rucaparib

High Alert

Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have experienced a complete or partial response to platinum-based chemotherapy.
Deleterious BRCA mutation-associated metastatic, castration-resistant prostate cancer in patients who have been treated with androgen-receptor directed therapy and a taxane-based chemotherapy regimen.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Severe hepatic impairment;
Severe renal impairment or dialysis;
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: photosensitivity, rash, palmar-plantar erythrodysaesthesia syndrome, pruritus

Endo: hypercholesterolemia

GI: ↓appetite, ↑liver function tests, abdominal pain, constipation, diarrhea, nausea, vomiting

GU: ↑serum creatinine

Hemat: anemia, lymphocytopenia, neutropenia, thrombocytopenia, MYELODYSPLASTIC SYNDROME/ACUTE MYELOID LEUKEMIA

Neuro: dizziness, dysgeusia, fatigue

Resp: dyspnea

Misc: fever

Interactions ⬆ ⬇

Drug-drug:

May ↑ levels and toxicity of CYP1A2 substrates, CYP2C9 substrates, CYP2C19 substrates, and CYP3A substrates; if concurrent administration unavoidable, consider ↓ dose of CYP1A2, CYP2C9, CYP2C19, or CYP3A substrate; if concurrent administration with warfarin unavoidable, monitor INR more frequently.

Availability ⬆ ⬇

Tablets: 200 mg; 250 mg; 300 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 600 mg twice daily until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a poly (ADP-ribose) polymerase (PARP) inhibitor, thereby disrupting DNA transcription, cell cycle regulation and DNA repair.

Therapeutic effects:

Decreased growth and spread of epithelial ovarian, fallopian tube, primary peritoneal, or prostate cancer.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: 30–45% absorbed following oral administration; bioavailability increased but delayed with high-fat meal.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Extensively metabolized primarily by the CYP2D6 isoenzyme and to a lesser extent by the CYP1A2 and CYP3A4 isoenzymes; information regarding mode of elimination unknown.

Half-Life: 17–19 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2 hr	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to take rucaparib as directed. If a dose is missed, omit and take next dose at scheduled time. Do not replace vomited doses.
Advise patient to notify health care professional if signs and symptoms of myelodysplastic syndrome/acute myeloid leukemia (weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool) occur.
Advise patient to wear protective clothing and sunscreen to prevent photosensitivity reactions.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo following last dose of rucaparib and to avoid breastfeeding during and for 2 wk after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. Advise males to avoid donating sperm during therapy and for 3 mo after last dose.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

69660- Clovis Oncology, Inc.
- 69660-201- Rubraca
  - 69660-201-91- 60 TABLET, FILM COATED in 1 BOTTLE (69660-201-91)

82154- pharmaand GmbH
- 82154-0783- Rubraca
  - 82154-0783-1- 60 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1)

82154- pharmaand GmbH
- 82154-0784- Rubraca
  - 82154-0784-1- 60 TABLET, FILM COATED in 1 BOTTLE (82154-0784-1)

82154- pharmaand GmbH
- 82154-0785- Rubraca
  - 82154-0785-1- 60 TABLET, FILM COATED in 1 BOTTLE (82154-0785-1)

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Indications ⬇