Description

1. Product Overview:
Nivorest® is an injectable formulation of Nivolumab, a monoclonal antibody used in immuno-oncology for the treatment of multiple advanced malignancies including non-small cell lung cancer, melanoma, renal cell carcinoma, Hodgkin lymphoma, and head & neck cancers.

2. Composition:
Active Ingredient: Nivolumab | Dosage Form: Injection (Concentrate for Infusion)

3. Pharmacological Class:
Programmed Death-1 (PD-1) Immune Checkpoint Inhibitor

4. Mechanism of Action:
Nivolumab binds to the PD-1 receptor on T-cells, blocking its interaction with PD-L1/PD-L2. This restores immune system activity against cancer cells, enabling the body to detect and destroy tumor cells effectively.

5. Indications:
Non-small cell lung cancer (NSCLC) | Melanoma | Renal cell carcinoma | Hodgkin lymphoma | Head and neck squamous cell carcinoma | Other advanced solid tumors

6. Dosage & Administration:
As prescribed by oncologist | Intravenous infusion only | Administered in hospital or clinical setting | Dose and schedule depend on cancer type and patient condition

7. Clinical Benefits:
Enhances immune response against tumors | Improves overall survival in several cancers | Provides durable response in selected patients | Broad-spectrum immunotherapy option

8. Contraindications:
Hypersensitivity to Nivolumab or any component of the formulation

9. Precautions:
Risk of immune-related adverse effects (pneumonitis, colitis, hepatitis, endocrinopathies) | Requires regular monitoring of organ functions | Use under strict oncology supervision

10. Drug Interactions:
May interact with immunosuppressive drugs such as corticosteroids, potentially reducing therapeutic effectiveness

11. Special Populations:
Pregnancy: Not recommended | Lactation: Not recommended | Pediatric: Use only under specialist supervision | Elderly: Requires careful monitoring

12. Adverse Effects:
Fatigue | Skin rash | Diarrhea | Immune-related inflammation of lungs, liver, or intestines | Thyroid dysfunction

13. Storage Conditions:
Store at 2°C–8°C (refrigerated) | Do not freeze | Protect from light | Keep out of reach of children

14. Packaging:
Injection vial

15. Manufacturer:
Everest Pharmaceutical Ltd.