Ninacent 150 | 10 Capsules

✔️ Use in Special Populations

• Pregnancy: Contraindicated. May cause fetal harm. Use contraception during and for 3 months after treatment.
• Lactation: Not recommended. Unknown if excreted in human milk.
• Fertility: No impairment observed in males; data in females limited
• Children: Safety and efficacy not established
• Elderly (≥65 years): No dose adjustment needed, but monitor closely
• Renal impairment: No dose adjustment in mild/moderate cases; not studied in severe impairment

Hepatic impairment:

• Mild (Child Pugh A): 100 mg twice daily recommended
• Moderate to severe (Child Pugh B/C): Use not recommended

✔️ Dosage & Administration

For IPF, ILDs & SSc-ILD:

• Recommended dose: 150 mg twice daily (approximately 12 hours apart)
• If not tolerated: 100 mg twice daily
• Missed dose: Skip and resume at the next scheduled time. Do not double-dose.
• Maximum daily dose: 300 mg

For NSCLC (with Docetaxel):

200 mg twice daily on Days 2 to 21 of a 21-day treatment cycle

Do not take Ninacent on Day 1 (docetaxel administration day)

Continue Ninacent alone after docetaxel if clinical benefit persists

Maximum daily dose: 400 mg

Capsules should be taken orally with food, swallowed whole (not chewed/crushed), with water.

Dose Adjustment Guidelines

In case of side effects:

Reduce dose to 100 mg twice daily

Interrupt therapy if liver enzymes exceed 3× ULN; resume at a lower dose once normalized

Discontinue permanently if 100 mg twice daily is not tolerated

✔️ Common Side Effects

• Very common (≥1/10): Diarrhea, nausea, vomiting, abdominal pain, loss of appetite, weight loss, elevated liver enzymes
• Common (≥1/100 to <1/10): Bleeding, hypertension, rash
• Uncommon to rare: GI perforation, thromboembolic events, liver injury

✔️ Drug Interactions

P-glycoprotein (P-gp): Nintedanib is a substrate.

Inhibitors (e.g., ketoconazole, erythromycin): ↑ drug levels—monitor closely

Inducers (e.g., rifampicin, phenytoin): ↓ effectiveness—avoid if possible

CYP Enzymes: Minimal metabolism via CYP pathways—low risk of CYP-mediated interactions

Hormonal contraceptives: Interaction not studied; use barrier methods as backup contraception

✔️ Contraindications

Known hypersensitivity to Nintedanib, peanuts, soy, or any excipients

✔️ Special Warnings & Precautions

• Diarrhea: Most common side effect. Treat early with hydration and antidiarrheals (e.g., loperamide).
• Nausea/Vomiting: If persistent, consider dose adjustment or temporary discontinuation

Liver Function:

Monitor ALT, AST, bilirubin prior to treatment and regularly during first 3 months

Higher risk in: Females, elderly, Asians, low body weight (<65kg)

Dose reduce or interrupt if transaminases >3x ULN

1. Renal Function: Monitor in at-risk patients; rare cases of renal failure reported
2. Bleeding Risk: Caution in patients on full anticoagulation or with bleeding tendencies
3. Arterial Thromboembolism: Monitor in patients with cardiovascular risks
4. Gastrointestinal Perforation: Rare, but serious. Avoid in patients with GI disorders or recent surgery

Hypertension: Monitor BP regularly

• Wound Healing: Delay therapy initiation after surgery until adequate healing
• QT Prolongation Risk: Low, but exercise caution in susceptible individuals
• Soya/Peanut Allergy: Contraindicated due to excipient content

✔️ Storage Conditions

Store in a cool, dry place, protected from light.
Do not store above 25°C.
Keep out of reach of children.