Rubraca (rucaparib)
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 chemotherapies[1]. Patients should be selected for therapy based on the FDA-approved FoundationFocus CDxBRCA test (Foundation Medicine Inc.)[2,1]. Approximately 15 to 20% of patients with ovarian cancer have a BRCA gene mutation[3].
for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy[1].
How does Rubraca (rucaparib) work?
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 growth[3].
Where has Rubraca (rucaparib) been approved?
Rubraca (rucaparib) was approved by:
Food and Drug Administration (FDA), USA:
on December 19, 2016, 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 chemotherapies[1]
on April 6, 2018, for the for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy[1]
European Medicines Agency (EMA), EU, on May 23, 2018, for the treatment of patients with:
platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer[7]
What are you looking for?
en
Menu
Medicines
Is this legal?
About us
Contact us
Resources
Healthcare Professionals & Pharmacies
Account
Rubraca (rucaparib)
This medicine requires a prescription. See “Prescription Guide”.
We can only help if the medicine is not available in your country. Learn more.
Price Frequently Asked Questions Details Patient stories Import guides
Rubraca (rucaparib) is a medication used for the treatment of ovarian, fallopian tube and primary peritoneal cancer.
Skip to the end of the images gallery
Rubraca
Skip to the beginning of the images gallery
Disease Indications
Gynaecological Cancer
Manufacturer
Clovis Oncology, Inc.
Usage
Oral
Medicine approved by
European Medical Agency (EMA)
Food and Drug Administration (FDA)
Patients helped
Over 1.2 million patients reached
More than 11,000 patients helped
100% successful deliveries to 88 countries
We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
Rubraca (rucaparib)
Enquire
GDP compliant. View certificate.
Licensed wholesale distributor. View certificate.
Details
Clinical trials
Price & costs
Shipping
Our process
Approvals
FAQ
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 chemotherapies[1]. Patients should be selected for therapy based on the FDA-approved FoundationFocus CDxBRCA test (Foundation Medicine Inc.)[2,1]. Approximately 15 to 20% of patients with ovarian cancer have a BRCA gene mutation[3].
for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy[1].
How does Rubraca (rucaparib) work?
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 growth[3].
Where has Rubraca (rucaparib) been approved?
Rubraca (rucaparib) was approved by:
Food and Drug Administration (FDA), USA:
on December 19, 2016, 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 chemotherapies[1]
on April 6, 2018, for the for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy[1]
European Medicines Agency (EMA), EU, on May 23, 2018, for the treatment of patients with:
platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer[7]
How is Rubraca (rucaparib) taken?
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 confirmed[1].
Complete information about Rubraca (rucaparib) dosage and administration can be found in the references section.
Note: Consult your treating doctor for personalised dosing.
Are there any known side effects or adverse reactions of Rubraca (rucaparib)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include:
nausea
fatigue
vomiting
anemia
abdominal pain
dysgeusia (distortion of the sense of taste)
constipation
decreased appetite
diarrhoea
thrombocytopenia (deficiency of platelets in the blood)
dyspnea (difficult breathing)[1].
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).
Use in specific populations
Rubraca (rucaparib) can be fatal for a fetus, it is advised to avoid pregnancies and breast feeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information[1].
References
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
6. Pending EC decisions: Rubraca EMA, 22/03/2018
7. Summary of Product Characteristics [EMA]: Rubraca (rucaparib) [PDF]
Clovis Oncology Inc., May 2019