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Itovebi
inavolisib
Adult Dosing .
Dosage forms: TAB: 3 mg, 9 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
PIK3CA-mutated hormone receptor-positive HER2-negative breast CA, locally advanced or metastatic
- [9 mg PO qd]
- Info: for endocrine-resistant dz; use w/ palbociclib and fulvestrant; give w/ LHRH agonist in pre/perimenopausal female pts; consider giving w/ LHRH agonist in male pts; do not cut/crush/chew tab
renal dosing
- [see below]
- eGFR 30-59: 6 mg qd; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x1wk after D/C
- caution: female pts of reproductive potential
- caution: male pts of reproductive potential
- caution: pts >65 yo
- caution: diabetes mellitus
- caution: hyperglycemia risk
Drug Interactions .
Overview
inavolisib
PI3KCA inhibitor; kinase inhibitor
- hyperglycemic effects
Monitor/Modify Tx
- acarbose
- alogliptin
- bexagliflozin
- bromocriptine
- canagliflozin
- colesevelam
- dapagliflozin
- dulaglutide
- empagliflozin
- ertugliflozin
- exenatide
- glimepiride
- glipizide
- glyburide
- insulin
- linagliptin
- liraglutide
- metformin
- miglitol
- nateglinide
- pioglitazone
- pramlintide
- repaglinide
- rosiglitazone
- saxagliptin
- semaglutide
- sitagliptin
- tirzepatide
Adverse Reactions .
Serious Reactions
- hyperglycemia, severe
- stomatitis, severe
- diarrhea, severe
- anemia
- infection
- hemorrhage
- acute coronary syndrome
- cerebrovascular event
Common Reactions
- hyperglycemia
- stomatitis
- diarrhea
- fatigue
- nausea
- rash
- appetite decr.
- COVID-19
- headache
- alopecia
- weight decr.
- vomiting
- UTI
- xeroderma
- neutrophils decr.
- Hgb decr.
- platelets decr.
- lymphocytes decr.
- calcium decr.
- potassium decr.
- Cr incr.
- ALT incr.
- sodium decr.
- magnesium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; fasting glucose at baseline, then q3 days x1wk, then qwk x3wk, then q2wk x8wk, then q4wk and as clinically indicated; HbA1c at baseline, then q3mo and as clinically indicated
Pregnancy/Lactation .
Pregnancy
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective non-hormonal contraception during tx and x1wk after D/C in female pts and using effective contraception during tx and x1wk after D/C in male pts
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity, embryo-fetal death, and decr. fetal wt based on animal data at 0.9x or greater systemic exposure and drug's mechanism of action
Lactation
Clinical Summary
avoid breastfeeding during tx and x1wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: hydrolysis primarily; CYP450: 3A substrate
Excretion: urine 49% (40% unchanged), feces 48% (11% unchanged); Half-life: 15h
Subclass: Kinase Inhibitors, PI3K Inhibitors
Mechanism of Action
inhibits phosphatidylinositol 3-kinase (PI3K) and its downstream signaling pathway activated by catalytic alpha-subunit of PI3K (PIK3CA) mutation, resulting in reduced tumor growth
Formulary .
No Formulary Selected
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