Rucaparib

Name: Rucaparib

What should I do if I forget a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Administration

Oral Administration

May administer with or without food

Missed/vomited dose: Instruct patients to take the next dose at its scheduled time (ie, do not take an extra dose)

Storage

Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

What is rucaparib?

Rucaparib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Rucaparib is used to treat advanced ovarian cancer.

Rucaparib is used only if your tumor has a specific genetic marker, for which your doctor will test.

Rucaparib is usually given after at least 2 other cancer medicines have been tried without success.

Rucaparib may also be used for purposes not listed in this medication guide.

What is the most important information I should know about rucaparib?

Rucaparib can cause leukemia or serious bone marrow problems. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, blood in your urine or stools, shortness of breath, or signs of infection (fever, feeling weak or tired, weight loss).

Rucaparib dosing information

Usual Adult Dose for Ovarian Cancer:

600 mg orally twice a day
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity.

Comments:
-Administer each dose about 12 hours apart, with or without food.
-Select patients based on the results of the approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer; the test is available at http://www.fda.gov/CompanionDiagnostics.

Use: Monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with 2 or more chemotherapies.

Commonly used brand name(s)

In the U.S.

  • Rubraca

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

What do I need to tell my doctor BEFORE I take Rucaparib?

  • If you have an allergy to rucaparib or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding. Do not breast-feed while you take rucaparib and for 2 weeks after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Pronunciation

(roo KAP a rib)

Brand Names U.S.

  • Rubraca

Special Populations Renal Function Impairment

Patients receiving rucaparib 600 mg twice daily with CrCl 60 to 89 mL/minute and those with CrCl between 30 to 59 mL/minute had approximately 15% and 32% higher steady-state AUC, respectively, compared to patients with normal renal function (CrCl 90 mL/minute or above).

Dosing Geriatric

Refer to adult dosing.

Usual Adult Dose for Ovarian Cancer

600 mg orally twice a day
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity.

Comments:
-Administer each dose about 12 hours apart, with or without food.
-Select patients based on the results of the approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer; the test is available at http://www.fda.gov/CompanionDiagnostics.

Use: Monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with 2 or more chemotherapies.

Renal Dose Adjustments

-Mild to Moderate Renal Impairment (CrCl 30 to 89 mL/min): No starting dose adjustment recommended.
-Severe Renal Impairment (CrCl less than 30 mL/min): Data not available.

Dialysis

Data not available.

(web3)