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Votrient (200mg / 400mg) - Pazopanib Tablets

Votrient is an oral anti-cancer medication containing Pazopanib, a tyrosine kinase inhibitor (TKI) used in the treatment of certain advanced cancers like renal cell carcinoma (RCC) and soft tissue sarcoma (STS). It works by inhibiting angiogenesis—the formation of new blood vessels that tumors need to grow.

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General Information:
Generic Name: Pazopanib
Brand Name: Votrient
Packing: Bottle of 30 tablets
Strength: 200mg / 400mg per tablet
Manufacturer: Novartis India Ltd
Form: Film-coated oral tablets
Category: Antineoplastic agent, Tyrosine kinase inhibitor (VEGFR, PDGFR, KIT)
Product Introduction:
Votrient is a targeted therapy used in the treatment of advanced kidney cancer and certain types of soft tissue sarcomas. By selectively targeting multiple receptors involved in tumor growth and angiogenesis, it helps in slowing disease progression, reducing tumor size, and improving progression-free survival in patients with late-stage cancers.

Uses (Indications):
Votrient (Pazopanib) is primarily used in:
  1. Advanced Renal Cell Carcinoma (RCC)
  2. Advanced Soft Tissue Sarcoma (STS) in patients who have received prior chemotherapy
  3. Malignant Fibrous Histiocytoma and Liposarcoma (subtypes of STS)
  4. Investigational use in ovarian cancer and thyroid cancer
  5. Off-label uses in various rare tumors with angiogenic activity
  6. Sometimes used as second-line therapy after failure of prior targeted therapies

Storage Instructions:
  1. Store at 20°C to 25°C (68°F to 77°F)
  2. Keep in the original container with the cap tightly closed
  3. Protect from light and moisture
  4. Do not use if tablets are discolored or damaged
  5. Keep away from children and pets

How It Works (Mechanism of Action):
Pazopanib is a multi-targeted tyrosine kinase inhibitor that interferes with tumor growth and angiogenesis by blocking several key receptors:
  1. VEGFR-1, VEGFR-2, VEGFR-3 (Vascular Endothelial Growth Factor Receptors)
  2. PDGFR-α and PDGFR-β (Platelet-Derived Growth Factor Receptors)
  3. c-KIT, a stem cell growth factor receptor
By blocking these receptors, Pazopanib inhibits the signaling pathways involved in the proliferation of endothelial cells, reducing blood supply to the tumor, and ultimately starving the tumor of nutrients and oxygen, slowing or stopping growth.

Side Effects:
Common Side Effects:
  1. Diarrhea
  2. Hypertension
  3. Hair color changes (depigmentation)
  4. Fatigue
  5. Nausea and vomiting
  6. Anorexia (loss of appetite)
Serious Side Effects:
  1. Hepatotoxicity – Elevated liver enzymes (ALT, AST), possibly fatal
  2. Cardiac dysfunction – Including QT prolongation and heart failure
  3. Thrombotic events – Arterial and venous clots
  4. Hemorrhage – Gastrointestinal or pulmonary bleeding
  5. Proteinuria – Excess protein in urine
  6. Wound healing complications – Avoid perioperative use
  7. Rare: GI perforation, pancreatitis, interstitial lung disease
Regular monitoring is essential to prevent and manage serious side effects.

Dosage (Typical Recommended Dose):
  1. Standard adult dose: 800mg orally once daily
  2. Can be given as two 400mg tablets or four 200mg tablets
  3. Taken on an empty stomachat least 1 hour before or 2 hours after food
  4. Dose adjustments may be required in hepatic impairment or due to toxicity
  5. Pediatric dosing not established for cancer treatment

Method of Administration:
  1. Take orally with water, whole – do not crush, split, or chew tablets
  2. Must be taken on an empty stomach to avoid increased absorption and toxicity
  3. Consistency is key – take it at the same time each day
  4. Swallow tablets whole to maintain bioavailability and drug integrity

Precautions:
  1. Liver function monitoring before and during treatment is crucial
  2. Monitor blood pressure regularly and manage hypertension
  3. Avoid in patients with recent surgical wounds or poor healing capacity
  4. Use with caution in patients with cardiac history or arrhythmia
  5. Risk of bleeding – avoid in patients with bleeding disorders
  6. Not recommended in pregnant or breastfeeding women
  7. Effective contraception must be used by both men and women during and for several weeks after therapy

Drug Interactions:
  1. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) – may increase Pazopanib levels
  2. CYP3A4 inducers (e.g., rifampin, phenytoin) – may reduce efficacy
  3. Proton pump inhibitors, antacids – reduce drug absorption due to pH changes
  4. May increase exposure to CYP substrates like paclitaxel and statins
  5. Avoid grapefruit juice, which may alter drug metabolism

Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity reactions are rare but may include rash, itching, and angioedema
  2. Discontinue immediately if there are signs of anaphylaxis or breathing difficulty
  3. Patients with known allergy to Pazopanib or its excipients should not use it

Overdose Information:
  1. Symptoms may include severe hypertension, liver toxicity, and cardiac complications
  2. No specific antidote exists
  3. Management is supportive and symptomatic
  4. In case of overdose, monitor ECG, liver function, and renal function
  5. Contact emergency medical services immediately

Missed Dose Instructions:
  1. If a dose is missed, skip it and take the next dose at the regular time
  2. Do not double up on the next dose
  3. Maintain the routine dosing schedule
  4. Contact your doctor if you miss more than one dose in a row

Additional Notes:
  1. Votrient is not a curative treatment but extends progression-free survival in advanced cancer
  2. It is a part of targeted therapy regimens used when surgery is not an option
  3. Regular imaging (CT/MRI scans) and blood tests are required to assess response
  4. Liver function tests should be done every 2 weeks for the first 2 months, then monthly
  5. Lifestyle modifications like low-salt diet and blood pressure monitoring help manage side effects
  6. Healthcare providers may stop treatment temporarily before surgical procedures

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