RUCAPARIB

Other

Brand names: Rubraca

Oral

Mechanism of Action

12.1 Mechanism of Action Rucaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair. In vitro studies have shown that rucaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cancer cell death. Increased rucaparib-induced cytotoxicity and anti-tumor activity was observed in tumor cell lines with deficiencies in BRCA1/2 and other DNA repair genes. Rucaparib has been shown to decrease tumor growth in mouse xenograft models of human cancer with or without deficiencies in BRCA .

Indications

fallopian tube

or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to RUBRACA, and some cases were fatal
Advise of the potential risk to a fetus and to use effective contraception
1 Myelodysplastic Syndrome/Acute Myeloid Leukemia Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions
In an animal reproduction study, administration of rucaparib to pregnant rats during the period of organogenesis resulted in embryo-fetal death at exposures that were 0

Known Side Effects

8 documented side effects by frequency

Fatigue

>10%

Nausea

>10%

Decreased Appetite

1-10%

Diarrhea

1-10%

Constipation

1-10%

Vomiting

1-10%

Weakness

0.1-1%

Drug Not Working

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral