Rubraca

Rubraca (rucaparib) is a prescription PARP inhibitor medicine used to treat advanced ovarian cancer and prostate cancer with BRCA mutations in certain patients.

Rubraca is a targeted therapy that inhibits poly ADP ribose polymerase (PARP), an enzyme that helps repair damaged DNA in cells. Rubraca works by preventing cells from repairing damaged DNA, causing the cancer cells to die, which can slow or inhibit tumor growth.

Rubraca is an oral tablet taken twice daily with or without food. Tablets should be taken approximately 12 hours apart.

Common Rubraca side effects are nausea, tiredness, vomiting, diarrhea, rash, low appetite, constipation, skin photosensitivity, changes in blood tests, and changes in liver or kidney function tests.

Rubraca is FDA-approved to treat:

• Ovarian cancer in adult patients that is:
• Prostate cancer in adult patients that is:

Patients may receive Rubraca if testing with an FDA-approved companion diagnostic shows it is appropriate for them.

Take Rubraca exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Rubraca is usually taken once every 12 hours, with or without food.

If you take Rubraca for prostate cancer, you may also be treated with another medicine called a gonadotropin-releasing hormone, or GnRH. GnRH helps prevent the testicles from producing testosterone.

If you vomit shortly after taking a dose of this medicine, do not take another dose. Wait until your next scheduled dose to take the medicine again, but do not take 2 doses at the same time.

You may need frequent medical tests, and your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Rubraca has a warning for bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML). MDS or AML is a serious condition that may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

Symptoms of low blood cell counts are common during treatment with Rubraca, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Rubraca:

• weakness
• weight loss
• Fever
• frequent infections
• blood in urine or stool
• shortness of breath
• feeling very tired
• bruising or bleeding more easily

Your healthcare provider will do blood tests to check your blood cell counts:

• before treatment with Rubraca.
• every month during treatment with Rubraca.
• weekly if you have low blood cell counts for a long

Using Rubraca may increase your risk of developing serious bone marrow problems or other types of cancer, such as leukemia. Ask your doctor about your specific risk.

Rucaparib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use rucaparib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine.
• If you are a man, use effective birth control if your sexual partner can get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Rubraca: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blood in your urine; or
• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Rubraca side effects may include:

• low blood cell counts;
• shortness of breath;
• upset stomach, loss of appetite;
• nausea, vomiting, diarrhea, constipation;
• changes in your sense of taste;
• dizziness, feeling weak or tired;
• increased sensitivity to light;
• rash; or
• abnormal liver and kidney function tests.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects tothe FDA at 1-800-FDA-1088.

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
• Treatment is recommended until disease progression or unacceptable toxicity.
• Dose may be interrupted, reduced, or stopped due to adverse reactions.

Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Men should not donate sperm while taking Rubraca and for at least 3 months after the last dose.

Rucaparib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with rucaparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

• Store 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.

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.

Manufactured for: pharmaand GmbH, Taborstrasse 1, 1020 Wien, Austria

Distributed by: Summit SD LLC, 420 NW Capital Drive, Lee’s Summit, MO 64086

• What type of cancer is Rubraca used to treat?