ANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
Rubraca™ 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. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca [see Dosage and Administration (2.1)].
This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of advanced ovarian cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic)[see Indications and Usage (1) and Clinical Studies (14)]. Information on the FDA-approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended Dose
The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken orally twice daily with or without food.
Continue treatment until disease progression or unacceptable toxicity.
If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time. Vomited doses should not be replaced.
2.3 Dose Modifications for Adverse Reactions
To manage adverse reactions, consider interruption of treatment or dose reduction. Recommended dose reductions are indicated in TABLE 1.
Table 1. Recommended Dose Adjustments
Dose Reduction Dose
Starting Dose 600 mg twice daily (two 300 mg tablets)
First Dose Reduction 500 mg twice daily (two 250 mg tablets )
Second Dose Reduction 400 mg twice daily (two 200 mg tablets)
Third Dose Reduction 300 mg twice daily (one 300 mg tablet) CLOSE
3 DOSAGE FORMS AND STRENGTHS
Tablets (200 mg): blue, round, immediate-release, film-coated, debossed with “C2”.
Tablets (250 mg): white, diamond, immediate-release, film-coated, debossed with “C25”.
Tablets (300 mg): yellow, oval, immediate-release, film-coated, debossed with “C3”.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia
Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) was reported in 2 of 377 (0.5%) patients with ovarian cancer treated with Rubraca. The duration of Rubraca treatment prior to the diagnosis of MDS/AML was 57 days and 539 days. Both patients received prior treatment with platinum and other DNA damaging agents.
In addition, AML was reported in 2 (< 1%) patients with ovarian cancer enrolled in a blinded, randomized trial eva luating Rubraca versus placebo. One case of AML was fatal. The duration of treatment prior to the diagnosis of AML was 107 days and 427 days. Both patients had received prior treatment with platinum and other DNA damaging agents.
Monitor complete blood count testing at baseline and monthly thereafter. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). For prolonged hematological toxicitie |
