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Drug overview for KISQALI (ribociclib succinate):
Generic name: RIBOCICLIB SUCCINATE (RYE-boe-SYE-klib)
Drug class: Antineoplastic- Cyclin-Dependent Kinase (CDK) 4/6 Inhibitors
Therapeutic class: Antineoplastics
Ribociclib, a selective inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: RIBOCICLIB SUCCINATE (RYE-boe-SYE-klib)
Drug class: Antineoplastic- Cyclin-Dependent Kinase (CDK) 4/6 Inhibitors
Therapeutic class: Antineoplastics
Ribociclib, a selective inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
KISQALI 600 MG DAILY DOSE
KISQALI 400 MG DAILY DOSE
KISQALI 200 MG DAILY DOSE
The following indications for KISQALI (ribociclib succinate) have been approved by the FDA:
Indications:
Hormone receptor (HR)-positive, HER2-negative advanced breast cancer
Hormone receptor (HR)-positive, HER2-negative early-stage breast cancer
Professional Synonyms:
Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer
Hormone receptor(+), HER2(-) early breast cancer
HR+, HER2- early breast CA
HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer
HR-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer
Indications:
Hormone receptor (HR)-positive, HER2-negative advanced breast cancer
Hormone receptor (HR)-positive, HER2-negative early-stage breast cancer
Professional Synonyms:
Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer
Hormone receptor(+), HER2(-) early breast cancer
HR+, HER2- early breast CA
HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer
HR-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer
The following dosing information is available for KISQALI (ribociclib succinate):
Dosage of ribociclib succinate is expressed in terms of ribociclib.
Dosage interruption and/or reduction, or discontinuance of ribociclib therapy, may be necessary based on severity of adverse reactions. Dosage adjustment of ribociclib is recommended based on individual safety and tolerability.
Early breast cancer: If dosage reduction from 400 mg once daily is necessary, the dosage should be reduced to 200 mg once daily. If the toxicity recurs at a dosage of 200 mg once daily, ribociclib therapy should be discontinued.
Advanced or metastatic breast cancer: If dosage reduction from 600 mg once daily is necessary, the dosage should be reduced to 400 mg once daily. If the toxicity recurs at a dosage of 400 mg once daily, the dosage should be reduced to 200 mg once daily. If the toxicity recurs at a dosage of 200 mg once daily, ribociclib therapy should be discontinued.
Concomitant use of ribociclib with drugs that are strong inhibitors of cytochrome P-450 (CYP) isoenzyme 3A should be avoided, and selection of an alternative drug with less CYP3A inhibition potential is recommended. If concomitant use of a strong CYP3A inhibitor cannot be avoided, the manufacturer recommends reducing the dosage of ribociclib to 200 mg once daily in patients with early breast cancer and 400 mg once daily in patients with advanced or metastatic breast cancer. When concomitant use of the strong CYP3A inhibitor is discontinued, the ribociclib dosage should be returned (after at least 5 elimination half-lives of the CYP3A inhibitor) to the dosage used prior to initiation of the strong CYP3A inhibitor.
Dosage interruption and/or reduction, or discontinuance of ribociclib therapy, may be necessary based on severity of adverse reactions. Dosage adjustment of ribociclib is recommended based on individual safety and tolerability.
Early breast cancer: If dosage reduction from 400 mg once daily is necessary, the dosage should be reduced to 200 mg once daily. If the toxicity recurs at a dosage of 200 mg once daily, ribociclib therapy should be discontinued.
Advanced or metastatic breast cancer: If dosage reduction from 600 mg once daily is necessary, the dosage should be reduced to 400 mg once daily. If the toxicity recurs at a dosage of 400 mg once daily, the dosage should be reduced to 200 mg once daily. If the toxicity recurs at a dosage of 200 mg once daily, ribociclib therapy should be discontinued.
Concomitant use of ribociclib with drugs that are strong inhibitors of cytochrome P-450 (CYP) isoenzyme 3A should be avoided, and selection of an alternative drug with less CYP3A inhibition potential is recommended. If concomitant use of a strong CYP3A inhibitor cannot be avoided, the manufacturer recommends reducing the dosage of ribociclib to 200 mg once daily in patients with early breast cancer and 400 mg once daily in patients with advanced or metastatic breast cancer. When concomitant use of the strong CYP3A inhibitor is discontinued, the ribociclib dosage should be returned (after at least 5 elimination half-lives of the CYP3A inhibitor) to the dosage used prior to initiation of the strong CYP3A inhibitor.
