• Advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer (as initial endocrine-based therapy) (in combination with an aromatase inhibitor).
• Advanced or metastatic HR-positive, HER2-negative breast cancer (as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men) (in combination with fulvestrant).

Contraindicated in:

• QT interval prolongation (QT interval 450 msec)
• Uncorrected hypokalemia or hypomagnesemia
• Recent MI, HF, unstable angina, or bradycardia
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Severe renal impairment (↓ dose)
• Moderate or severe hepatic impairment (↓ dose)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: peripheral edema, QT interval prolongation, syncope.

Derm: alopecia, pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

F and E: hypokalemia, hypophosphatemia.

GI: ↑liver enzymes, abdominal pain, constipation, diarrhea, nausea, stomatitis, vomiting, hyperbilirubinemia.

GU: ↑serum creatinine, ↓ fertility (males).

Hemat: anemia, neutropenia, thrombocytopenia.

Metab: ↓appetite.

MS: back pain.

Neuro: fatigue, headache, insomnia.

Resp: dyspnea, INTERSTITIAL LUNG DISEASE (ILD).

Misc: fever.

Drug-Drug:

• Strong CYP3A4 inhibitors, including clarithromycin, conivaptan, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, or voriconazole may ↑ levels and the risk of toxicity; avoid concurrent use, if possible (if unavoidable, ↓ dose of ribociclib).
• Strong CYP3A4 inducers, including carbamazepine, phenytoin, or rifampin can ↓ levels and effectiveness; avoid concurrent use.
• May ↑ levels and effects/toxicity of cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, midazolam, pimozide, quinidine, sirolimus and tacrolimus; if concurrent use is required, dose ↓ may be necessary.
• QT-interval-prolonging medications, including amiodarone, chloroquine, clarithromycin, disopyramide, haloperidol, methadone, moxifloxacin, ondansetron, pimozide, procainamide, quinidine, sotalol, and tamoxifen may ↑ risk of QT interval prolongation; avoid concurrent use.

Drug-Natural Products:

• St. John's wort may ↓ levels and effectiveness; avoid concurrent use.

Drug-Food:

• Grapefruit/grapefruit juice or pomegranate/pomegranate juice may ↑ levels and the risk of toxicity; avoid ingestion.

• Tablets: 200 mg;

• PO (Adults): 600 mg once daily for 21 days, followed by 7 days off to complete a 28-day treatment cycle; continue treatment cycles until disease progression or unacceptable toxicity. Concurrent use of strong CYP3A4 inhibitor: 400 mg once daily for 21 days, followed by 7 days off to complete a 28-day treatment cycle; continue treatment cycles until disease progression or unacceptable toxicity.

Kisqali

• Inhibits kinases (cyclin-dependent kinases 4 and 6) that are part of the signaling pathway for cell proliferation.

• Improved survival and decreased spread of breast cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: 66% absorbed following oral administration.

Distribution: Extensively distributed to the tissues.

Metabolism/Excretion: Mostly metabolized in the liver by the CYP3A4 isoenzyme; 17% excreted unchanged in feces, 12% in urine.

Half-life: 32 hr.

(plasma concentrations)

• Instruct patient to take ribociclib as directed. If patient vomits after taking dose or misses dose, do not take more that day. Take next dose next day at usual time. Advise patient to read Patient Information prior to starting and with each Rx refill in case of changes.
• Advise patient to avoid eating pomegranate or grapefruit and to avoid drinking pomegranate or grapefruit juice during therapy.
• Advise patient to notify health care professional if signs and symptoms of heart rhythm problems (change in heartbeat [fast or irregular], dizziness, feeling faint), low white blood cell counts (fever and chills), or liver problems (yellowing of skin or whites of eyes, jaundice, dark or brown, tea-colored urine, feeling very tired, loss of appetite, pain on upper right side of abdomen, unusual bleeding or bruising) or skin reactions occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and to avoid breastfeeding during and for at least 3 wk after last dose of therapy. Inform male patients that ribociclib may impair fertility.

rye-boe-SYE-klib

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0860- KISQALI
    • 0078-0860-01- 1 BLISTER PACK in 1 CARTON (0078-0860-01) > 21 TABLET, FILM COATED in 1 BLISTER PACK

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0867- KISQALI
    • 0078-0867-42- 3 BLISTER PACK in 1 CARTON (0078-0867-42) > 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0874- KISQALI
    • 0078-0874-63- 3 BLISTER PACK in 1 CARTON (0078-0874-63) > 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)