Rucaparib
What is Rucaparib?[edit | edit source]
- Rucaparib (Rubraca) is a poly (ADP-ribose) polymerase (PARP) inhibitor used as an anti-cancer agent.
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:
- nausea
- tiredness or weakness
- vomiting
- decrease in hemoglobin (anemia)
- changes in how food tastes
- changes in liver function tests
- constipation
- decreased appetite
- diarrhea
- low blood cell counts
- mouth sores
- upper respiratory tract infection
- shortness of breath
- rash
- stomach (abdomen) pain or swelling
The most common side effects of Rubraca in people with prostate cancer include:
- tiredness or weakness
- nausea
- decrease in hemoglobin (anemia)
- changes in liver function tests
- decreased appetite
- rash
- constipation
- low blood cell counts
- vomiting
- diarrhea
Rubraca may cause serious side effects:
- Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML)
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]
- Distributed by: Clovis Oncology, Inc. Boulder, Colorado
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.
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