Nivomab
Generic Name
Nivomab 40 mg injection
Manufacturer
Generic Pharma Co.
Country
United States
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nivomab 40 mg injection | ৳ 34,805.00 | N/A |
Description
Overview of the medicine
Nivomab is a programmed death-1 (PD-1)-blocking antibody used in immunotherapy for various cancers. It works by blocking the PD-1 pathway, thereby releasing the PD-1 pathway-mediated inhibition of the anti-tumor immune response.
Uses & Indications
Dosage
Adults
Typically 240 mg intravenously every 2 weeks or 480 mg every 4 weeks, adjusted based on indication and patient weight/BSA for some regimens. Administered over 30 minutes.
Elderly
No specific dose adjustment required based on age alone.
Renal_impairment
No dose adjustment recommended for mild to moderate renal impairment. Data limited for severe renal impairment.
How to Take
Administered as an intravenous infusion over 30 minutes. Should not be administered as an intravenous push or bolus. Dilution may be required before infusion.
Mechanism of Action
Nivomab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor found on T-cells. By blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), Nivomab prevents the inhibition of T-cell activation and proliferation, thus restoring anti-tumor immunity.
Pharmacokinetics
Onset
Pharmacodynamic effects can be observed within hours, but clinical response typically takes weeks to months.
Excretion
Primarily through cellular uptake and degradation, with minimal renal or hepatic excretion of the intact antibody.
Half life
Approximately 25 days (linear kinetics at therapeutic doses).
Absorption
Administered intravenously, hence 100% bioavailability.
Metabolism
Expected to be metabolized via catabolic pathways of proteins, not via cytochrome P450 enzymes.
Side Effects
Contraindications
- Hypersensitivity to nivomab or any excipients
- Severe autoimmune reactions or organ transplant history (relative contraindication, requires careful assessment)
Drug Interactions
Live vaccines
Avoid administering live or attenuated live vaccines concurrently with Nivomab due to potential for increased vaccine-related adverse reactions.
Systemic corticosteroids or other immunosuppressants
May interfere with the pharmacodynamic activity of Nivomab and should be avoided prior to initiation of treatment, unless used for immune-mediated adverse reactions.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
There is no specific information on overdose with Nivomab. In case of an overdose, patients should be closely monitored for signs and symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.
Pregnancy & Lactation
Pregnancy Category D. Nivomab can cause fetal harm. Advise pregnant women of potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose. It is unknown if Nivomab is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 5 months after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months when stored as recommended. Once diluted, stability may vary (e.g., 24 hours at room temperature, 48 hours refrigerated).
Availability
Hospitals, Specialty pharmacies, Cancer treatment centers
Approval Status
Approved by FDA and other regulatory bodies worldwide
Patent Status
Under patent
Clinical Trials
Nivomab (Nivolumab) has been extensively studied in numerous Phase 1, 2, and 3 clinical trials across various cancer types, demonstrating significant improvements in overall survival and progression-free survival compared to standard therapies.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin)
- Thyroid function tests (TSH, free T4)
- Renal function tests (creatinine, BUN)
- Electrolytes
- Complete blood count with differential
Doctor Notes
- Educate patients on immune-mediated adverse events and the importance of early reporting.
- Monitor patients for signs and symptoms of immune-mediated reactions throughout treatment and for several months after the last dose.
- Consider corticosteroids for management of severe immune-mediated adverse reactions.
Patient Guidelines
- Report any new or worsening symptoms immediately to your healthcare provider.
- Do not stop Nivomab without consulting your doctor.
- Attend all scheduled appointments and lab tests.
- Understand the potential for immune-mediated side effects and their symptoms.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. Consult a healthcare professional for rescheduling the next dose.
Driving Precautions
Nivomab may cause fatigue, dizziness, or other side effects that could affect your ability to drive or operate machinery. Exercise caution until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Engage in light to moderate physical activity as tolerated.
- Avoid unnecessary exposure to infections.
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Global Brand Names
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