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Rubraca is a brand name for Rucaparib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Rubraca should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The recommended dose of Rubraca is 600 mg taken twice daily, equivalent to a total daily dose of 1 200 mg.
Patients should start the maintenance treatment with Rubraca no later than 8 weeks after completion of their final dose of the platinum containing regimen.
Duration of treatment First-line maintenance treatment of advanced ovarian cancer:
Patients can continue treatment until disease progression, unacceptable toxicity or completion of 2 years treatment.
Maintenance treatment of platinum-sensitive relapsed ovarian cancer:
Patients can continue treatment until disease progression or unacceptable toxicity. If a patient vomits after taking Rubraca, the patient should not retake the dose and should take the next scheduled dose. Missed doses If a dose is missed, the patient should resume taking Rubraca with the next scheduled dose.
e. CTCAE Grade 3 or 4) such as neutropenia, anaemia and thrombocytopenia. Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient. Grade 1 to 3 elevations in AST/ALT can be managed without change to the rucaparib dose, or with treatment modification (interruption and/or dose reduction).
Grade 4 reactions require treatment modification (see Table 2). Other moderate to severe non-haematological adverse reactions such as nausea and vomiting, can be managed through dose interruption and/or reductions, if not adequately controlled by appropriate symptomatic management.
Table 1. Recommended dose adjustments Dose reduction Dose Starting dose 600 mg twice daily (two 300 mg tablets twice daily) First dose reduction 500 mg twice daily (two 250 mg tablets twice daily) Second dose reduction 400 mg twice daily (two 200 mg tablets twice daily) Third dose reduction 300 mg twice daily (one 300 mg tablet twice daily) 4 Table 2.
2). Greater sensitivity of some elderly patients (≥ 65 years of age) to adverse events cannot be ruled out. There are limited clinical data in patients aged 75 or over. 2). Patients with moderate hepatic impairment should be carefully monitored for hepatic function and adverse reactions.
Summary of the safety profile The overall safety profile of rucaparib is based on data from 1 594 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy. 4 months. Adverse reactions occurring in ≥ 20% of patients receiving rucaparib were nausea, fatigue/asthenia, vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, neutropenia and thrombocytopenia.
The majority of adverse reactions were mild to moderate (Grade 1 or 2). The ≥ Grade 3 adverse reactions occurring in > 5% of patients were anaemia (25%), ALT elevations (10%), neutropenia (10%), fatigue/asthenia (9%), and thrombocytopenia (7%).
The only serious adverse reaction occurring in > 2% of patients was anaemia (5%). Adverse reactions that most commonly led to dose reduction or interruption were anaemia (23%), fatigue/asthenia (15%), nausea (14%), thrombocytopenia (14%), neutropenia (10%) and AST/ALT elevations (10%).
Adverse reactions leading to permanent discontinuation occurred in 15% of patients; with the most frequently reported being thrombocytopenia, nausea, anaemia, and fatigue/asthenia. Tabulated list of adverse reactions The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level.
Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from the available data).
Table 3. Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions MedDRA system organ class Frequency of all CTCAE grades Frequency of CTCAE grade 3 and above Neoplasms benign, malignant and unspecified (including cysts and polyps) Common Myelodysplastic syndrome / Acute myeloid leukaemia a Common Myelodysplastic syndrome / Acute myeloid leukaemia a Blood and lymphatic system disorders Very common Anaemia b, Thrombocytopenia b, Neutropenia b, Leukopenia b Common Lymphopenia b, Febrile neutropenia Very common Anaemia b, Neutropenia b Common Thrombocytopenia b, Febrile neutropenia, Leukopenia b, Lymphopenia b 9 Immune system disorders Common Hypersensitivity c Uncommon Hypersensitivity c Metabolism and nutrition disorders Very common Decreased appetite, Increased blood creatinine b, Hypercholesterolaemia b, Common Dehydration Common Decreased appetite, Dehydration, Hypercholesterolaemia b Uncommon Increased blood creatinine b Nervous system disorders Very common Dysgeusia, Dizziness Uncommon Dysgeusia, Dizziness Respiratory, thoracic and mediastinal disorders Very common Dyspnoea Uncommon Dyspnoea Gastrointestinal disorders Very common Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain Common Intestinal obstruction d, Stomatitis Common Nausea, Vomiting, Diarrhoea, Abdominal pain, Intestinal obstruction d Uncommon Dyspepsia, Stomatitis Hepatobiliary disorders Very common Increased alanine aminotransferase, Increased aspartate aminotransferase Common Increased transaminases b Common Increased alanine aminotransferase, Increased aspartate aminotransferase Uncommon Increased transaminases b Skin and subcutaneous tissue disorders Very common Photosensitivity reaction, Rash Common Rash maculo-papular, Palmar- plantar erythrodysaesthesia syndrome, Erythema Uncommon Photosensitivity reaction, Rash, Rash maculo-papular, Palmar- plantar erythrodysaesthesia syndrome General disorders and administration site conditions Very common Fatigue e, Pyrexia Common Fatigue e Uncommon Pyrexia a MDS/AML rate is based on overall total patient population of 3 025 who have received one dose of oral rucaparib.
Haematological toxicity During treatment with rucaparib, events of myelosuppression (anaemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8 to 10 weeks of treatment with rucaparib. These reactions are manageable with routine medical treatment and/or dose adjustment 5 for more severe cases.
Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1).
Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anaemia and neutropenia. 2) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE Grade 1 or better after 4 weeks, the patient should be referred to a haematologist for further investigations.
Myelodysplastic syndrome/acute myeloid leukaemia Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib. The duration of therapy with rucaparib in patients who developed MDS/AML varied from < 2 months to approximately 6 years.
If MDS/AML is suspected, the patient should be referred to a haematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.
Photosensitivity Photosensitivity has been observed in patients treated with rucaparib. Patients should avoid spending time in direct sunlight because they may burn more easily during rucaparib treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor (SPF) of 50 or greater.
1. 6).
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, total bilirubin > 3 times ULN), therefore rucaparib is not recommended for use in patients with severe hepatic impairment. 2). There are no clinical data in patients with severe renal impairment (CLcr less than 30 mL/min), therefore rucaparib is not recommended for use in patients with severe renal impairment.
Rucaparib may only be used in patients with severe renal impairment if the potential benefit outweighs the risk. Patients with moderate or severe renal impairment should be carefully monitored for renal function and adverse reactions.
Paediatric population The safety and efficacy of Rubraca in children or adolescents aged less than 18 years have not been established. No data are available. Method of administration Rubraca is for oral use and can be taken with or without food.
The doses should be taken approximately 12 hours apart. 2.
b Includes laboratory findings c Most commonly observed events include hypersensitivity, drug hypersensitivity and swelling/oedema of the face and eyes. d Includes intestinal obstruction, large intestinal obstruction, and small intestinal obstruction e Includes fatigue, asthenia and lethargy Description of selected adverse reactions Haematological toxicity Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and neutropenia were reported in 46%, 26% and 21% of patients, respectively.
Anaemia and thrombocytopenia led to discontinuation in 2% and 1% of patients, respectively. Adverse reactions CTCAE Grade 3 or higher occurred in 25% (anaemia), 10% (neutropenia) and 7% (thrombocytopenia) of patients. The time of onset for adverse reactions of myelosuppression Grade 3 or higher was generally later in treatment (after 2 or more months).
4. 1%) for all patients including during the long term safety follow up (rate is calculated based on overall safety population of 3 025 patients exposed 10 to at least one dose of oral rucaparib in all clinical studies). 5%, respectively.
Although no cases were reported during therapy in patients who received placebo, six cases have been reported in placebo-treated patients during the long term safety follow up. All patients had potential contributing factors for the development of MDS/AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.
4. Gastrointestinal toxicities Vomiting and nausea were reported in 37% and 68% of patients, respectively, and were generally low grade (CTCAE Grade 1 to 2). Abdominal pain (combined terms abdominal pain, abdominal pain lower, abdominal pain upper) was reported in 39% of rucaparib treated patients, but was […]
Gastrointestinal toxicities Gastrointestinal toxicities (nausea and vomiting) are frequently reported with rucaparib, are generally low grade (CTCAE Grade 1 or 2) and may be managed with dose reduction (refer to Table 1) or interruption.
, preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalisation.
1%). The underlying disease may play a role in the development of intestinal obstruction in patients with ovarian cancer. In the event of suspected intestinal obstruction, a prompt diagnostic evaluation should be conducted and the patient should be treated appropriately.
Embryofoetal toxicity Rubraca can cause foetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. 3). 6 Pregnancy/contraception Pregnant women should be informed of the potential risk to a foetus.
6). A pregnancy test before initiating treatment is recommended in women of reproductive potential. Excipients This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.