NINTEMED

NINTEMED

Nintedanib 150mg
Net Qty- 3x1x10 Soft gel Capusles
Self-Life- 2 Years

Nintemed (Nintedanib 150mg) Soft Gelatin Capsule contains Nintedanib, is used in the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer. It works by targeting certain pathways involved in the growth and progression of these diseases and helps to stop or slow the spread of cancer cells. It’s a medication primarily used to treat idiopathic pulmonary fibrosis (IPF) and certain types of cancers.

USE

Nintemed is prescribed for:

✅ Idiopathic pulmonary fibrosis (IPF)

✅ Non-small cell lung cancer (NSCLC)

✅ Pancreatic cancer

✅ Small cell lung cancer

✅ Liver and kidney cancers

✅ Thyroid cancer

✅ Chronic myeloid leukemia

✅ Gastrointestinal stromal tumors

✅ Colon and rectal cancers

✅ Soft tissue sarcoma

✅ Chronic idiopathic myelofibrosis

✅ Breast cancer

 

It works by inhibiting multiple tyrosine kinases, thereby slowing disease progression and reducing fibrosis.

Mechanism
of Action

Nintedanib is a multi-kinase inhibitor with anti-fibrotic, anti-inflammatory, and anti-angiogenic effects. It works by targeting several receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases involved in fibrosis and tumor growth.

🧬 How It Works

🔹 1. Inhibition of Tyrosine Kinases

  • Nintedanib blocks multiple pro-fibrotic and pro-tumor kinases, including:
  • VEGFR (Vascular Endothelial Growth Factor Receptors) – inhibits blood vessel formation (angiogenesis)
  • FGFR (Fibroblast Growth Factor Receptors) – reduces fibroblast activation and tissue scarring
  • PDGFR (Platelet-Derived Growth Factor Receptors) – prevents proliferation of mesenchymal cells
  • Src family kinases – involved in cell survival, proliferation, and migration

🫁 In Idiopathic Pulmonary Fibrosis (IPF)

Nintedanib slows the progression of lung fibrosis by:

  • Reducing fibroblast activity
  • Inhibiting the deposition of extracellular matrix (ECM)
  • Preventing further scarring of lung tissue

🧪 In Cancer (e.g., NSCLC)

It inhibits tumor growth and spread by:

  • Blocking the formation of new blood vessels that supply tumors (anti-angiogenic effect)
  • Slowing down cancer cell proliferation and migration

🧠 Simple Analogy:

Think of Nintedanib as cutting off the fuel and pathways that both fibrosis and cancer cells need to grow and spread.

Dosage and Administration

💊 Take the capsule whole with food.

💊 Do not crush or chew.

💊 Follow your doctor’s prescribed dosage schedule

Common Side Effects

Common side effects include:

⚠️ Diarrhea

⚠️ Nausea and vomiting

⚠️Abdominal pain

⚠️Elevated liver enzymes

⚠️Decreased appetite

⚠️Headache

⚠️Weight loss

Serious side effects may involve liver toxicity, cardiovascular issues, and gastrointestinal bleeding. Consult your doctor if you experience any concerning symptoms.

Monitoring

🩺 Monitoring Requirements for Nintemed 150 Soft Gelatin Capsule (Nintedanib), because Nintedanib can affect multiple organs and systems, regular monitoring is essential to ensure safety and effectiveness.

🔍 Liver Function Tests (LFTs)

  • When: Before starting treatment, then monthly for the first 3 months, and periodically thereafter.
  • Why: Nintedanib can cause elevated liver enzymes and, rarely, serious liver injury.
  • Monitor: ALT, AST, Bilirubin levels
    • 🚨 Discontinue if liver enzymes are >3x ULN with symptoms or >5x ULN without symptoms.

💉 Complete Blood Count (CBC)

  • Why: To detect anemia, thrombocytopenia, or other bone marrow suppression effects.
  • How Often: Periodically during therapy, especially if used with chemotherapy.

💧 Renal Function (Kidney Tests)

  • Why: Although less common, Nintedanib may affect kidney function, especially if dehydration or vomiting occurs.
  • Monitor: Serum creatinine, electrolytes, especially in elderly or high-risk patients.

❤️ Cardiovascular Monitoring

  • Why: Risk of hypertension, thromboembolism, and rarely cardiac events.
  • Check: Blood pressure regularly
  • Consider ECG if the patient has underlying heart disease.

🩸 Coagulation Parameters (if on anticoagulants)

  • Why: Nintedanib may increase the risk of bleeding.
  • What to monitor: INR if on warfarin, signs of bleeding (gums, bruising, GI bleeding)

🧪 Gastrointestinal Tolerance

  • Watch for: Persistent diarrhea, nausea, vomiting, or abdominal pain
  • May require dose adjustment or supportive care.

📋 Patient Self-Monitoring Tips

  • Report any unexplained bruising or bleeding
  • Notify your doctor about loss of appetite, fatigue, or yellowing of the skin
  • Stay hydrated and avoid alcohol to protect liver and kidneys

Precautions

Here are the key precautions to keep in mind when using Nintemed 150 Soft Gelatin Capsule (Nintedanib):

⚠️ General Precautions

🧪 Liver Impairment

  • Nintedanib can cause elevated liver enzymes or hepatotoxicity.
  • Avoid or use with caution in patients with moderate to severe hepatic impairment (Child-Pugh B or C).
  • Monitoring: Regular liver function tests are essential.

💉 Bleeding Risk

  • Nintedanib may increase bleeding tendency, especially if taken with anticoagulants or antiplatelets.
  • Caution in patients with known bleeding disorders or history of gastrointestinal bleeding.

