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NINDANIB 150 MG

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GLENMARK PHARMACEUTICALS

Rs 1,702.08

Rs 1,891.20
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ID: nindanib-150-mg

**Nintedanib 150 mg Capsules**  
 

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## 1. What Is Nintedanib?

| Feature | Detail |
|---------|--------|
| **Drug class** | Oral tyrosine‑kinase inhibitor (targets VEGF, FGF, PDGF receptors) |
| **Mechanism** | Blocks signaling pathways that drive fibroblast proliferation & angiogenesis, slowing fibrotic processes and tumor growth. |
 

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## 2. Approved Uses

| Indication | Typical dose | Route |
|------------|--------------|-------|
| **Idiopathic Pulmonary Fibrosis (IPF)** | 150 mg × 2 (i.e., 300 mg/day) | Oral |
| **Pulmonary Lymphangioleiomyomatosis (LAM)** | 150 mg × 2 | Oral |
| **Non‑small‑cell lung cancer (NSCLC) – adenocarcinoma** | 150 mg × 2 (in combination with docetaxel) | Oral |
| **Other** (e.g., metastatic colorectal, ovarian, etc.) – investigational | 150 mg × 2 | Oral |

> **Capsule strength**: 150 mg each. Patients usually take two capsules twice daily (morning & evening) to achieve a 300 mg/day dose.

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## 3. Dosing & Administration

1. **Take with food** – helps improve absorption and tolerability.  
2. **Timing** – best taken at the same time each day (e.g., 8 AM and 8 PM).  
3. **Swallow whole** – do not crush or chew.  
4. **Missed dose** – take as soon as remembered; if it’s near the next dose, skip the missed dose (do **not** double up).  

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## 4. Common Adverse Events

| System | Incidence | Management |
|--------|-----------|------------|
| **Gastrointestinal** (diarrhea, nausea, vomiting, abdominal pain) | 70–90 % | Oral rehydration, loperamide for diarrhea; anti‑emetics; consider dose reduction if severe. |
| **Liver enzymes (ALT/AST)** | 10–15 % | Monitor liver function every 4–8 weeks; hold dose if transaminases rise >5× ULN. |
| **Bleeding** (e.g., epistaxis, GI bleeding) | < 5 % | Avoid NSAIDs, anticoagulants if possible; treat bleeding promptly. |
| **Hypertension** | 10–20 % | Monitor BP; antihypertensives as needed. |
| **Fatigue, weight loss** | 5–10 % | Symptomatic support, nutritional counseling. |
| **Others** (rash, pruritus, headache) | < 5 % | Treat symptomatically. |

> **Note**: Diarrhea is the most frequent dose‑limiting toxicity; most patients can continue therapy with supportive care.

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## 5. Drug Interactions

| Interaction | What to Watch For | Recommendation |
|-------------|-------------------|----------------|
| **CYP3A4 inhibitors** (e.g., ketoconazole, clarithromycin) | ↑ Nintedanib levels → ↑ toxicity | Avoid concurrent use or adjust dose. |
| **CYP3A4 inducers** (e.g., rifampin, carbamazepine) | ↓ Nintedanib levels → ↓ efficacy | Consider dose adjustment or alternative therapy. |
| **Anticoagulants** (warfarin, DOACs) | ↑ bleeding risk | Use with caution; monitor coagulation. |
| **Other TKIs** | Possible additive toxicity | Assess risk–benefit; may require dose modification. |

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## 6. Monitoring

| Parameter | Frequency | Why |
|-----------|-----------|-----|
| **Baseline labs** (CBC, CMP, LFTs, creatinine) | Before starting | Establish baseline, screen for contraindications. |
| **CBC & CMP** | Every 4–8 weeks | Detect anemia, liver toxicity, renal function changes. |
| **Liver enzymes** | Every 4–8 weeks | Early detection of hepatotoxicity. |
| **Weight & BMI** | Every visit | Monitor for cachexia or weight loss. |
| **Symptom diary** | Daily | Track GI symptoms; adjust dose if needed. |
| **Imaging (for IPF)** | Every 6–12 months | Assess progression. |

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## 7. Precautions & Contraindications

| Issue | Note |
|-------|-----|
| **Pregnancy/Lactation** | Category C; avoid if possible. |
| **Severe hepatic impairment** | Contraindicated. |
| **Active bleeding or severe GI ulcer** | Contraindicated. |
| **Concurrent use of strong CYP3A4 inhibitors** | Contraindicated or requires dose adjustment. |
| **History of hypersensitivity to nintedanib** | Contraindicated. |

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## 8. Quick Reference Cheat‑Sheet

| Item | Detail |
|------|--------|
| **Drug** | Nintedanib 150 mg capsule |
| **Common brand** | Ofev® |
| **Dose** | 150 mg × 2 per day (300 mg/day) |
| **Take** | With food, at same times each day |
| **Common side‑effects** | Diarrhea, nausea, liver enzyme elevations, bleeding |
| **Key monitoring** | CBC/CMP/LFTs every 4–8 weeks, weight, symptoms |
| **Avoid** | CYP3A4 inhibitors, NSAIDs, strong anticoagulants (unless necessary) |

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### Bottom Line

Nintedanib 150 mg capsules are a standard oral therapy for idiopathic pulmonary fibrosis and other fibrotic conditions, and they’re also used in certain cancers. The typical regimen is two capsules twice daily with food. The main challenge is managing GI side‑effects, especially diarrhea, which can be mitigated with supportive care and dose adjustments. Regular labs and symptom monitoring are essential to keep therapy both effective and safe.

 


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