Itovey Bejeong 3 mg (Inavolisib)

Adult dose

The recommended dose of this drug is 9 mg orally once daily, regardless of meals. Take this drug at approximately the same time each day, if possible. It is recommended that treatment with this drug continue until disease progression or unacceptable toxicity occurs. Swallow this drug whole with water; do not chew, crush, or split it. If a dose of this drug is missed, it may be taken within 9 hours of the usual dosing time. If more than 9 hours have passed, skip the dose for that day and take this drug at the usual time the following day. If the patient vomits after taking this drug, do not take an additional dose that day; resume taking it at the usual time the following day. This drug must be administered in combination with palbociclib and fulvestrant. The recommended dose of palbociclib is 125 mg orally once daily for 21 consecutive days, followed by 7 days off treatment, in a 28-day cycle. Refer to the prescribing information for the doses of palbociclib and fulvestrant. For premenopausal/perimenopausal women, a luteinizing hormone-releasing hormone (LHRH) agonist should also be administered according to local clinical practice guidelines. For men, consider administration of a luteinizing hormone-releasing hormone (LHRH) agonist according to clinical practice guidelines. Temporary interruption, dose reduction, or discontinuation of this drug may be necessary to manage adverse reactions. Dose reduction schedule Starting dose: 9 mg once daily First dose reduction: 6 mg once daily Second dose reduction: 3 mg once daily If the patient cannot tolerate a dose of 3 mg once daily, permanently discontinue this drug. Hyperglycemia After starting treatment with this drug, the patient's fasting plasma glucose (FPG or FBG) level should be monitored or self-monitored according to the recommended schedule (see Precautions for Use, 3. General Precautions). >ULN–160mg/dL (>ULN-8.9 mmol/L): No dose adjustment of this drug is required. Consider dietary modification and ensure adequate hydration. For patients with risk factors for hyperglycemiab, consider initiating or intensifying oral antihyperglycemic therapy. >160–250 mg/dL (>8.9–13.9 mmol/L): Temporarily withhold this drug until the fasting blood glucose level decreases to ≤160 mg/dL(≤8.9 mmol/L). Initiate or intensify antihyperglycemic therapy. Resume this drug at the same dose level. If the fasting blood glucose level remains >200–250 mg/dL(>11.1–13.9 mmol/L) for 7 days despite appropriate antihyperglycemic therapy, consult a physician experienced in treating hyperglycemia. >250–500 mg/dL (>13.9–27.8 mmol/L): Temporarily withhold this drug. Initiate or intensify antihyperglycemic therapy. Provide adequate hydration, if needed. If the fasting blood glucose level decreases to ≤160 mg/dL(≤8.9 mmol/L) within 7 days, resume this drug at the same dose level. If the fasting blood glucose level decreases to ≤160 mg/dL(≤8.9 mmol/L) after 8 days, resume this drug at one lower dose level (see Table 1). If the fasting blood glucose level again becomes >250–500 mg/dL(>13.9–27.8 mmol/L) within 30 days, temporarily withhold this drug until the fasting blood glucose level decreases to ≤160 mg/dL(≤8.9 mmol/L). Resume this drug at one lower dose level (see Table 1). >500 mg/dL (>27.8 mmol/L): Temporarily withhold this drug. Initiate or intensify antihyperglycemic therapy. Assess for volume depletion and ketosis, and provide adequate hydration. If the fasting blood glucose level decreases to ≤160 mg/dL(≤8.9 mmol/L), resume this drug at one lower dose level (see Table 1). If the fasting blood glucose level again becomes > 500 mg/dL(>27.8 mmol/L) within 30 days, permanently discontinue this drug. ULN = Upper Limit of Normal a Confirm the fasting plasma glucose (FPG or FBG) level before starting treatment. The fasting blood glucose levels in this table reflect hyperglycemia grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. b Risk factors for hyperglycemia include, but are not limited to, diabetes (prediabetes), HbA1C≥5.7%, BMI≥30 kg/m2, age≥45 years, a history of gestational diabetes, and a family history of diabetes (see Precautions for Use, 3. General Precautions). Stomatitis Grade 1: No dose adjustment of this drug is required. Initiate or intensify appropriate treatment (e.g., a corticosteroid-containing mouthwash) as clinically indicated. Grade 2: Temporarily withhold this drug until recovery to Grade 1 or lower. Initiate or intensify appropriate treatment. Resume this drug at the same dose level. If Grade 2 stomatitis recurs, temporarily withhold this drug until recovery to Grade 1 or lower, then resume this drug at one lower dose level (see Table 1). Grade 3: Temporarily withhold this drug until recovery to Grade 1 or lower. Initiate or intensify appropriate treatment. Resume this drug at one lower dose level (see Table 1). Grade 4: Permanently discontinue this drug. aBased on CTCAE version 5.0. Diarrhea Grade 1: No dose adjustment of this drug is required. Initiate appropriate treatment and monitoring as clinically indicated. Grade 2: Temporarily withhold this drug until recovery to Grade 1 or lower, then resume this drug at the same dose level. Initiate or intensify appropriate treatment and monitoring as clinically indicated. If Grade 2 diarrhea recurs, temporarily withhold this drug until recovery to Grade 1 or lower, then resume this drug at one lower dose level (see Table 1). Grade 3: Temporarily withhold this drug until recovery to Grade 1 or lower, then resume this drug at one lower dose level (see Table 1). Initiate or intensify appropriate treatment and monitoring as clinically indicated. Grade 4: Permanently discontinue this drug. aBased on CTCAE version 5.0. Hematologic abnormalities Grade 1, 2, or 3: No dose adjustment of this drug is required. Monitor complete blood counts and signs or symptoms of hematologic abnormalities as clinically indicated. Grade 4: Temporarily withhold this drug until recovery to Grade 2 or lower. Resume this drug at the same dose level or one lower dose level, as clinically indicated (see Table 1). aBased on CTCAE version 5.0. Other adverse reactions Grade 1: No dose adjustment of this drug is required. Grade 2: If clinically necessary, consider temporarily withholding this drug until recovery to Grade 1 or lower. Resume this drug at the same dose level. Grade 3, first occurrence: Temporarily withhold this drug until recovery to Grade 1 or lower. Resume this drug at the same dose level or one lower dose level, based on clinical judgment (see Table 1). Grade 3, recurrence: Temporarily withhold this drug until recovery to Grade 1 or lower. Resume this drug at one lower dose level (see Table 1). Grade 4: Permanently discontinue this drug. aBased on CTCAE version 5.0.