Ribociclib is administered orally without regard to food at approximately the same time each day, preferably in the morning. The tablets should be swallowed intact and should not be broken, chewed, crushed, or split. If a dose of ribociclib is missed or vomited, patients should not take an extra dose.
The next dose should be taken at the regularly scheduled time. Store ribociclib tablets at 20oC to 25oC for up to 2 months. Ribociclib is commercially available as a single entity (Kisqali(R)) and also available copackaged with letrozole (Kisqali(R) Femara(R) Co-Pack). Clinicians should consult the respective manufacturers' labeling for information on dosage and administration (including dosage adjustments), adverse effects, and contraindications of other antineoplastic agents used in combination regimens.
The next dose should be taken at the regularly scheduled time. Store ribociclib tablets at 20oC to 25oC for up to 2 months. Ribociclib is commercially available as a single entity (Kisqali(R)) and also available copackaged with letrozole (Kisqali(R) Femara(R) Co-Pack). Clinicians should consult the respective manufacturers' labeling for information on dosage and administration (including dosage adjustments), adverse effects, and contraindications of other antineoplastic agents used in combination regimens.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| KISQALI 200 MG DAILY DOSE | Maintenance | Adults take 1 tablet (200 mg) by oral route once daily at approximately the same time each day on days 1 through 21 of a 28 day treatment cycle |
| KISQALI 400 MG DAILY DOSE | Maintenance | Adults take 2 tablets (400 mg) by oral route once daily at approximately the same time each day on days 1 through 21 of a 28 day treatment cycle |
| KISQALI 600 MG DAILY DOSE | Maintenance | Adults take 3 tablets (600 mg) by oral route once daily at approximately the same time each day on days 1 through 21 of a 28 day treatment cycle |
No generic dosing information available.
The following drug interaction information is available for KISQALI (ribociclib succinate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for KISQALI (ribociclib succinate):
Drug contraindication overview.
*None.
*None.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| 30 day risk period post-myocardial infarction |
| Congenital long QT syndrome |
| Lactation |
| Torsades de pointes |
There are 13 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bradycardia |
| Child-pugh class B hepatic impairment |
| Child-pugh class C hepatic impairment |
| Chronic heart failure |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Disease of liver |
| Interstitial lung disease |
| Neutropenic disorder |
| Pregnancy |
| Prolonged QT interval |
| Severe aortic valve stenosis |
| Thromboembolic disorder |
There are 7 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypertension |
| Hypocalcemia |
| Hypokalemia |
| Hypomagnesemia |
| Hypophosphatemia |
| Hypothyroidism |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for KISQALI (ribociclib succinate):
Adverse reaction overview.
Adverse effects reported in 20% or more of patients receiving ribociclib for early breast cancer include decreased lymphocytes, leukocytes, neutrophils, and hemoglobin, increased ALT and AST, infections, increased creatinine, decreased platelets, headache, nausea, and fatigue. Adverse effects reported in 20% or more of patients receiving ribociclib for advanced or metastatic breast cancer include decreased leukocytes, neutrophils, hemoglobin, and lymphocytes, increased ALT, AST, and gamma glutamyl transferase, infections, nausea, increased creatinine, fatigue, decreased platelets, diarrhea, vomiting, headache, constipation, alopecia, rash, cough, back pain, and decreased serum glucose.
Adverse effects reported in 20% or more of patients receiving ribociclib for early breast cancer include decreased lymphocytes, leukocytes, neutrophils, and hemoglobin, increased ALT and AST, infections, increased creatinine, decreased platelets, headache, nausea, and fatigue. Adverse effects reported in 20% or more of patients receiving ribociclib for advanced or metastatic breast cancer include decreased leukocytes, neutrophils, hemoglobin, and lymphocytes, increased ALT, AST, and gamma glutamyl transferase, infections, nausea, increased creatinine, fatigue, decreased platelets, diarrhea, vomiting, headache, constipation, alopecia, rash, cough, back pain, and decreased serum glucose.
