The list below includes some common terms your doctor may use when discussing treatment

Acute myeloid leukemia

A type of blood and bone marrow cancer. Also known as AML.

Androgen deprivation therapy

A type of hormone therapy used to reduce male hormones causing prostate cancer growth. Otherwise known as chemical castration. Also known as ADT.

Androgen receptor-directed therapy

A treatment for prostate cancer that blocks the action of androgens in the body. Also known as ART or ARDT.

Advanced prostate cancer

Prostate cancer that has spread beyond the prostate gland to other parts of the body.

Biopsy

The removal of a small piece of tissue, which is then examined under a microscope.

Bladder

An organ that holds urine.

BRCA

The abbreviation for the BReast CAncer gene. BRCA1 and BRCA2 are 2 different genes that, when mutated, can increase the risk of patients developing certain cancers like prostate cancer.

Cancer

A general term for a large group of diseases in which abnormal cells grow and spread throughout the body.

Castration resistant

Cancer that is no longer responding to medical or surgical treatment that lowers testosterone.

Castration sensitive

Cancer that can be controlled by keeping testosterone levels low.

Duration of response

How long a patient responds to a cancer treatment before a disease progresses.

Fatigue

Extreme tiredness.

Germline testing

A type of genetic test that looks for inherited mutations that are present in every cell of the body and have been present since birth.

Hormones

Chemicals released by glands into the bloodstream to control how organs and tissues function.

Metastatic cancer

Cancer that has spread from where it started to a distant part of the body (metastatic) but still responds to treatments in the body.

Metastatic castration-resistant prostate cancer

A type of advanced prostate cancer in which the disease has spread beyond the prostate and the disease keeps growing even though there is low testosterone. Also known as mCRPC.

Metastatic castration-sensitive prostate cancer

A type of prostate cancer in which the disease has spread to other parts of the body but still responds to treatments in the body. Also known as mCSPC.

Myelodysplastic syndrome

A group of disorders caused by blood cells that are poorly formed or don’t work properly. Also known as MDS.

Monotherapy

A treatment that uses a single drug or type of treatment to treat a disease.

Objective response rate

The percentage of patients in a clinical trial who experience a complete or partial response to a treatment within a specific time period.

PARP inhibitor

Another name for poly (adenosine diphosphate-ribose) polymerase inhibitor. PARP inhibitors are a type of cancer drug that target the PARP protein to prevent repair of damaged DNA in cancer cells so the cancer cells die. Also known as PARPi.

Prostate gland

A walnut-sized gland that surrounds the male urethra, located between the bladder and the penis.

Somatic testing

A type of genetic test that looks for acquired mutations in a confined set of cells or tissue.

Taxane-based chemotherapy

A type of cancer treatment that stops cancer cells from replicating.

Testosterone

A male sex hormone produced mostly by the testicles, although a small amount is made by the adrenal glands.

Tumor

An abnormal growth of body tissue, which can be benign (not cancerous) or malignant (cancerous).

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IMPORTANT SAFETY INFORMATION

What is RUBRACA used for?

RUBRACA 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 (metastatic), 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.
  • 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.

What Warnings should you 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 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 healthcare provider will stop treatment with RUBRACA. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily. Symptoms of low blood cell counts are common during treatment with RUBRACA, but can be a sign of serious problems, including MDS or AML.

Before you take RUBRACA, tell your healthcare provider about all of your medical conditions, including 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 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, and diarrhea. These are not all the possible side effects of RUBRACA. Call your healthcare provider for medical advice about side effects.

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 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 pharma& at 1-800-506-8501.
This information is not comprehensive.
How to get more information:
  • Talk to your health care provider or pharmacist.
Please see full Prescribing Information for RUBRACA.

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