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Bracanat (100mg / 150mg) - Olaparib Tablets

Bracanat is a targeted oral therapy containing Olaparib, a PARP inhibitor used to treat BRCA-mutated cancers such as ovarian, breast, pancreatic, and prostate cancer. It works by blocking DNA repair in cancer cells, leading to cell death.

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General Information:
Generic Name: Olaparib
Brand Name: Bracanat
Strengths Available: 100mg and 150mg
Packing: Bottle of 30 tablets
Manufacturer: Natco Pharma Ltd.
Form: Oral tablets
Category: Targeted Therapy / PARP Inhibitor / Antineoplastic
Product Introduction:
Bracanat is an oral formulation of Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor developed for patients with specific genetic mutations (BRCA1/2). By interfering with DNA damage repair mechanisms, Olaparib selectively targets cancer cells that rely heavily on PARP for survival. It is primarily used as maintenance or first-line treatment in BRCA-mutated cancers.

Uses:
Bracanat (Olaparib) is used for:
  1. Maintenance treatment of platinum-sensitive ovarian cancer
  2. Germline BRCA-mutated HER2-negative metastatic breast cancer
  3. Metastatic pancreatic cancer with BRCA mutations
  4. Metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations
  5. Advanced fallopian tube or peritoneal cancer
  6. Combination therapy with bevacizumab in advanced ovarian cancer (in select cases)

Storage Instructions:
  1. Store at 25°C (may be exposed to 15–30°C)
  2. Keep container tightly closed
  3. Protect from moisture and light
  4. Keep out of reach of children

How It Works (Mechanism of Action):
Olaparib inhibits PARP enzymes, which are crucial for the repair of single-strand DNA breaks. In BRCA1/2-mutated cells, where homologous recombination is already defective, PARP inhibition leads to accumulation of DNA damage, ultimately causing cell death through synthetic lethality. This makes Olaparib highly effective in selectively targeting cancer cells with defective DNA repair pathways.

Side Effects:
Common side effects:
  1. Nausea and vomiting
  2. Fatigue
  3. Anemia
  4. Headache
  5. Decreased appetite
  6. Diarrhea
Serious side effects:
  1. Myelodysplastic syndrome (MDS)
  2. Acute myeloid leukemia (AML)
  3. Pneumonitis
  4. Severe anemia or neutropenia
  5. Liver function abnormalities

Dosage (Typical Recommended Dose):
  1. Standard dose: 300 mg (two 150mg tablets) taken twice daily (total 600mg/day)
  2. For the 100mg strength: 3 tablets twice daily (total 600mg/day)
  3. Dose may be adjusted based on renal function, tolerability, and side effects
  4. Continue until disease progression or unacceptable toxicity

Method of Administration:
  1. Take orally, with or without food
  2. Swallow tablets whole, do not crush, chew, or split
  3. Administer at the same time each day
  4. Ensure adequate hydration during treatment

Precautions:
  1. Monitor complete blood counts before and during treatment
  2. Assess patients for BRCA mutation status before initiating therapy
  3. Avoid use in pregnant or breastfeeding women
  4. Use effective contraception during treatment and for 6 months after last dose
  5. Patients with renal impairment may need dose adjustment

Drug Interactions:
  1. Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) can increase Olaparib levels
  2. CYP3A4 inducers (e.g., rifampin, phenytoin) may reduce its effectiveness
  3. Avoid grapefruit juice and St. John’s Wort
  4. Monitor for toxicity when used with other myelosuppressive agents

Allergies:
  1. Contraindicated in patients with known hypersensitivity to Olaparib or any tablet component
  2. Rare allergic reactions include rash, itching, and angioedema

Overdose Information:
  1. Symptoms may include nausea, vomiting, and bone marrow suppression
  2. No specific antidote – manage with supportive care and symptomatic treatment
  3. Seek immediate medical attention in case of overdose

Missed Dose Instructions:
  1. If a dose is missed, take it as soon as remembered
  2. If it's almost time for the next dose, skip the missed dose – do not double the dose
  3. Resume regular dosing schedule

Additional Notes:
  1. Regular CBC and liver function monitoring is essential
  2. Educate patients to report symptoms of fatigue, breathlessness, or bruising
  3. Therapy is oral and home-based, improving patient convenience
  4. Only patients with confirmed BRCA mutations (germline or somatic) should receive Bracanat

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