🟩 Nivolunix 100 mg

Generic Name: Nivolumab
Brand Name: Nivolunix
Manufacturer: Beacon Pharmaceuticals Ltd.
Dosage Form & Strength: Injection, 100 mg/10 mL (concentrate for solution)
Therapeutic Class: Anticancer | Immune Checkpoint Inhibitor (PD-1 Blocker)

📌 Indications:

Nivolunix (Nivolumab) is indicated for the treatment of multiple cancers, including:

• Non–Small Cell Lung Cancer (NSCLC) – after progression on platinum-based chemotherapy.

• Small Cell Lung Cancer (SCLC) – in certain relapsed/refractory cases.

• Renal Cell Carcinoma (RCC) – advanced or metastatic cases.

• Melanoma – unresectable or metastatic melanoma.

• Classical Hodgkin Lymphoma (cHL) – relapsed/refractory after autologous stem cell transplant or brentuximab vedotin.

• Head and Neck Squamous Cell Carcinoma (HNSCC).

• Hepatocellular Carcinoma (HCC).

• Urothelial Carcinoma.

• Other malignancies where PD-1 inhibition provides clinical benefit.

💊 Pharmacology:

Nivolunix (Nivolumab) is a fully human IgG4 monoclonal antibody targeting programmed death-1 (PD-1) receptor.

• PD-1 is an immune checkpoint receptor on T-cells that downregulates immune activity when engaged by its ligands PD-L1/PD-L2.

• Cancer cells exploit this pathway by expressing PD-L1, suppressing T-cell function, and escaping immune destruction.

• Nivolumab binds to PD-1, blocking its interaction with PD-L1/PD-L2, thereby restoring T-cell mediated anti-tumor immunity.

💉 Dosage & Administration:

• Standard Adult Dose:

  • 240 mg every 2 weeks, OR

  • 480 mg every 4 weeks (intravenous infusion over 30 minutes).

• May be used alone or in combination with other agents (e.g., ipilimumab, chemotherapy, targeted therapy).

• Treatment continues until disease progression or unacceptable toxicity.

⚠️ Important: Nivolunix should be administered under the supervision of an experienced oncologist.

⚠️ Precautions & Warnings:

Because Nivolunix activates the immune system, it may cause immune-related adverse reactions (irAEs) that can affect vital organs. Monitoring is essential.

• Immune-mediated reactions: pneumonitis, colitis, hepatitis, endocrinopathies (thyroid dysfunction, adrenal insufficiency, hypophysitis, diabetes mellitus), nephritis, dermatologic toxicity.

• Infusion-related reactions may occur.

• Baseline and periodic monitoring of liver, renal, and thyroid function is recommended.

• Use caution in patients with pre-existing autoimmune diseases or organ transplants.

❌ Contraindications:

• Hypersensitivity to Nivolumab or any excipients.

• Use in pregnancy unless absolutely necessary.

🤰 Pregnancy & Lactation:

• Pregnancy: May harm the fetus by altering maternal immune tolerance. Effective contraception required during treatment and for 5 months after the last dose.

• Breastfeeding: Not recommended during therapy and for at least 5 months after the last dose.

⚕️ Side Effects:

Common:

• Fatigue

• Rash, pruritus

• Cough, dyspnea

• Diarrhea, nausea, decreased appetite

• Joint or muscle pain

Serious (immune-related):

• Pneumonitis

• Hepatitis

• Colitis

• Endocrinopathies (thyroiditis, diabetes, adrenal insufficiency)

• Nephritis

• Infusion-related reactions

Prompt recognition and management with corticosteroids or immunosuppressants may be required.

🧊 Storage Conditions:

• Store at 2°C – 8°C (refrigerated).

• Do not freeze or shake.

• Protect from light.

• Diluted solution should be used immediately or stored under proper conditions as per guidelines.