There are 19 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Infection Leukopenia Neutropenic disorder |
Anemia Hyperbilirubinemia Hypocalcemia Increased alanine transaminase Increased aspartate transaminase Lymphopenia Thrombocytopenic disorder Thromboembolic disorder |
| Rare/Very Rare |
|---|
|
Cataracts DRESS syndrome Drug-induced hepatitis Interstitial lung disease Interstitial pneumonitis Prolonged QT interval Stevens-johnson syndrome Toxic epidermal necrolysis |
There are 29 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Alopecia Back pain Constipation Cough Diarrhea Fatigue Headache disorder Nausea Skin rash Vomiting |
Acute abdominal pain Anorexia Dry eye Dry skin Dyspepsia Dyspnea Erythema Eye tearing Fever General weakness Insomnia Pain in oropharynx Peripheral edema Pruritus of skin Stomatitis Syncope Urinary tract infection Vitiligo |
| Rare/Very Rare |
|---|
|
Blurred vision |
The following precautions are available for KISQALI (ribociclib succinate):
Safety and efficacy of ribociclib have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Ribociclib may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. (See Fetal/Neonatal Morbidity and Mortality under Cautions.) There are no available human data informing the drug-associated risk. Confirmation of pregnancy status prior to initiation of ribociclib therapy is recommended.
Ribociclib and its metabolites are distributed into milk in rats; it is not known whether the drug is distributed into milk in humans. Because of the potential for serious adverse reactions to ribociclib in nursing infants, women should be advised to discontinue breastfeeding during and for at least 3 weeks after discontinuance of ribociclib therapy. The effects of the drug or its metabolites on nursing infants or on milk production are unknown.
In the NATALEE study, 16% of patients were 65 years of age and older and 2.4% of patients were 75 years of age and older. No overall differences in safety and efficacy were observed between geriatric patients and younger adults with early breast cancer.
In the MONALEESA-2 or MONALEESA-3 study, 45 or 47%, respectively, of patients were 65 years of age or older and 11 or 14%, respectively, were 75 years of age or older. No overall differences in safety and efficacy were observed between geriatric patients and younger adults with advanced or metastatic breast cancer.
In the MONALEESA-2 or MONALEESA-3 study, 45 or 47%, respectively, of patients were 65 years of age or older and 11 or 14%, respectively, were 75 years of age or older. No overall differences in safety and efficacy were observed between geriatric patients and younger adults with advanced or metastatic breast cancer.
The following prioritized warning is available for KISQALI (ribociclib succinate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for KISQALI (ribociclib succinate)'s list of indications:
| Hr-positive, HEr2-negative advanced breast cancer | |
| C50 | Malignant neoplasm of breast |
| C50.1 | Malignant neoplasm of central portion of breast |
| C50.11 | Malignant neoplasm of central portion of breast, female |
| C50.111 | Malignant neoplasm of central portion of right female breast |
| C50.112 | Malignant neoplasm of central portion of left female breast |
| C50.119 | Malignant neoplasm of central portion of unspecified female breast |
| C50.12 | Malignant neoplasm of central portion of breast, male |
| C50.121 | Malignant neoplasm of central portion of right male breast |
| C50.122 | Malignant neoplasm of central portion of left male breast |
| C50.129 | Malignant neoplasm of central portion of unspecified male breast |
| C50.2 | Malignant neoplasm of upper-inner quadrant of breast |
| C50.21 | Malignant neoplasm of upper-inner quadrant of breast, female |
| C50.211 | Malignant neoplasm of upper-inner quadrant of right female breast |
| C50.212 | Malignant neoplasm of upper-inner quadrant of left female breast |
| C50.219 | Malignant neoplasm of upper-inner quadrant of unspecified female breast |
| C50.22 | Malignant neoplasm of upper-inner quadrant of breast, male |
| C50.221 | Malignant neoplasm of upper-inner quadrant of right male breast |
| C50.222 | Malignant neoplasm of upper-inner quadrant of left male breast |
| C50.229 | Malignant neoplasm of upper-inner quadrant of unspecified male breast |
| C50.3 | Malignant neoplasm of lower-inner quadrant of breast |
| C50.31 | Malignant neoplasm of lower-inner quadrant of breast, female |
| C50.311 | Malignant neoplasm of lower-inner quadrant of right female breast |
| C50.312 | Malignant neoplasm of lower-inner quadrant of left female breast |
| C50.319 | Malignant neoplasm of lower-inner quadrant of unspecified female breast |
