Rubraca

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to rucaparib when you start treatment and at various times throughout your treatment.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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.

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).

You should not use rucaparib if you are allergic to it.

Using rucaparib 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.

Do not use rucaparib if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose. Tell your doctor right away if you become pregnant.

It is not known whether rucaparib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 2 weeks after your last dose.

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

Other drugs may interact with rucaparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Rucaparib is usually taken once every 12 hours. Follow your doctor's dosing instructions very carefully.

You may take rucaparib with or without food.

If you vomit shortly after taking rucaparib, 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.

Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat.

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

General

Rucaparib camsylate is available in the following dosage form(s) and strength(s):

Tablets: 200 mg and 300 mg1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Recommended dose is 600 mg orally twice daily with or without food.1

• Continue treatment until disease progression or unacceptable toxicity.1

• For adverse reactions, consider interruption of treatment or dose reduction.1

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Rucaparib is used to treat advanced ovarian cancer in patients who have who have received 2 or more cancer medicines. It is only used in patients who have deleterious BRCA mutation. Your doctor will use a test to check for the mutation before you receive the medicine.

This medicine is available only with your doctor's prescription.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 6 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor if you have a bone pain, blood in the urine or stools, fever or chills, cough, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a bone marrow problem called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

This medicine may make your skin more sensitive to sunlight. Use sunscreen or sunblock lotions and lip balms with a sun protection factor (SPF) of at least 30 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 AM and 3 PM. Avoid sunlamps and tanning beds.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• chills
• cough
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• sore throat
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

• Bleeding gums
• pinpoint red spots on the skin

• Bone pain
• chest pain
• hoarseness
• swollen glands

• Difficult or labored breathing
• tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness
• increased sensitivity of the skin to sunlight
• itching or skin rash
• lack or loss of strength
• redness or other discoloration of the skin
• severe sunburn

• Abdominal or stomach pain
• decreased appetite
• diarrhea
• difficulty having a bowel movement (stool)
• nausea
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• tingling of the hands and feet

• Change in taste
• loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Stomach pain.
• Change in taste.
• Not hungry.
• Feeling tired or weak.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

The following serious adverse reactions are discussed elsewhere in the labeling:

• Myelodysplastic Syndrome/Acute Myeloid Leukemia [see Warnings and Precautions (5.1)].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Rubraca 600 mg twice daily as monotherapy, has been studied in 377 patients with ovarian cancer treated in two open-label, single arm trials. In these patients, the median age was 62 years (range 31 to 86), 100% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, 38% had BRCA-mutated ovarian cancer, 45% had received 3 or more prior lines of chemotherapy, and the median time since ovarian cancer diagnosis was 43 months (range 6 to 197).

Adverse reactions led to dose reduction or interruption in 62% of patients, most frequently from anemia (27%), and fatigue/asthenia (22%). Adverse reactions led to dose discontinuation in 10% of patients, most frequently from fatigue/asthenia (2%). The median duration of treatment was 5.5 months (range 0.1 to 28.0).

Table 2 and Table 3 summarize the common adverse reactions and abnormal laboratory findings, respectively, observed in patients treated with Rubraca.

The following adverse reactions have been identified in < 20% of the 377 patients treated with Rubraca 600 mg twice daily: dizziness (17%), neutropenia (15%), rash (includes rash, rash erythematous, rash maculopapular and dermatitis) (13%), pyrexia (11%), photosensitivity reaction (10%), pruritus (includes pruritus and pruritus generalized) (9%), Palmar-plantar erythrodysaesthesia syndrome (2%), and febrile neutropenia (1%).

Other drugs may interact with rucaparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.