Neomib at the recommended dose of 1.3 mg/m2. The safety profile of Neomib 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 Neomib. 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 Neomib if you are pregnant. It could harm the unborn baby.
Neomib 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.
Active ingredient matches for Neomib:
Bortezomib in Georgia, Philippines.
List of Neomib substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Mylosome 2mg Injection (Fresenius Kabi India Pvt Ltd)||$ 190.19|
|Onbort 2 mg Injection (Neon Laboratories Ltd)||$ 0.25|
|Onbort 3.5 mg Injection (Neon Laboratories Ltd)||$ 0.27|
|Ortez 2mg POWD / 1 (Zuventus)||$ 198.41|
|Ortez 3.5mg POWD / 1 (Zuventus)||$ 238.10|
|ORTEZ 2MG INJECTION 1 vial / 1 injection each (Zuventus)||$ 201.53|
|Ortez 2mg Injection (Zuventus)||$ 201.53|
|PROTEOZ 2MG INJECTION 1 vial / 1 injection each (Zydus Cadila)||$ 183.22|
|TAZENTA 2MG INJECTION 1 vial / 1 injection each (Biocon)||$ 208.17|
|Velcade (Antigua & Barbuda, Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Croatia (Hrvatska), Czech Republic, Denmark, Ecuador, Finland, France, Georgia, Germany, Greece, Grenada, Guyana, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Romania, Russian Federation, Saint Lucia, Saint Vincent & The Grenadines, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Suriname, Switzerland, Thailand, Trinidad & Tobago, Turkey, United Kingdom, United States, Venezuela, Vietnam)|
|Injectable; Injection; Bortezomib 1 mg (Johnson & Johnson)|
|Injectable; Injection; Bortezomib 3.5 mg (Johnson & Johnson)|
|Velcade / vial 3.5 mg x 10 mL (Johnson & Johnson)|
|Velcade 3.5 mg x 1's (Johnson & Johnson)||$ 1283.40|
|Velcade 1mg VIAL / 1 (Johnson & Johnson)||$ 315.08|
|Velcade 3.5mg VIAL / 1 (Johnson & Johnson)||$ 958.10|
|Velcade 1 mg x 5 mL x 1's (Johnson & Johnson)|
|Velcade 3.5 mg x 10 mL x 1's (Johnson & Johnson)|
|Velcade / single-use 3.5 mg x 1's (Johnson & Johnson)||$ 12800.00|
|1 mg x 1's (Johnson & Johnson)||$ 315.08|
|3.5 mg x 1's (Johnson & Johnson)||$ 958.10|
|Velcade / vial 3.5 mg x 1's (Johnson & Johnson)|
|Velcade 1 mg x 1 Bottle 5 mL (Johnson & Johnson)|
|Velcade 3.5 mg x 1 Bottle 10 mL (Johnson & Johnson)|
|3.5 milliliter in 1 vial, single-use (Johnson & Johnson)|
|Velcade / Single-dose 3.5 mg x 1's (Johnson & Johnson)|
|VELCADE 3.5 MG INJECTION 1 vial / 1 injection each (Johnson & Johnson)||$ 967.31|
|Velcade inj 3.5 mg / vial 10 mL x 1's (Johnson & Johnson)||$ 2088.33|
|Velcade 3.5mg Injection (Johnson & Johnson)||$ 967.31|
|Velcade 1mg (Luxembourg, Switzerland)|
|Velcade 3.5 mg (Hungary)|
|Velcade 3.5mg (Austria, Germany, Luxembourg, Oman, Switzerland, Uruguay)|
|VELTIP 2MG INJECTION 1 vial / 1 injection each (Pfizer Ltd)||$ 246.14|
|Vortemyel (Estonia, Netherlands)|
|Vortemyel 3.5 mg (Hungary)|
|Zegomib 3.5 mg (Hungary)|
|ZOMIBET 2MG INJECTION 1 vial / 1 injection each (Sun Pharma Laboratories Ltd)||$ 193.65|
- 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).
- PubChem. "Bortezomib". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Bortezomib". http://www.drugbank.ca/drugs/DB00188 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Neomib 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 Neomib. 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.
1 consumer reported usefulWas the Neomib drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
2 consumers reported price estimatesWas the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Neomib drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Consumer reported time for resultsNo survey data has been collected yet
2 consumers reported age
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology