Rucaparib

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What is Rucaparib?[edit | edit source]

  • Rucaparib (Rubraca) is a poly (ADP-ribose) polymerase (PARP) inhibitor used as an anti-cancer agent.
Rucaparib.svg


What are the uses of this medicine?[edit | edit source]

This medicine is used in adults for:

  • the maintenance treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer when your cancer has come back and you are in response (complete or partial response) to a platinum-based chemotherapy.
  • the treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene, and you have been treated with 2 or more chemotherapy medicines for your cancer.
  • Your healthcare provider will perform a test to make sure Rubraca is right for you.
  • the treatment of castration-resistant prostate cancer (prostate cancer that no longer responds to medical or surgical treatment that lowers testosterone):
  • that has spread to other parts of the body, and
  • has a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene, and you have been treated with certain medicines for your cancer.


How does this medicine work?[edit | edit source]

  • Rucaparib (roo kap' a rib) is an orally available, small molecule inhibitor of poly adenine diphosphate (ADP)-ribose polymerase (PARP), an enzyme involved in DNA transcription and repair.
  • Patients with mutations of the BRCA 1 and 2 genes are at increased risk for cancer, particularly ovarian and breast cancer in women.
  • The BRCA gene encodes DNA repair enzymes, and tumor cells with BRCA mutations are dependent upon other pathways of DNA repair and thus have increased sensitivity to inhibition of PARP.
  • Clinical trials of rucaparib in women with BRCA 1 and 2 germline mutations and advanced, refractory ovarian carcinoma have shown response rates of 30% to 40% and prolongation of progression free survival.
  • Rucaparib is also under evaluation as therapy for advanced breast cancer and other malignant diseases associated mutations in BRCA or other DNA repair enzymes.


Who Should Not Use this medicine ?[edit | edit source]

  • This medicine have no usage limitation.


What drug interactions can this medicine cause?[edit | edit source]

  • Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.


Is this medicine FDA approved?[edit | edit source]

  • It was approved for use in the United States in 2016.


How should this medicine be used?[edit | edit source]

  • Select patients for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic).
  • Select patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma specimens.

Recommended Dosage:

  • The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken orally twice daily with or without food, for a total daily dose of 1,200 mg.
  • Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Administration

  • Take Rubraca exactly as your healthcare provider tells you.
  • Your healthcare provider may temporarily stop treatment with Rubraca or change your dose of Rubraca if you have side effects.
  • Do not change your dose or stop taking Rubraca unless your healthcare provider tells you to.
  • Take Rubraca 2 times a day.
  • Each dose should be taken about 12 hours apart.
  • Take Rubraca with or without food.
  • If you are taking Rubraca for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with Rubraca unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
  • If you miss a dose of Rubraca, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose.
  • If you vomit after taking a dose of Rubraca, do not take an extra dose.
  • Take your next dose at your usual time.
  • If you take too much Rubraca, call your healthcare provider or go to the nearest emergency room right away.


What are the dosage forms and brand names of this medicine?[edit | edit source]

This medicine is available in fallowing doasage form:

  • As Tablets: 200 mg, 250 mg, and 300 mg

This medicine is available in fallowing brand namesː

  • Rubraca


What side effects can this medication cause?[edit | edit source]

The most common side effects of Rubraca in people with ovarian cancer include:

The most common side effects of Rubraca in people with prostate cancer include:

Rubraca may cause serious side effects:


What special precautions should I follow?[edit | edit source]

  • Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and some cases were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Interrupt or reduce the dose.
  • Rubraca can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.


What to do in case of emergency/overdose?[edit | edit source]

Management for overdosage:

  • There is no specific treatment in the event of Rubraca overdose, and symptoms of overdose are not established.
  • In the event of suspected overdose, physicians should follow general supportive measures and should treat symptomatically.


Can this medicine be used in pregnancy?[edit | edit source]

  • Rubraca can cause fetal harm when administered to pregnant women.
  • There are no available data in pregnant women to inform the drug-associated risk.


Can this medicine be used in children?[edit | edit source]

  • The safety and effectiveness of Rubraca in pediatric patients have not been established.


What are the active and inactive ingredients in this medicine?[edit | edit source]

  • Active ingredient: rucaparib
  • Inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. The film coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, and talc. The blue film coating contains brilliant blue aluminum lake and indigo carmine aluminum lake. The yellow film coating contains yellow iron oxide.


Who manufactures and distributes this medicine?[edit | edit source]


What should I know about storage and disposal of this medication?[edit | edit source]

  • Store Rubraca at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Rubraca and all medicines out of the reach of children.
Rucaparib Resources

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