How should I take Rubraca? | Rubraca® (rucaparib) tablets
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How should I take Rubraca?
How should I take Rubraca?

Rubraca is a tablet taken by mouth

Before you take Rubraca, tell your doctor about all of your medical conditions and all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The starting dose of Rubraca is 600 mg twice a day, for a total daily dose of 1200 mg (4 tablets)

Take 2 Rubraca tablets:
orally
Orally
2x
Twice a day
12hours
About 12 hours apart
without_food
With or without food
2 tablets in the morning2 tablets in the morning
 
2 tablets at night2 tablets at night
Tablets shown are not actual size.

Take Rubraca exactly as your doctor tells you

  • Your doctor 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 doctor tells you to
  • 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 team or go to the nearest emergency room right away

If necessary, your doctor may decide to modify your dose to help manage side effects

There are 3 different tablet strengths of Rubraca so your doctor can find the right dose for you. 

Dose image Dose image

In the clinical study:

  • 41% of men studied (47 of 115) had their dose of Rubraca lowered by their doctor
  • 57% of men studied (66 of 115) had their treatment of Rubraca paused for some time by their doctor, but then began taking it again at a later date
  • 8% of men (9 of 115) were taken off Rubraca entirely by their doctors due to side effects; however, the reason was different for each patient

Helpful tips to consider when taking Rubraca

  • Make Rubraca part of your twice-daily routine, such as at mealtimes or when brushing your teeth, to help you remember to take it at the same times each day
  • Set an alarm to remind you when to take your medication

How should I store Rubraca?

  • 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

INDICATION

Read Full ISI

What is Rubraca used for?

Rubraca® (rucaparib) tablets are a prescription medicine used in adults for 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.

Rubraca was approved based on response rate and how long patients’ responses lasted. There are ongoing studies to confirm the clinical benefit of Rubraca. Your healthcare provider will perform a test to make sure Rubraca is right for you.

It is not known if Rubraca is safe and effective in children.

SELECT IMPORTANT SAFETY INFORMATION

What Warnings should I know about Rubraca?

Rubraca tablets may cause serious side effects including bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca, although MDS or AML was not observed in men with prostate cancer during the clinical study. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

You should not use Rubraca if you are a male with a female partner who is pregnant or able to become pregnant. Effective birth control should be used during treatment and for 3 months after the last dose of Rubraca. Do not donate sperm during use and for 3 months after the last dose of Rubraca.

What other important information should I know about Rubraca?

Your healthcare provider will do blood tests before, and every month during treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve.

Avoid spending time in sunlight while on Rubraca since your skin may become more sensitive to the sun and may sunburn more easily. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.

What are the side effects of Rubraca?

The most common side effects for men in Rubraca clinical studies were weakness/fatigue, nausea, decreased red blood cell count, changes in liver function tests, decreased appetite, constipation, rash, decreased platelet count, vomiting, and diarrhea.

What other medications might interact with Rubraca?

Rubraca can increase the amounts of other medications you may be taking which can increase the risk of side effects. Tell your healthcare provider about all of your medical conditions and all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1‑415‑409‑7220 (US toll) or 1‑844‑CLVS‑ONC (1‑844‑258‑7662; US toll-free).

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.

INDICATION

Read Full ISI

What is Rubraca used for?

Rubraca® (rucaparib) tablets are a prescription medicine used in adults for 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.

Rubraca was approved based on response rate and how long patients’ responses lasted. There are ongoing studies to confirm the clinical benefit of Rubraca. Your healthcare provider will perform a test to make sure Rubraca is right for you.

It is not known if Rubraca is safe and effective in children.

SELECT IMPORTANT SAFETY INFORMATION

What Warnings should I know about Rubraca?

Rubraca tablets may cause serious side effects including bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca, although MDS or AML was not observed in men with prostate cancer during the clinical study. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

You should not use Rubraca if you are a male with a female partner who is pregnant or able to become pregnant. Effective birth control should be used during treatment and for 3 months after the last dose of Rubraca. Do not donate sperm during use and for 3 months after the last dose of Rubraca.

What other important information should I know about Rubraca?

Your healthcare provider will do blood tests before, and every month during treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve.

Avoid spending time in sunlight while on Rubraca since your skin may become more sensitive to the sun and may sunburn more easily. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.

What are the side effects of Rubraca?

The most common side effects for men in Rubraca clinical studies were weakness/fatigue, nausea, decreased red blood cell count, changes in liver function tests, decreased appetite, constipation, rash, decreased platelet count, vomiting, and diarrhea.

What other medications might interact with Rubraca?

Rubraca can increase the amounts of other medications you may be taking which can increase the risk of side effects. Tell your healthcare provider about all of your medical conditions and all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1‑415‑409‑7220 (US toll) or 1‑844‑CLVS‑ONC (1‑844‑258‑7662; US toll-free).

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.