Important things to know about Rubraca

Rubraca 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 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.

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 doctor 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 doctor will do blood tests to monitor 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 time. If this happens, your doctor may stop treatment with Rubraca until your blood cell counts improve

What are the possible side effects of Rubraca?

The most common side effects of Rubraca include:

  • Nausea
  • Fatigue
  • Vomiting
  • Stomach-area pain
  • Changes in how food tastes
  • Constipation
  • Decreased appetite
  • Diarrhea
  • Shortness of breath
  • Decrease in hemoglobin (anemia)
  • Low blood cell counts
  • Changes in liver or kidney function blood tests
  • Increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

SELECT IMPORTANT SAFETY INFORMATION
SELECT IMPORTANT SAFETY INFORMATION

There are no contraindications for Rubraca.

Rubraca 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 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.

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 doctor 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 doctor 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 doctor may stop treatment with Rubraca until your blood cell counts improve.

Before you take Rubraca, tell your doctor about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Rubraca.
    • If you are able to become pregnant, your doctor may do a pregnancy test before you start treatment with Rubraca.
    • Females who are able to become pregnant should use effective birth control during treatment and for at least 6 months after receiving the last dose of Rubraca. Talk to your doctor about birth control methods that may be right for you.
    • Tell your doctor right away if you become pregnant.
  • are breastfeeding or plan to breastfeed. 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 doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While taking Rubraca, avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may burn more easily during treatment with Rubraca. 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.

The most common side effects of Rubraca include:

  • nausea
  • fatigue
  • vomiting
  • stomach-area pain
  • changes in how food tastes
  • constipation
  • decreased appetite
  • diarrhea
  • shortness of breath
  • decrease in hemoglobin (anemia)
  • low blood cell counts
  • changes in liver or kidney function blood tests
  • increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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 Clovis Oncology, Inc. at 1-844-258-7662.

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.