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Treatment Name: Rucaparib (Rubraca®)

Rucaparib (Rubraca®) is a Chemotherapy Regimen for Ovarian Cancer

How does rucaparib work?

Rucaparib inhibits a family of enzymes called PARP (poly ADP ribose polymerase). When PARP enzymes are blocked by rucaparib, cancer cell DNA is severely damaged. BRCA (pronounced "Bracka") is a mechanism that cells use to repair damaged DNA. Ovarian cancer cells sometimes have mutations in BRCA, and these mutations stop BRCA from repairing damaged DNA. When rucaparib is used in patients with BRCA mutations, the cancer cells can no longer repair damage to DNA. When DNA damage is unable to be repaired, cancer cells die.

What are the rucaparib goals of therapy? 

Rucaparib may be taken to shrink ovarian cancer tumors in patients with BRCA mutations that are either inherited or acquired and is not commonly given with the goal of cure.

Rucaparib may also be taken as maintenance therapy for patients with recurrent ovarian cancer who are presently in response to prior chemotherapy. Mutations in BRCA are not required when rucaparib is used as maintenance therapy for ovarian cancer. When Rucaparib is given as maintenance therapy, it is not commonly given with the goal of cure, but may be given to help ovarian cancer cells stop growing or spreading.

Schedule

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  • Usual rucaparib (Rubraca®) starting dose: 600 mg (two 300-mg tablets) by mouth twice daily
    • It is recommended to separate each scheduled rucaparib dose by 12 hours

Rucaparib must be dispensed by a specialty pharmacy and is taken at home. Treatment is continued until the drug no longer works or unacceptable side effects are experienced.

Side Effects

In clinical studies, the most commonly reported rucaparib (Rubraca®) side effects are shown here. Side effects sometimes have percentage ranges [example 75 – 77%] because they differed between clinical studies:

A note about side effect percentages.

  • Nausea (75% – 77%)
  • Fatigue (69% – 77%)
  • Vomiting (37% – 46%)
  • Anemia [low red blood cells] (37% – 44%)
  • Liver function test abnormalities (34% – 41%)
  • Constipation (37% – 40%)
  • Increases in cholesterol (40%)
  • Decreased appetite (23% – 39%)
  • Altered taste (39%)
  • Diarrhea (32% – 35%)
  • Low white blood cells [neutropenia] (18% – 35%)
  • Abdominal pain (30% – 32%)
  • Shortness of breath (22%)
  • Low platelets [thrombocytopenia] (21% – 28%)
  • Worsened kidney function test (15% – 21%)
  • Headache (18%)

A small number of patients that received rucaparib experienced serious disorders in the bone marrow called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Roughly 10% to 13% of patients discontinued treatment with rucaparib due to unacceptable side effects.

Watch side effect videos from rucaparib treatement below

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue AnemiaAnemiaConstipationConstipationDiarrheaDiarrheaPainPain

Monitoring

How often is rucaparib monitoring needed?

Labs (blood tests) may be checked before treatment starts, then monthly throughout treatment. The frequency of labs may depend on how well you are tolerating treatment with rucaparib. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), CA-125 (a tumor marker for ovarian cancer), plus any others your doctor may order.

How often is rucaparib imaging needed? 

Imaging may be checked before treatment and during treatment at the discretion of your doctor. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.

How might blood test results/imaging affect rucaparib treatment? 

Depending upon the test results and how well you are tolerating rucaparib, your doctor may advise to continue rucaparib as planned, temporarily stop therapy with rucaparib, change the rucaparib dose, or switch therapy.

ChemoExperts Tips

What are the most important things to know about rucaparib therapy?

  • A large number of patients experience nausea while taking rucaparib. Discuss with your doctor about taking anti-nausea medicines to manage nausea
  • Rucaparib can cause low red blood cells, white blood cells, and platelets. In very rare cases rucaparib can lead to the development of bone marrow disorders such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Notify your doctor immediately if you are experience unusual bruising or bleeding, severe fatigue and shortness of breath, or frequent infections and fevers. These symptoms may be a sign of low blood counts from rucaparib or a more serious bone marrow disorder
  • Rucaparib may cause you to be more sensitive to sunlight. Wear sunscreen/sun protection while taking rucaparib
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for ovarian cancer. Ask your doctor if any trials are currently enrolling in your area. If not, go to clinicaltrials.gov to search for cancer centers offering clinical trials

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Rucaparib (Rubraca®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Rucaparib (Rubraca®). Depending upon your income, they may be able to help cover the cost of:

  • Rucaparib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Rucaparib (Rubraca®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Rucaparib (Rubraca®)

Individual Drug Label Information

Rucaparib (Rubraca®)

  • ​Rucaparib tablets are available in 200 mg, 250 mg, and 300 mg
  • Take rucaparib with or without food. Swallow tablets whole. Do not open, chew, crush, divide, or dissolve tablets
  • If you miss a dose, skip the missed dose and take the next dose at the regular scheduled time. DO NOT take 2 doses to make up for the missed dose
  • Store tablets at room temperature (68°F – 77°F) in a cool, dry place. Store tablets in the original bottle to protect from moisture
  • Dosage adjustments may be required to manage rucaparib-related side effects
  • May cause fetal harm if taken while pregnant. Contraception (birth control) is recommended during therapy and for 6 months after completing therapy
  • It is not recommended to breastfeed during treatment with rucaparib and for 2 weeks after the last dose of rucaparib.
  • Development of blood disorders such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) while receiving rucaparib have been reported

General side effects from rucaparib (Rubraca®)
  • Nausea and vomiting
  • Weakness or fatigue
  • Low red and white blood cells, and low platelets
  • Diarrhea or constipation
  • Various gastrointestinal side effects such as abdominal pain, decreased appetite, and altered taste 
  • Breathing difficulty 
  • Worsened creatinine (a kidney function test) and liver function tests
  • Cholesterol level increases from baseline

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

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References

1) Oza AM, Tinker AV, Oaknin A, et al. Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2. Gynecologic Oncology. 2017;147:267-275.

2) Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390:1949-61.

Created: February 16, 2019 Updated: April 5, 2020

What is Ovarian Cancer?

What is Ovarian Cancer?
A disease of the cells found in the ovaries in women. Ovarian cancer is not common, but is the fifth leading cause of cancer related death in women. The exact cause is not known, however risk factors include: older age, obesity, first period at an early age, late menopause, hormone replacement therapy (HRT) after menopause, family history, and genetic causes such as the BRCA (pronounced "bracka") mutation. The use of oral contraceptives or having one or more full-term pregnancies can decrease the risk of ovarian cancer.

The stage of ovarian cancer can vary at diagnosis and throughout treatment. Ovarian cancer is staged using the Tumor, Node, Metastasis (TNM) staging system, as well as Stage Grouping I, II, III, or IV. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common starting doses for Rucaparib (Rubraca®)

  • Usual rucaparib (Rubraca®) starting dose: 600 mg (two 300-mg tablets) by mouth twice daily

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is Specialty Pharmacy?

A pharmacy that manages the handling and services for drugs used by patients with rare or chronic diseases. This has expanded in the last several years to include very expensive drugs used to treat cancer, mainly oral cancer medications or injections that can be taken at home.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

Clinical Studies

1) Oza AM, Tinker AV, Oaknin A, et al. Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2. Gynecologic Oncology. 2017;147:267-275.

2) Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390:1949-61.

A note about side effect percentages

The number you see next to the percent sign (%) means how many people out of 100 are likely to experience this side effect.

For example, if the side effect is reported to occur in 8% of patients, this means that roughly 8 out of 100 people receiving this treatment will experience this side effect.