Pronunciation:

roo-KAP-a-rib

Brand Names:

• Rubraca

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Rucaparib is used as maintenance treatment in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back. It is only used in patients who have a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. Your doctor will test for the presence of this gene. It is used in patients who have received complete or partial treatment with platinum-based cancer medicines.

Rucaparib is also used to treat metastatic castration-resistant prostate cancer (prostate cancer that has spread and is resistant to medical or surgical treatments that lower testosterone). It is only used in patients who have a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. Your doctor will test for the presence of this gene.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rucaparib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rucaparib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Your doctor may also give you other medicines (eg, gonadotropin-releasing hormone medicine) during prostate cancer treatment with this medicine or you should have had surgical removal of the testes before using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For advanced ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or prostate cancer:
    • Adults—600 milligrams (mg) (two 300 mg tablets) 2 times a day. Each dose should be taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking a dose, do not take an extra dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to check for any problems 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment with this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not donate sperm while you are using this medicine and for at least 3 months after your last dose.

Tell your doctor if you have 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 lotion and lip balm 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 A.M. and 3 P.M. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

body aches or pain

chills

cough

difficulty in breathing

ear congestion

fever

headache

loss of voice

lower back or side pain

muscle aches

nasal congestion

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid weight gain

sneezing

sore throat

stuffy or runny nose

tingling of the hands or feet

trouble breathing

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Less common

Redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

tenderness of the palms and soles

tingling of the hands and feet

ulceration of the skin

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:

More common

Belching

change in taste

constipation

decreased appetite

diarrhea

discouragement

dizziness

feeling sad or empty

heartburn

increased sensitivity of the skin to sunlight

indigestion

irritability

itching, skin rash

lack of appetite

lack or loss of strength

loss of interest or pleasure

loss of taste

nausea

redness or other discoloration of the skin

severe sunburn

stomach discomfort, upset, or pain

stomach distention

swelling or inflammation of the mouth

trouble concentrating

trouble sleeping

vomiting

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.