Rubraca (rucaparib)

In stock
Rubraca (rucaparib)

How to buy Rubraca (rucaparib): You can order Rubraca (rucaparib) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

Oncology Gynaecological Cancer
Marketing Authorisation Holder Clovis Oncology, Inc.
Mode of Action PARP inhibitor
Administration Oral
Regulatory agency approval Food and Drug Administration (FDA), USA
Package 60 Tablets

What is Rubraca (rucaparib) for?

Rubraca (rucaparib) is indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies1Patients should be selected for therapy based on the FDA-approved FoundationFocus CDxBRCA test (Foundation Medicine Inc.)2,1.

How does Rubraca (rucaparib) work?

Approximately 15 to 20% of patients with ovarian cancer have a BRCA gene mutation. BRCA genes are involved with repairing damaged DNA and normally work to prevent tumour development. However, mutations of these genes may lead to certain cancers, including ovarian cancers. Rubraca (rucaparib) is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slowdown or stoppage of tumour growth3.

Is Rubraca (rucaparib) approved?

Rubraca (rucaparib) was approved for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies1 by:

  • Food and Drug Administration (FDA) (USA) on December 19, 2016

How do I take Rubraca (rucaparib)?

The standard dosage is:

  • 600 mg orally twice daily.

Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of Rubraca (rucaparib) should be discontinued if myelodysplastic syndrome (MDS) / acute myeloid leukemia (AML) is confirmed1.

Complete information about Rubraca (rucaparib) dosage and administration can be found in the resources section. 

Consult your treating doctor for personalised dosing.

Are there any known side effects of Rubraca (rucaparib)?

The most common side effects were:

  • nausea
  • fatigue
  • vomiting
  • anemia
  • abdominal pain
  • dysgeusia (distortion of the sense of taste)
  • constipation
  • decreased appetite
  • diarrhea
  • thrombocytopenia (deficiency of platelets in the blood)
  • dyspnea (difficult breathing)1.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.

More Information
Working ingredient rucaparib
Shipping method Controlled room temperature (temperature controlled)
Package 60
Therapeutic Area Oncology
Oncology Gynaecological Cancer
Indication BRCA+ ovarian cancer
Administration Oral
Mode of Action PARP inhibitor
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Clovis Oncology, Inc.
HS Code N/A
CAS Number N/A

The approval was based on a study involving 106 adults with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens. BRCA gene mutations were confirmed in 96% of tested trial participants with available tumour tissue using the FDA approved diagnostic FoundationFocus CDxBRCA2. Of the participants who received Rubraca (rucaparib) in the trials, 54% experienced complete or partial shrinkage of their tumours lasting a median of 9.2 months4.

The safety of Rubraca (rucaparib) was evaluated in 377 patients with advanced ovarian cancer. The most common adverse reactions (greater than or equal to 20%) experienced by patients were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. MSD/AML was reported in 2 out of 377 (0.5%) patients with ovarian cancer. In addition, AML was reported in 2 (<1%) patients with ovarian cancer enrolled in a blinded, randomised trial evaluating rucaparib versus placebo4.

On October 12, 2012, the European EMA granted orphan designation to Clovis Oncology UK Limited, United Kingdom, for rucaparib for the treatment of ovarian cancer5.

1. Summary of Product Characteristics [FDA]: Rubraca (rucaparib) [PDF]
    Clovis Oncology Inc., Dec. 2016

2. Foundation Focus CDXBRCA
    Foundation Medicine, cited Jan 2017

3. FDA grants accelerated approval to new treatment for advanced ovarian cancer
    FDA, Dec 2016

4. Approved Drugs: Rucaparib
    FDA, Dec 2016

5. Rare disease designations: EU/3/12/1049
    EMA, cited Jan 2017

Shipping Type Cold Chain
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.