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What are the possible side effects of Zegomib 3.5 mg?
Get emergency medical help if you have any signs of an allergic reaction to Zegomib 3.5 mg: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Zegomib 3.5 mg may cause a serious viral infection of the brain that can lead to disability or death. 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.
Also call your doctor at once if you have:
a light-headed feeling, like you might pass out;
chest pain, dry cough, swelling in your hands or ankles, feeling short of breath, even with mild exertion;
diarrhea that is severe or ongoing;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
new or worsening cough, shortness of breath;
new or worsening nerve problems such as numbness, burning, pain, weakness, or tingly feeling;
pain, redness, bruising, tenderness, or a hard lump where the medicine was injected;
dehydration symptoms - muscle cramps, feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
high blood pressure - severe headache, pounding in your neck or ears, anxiety, irregular heartbeats;
liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
low white blood cell counts - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
signs of tumor cell breakdown - lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.
Common Zegomib 3.5 mg side effects may include:
numbness, tingling, or burning pain in your hands or feet;
loss of appetite, nausea, vomiting;
diarrhea, constipation, bloating;
fever, chills, cold or flu symptoms;
pale skin, easy bruising or bleeding;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Zegomib 3.5 mg in details
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:
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).
What is the most important information I should know about Zegomib 3.5 mg?
- Zegomib 3.5 mg may cause dizziness, fatigue, fainting, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Zegomib 3.5 mg with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Zegomib 3.5 mg may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Zegomib 3.5 mg may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower your chance of getting cut, bruised, or injured.
- Zegomib 3.5 mg may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Contact your doctor if you experience new or worsening nerve problems (eg, tingling, numbness, pain, or burning in the feet or hands; weakness in the arms or legs). Your dose may need to be changed.
- A serious and possibly fatal condition called tumor lysis syndrome (TLS) has been reported in certain patients taking Zegomib 3.5 mg. Contact your doctor right away if you develop symptoms, such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- Heart failure, as well as heart failure that has gotten worse in people who already have it, has happened with Zegomib 3.5 mg. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, irregular heartbeat, or swelling in the arms or legs that is new or worse.
- Serious and sometimes fatal lung problems have happened with Zegomib 3.5 mg. Call your doctor right away if you have lung or breathing problems (eg, trouble breathing, shortness of breath, a cough that is new or worse).
- A serious and sometimes fatal brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Zegomib 3.5 mg. Call your doctor right away if you have confusion, seizures, severe headache, sluggishness, or vision changes (eg, vision loss).
- Carry an ID card at all times that says you take Zegomib 3.5 mg.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you experience dizziness, light-headedness, or fainting.
- Diabetes patients - Zegomib 3.5 mg may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Women who may become pregnant should avoid becoming pregnant while being treated with Zegomib 3.5 mg. Be sure to use effective birth control while using Zegomib 3.5 mg. If you have questions about effective birth control, talk with your doctor.
- Lab tests may be performed while you use Zegomib 3.5 mg. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: Zegomib 3.5 mg may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zegomib 3.5 mg while you are pregnant. It is not known if Zegomib 3.5 mg is found in breast milk. Do not breast-feed while using Zegomib 3.5 mg.
Zegomib 3.5 mg contraindications
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).
- DTP/NCI. "Bortezomib: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "N,N',N''-((2S,2'S,2''S)-(((1R,1'R,1''R)-(1,3,5,2,4,6-trioxatriborinane-2,4,6-triyl)tris(3-methylbutane-1,1-diyl))tris(azanediyl))tris(1-oxo-3-phenylpropane-2,1-diyl))tris(pyrazine-2-carboxamide): The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
ReviewsThe 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.
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Information checked by Dr. Sachin Kumar, MD Pharmacology