ITOVEBI (inavolisib)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Hyperglycemia
Pregnancy

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Kidney disease with likely reduction in glomerular filtration rate (GFr)

There are 13 severe adverse reactions.

More Frequent	Less Frequent
Anemia Diarrhea Hyperglycemia Stomatitis	Urinary tract infection

Rare/Very Rare
Acute coronary syndrome Bone pain Gastrointestinal hemorrhage Gastrointestinal ulcer Intestinal perforation Intracerebral hemorrhage Musculoskeletal pain Weight loss

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Anorexia COVId-19 Dry skin Elevated serum lipase Fatigue Headache disorder Hypocalcemia Hypokalemia Hypomagnesemia Hyponatremia Increased alanine transaminase Kidney disease with reduction in glomerular filtration rate (GFr) Lymphopenia Nausea Neutropenic disorder Skin rash Thrombocytopenic disorder Vomiting	Fever Leukopenia Upper respiratory infection

Rare/Very Rare
None.

Inavolisib is used in combination with palbociclib and fulvestrant. Refer to the Full Prescribing Information of palbociclib and fulvestrant for pregnancy information. Based on animal data and its mechanism of action, inavolisib can cause fetal harm when administered to a pregnant woman.

There are no available data on the use of inavolisib in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of inavolisib to pregnant rats during the period of organogenesis caused adverse developmental outcomes, including embryo-fetal mortality, structural abnormalities, and alterations to growth at maternal exposures approximately equivalent to the human exposure at the recommended dose of 9 mg/day based on AUC. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.

general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies in the U.S. general population.

Inavolisib is used in combination with palbociclib and fulvestrant. Refer to the Full Prescribing Information of palbociclib and fulvestrant for lactation information. There are no data on the presence of inavolisib or its metabolites in human milk, its effects on milk production or a breastfed child. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women to not breastfeed during treatment with inavolisib and for 1 week after the last dose.

Of the 162 patients who received inavolisib in the INAVO120 study, 15% were >= 65 years of age, and 3% were >= 75 years of age. Dosage modifications or interruptions of inavolisib due to adverse reactions occurred at a higher incidence for patients >= 65 years of age compared to younger patients (79% versus 68%, respectively). Clinical studies of inavolisib did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently from younger patients.