What is Rubraca (rucaparib) for?

Rubraca (rucaparib) is a medication used to treat certain types of ovarian cancer, including advanced ovarian cancer that has relapsed or progressed despite previous treatment. It is also used for maintenance treatment in patients with a certain type of ovarian cancer who have responded to chemotherapy. Rubraca belongs to a class of drugs called PARP inhibitors, which work by blocking an enzyme called poly (ADP-ribose) polymerase (PARP) that helps cancer cells repair their DNA. By blocking this enzyme, Rubraca can slow or stop the growth of cancer cells.

How does Rubraca (rucaparib) work?

Rubraca (rucaparib) belongs to a class of drugs called PARP inhibitors. PARP enzymes play a critical role in DNA repair processes in cells. When DNA in normal cells is damaged, PARP helps to repair the damage. However, in some cancer cells, which already have genetic defects, PARP helps to keep the cells alive by assisting in an alternative DNA repair pathway. Rubraca blocks PARP enzymes and prevents them from repairing DNA damage, causing the cancer cells to die. When Rubraca is used to treat advanced ovarian cancer patients, it aims to make cancer cells more vulnerable to chemotherapy. When used as a maintenance treatment, it helps to prevent or delay the worsening of the disease by stopping the cancer cells from developing and growing further.

What is the method of taking Rubraca (rucaparib)?

Rubraca (rucaparib) is usually taken orally, in tablet form. The specific dose and dosing schedule will be determined by a doctor, based on a patient’s individual condition, age, weight, and overall health. For the treatment of advanced ovarian cancer, the usual starting dose of Rubraca is 600 milligrams taken by mouth twice a day, with or without food. For maintenance treatment, the usual dose is 300 milligrams by mouth twice a day. The tablets should be swallowed whole, not chewed, crushed, or split. If a dose is missed, it should be taken as soon as possible. However, if it is close to the next scheduled dose, patients should skip the missed dose and take the next dose at the regular time. Patients should not take two doses of Rubraca at the same time. It is important to follow the doctor’s instructions and the medication guide carefully, as Rubraca treatment requires close monitoring and may cause side effects.

Do Rubraca (rucaparib) have any recognized side effects?

Yes, there are some known side effects of Rubraca (rucaparib). Some of the common side effects include:

– Nausea
– Fatigue
– Vomiting
– Anemia
– Decreased appetite
– Constipation
– Diarrhea
– Abdominal pain
– Headache
– Dizziness
– Insomnia or difficulty sleeping
– Elevated liver enzymes
– Urinary tract infection

Less common but more serious side effects may include:

– Neural tube defects in newborns of pregnant women
– Myelodysplastic syndrome or acute myeloid leukemia
– Hypersensitivity reactions such as hives, rash, or difficulty breathing
– Pneumonitis or inflammation of the lungs

Patients should report any side effects to their doctor immediately. The doctor may adjust the dose or change the treatment plan to help manage the side effects. Some side effects may require stopping the treatment altogether.

Clinical trials 

Treatment of BRCA-Mutated Ovarian Cancer:

Rubraca (rucaparib) was approved by the Food and Drug Administration (FDA) in the USA as a third-line treatment for BRCA-mutated ovarian cancer. The FDA based their approval on two open-label clinical trials, Study 10 (NCT01482715) and ARIEL2 (NCT01891344), which involved 106 adults with advanced ovarian cancer. These patients received Rubraca (rucaparib) until disease progression or unacceptable toxicity. The efficacy outcome measures were the objective response rate (ORR) and the duration of response (DOR). The ORR was 54% with a median DOR of 9.2 months. The European Medicines Agency (EMA) granted orphan designation for rucaparib in 2012 and a conditional marketing authorization was granted in 2018.

Maintenance Treatment of Recurrent Ovarian Cancer:

Rubraca (rucaparib) was approved by the FDA in the USA for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. The FDA based their approval on the double-blind, multicentre clinical trial ARIEL3 (NCT01968213), which involved 564 patients who received Rubraca tablets or a placebo. Efficacy outcome measures were the progression-free survival (PFS) in all patients and two subgroups: homologous recombination deficiency (HRD) and positive rious BRCA mutation (tBRCA). In all patients, the median PFS was 10.2 months with Rubraca (rucaparib) and 5.4 months with placebo. In the HRD group, the median PFS was 13.6 months with Rubraca (rucaparib) and 5.4 months with placebo. In the tBRCA group, the median PFS was 16.6 months with Rubraca (rucaparib) and 5.4 months with placebo.