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Rucaza (200mg / 300mg) - Rucaparib Tablets

Rucaza contains Rucaparib, a potent oral PARP inhibitor used primarily in the treatment of ovarian and related cancers with BRCA mutations. It works by impairing DNA repair in cancer cells, leading to cell death, especially in tumors deficient in homologous recombination repair mechanisms.

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General Information:
Generic Name: Rucaparib
Brand Name: Rucaza
Packing: 60 tabs
Strengths Available: 200mg and 300mg tablets
Manufacturer: Intas Pharmaceuticals Ltd
Form: Oral film-coated tablets
Category: Poly (ADP-ribose) polymerase (PARP) inhibitor; Antineoplastic agent
Product Introduction:
Rucaza is an anti-cancer drug formulated with Rucaparib, primarily indicated for advanced ovarian cancer and maintenance therapy in patients who have responded to platinum-based chemotherapy. As a targeted therapy, it offers a significant treatment option for patients with BRCA mutations or other homologous recombination deficiencies (HRD).

Uses (Indications):
Rucaza (Rucaparib) is used for:
  1. Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
  2. Treatment of BRCA-mutated advanced ovarian cancer in patients who have received two or more chemotherapies
  3. Prostate cancer with deleterious BRCA mutations, as a part of targeted treatment in specific patients
  4. Pancreatic cancer under investigational settings with germline BRCA mutations
  5. Potential use in combination therapy for other solid tumors in clinical trials

Storage Instructions:
  1. Store at room temperature (20–25°C)
  2. Protect from light and moisture
  3. Keep tablets in the original container
  4. Do not refrigerate or freeze
  5. Keep out of reach of children

How It Works (Mechanism of Action):
Rucaparib is a selective inhibitor of PARP1, PARP2, and PARP3 enzymes, which are critical for repairing single-strand breaks in DNA via the base excision repair pathway.
  1. Inhibition of PARP leads to the accumulation of DNA damage
  2. This is especially lethal in tumor cells with BRCA1/2 mutations or HRD, which already have deficient double-strand DNA repair capability
  3. This dual-hit leads to synthetic lethality, selectively killing cancer cells while sparing normal cells
  4. Additionally, it traps PARP on damaged DNA, further preventing repair and replication

Side Effects:
Common Side Effects:
  1. Nausea
  2. Fatigue
  3. Vomiting
  4. Anemia
  5. Decreased appetite
  6. Constipation
  7. Dysgeusia (altered taste)
Serious Side Effects:
  1. Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) – rare but potentially fatal
  2. Liver enzyme elevations (ALT, AST) – require regular monitoring
  3. Photosensitivity reactions – patients should avoid sunlight or use protection
  4. Renal dysfunction – increases in creatinine levels may occur
  5. Thrombocytopenia and neutropenia – severe hematologic toxicities in some patients

Dosage (Typical Recommended Dose):
  1. The recommended dose for most adults is 600 mg orally twice daily (total 1200 mg/day)
  2. Tablets may be taken with or without food
  3. Dose modifications may be required in response to side effects or toxicity
  4. Doses may be reduced in steps: 500 mg BID → 400 mg BID → 300 mg BID
  5. Always follow the oncologist's prescription and monitoring plan

Method of Administration:
  1. Take orally with a full glass of water
  2. Can be taken with or without food
  3. Do not crush or split the tablets
  4. Maintain 12-hour intervals between doses
  5. If vomiting occurs after a dose, do not retake the dose—continue with the next scheduled one

Precautions:
  1. Monitor CBC, renal and hepatic function regularly
  2. Use contraception during treatment and for 6 months after the last dose (both males and females)
  3. Not recommended in pregnancy or breastfeeding due to fetal toxicity
  4. Patients with hematologic abnormalities should be monitored for MDS/AML
  5. Caution in elderly patients and those with renal/hepatic impairment
  6. Inform physician of any history of photosensitivity or skin cancer

Drug Interactions:
  1. Strong CYP1A2 inhibitors or inducers – may alter metabolism
  2. P-glycoprotein (P-gp) substrates – may interfere with drug transport
  3. Warfarin – increased bleeding risk; INR monitoring needed
  4. Antacids and multivitamins – may affect absorption if taken simultaneously
  5. Avoid concurrent use with other myelosuppressive agents unless supervised

Allergies (Warnings for Allergic Reactions):
  1. Avoid in patients with hypersensitivity to Rucaparib or its components
  2. Signs of allergic reaction include rash, swelling, itching, chest tightness, or difficulty breathing
  3. Discontinue immediately and seek medical attention if allergic symptoms appear

Overdose Information:
  1. No specific antidote available
  2. Overdose may lead to severe nausea, hematologic toxicity, or organ dysfunction
  3. Supportive care and symptomatic treatment should be administered
  4. Monitor CBC and organ function closely
  5. Activated charcoal may be considered if ingestion was recent

Missed Dose Instructions:
  1. If a dose is missed, take it as soon as remembered
  2. If it’s close to the next dose, skip the missed dose
  3. Do not take two doses at the same time
  4. Continue with the regular dosing schedule
  5. Maintain consistency to ensure therapeutic effect

Additional Notes:
  1. Treatment should be supervised by a healthcare professional experienced in cancer therapy
  2. Periodic genetic testing for BRCA mutations or HRD may guide use
  3. Patients should undergo regular skin checks due to risk of secondary skin malignancies
  4. Rucaza plays a critical role in personalized oncology, particularly in BRCA-mutated ovarian and prostate cancers
  5. Educate patients about photosensitivity precautions and importance of routine blood monitoring

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