Breast cancer:

Indications for KISQALI FEMARA CO-PACK:

Initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

Adult:

Take together preferably in the AM. Swallow whole. Kisqali: initially 600mg once daily for 21 consecutive days, followed by 7 days off treatment for a complete 28-day cycle. Femara: 2.5mg once daily throughout the 28-day cycle. Pre/perimenopausal women: also treat with LHRH agonist. Concomitant strong CYP3A4 inhibitors: avoid; if coadmin necessary, reduce Kisqali to 400mg once daily. Hepatic impairment: initially Kisqali 400mg once daily (moderate and severe); Femara 2.5mg every other day (cirrhosis and severe dysfunction). Severe renal impairment: initially Kisqali 200mg once daily. Dose modifications for toxicity: see full labeling.

Children:

Not established.

Warnings/Precautions:

Monitor for interstitial lung disease (ILD)/pneumonitis; interrupt immediately and evaluate if suspected. Permanently discontinue if recurrent symptomatic or severe ILD/pneumonitis occurs. Avoid in patients with long QT syndrome, uncontrolled or significant cardiac disease including recent MI, CHF, unstable angina and bradyarrhythmias, electrolyte abnormalities. Assess ECG prior to initiation; start therapy only if QTcF values <450 msec. Repeat ECG at Day 14 of Cycle 1, beginning of Cycle 2, and as clinically indicated; monitor more frequently if any QTcF prolongation occurs. Monitor serum electrolytes prior to initiation, at the beginning of the first 6 cycles, and as clinically indicated; correct any abnormality before starting. Permanently discontinue if QTcF >500msec or >60msec change from baseline and associated with any of the following: Torsades de Pointes, polymorphic ventricular tachycardia, unexplained syncope, or serious arrhythmia. Perform LFTs prior to initiation; monitor every 2 weeks for first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated; monitor more frequently if Grade ≥2 abnormalities noted. Discontinue if AST/ALT >20×ULN, Grade 3 (AST/ALT >5 to 20×ULN) recurs, or AST/ALT >3×ULN with total bilirubin >2×ULN. Perform CBC prior to initiation; monitor every 2 weeks for first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥3 weeks after last dose. Nursing mothers: not recommended (during and for ≥3 weeks after last dose).

Pharmacologic Class:

Kinase inhibitor + aromatase inhibitor.

Interactions:

Avoid concomitant with strong CYP3A inhibitors (eg, boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, voriconazole); consider alternatives or see Adult. Avoid grapefruit, grapefruit juice, pomegranates, pomegranate juice. Avoid concomitant with strong CYP3A inducers (eg, phenytoin, rifampin, carbamazepine, St. John’s wort); consider alternatives. Caution with concomitant CYP3A substrates with a narrow therapeutic index (eg, alfentanil, cyclosporine, ergots, everolimus, fentanyl, midazolam, pimozide, quinidine, sirolimus, tacrolimus); may need to reduce these doses. Avoid concomitant with drugs known to prolong QT interval (eg, amiodarone, bepridil, chloroquine, clarithromycin, disopyramide, halofantrine, haloperidol, methadone, moxifloxacin, ondansetron, pimozide, procainamide, quinidine, sotalol). Avoid concomitant Kisqali with tamoxifen.

Adverse Reactions:

Neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, back pain, rash, anemia; QT prolongation, hepatobiliary toxicity, ILD/pneumonitis.

Generic Availability:

NO

How Supplied:

Cartons—28 days of therapy (63 tabs x 200mg + 28 tabs); (42 tabs x 200mg + 28 tabs); (21 tabs x 200mg + 28 tabs)