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.

There are no adequate and well-controlled studies of inavolisib in pregnant women; however, based on findings of animal reproductive studies and its mechanism of action, inavolisib may cause embryo-fetal harm when administered to pregnant females.

It is not known whether inavolisib is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions to inavolisib in nursing infants, advise patients to discontinue breastfeeding during and for 1 week after final dose.

In the INAVO120 study, 15% of patients were >=65 years of age and 3% were >=75 years of age. Patients >=65 years of age in this study had a higher incidence of dosage modifications or interruptions of therapy due to adverse effects than younger patients (79 versus 68%). An insufficient number of patients >=65 years of age were included in clinical studies to determine whether they respond differently from younger patients.