💊 Gastrointestinal Disorders

  • Common side effects include diarrhea, nausea, vomiting, and abdominal pain.
  • Caution in patients with:
  • Peptic ulcers
  • Diverticular disease
  • Inflammatory bowel disease

💓 4. Cardiovascular Conditions

  • May cause or worsen hypertension and arterial thromboembolic events.
  • Use cautiously in those with a history of:
  • Heart disease
  • Stroke
  • Hypertension

🩸 Kidney Impairment

  • Diarrhea and vomiting can lead to dehydration and renal impairment.
  • Monitor renal function, especially in elderly patients.

👶 Pregnancy & Breastfeeding

  • Contraindicated in pregnancy – may cause fetal harm.
  • Not recommended during breastfeeding – unknown if excreted in breast milk.
  • Women of childbearing age should use effective contraception during and for 3 months after treatment.

🧴 Other Precautions

  • Avoid alcohol – increases risk of liver toxicity.
  • Don’t crush or chew the capsule – swallow whole with food.
  • Avoid grapefruit juice – it may increase drug levels in the blood.

Drug Interactions

⚠️ Common Drug Interactions with Nintemed (Nintedanib)

💊 Anticoagulants (Blood Thinners)

  • Examples: Warfarin, Heparin, Apixaban, Rivaroxaban
  • Risk: Increased risk of bleeding due to Nintedanib’s effect on blood vessels.
  • Tip: Monitor INR and signs of bleeding (e.g., bruising, bloody stools).

💊 CYP3A4 and P-gp Modulators

Nintedanib is metabolized by CYP3A4 and transported by P-glycoprotein (P-gp). Drugs that affect these pathways may change its levels in the body.

🚫 Inhibitors (increase Nintedanib levels)

  • Examples: Ketoconazole, Erythromycin, Ritonavir, Itraconazole
  • Risk: Higher side effects (nausea, diarrhea, liver toxicity)

⬇️ Inducers (decrease Nintedanib levels)

  • Examples: Rifampicin, Carbamazepine, Phenytoin, St. John’s Wort
  • Risk: Reduced effectiveness

💊 Other Tyrosine Kinase Inhibitors or Cancer Therapies

  • Examples: Erlotinib, Sorafenib, Sunitinib
  • Risk: Additive toxicity, especially liver-related or GI effects

💊 NSAIDs and Corticosteroids

Risk: Increased gastrointestinal irritation or bleeding

💊 Hepatotoxic Drugs

  • Examples: Methotrexate, Isoniazid, Statins
  • Risk: Additive liver toxicity; monitor liver enzymes

Clinical Effectiveness

🫁 Slows Progression of Idiopathic Pulmonary Fibrosis (IPF)

  • Helps reduce scarring (fibrosis) in the lungs.
  • Improves or stabilizes lung function over time.
  • Delays worsening of respiratory symptoms like breathlessness and chronic cough.

🎯 Effective in Treating Non-Small Cell Lung Cancer (NSCLC)

  • Used in combination with other chemotherapy agents.
  • Inhibits tumor growth by targeting multiple tyrosine kinases involved in cancer progression.
  • May extend progression-free survival in advanced cancer cases.

🧬 Targets Multiple Disease Pathways

  • Blocks receptors involved in fibrosis, inflammation, and tumor growth (e.g., VEGFR, FGFR, PDGFR).
  • Offers a broader mechanism of action compared to single-target drugs.

🛡️ Potential Use in Other Cancers

  • Investigated and sometimes used in liver cancer, pancreatic cancer, and colorectal cancers.
  • Helps prevent new blood vessel formation in tumors (anti-angiogenic effect).

💊 Oral Administration & Convenient Dosing

  • Soft gelatin capsule makes it easier to swallow.
  • Taken orally with food, making it less invasive than injectable treatments.

Tips for Patients

Absolutely! Here are some clear and practical tips for patients taking Nintedanib 150 Soft Gelatin Capsule to help ensure safety and effectiveness of the treatment:

💡 Patient Tips for Taking Nintedanib 150

🕒 Take It with Food

  • Always take the capsule with food to reduce nausea and improve absorption.
  • Swallow whole—do not crush, chew, or open the capsule.

💊 Stick to the Schedule

  • Take it at the same time every day, usually twice daily (12 hours apart).
  • If you miss a dose, skip it—don’t double up to make up for it.

🧪 Monitor Liver Health

  • You’ll need regular liver function tests. Keep your lab appointments.
  • Report signs of liver issues: yellow skin/eyes, dark urine, or severe fatigue.

🚽 Watch for GI Side Effects

  • Diarrhea is common—stay well hydrated.
  • If diarrhea is severe or persistent, inform your doctor—medication like loperamide may help.
  • Also report nausea, vomiting, or stomach pain.

💧 Stay Hydrated

  • Drink plenty of fluids, especially if you’re experiencing diarrhea or vomiting.
  • Dehydration can worsen kidney function.

⚠️ Be Cautious with Other Medications

  • Tell your doctor about all medicines, supplements, and herbal products, especially:
  • Blood thinners (warfarin, aspirin)
  • CYP3A4 inhibitors or inducers
  • Avoid grapefruit or grapefruit juice.

🩸 Look Out for Bleeding

  • Increased risk of bleeding—report unusual bruising, nosebleeds, black/tarry stools, or pink urine.
  • Be extra careful with sharp objects or activities that risk injury.

👶 Pregnancy Precautions

  • Do NOT use if pregnant or planning to become pregnant.
  • Use effective birth control during treatment and for at least 3 months after stopping.

🧘‍♀️ Lifestyle Matters

  • Avoid alcohol—protects your liver.
  • Eat a balanced diet, rest well, and do not smoke—especially important in lung disease.

📞 Stay in Touch with Your Healthcare Team

  • Keep all appointments.
  • Don’t hesitate to report new or worsening symptoms.