Rucaparib

What is Rucaparib?

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

What are the uses of this medicine?

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?

• 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 ?

• This medicine have no usage limitation.

What drug interactions can this medicine cause?

• 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?

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

How should this medicine be used?

• 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?

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?

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?

• 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?

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?

• 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?

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

What are the active and inactive ingredients in this medicine?

• 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?

• Distributed by: Clovis Oncology, Inc. Boulder, Colorado

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Rucaparib
• FDA Rucaparib