VIDAZA 100 MG 1 FLC

VIDAZA (Azacitidine) is a chemotherapy drug used primarily in the treatment of myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by the bone marrow’s inability to produce healthy blood cells. Azacitidine is an antineoplastic agent that belongs to a class of drugs known as DNA methyltransferase inhibitors. It works by inhibiting the abnormal growth of bone marrow cells and encouraging the production of healthy cells, thereby reducing the symptoms and progression of MDS.

How VIDAZA Works

Mechanism of Action

1. Epigenetic Modulation:
   • VIDAZA works by inhibiting DNA methyltransferase, an enzyme responsible for adding methyl groups to DNA. This methylation can alter gene expression and is often found to be abnormal in cancer cells, leading to uncontrolled growth. By inhibiting this enzyme, VIDAZA helps restore normal gene function.
2. DNA Incorporation:
   • Azacitidine incorporates itself into the DNA and RNA of rapidly dividing cells. Once incorporated, it disrupts the synthesis of these nucleic acids, ultimately preventing cancer cells from growing and dividing properly.
3. Reactivating Tumor Suppressor Genes:
   • The drug works by reactivating tumor suppressor genes that are typically silenced by abnormal methylation in cancer cells, thus slowing down or stopping the progression of cancer.
4. Inducing Cell Death:
   • By disrupting DNA and RNA synthesis, VIDAZA triggers programmed cell death (apoptosis) in abnormal bone marrow cells, leading to the reduction of cancer cells.
5. Improvement of Hematopoiesis:
   • VIDAZA helps improve the production of normal blood cells, reducing the need for blood transfusions and other supportive treatments in patients with MDS.

Side Effects

Common Side Effects

• Nausea and Vomiting:
  • These are common gastrointestinal side effects that can be managed with anti-nausea medications.
• Fatigue:
  • Patients often experience tiredness and a lack of energy, which can affect their daily activities.
• Injection Site Reactions:
  • Pain, redness, and swelling at the injection site are frequently reported.
• Diarrhea or Constipation:
  • Gastrointestinal disturbances are common, which can sometimes lead to significant discomfort.
• Fever:
  • A mild to moderate fever can occur due to the body’s response to the drug.
• Loss of Appetite:
  • Reduced desire to eat, which can contribute to weight loss.
• Low Blood Cell Counts (Neutropenia, Thrombocytopenia, Anemia):
  • VIDAZA can cause low levels of white blood cells, platelets, and red blood cells, increasing the risk of infections, bleeding, and fatigue.

Serious Side Effects

• Severe Neutropenia:
  • Critically low white blood cell counts that increase the risk of severe infections.
• Pulmonary Toxicity:
  • Lung-related issues, including pneumonia and interstitial lung disease, can occur, requiring immediate medical attention.
• Tumor Lysis Syndrome:
  • A potentially fatal condition caused by the rapid destruction of cancer cells, leading to kidney failure, heart problems, and electrolyte imbalances.
• Severe Liver Dysfunction:
  • VIDAZA can cause hepatotoxicity, especially in patients with pre-existing liver conditions.
• Renal Impairment:
  • Acute kidney injury, sometimes severe, particularly in patients with underlying kidney disease.

Indications

VIDAZA is indicated for:

• Treatment of Myelodysplastic Syndromes (MDS):
  • Including refractory anemia, refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, and chronic myelomonocytic leukemia.
• Acute Myeloid Leukemia (AML):
  • In patients not eligible for intensive chemotherapy, VIDAZA can be used as an alternative therapy to control disease progression.
• Chronic Myelomonocytic Leukemia (CMML):
  • Particularly in patients who are at high risk of progression to AML.

Contraindications

VIDAZA is contraindicated in the following situations:

• Hypersensitivity to Azacitidine or Any Component of the Product:
  • Patients with a known allergy to azacitidine or its excipients should not use VIDAZA.
• Advanced Liver Cancer:
  • VIDAZA is not recommended for patients with advanced malignant hepatic tumors due to the risk of severe hepatotoxicity.
• Pregnancy and Lactation:
  • VIDAZA can cause fetal harm when administered to pregnant women. It is contraindicated during pregnancy and breastfeeding.
• Severe Renal Impairment:
  • The drug should be used with caution in patients with severe renal dysfunction, and dose adjustments are necessary.
• Uncontrolled Infections:
  • Patients with active, severe infections should not begin treatment until the infection is controlled.

Price in Different Countries

VIDAZA prices can vary significantly by country due to differences in healthcare systems, insurance coverage, and local market conditions. Below is an approximate price list for VIDAZA 100 mg in various countries.

Country	Price (Per Vial)	Reference
United States	$1,500 – $2,000	GoodRx
United Kingdom	£1,200 – £1,500	NHS UK
Canada	CAD $1,800 – $2,200	Canada Drugs
Australia	AUD $2,300 – $2,700	PBS Australia
India	₹90,000 – ₹120,000	1mg

Top 5 Global Brands

1. VIDAZA (Azacitidine) – Celgene Corporation:
   • The original and most widely used brand, developed and marketed by Celgene, it is considered the gold standard for the treatment of MDS.
2. Azacitidine by Dr. Reddy’s Laboratories:
   • A generic version available in several countries, offering a more affordable alternative to the branded version.
3. Azacitidine Accord – Accord Healthcare:
   • Another generic option that is widely available in Europe and other regions, known for its cost-effectiveness.
4. Azacitidine Sandoz – Sandoz (a Novartis division):
   • Sandoz offers a trusted generic version that is commonly used across various healthcare settings globally.
5. Azacitidine Teva – Teva Pharmaceuticals:
   • Teva’s version of Azacitidine provides a reliable alternative for patients in need of affordable MDS treatment options.