nancy. Females of reproductive potential should avoid pregnancy and use effective contraception (resulting in less than 1% pregnancy rates) during and for at least 3 weeks after treatment with ribociclib; letrozole. Females of reproductive potential should undergo pregnancy testing prior to initiation of ribociclib; letrozole. Women who become pregnant while receiving ribociclib; letrozole should be apprised of the potential hazard to the fetus. Although there are no data regarding the effect of ribociclib; letrozole on human fertility, male and female infertility has been observed in animal studies.
Breast-feeding
Due to the potential for serious adverse reactions in nursing infants from ribociclib; letrozole, advise women to discontinue breast-feeding during treatment and for 3 weeks after the final dose. It is not known whether ribociclib or letrozole is present in human milk, although many drugs are excreted in human milk.
ADVERSE REACTIONS
Severe
neutropenia / Delayed / 60.0-60.0
leukopenia / Delayed / 21.0-21.0
hyperbilirubinemia / Delayed / 0-10.0
elevated hepatic enzymes / Delayed / 7.0-10.0
lymphopenia / Delayed / 7.0-7.0
hypophosphatemia / Delayed / 6.0-6.0
vomiting / Early / 4.0-4.0
anemia / Delayed / 0-2.0
anorexia / Delayed / 2.0-2.0
nausea / Early / 2.0-2.0
fatigue / Early / 0-2.0
back pain / Delayed / 2.0-2.0
hypokalemia / Delayed / 2.0-2.0
diarrhea / Early / 1.0-1.0
abdominal pain / Early / 1.0-1.0
constipation / Delayed / 1.0-1.0
stomatitis / Delayed / 0-1.0
dyspnea / Early / 1.0-1.0
rash (unspecified) / Early / 1.0-1.0
pruritus / Rapid / 1.0-1.0
headache / Early / 0-1.0
insomnia / Early / 0-1.0
infection / Delayed / 1.0-1.0
fever/Early/1.0-1.0
renal failure (unspecified)/Delayed/1.0-1.0
Moderate
peripheral edema/Delayed/12.0-12.0
QT prolongation/Rapid/0.3-3.0
Mild
alopecia/Delayed/33.0-33.0
syncope/Early/2.7-2.7
DRUG INTERACTIONS
Abacavir; Dolutegravir; Lamivudine: (Minor) Use caution if coadministration of ribociclib with dolutegravir is necessary, as the systemic exposure of dolutegravir may be increased resulting in an increase in treatment-related adverse reactions. Ribociclib is a CYP3A4 inhibitor in vitro at clinically relevant concentrations. Dolutegravir is metabolized by UGT1A1 with some contribution from CYP3A.
Acetaminophen; Butalbital: (Moderate) Use caution if coadministration of ribociclib with butalbital is necessary, as the systemic exposure of ribociclib may be decreased resulting in decreased efficacy. Ribociclib is extensively metabolized by CYP3A4 and butalbital is a CYP3A4 inducer.
Acetaminophen; Butalbital; Caffeine: (Moderate) Use caution if coadministration of ribociclib with butalbital is necessary, as the systemic exposure of ribociclib may be decreased resulting in decreased efficacy. Ribociclib is extensively metabolized by CYP3A4 and butalbital is a CYP3A4 inducer.
Acetaminophen; Butalbital; Caffeine; Codeine: (Moderate) Use caution if coadministration of ribociclib with butalbital is necessary, as the systemic exposure of ribociclib may be decreased resulting in decreased efficacy. Ribociclib is extensively metabolized by CYP3A4 and butalbital is a CYP3A4 inducer. (Moderate) Use caution if coadministration of ribociclib with codeine is necessary, as the systemic exposure of codeine may be increased resulting in an increase in treatment-related adverse reactions including sedation and re |
