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NIVAMO 40 MG

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ZISKA PHARMA

Rs 40,500.00

Rs 45,000.00
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ID: nivamo-100-mg

**Nivamo (Nivolumab)**  
-a monoclonal antibody that blocks the PD‑1 receptor to unleash the immune system against cancer.  

 

 1. What Is Nivamo / Nivolumab?

| Feature | Details |

| **Drug class** | Immune‑checkpoint inhibitor (PD‑1 blocker) |
| **Mechanism** | Binds to PD‑1 on T‑cells → prevents tumor‑derived PD‑L1/L2 from turning off the immune response. |
| **Approved indications (US/Europe)** | 

• Metastatic melanoma

• NSCLC (non‑small‑cell lung cancer) ≥ PD‑L1 ≥ 50 %

• Renal cell carcinoma (clear‑cell) 

• Head & neck squamous cell carcinoma (≥ PD‑L1 ≥ 40 %) 

• Hepatocellular carcinoma (with atezolizumab + bevacizumab) 

• Urothelial carcinoma (≥ PD‑L1 ≥ 50 %) 

• MSI‑High / dMMR colorectal cancer 

• Hodgkin lymphoma (relapsed/refractory) 

• Others (gastric, bladder, etc.) |
| **Form** | 100 mg/200 mg/250 mg vial (IV infusion) |

> **Tip:** The “40 mg” dose you’ve seen is usually a **fraction** of a vial, not a standard clinical dose. Typical dosing is 240 mg IV every 2 weeks or 3 mg/kg IV every 2 weeks.

---

## 2. Typical Dosing Schedule

| Cancer Type | Dosing (IV) | Frequency |
|-------------|-------------|-----------|
| **Melanoma, NSCLC, RCC, HNSCC, Urothelial, MSI‑High CRC, Hodgkin** | 240 mg (fixed) | Every 2 weeks |
| **Weight‑based regimens** | 3 mg/kg | Every 2 weeks |

> **Infusion time**: 30–60 min (depends on dose).  
> **Premedication**: Usually none; antihistamine may be used for patients with prior infusion reactions.

---

## 3. Common Immune‑Related Adverse Events (irAEs)

| Organ System | Typical Incidence | Key Management |
|--------------|------------------|----------------|
| **Skin (rash, pruritus)** | 20–30 % | Topical steroids, antihistamines; severe cases → oral steroids (prednisone 0.5–1 mg/kg). |
| **Gastrointestinal (colitis, diarrhea)** | 5–10 % | Loperamide; if ≥ grade 2, start steroids then consider infliximab. |
| **Hepatic (hepatitis)** | 3–5 % | LFT monitoring; steroids for grade 2+. |
| **Endocrine (thyroiditis, hypophysitis, adrenal insufficiency)** | 5–15 % | Baseline and periodic labs; hormone replacement if needed. |
| **Pulmonary (pneumonitis)** | 1–5 % | Imaging; steroids if symptomatic. |
| **Other (arthritis, nephritis, ocular, etc.)** | < 5 % | Treat per organ‑specific guidelines. |

> **Remember:** Any new rash, fever, shortness of breath, or persistent diarrhea warrants prompt evaluation.  

---

## 4. Monitoring & Follow‑Up

| Parameter | Frequency | Why |
|-----------|-----------|-----|
| CBC, CMP, LFTs | Baseline, every 3–4 weeks | Detect cytopenias, liver injury |
| Thyroid panel (TSH, free T4) | Baseline, every 6–8 weeks | Endocrine irAEs |
| Cortisol/ACTH (if suspected adrenal) | As needed | Detect adrenal insufficiency |
| Imaging (CT/MRI) | Every 8–12 weeks | Tumor response |
| Patient‑reported symptoms | At each visit | Early irAE detection |

---

## 5. Drug Interactions & Precautions

| Issue | Recommendation |
|-------|----------------|
| **Other immunotherapies** | Combining with ipilimumab (CTLA‑4 blocker) increases toxicity; use cautiously. |
| **High‑dose steroids** | May blunt efficacy; reserve for irAEs. |
| **Infections** | Immunosuppressed patients have higher risk of opportunistic infections (TB, CMV). Screen as per guidelines. |
| **Pregnancy/Lactation** | Limited data; generally avoided. |
| **Renal/Hepatic impairment** | Dose adjustment usually not required; monitor function. |

---

## 6. Practical Tips for Patients & Caregivers

1. **Infusion Day**  
  - Bring a list of all medications (including OTC and supplements).  
  - Wear comfortable clothing (easy to remove if needed).  
  - Stay hydrated; bring a water bottle.  

2. **Post‑Infusion**  
  - Watch for mild infusion reactions (flushing, chills).  
  - Report any new rash, itching, fever, or abdominal pain to your oncologist immediately.  

3. **Lifestyle**  
  - Maintain a balanced diet; avoid excessive alcohol (may affect liver).  
  - Keep routine follow‑up appointments and lab tests.  

4. **When to Call**  
  - Fever >38 °C, persistent diarrhea, severe rash, breathing difficulty, severe fatigue, or any new unexplained symptoms.  

---

## 7. Quick Reference Sheet (Print‑out)

| Item | Detail |
|------|--------|
| **Drug** | Nivamo (Nivolumab) |
| **Class** | PD‑1 immune‑checkpoint inhibitor |
| **Typical dose** | 240 mg IV q2 wks or 3 mg/kg IV q2 wks |
| **Key side‑effects** | Skin rash, colitis, hepatitis, thyroiditis, pneumonitis |
| **Monitoring** | CBC/CMP/Thyroid every 3–4 weeks; imaging 8–12 weeks |
| **When to contact oncologist** | Fever >38 °C, severe diarrhea, breathing problems, new rash, persistent fatigue |

---

### Bottom Line

Nivamo (nivolumab) is a powerful immunotherapy that can dramatically extend survival in several advanced cancers. Its effectiveness hinges on a robust immune response, which also brings a spectrum of immune‑related side effects that require vigilance and timely management. Follow the dosing and monitoring plan prescribed by your oncology team, keep an eye on any new symptoms, and communicate promptly with your care team.


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