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Updated 6/19/20

Class: Biological Therapy

Generic Name: rucaparib (roo-kap-uh-rib)

Trade Name: Rubraca®

How is Rubraca drug used?Ovarian Cancer: Rubraca is approved for patients with:

· Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer as maintenance therapy after a complete or partial response to platinum-based chemotherapy.

· Epithelial ovarian, fallopian tube or primary peritoneal cancer whose genes have certain BRCA mutations (inherited or acquired) and have been treated with two or more chemotherapies. An FDA-approved diagnostic test will be administered for positive BRCA mutation before receiving Rubraca.

Prostate Cancer: Rubraca is approved for patients with metastatic castration-resistant prostate cancer (mCRPC) whose genes have certain BRCA mutations (inherited or acquired) and have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved by the FDA under accelerated approval and continued approval for this indication may be contingent upon verification of clinical benefit in additional studies.

What is the mechanism of action? Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that works by blocking an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.

How is Rubraca given (administered)? Rubraca is administered orally. For mCRPC, patients who have not had a bilateral orchiectomy should receive a gonadotropin-releasing hormone analog with Rubraca treatment.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Rubraca. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.

What are the most common side effects of treatment with Rubraca?

For ovarian cancer:

  • Fatigue
  • Nausea
  • Vomiting
  • Abdominal pain or swelling
  • Change in taste
  • Constipation
  • Decreased appetite
  • Diarrhea
  • Shortness of breath
  • Anemia
  • Low blood cell counts
  • Changes in liver function tests
  • Increased cholesterol levels
  • Mouth sores
  • Rash
  • Upper respiratory tract infection

For mCRPC:

· Fatigue

· Nausea

· Anemia

· Changes in liver function tests

· Decreased appetite

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· Rash

· Constipation

· Vomiting

· Diarrhea

· Low blood cell counts

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What are some of the less common but potentially serious side effects of Rubraca?

  • Bone marrow problems called myelodysplastic Syndrome (MDS)
  • A type of cancer 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. MDS or AML may lead to death. If you develop MDS or AML, your doctor will stop treatment with Rubraca.

Are there any special precautions patients should be aware of before starting treatment?

  • Avoid spending time in the sunlight. Rubraca may cause you to burn easily. Wear a hat and clothing that covers your skin and use sunscreen.
  • Females should be advised of the potential risk to a fetus and to use effective contraception during treatment and for at least 6 months after the final dose of Rubraca.
  • Rubraca can harm your unborn baby and may cause miscarriage. Tell your healthcare provider right away if you are pregnant or become pregnant while receiving Rubraca.
  • It is not known if Rubraca passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should patients be aware of during treatment of Rubraca? Symptoms of low blood counts are common during treatment with Rubraca, but can be a sign of serious problems including MDS or AML. Call your doctor right away if you have any of the following symptoms while taking Rubraca:

  • Weakness
  • Weight loss
  • Fever
  • Frequent infections
  • Blood in urine or stool
  • Shortness of breath
  • Feeling very tired
  • Bruising or bleeding more easily

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.