Itovebi Dosage
Generic name: INAVOLISIB 9mg
Dosage form: tablet, film coated
Drug class: PI3K inhibitors
Medically reviewed by Drugs.com. Last updated on Jan 22, 2025.
Patient Selection
Select patients for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer with ITOVEBI based on the presence of one or more PIK3CA mutations in plasma specimens.
Information on FDA-approved tests for the detection of PIK3CA mutations in breast cancer is available at: http://www.fda.gov/companiondiagnostics.
Recommended Evaluation Before Initiating ITOVEBI
Evaluate fasting plasma glucose (FPG)/blood glucose (FBG) and hemoglobin A1C (HbA1C) and optimize blood glucose prior to starting ITOVEBI and at regular intervals during treatment.
Recommended Dosage
The recommended dosage of ITOVEBI is 9 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity.
Advise patients to take ITOVEBI at approximately the same time each day.
Swallow ITOVEBI tablet(s) whole. Do not chew, crush, or split prior to swallowing.
If a patient misses a dose, instruct the patient to take the missed dose as soon as possible within 9 hours. After more than 9 hours, instruct the patient to skip the dose and take the next dose at the scheduled time.
If a patient vomits a dose, instruct patients not to take an additional dose on that day and resume the usual dosing schedule the next day.
Administer ITOVEBI in combination with palbociclib and fulvestrant. The recommended dosage of palbociclib is 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a cycle of 28 days. Refer to the Full Prescribing Information for palbociclib and fulvestrant for dosing information.
For premenopausal and perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice.
For men, consider administering an LHRH agonist in accordance with local clinical practice.
Dosage Modifications for Adverse Reactions
The recommended dose reduction levels of ITOVEBI for adverse reactions are listed in Table 1. Permanently discontinue ITOVEBI if patients are unable to tolerate the second dose reduction.
Dose Level | Dose and Schedule |
---|---|
Recommended starting dose | 9 mg daily |
First dose reduction | 6 mg daily |
Second dose reduction | 3 mg daily |
The recommended dosage modifications of ITOVEBI for adverse reactions are summarized in Table 2.
Adverse Reaction | Severity | Dosage Modification |
---|---|---|
Hyperglycemia* |
Fasting glucose levels (FPG or FBG) > ULN to 160 mg/dL (> ULN – 8.9 mmol/L) |
|
Fasting glucose levels > 160 to 250 mg/dL (> 8.9 – 13.9 mmol/L) |
|
|
Fasting glucose levels > 250 to 500 mg/dL (> 13.9 – 27.8 mmol/L) |
|
|
Fasting glucose levels > 500 mg/dL (> 27.8 mmol/L) |
|
|
Stomatitis |
Grade 1† |
|
Grade 2† |
|
|
Grade 3† |
|
|
Grade 4† |
|
|
Diarrhea |
Grade 1† |
|
Grade 2† |
|
|
Grade 3† |
|
|
Grade 4† |
|
|
Hematologic Toxicities |
Grade 1, 2, or 3† |
|
Grade 4† |
|
|
Other Adverse Reactions |
Grade 1† |
|
Grade 2† |
|
|
Grade 3 (first event)† |
|
|
Grade 3 (recurrent)† |
|
|
Grade 4† |
|
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