| C50.32 | Malignant neoplasm of lower-inner quadrant of breast, male |
| C50.321 | Malignant neoplasm of lower-inner quadrant of right male breast |
| C50.322 | Malignant neoplasm of lower-inner quadrant of left male breast |
| C50.329 | Malignant neoplasm of lower-inner quadrant of unspecified male breast |
| C50.4 | Malignant neoplasm of upper-outer quadrant of breast |
| C50.41 | Malignant neoplasm of upper-outer quadrant of breast, female |
| C50.411 | Malignant neoplasm of upper-outer quadrant of right female breast |
| C50.412 | Malignant neoplasm of upper-outer quadrant of left female breast |
| C50.419 | Malignant neoplasm of upper-outer quadrant of unspecified female breast |
| C50.42 | Malignant neoplasm of upper-outer quadrant of breast, male |
| C50.421 | Malignant neoplasm of upper-outer quadrant of right male breast |
| C50.422 | Malignant neoplasm of upper-outer quadrant of left male breast |
| C50.429 | Malignant neoplasm of upper-outer quadrant of unspecified male breast |
| C50.5 | Malignant neoplasm of lower-outer quadrant of breast |
| C50.51 | Malignant neoplasm of lower-outer quadrant of breast, female |
| C50.511 | Malignant neoplasm of lower-outer quadrant of right female breast |
| C50.512 | Malignant neoplasm of lower-outer quadrant of left female breast |
| C50.519 | Malignant neoplasm of lower-outer quadrant of unspecified female breast |
| C50.52 | Malignant neoplasm of lower-outer quadrant of breast, male |
| C50.521 | Malignant neoplasm of lower-outer quadrant of right male breast |
| C50.522 | Malignant neoplasm of lower-outer quadrant of left male breast |
| C50.529 | Malignant neoplasm of lower-outer quadrant of unspecified male breast |
| C50.6 | Malignant neoplasm of axillary tail of breast |
| C50.61 | Malignant neoplasm of axillary tail of breast, female |
| C50.611 | Malignant neoplasm of axillary tail of right female breast |
| C50.612 | Malignant neoplasm of axillary tail of left female breast |
| C50.619 | Malignant neoplasm of axillary tail of unspecified female breast |
| C50.62 | Malignant neoplasm of axillary tail of breast, male |
| C50.621 | Malignant neoplasm of axillary tail of right male breast |
| C50.622 | Malignant neoplasm of axillary tail of left male breast |
| C50.629 | Malignant neoplasm of axillary tail of unspecified male breast |
| C50.8 | Malignant neoplasm of overlapping sites of breast |
| C50.81 | Malignant neoplasm of overlapping sites of breast, female |
| C50.811 | Malignant neoplasm of overlapping sites of right female breast |
| C50.812 | Malignant neoplasm of overlapping sites of left female breast |
| C50.819 | Malignant neoplasm of overlapping sites of unspecified female breast |
| C50.82 | Malignant neoplasm of overlapping sites of breast, male |
| C50.821 | Malignant neoplasm of overlapping sites of right male breast |
| C50.822 | Malignant neoplasm of overlapping sites of left male breast |
| C50.829 | Malignant neoplasm of overlapping sites of unspecified male breast |
| C50.9 | Malignant neoplasm of breast of unspecified site |
| C50.91 | Malignant neoplasm of breast of unspecified site, female |
| C50.911 | Malignant neoplasm of unspecified site of right female breast |
| C50.912 | Malignant neoplasm of unspecified site of left female breast |
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast |
| C50.92 | Malignant neoplasm of breast of unspecified site, male |
| C50.921 | Malignant neoplasm of unspecified site of right male breast |
| C50.922 | Malignant neoplasm of unspecified site of left male breast |
| C50.929 | Malignant neoplasm of unspecified site of unspecified male breast |
| Z17.0 | Estrogen receptor positive status [Er+] |
| Z19.1 | Hormone sensitive malignancy status |
| Hr-positive, HEr2-negative early-stage breast cancer | |
| C50 | Malignant neoplasm of breast |
| C50.1 | Malignant neoplasm of central portion of breast |
| C50.11 | Malignant neoplasm of central portion of breast, female |
| C50.111 | Malignant neoplasm of central portion of right female breast |
| C50.112 | Malignant neoplasm of central portion of left female breast |
| C50.119 | Malignant neoplasm of central portion of unspecified female breast |
| C50.12 | Malignant neoplasm of central portion of breast, male |
| C50.121 | Malignant neoplasm of central portion of right male breast |
| C50.122 | Malignant neoplasm of central portion of left male breast |
| C50.129 | Malignant neoplasm of central portion of unspecified male breast |
| C50.2 | Malignant neoplasm of upper-inner quadrant of breast |
| C50.21 | Malignant neoplasm of upper-inner quadrant of breast, female |
