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Kisqali

Kisqali

ribociclib

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ribociclib
Indications/Uses
In combination w/ an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, w/ hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. In combination w/ fulvestrant for the treatment of postmenopausal women w/ HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.
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Dosage/Direction for Use
600 mg (3 tab) once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle).
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Overdosage
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Administration
May be taken with or without food: Take approx at the same time each day, preferably in the morning. Swallow whole, do not chew/crush/split.
Special Precautions
QT interval prolongation. Avoid use in patients w/ long QT syndrome, recent MI, CHF, unstable angina & bradyarrhythmias, electrolyte abnormalities. Monitor serum electrolytes (including K, Ca, P & Mg) prior to treatment initiation, at the beginning of the 1st 6 cycles, & as clinically indicated. Reports of elevated transaminases; neutropenia. Perform liver function tests (LFTs) & CBC before initiating therapy. Monitor LFTs & CBC every 2 wk for 1st 2 cycles, at the beginning of each subsequent 4 cycles, & as clinically indicated. Avoid concomitant use w/ drugs known to prolong QT interval &/or CPY3A inhibitors. Not indicated for concomitant use w/ tamoxifen. Moderate & severe hepatic impairment. Severe renal impairment. Can cause fetal harm. Women of childbearing potential should use effective contraception during & for at least 3 wk after last dose. Pregnancy & lactation.
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Adverse Reactions
Neutropenia, nausea, leukopenia. W/ letrozole: Fatigue, diarrhea, alopecia, vomiting, constipation, headache, back pain. W/ aromatase inhibitor: Infections, arthralgia, alopecia. W/ fulvestrant: Infections, cough, diarrhea, vomiting, constipation, pruritus, rash.
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Drug Interactions
Increased exposure w/ strong CYP3A inhibitors (eg, boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, & voriconazole). Decreased plasma exposure w/ strong CYP3A inducers (eg, phenytoin, rifampin, carbamazepine & St. John's Wort). Increased exposure of midazolam & other CYP3A substrates w/ narrow therapeutic index (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus & tacrolimus). Avoid co-administration w/ medicinal products w/ a known potential to prolong QT eg, antiarrhythmic medicines (eg, amiodarone, disopyramide, procainamide, quinidine & sotalol), chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide & ondansetron.
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Description
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Action
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MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EF02 - ribociclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.
Patient Counseling Information
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Presentation/Packing
Form
Kisqali FC tab 200 mg
Packing/Price
21's;3 × 21's
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