VIZIMPRO 45 MG 30 FILM KAPLI TABLET

VIZIMPRO (Dacomitinib) is a targeted cancer therapy used in the treatment of patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. It belongs to a class of drugs known as tyrosine kinase inhibitors (TKIs), specifically targeting the epidermal growth factor receptor (EGFR) pathway. VIZIMPRO is used as a first-line treatment for patients with metastatic NSCLC who have certain EGFR mutations. It is designed to inhibit the growth and spread of cancer cells by interfering with the signaling pathways that drive cancer progression.

How VIZIMPRO Works

Mechanism of Action

1. Inhibition of EGFR:
   • VIZIMPRO targets and binds to the epidermal growth factor receptor (EGFR) on the surface of cancer cells. EGFR is a protein that, when mutated, promotes cancer cell growth, division, and survival.
2. Blocking Cell Signaling Pathways:
   • Dacomitinib inhibits EGFR tyrosine kinase activity, which is crucial for the activation of downstream signaling pathways involved in tumor proliferation and survival, including the PI3K/AKT and RAS/RAF/MEK pathways.
3. Irreversible Binding:
   • Unlike some other EGFR inhibitors, VIZIMPRO binds irreversibly to the receptor, leading to sustained inhibition of the EGFR signaling and enhancing its antitumor effect.
4. Reducing Tumor Growth:
   • By blocking these pathways, VIZIMPRO helps to reduce the growth and spread of cancer cells, leading to potential tumor shrinkage and delayed progression of the disease.

Side Effects

Common Side Effects

• Diarrhea:
  • One of the most frequently reported side effects, which can range from mild to severe.
• Skin Reactions:
  • Acneiform rash, dry skin, itching, and other dermatologic side effects are common due to EGFR inhibition.
• Stomatitis:
  • Inflammation and sores in the mouth are frequently observed among patients taking VIZIMPRO.
• Decreased Appetite:
  • Loss of appetite and related weight loss are commonly reported side effects.
• Nail Disorders:
  • Changes in nail color, texture, or growth, including paronychia (infection around the nails).
• Fatigue:
  • General tiredness and lack of energy that can affect daily activities.
• Elevated Liver Enzymes:
  • Changes in liver function tests, which may indicate stress on the liver.

Serious Side Effects

• Interstitial Lung Disease (ILD)/Pneumonitis:
  • Rare but severe lung inflammation that can be life-threatening and requires immediate medical attention.
• Severe Diarrhea:
  • Persistent or severe diarrhea can lead to dehydration and electrolyte imbalances, necessitating dose adjustments or discontinuation.
• Hepatotoxicity:
  • Potential liver damage requiring regular monitoring of liver function tests during treatment.
• Severe Dermatologic Reactions:
  • Intense skin reactions that can significantly impact the patient’s quality of life and may require dose modifications.
• Gastrointestinal Perforation:
  • Rare cases of gastrointestinal tract perforations have been reported, which require immediate medical intervention.

Indications

VIZIMPRO is indicated for:

• First-Line Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC):
  • Specifically for patients with metastatic NSCLC who have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Contraindications

VIZIMPRO should not be used in the following conditions:

• Hypersensitivity to Dacomitinib:
  • Patients with known allergies to dacomitinib or any excipients in the formulation should avoid this medication.
• Severe Hepatic Impairment:
  • Not recommended for patients with severe liver dysfunction due to the increased risk of toxicity.
• Pregnancy:
  • VIZIMPRO may cause fetal harm; it is contraindicated in pregnant women, and effective contraception should be used during treatment.
• Lactation:
  • Breastfeeding mothers should not use VIZIMPRO as it is unknown if the drug is excreted in human milk.
• Severe Interstitial Lung Disease or Pneumonitis:
  • Patients with a history of severe ILD or pneumonitis should not be treated with VIZIMPRO due to the risk of exacerbation.

Price in Different Countries

The cost of VIZIMPRO 45 mg 30 film-coated tablets varies by country, influenced by healthcare systems, availability, and market conditions. Below is a table with estimated prices in different countries.

Country	Price (Per 30 Tablets)	Reference
United States	$12,000 – $15,000	GoodRx
United Kingdom	£9,000 – £11,500	NHS UK
Canada	CAD $16,000 – $18,000	Canada Drugs
Australia	AUD $18,500 – $20,000	PBS Australia
India	₹900,000 – ₹1,100,000	1mg

Top 5 Global Brands

1. VIZIMPRO (Dacomitinib) – Pfizer:
   • The original brand developed and marketed by Pfizer, it is widely available and recognized as the standard dacomitinib formulation.
2. Dacomitinib by Beacon Pharma:
   • Available in selected Asian markets, Beacon Pharma provides a cost-effective alternative to the original formulation.
3. Teva Dacomitinib – Teva Pharmaceuticals:
   • Teva’s generic version offers an alternative for patients in various European and North American markets.
4. Mylan Dacomitinib – Mylan:
   • Another reputable generic version that is commonly used in the United States and Europe, providing a more affordable option.
5. Natco Dacomitinib – Natco Pharma:
   • A well-known generic available in India and other emerging markets, offering a lower-cost alternative to VIZIMPRO.