| C50.211 | Malignant neoplasm of upper-inner quadrant of right female breast |
| C50.212 | Malignant neoplasm of upper-inner quadrant of left female breast |
| C50.219 | Malignant neoplasm of upper-inner quadrant of unspecified female breast |
| C50.22 | Malignant neoplasm of upper-inner quadrant of breast, male |
| C50.221 | Malignant neoplasm of upper-inner quadrant of right male breast |
| C50.222 | Malignant neoplasm of upper-inner quadrant of left male breast |
| C50.229 | Malignant neoplasm of upper-inner quadrant of unspecified male breast |
| C50.3 | Malignant neoplasm of lower-inner quadrant of breast |
| C50.31 | Malignant neoplasm of lower-inner quadrant of breast, female |
| C50.311 | Malignant neoplasm of lower-inner quadrant of right female breast |
| C50.312 | Malignant neoplasm of lower-inner quadrant of left female breast |
| C50.319 | Malignant neoplasm of lower-inner quadrant of unspecified female breast |
| C50.32 | Malignant neoplasm of lower-inner quadrant of breast, male |
| C50.321 | Malignant neoplasm of lower-inner quadrant of right male breast |
| C50.322 | Malignant neoplasm of lower-inner quadrant of left male breast |
| C50.329 | Malignant neoplasm of lower-inner quadrant of unspecified male breast |
| C50.4 | Malignant neoplasm of upper-outer quadrant of breast |
| C50.41 | Malignant neoplasm of upper-outer quadrant of breast, female |
| C50.411 | Malignant neoplasm of upper-outer quadrant of right female breast |
| C50.412 | Malignant neoplasm of upper-outer quadrant of left female breast |
| C50.419 | Malignant neoplasm of upper-outer quadrant of unspecified female breast |
| C50.42 | Malignant neoplasm of upper-outer quadrant of breast, male |
| C50.421 | Malignant neoplasm of upper-outer quadrant of right male breast |
| C50.422 | Malignant neoplasm of upper-outer quadrant of left male breast |
| C50.429 | Malignant neoplasm of upper-outer quadrant of unspecified male breast |
| C50.5 | Malignant neoplasm of lower-outer quadrant of breast |
| C50.51 | Malignant neoplasm of lower-outer quadrant of breast, female |
| C50.511 | Malignant neoplasm of lower-outer quadrant of right female breast |
| C50.512 | Malignant neoplasm of lower-outer quadrant of left female breast |
| C50.519 | Malignant neoplasm of lower-outer quadrant of unspecified female breast |
| C50.52 | Malignant neoplasm of lower-outer quadrant of breast, male |
| C50.521 | Malignant neoplasm of lower-outer quadrant of right male breast |
| C50.522 | Malignant neoplasm of lower-outer quadrant of left male breast |
| C50.529 | Malignant neoplasm of lower-outer quadrant of unspecified male breast |
| C50.6 | Malignant neoplasm of axillary tail of breast |
| C50.61 | Malignant neoplasm of axillary tail of breast, female |
| C50.611 | Malignant neoplasm of axillary tail of right female breast |
| C50.612 | Malignant neoplasm of axillary tail of left female breast |
| C50.619 | Malignant neoplasm of axillary tail of unspecified female breast |
| C50.62 | Malignant neoplasm of axillary tail of breast, male |
| C50.621 | Malignant neoplasm of axillary tail of right male breast |
| C50.622 | Malignant neoplasm of axillary tail of left male breast |
| C50.629 | Malignant neoplasm of axillary tail of unspecified male breast |
| C50.8 | Malignant neoplasm of overlapping sites of breast |
| C50.81 | Malignant neoplasm of overlapping sites of breast, female |
| C50.811 | Malignant neoplasm of overlapping sites of right female breast |
| C50.812 | Malignant neoplasm of overlapping sites of left female breast |
| C50.819 | Malignant neoplasm of overlapping sites of unspecified female breast |
| C50.82 | Malignant neoplasm of overlapping sites of breast, male |
| C50.821 | Malignant neoplasm of overlapping sites of right male breast |
| C50.822 | Malignant neoplasm of overlapping sites of left male breast |
| C50.829 | Malignant neoplasm of overlapping sites of unspecified male breast |
| C50.9 | Malignant neoplasm of breast of unspecified site |
| C50.91 | Malignant neoplasm of breast of unspecified site, female |
| C50.911 | Malignant neoplasm of unspecified site of right female breast |
| C50.912 | Malignant neoplasm of unspecified site of left female breast |
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast |
| C50.92 | Malignant neoplasm of breast of unspecified site, male |
| C50.921 | Malignant neoplasm of unspecified site of right male breast |
| C50.922 | Malignant neoplasm of unspecified site of left male breast |
| C50.929 | Malignant neoplasm of unspecified site of unspecified male breast |
| Z17.0 | Estrogen receptor positive status [Er+] |
| Z19.1 | Hormone sensitive malignancy status |
Formulary Reference Tool