This medication should not be used in patients with certain genetic conditions. For instance, patients who are allergic to this medication or its ingredients, or have genetic digestive disorders such as lactose intolerance, should not take this medication. This medication is primarily for the treatment of breast cancer, and various side effects may occur during its use. The most common side effects include reduced blood cell counts, elevated blood sugar levels, stomatitis, diarrhea, fatigue, and skin rashes. Particularly, hyperglycemia may occur frequently, so it is essential to well control blood sugar levels before starting this medication and to regularly monitor blood sugar during use. A rapid increase in blood sugar can lead to life-threatening conditions, hence caution is needed. Stomatitis and diarrhea are also common side effects, and it is important to receive appropriate treatment immediately if symptoms develop. The use of alcohol-free corticosteroid oral rinses is recommended to prevent stomatitis. This medication can harm the fetus during pregnancy; therefore, women who are pregnant or may become pregnant must consult a doctor and practice effective contraception during and for some time after treatment. Additionally, dosage adjustments may be necessary for patients with impaired kidney or liver function, so medication should be taken according to doctor's instructions. During the use of this medication, there may be the possibility of drug interactions, so it is crucial to inform healthcare professionals when taking other medications. Finally, keep this medication out of reach of children and do not transfer it to other containers, as this is safer.

• Anemia
• diarrhea
• urinary tract infection
• acute coronary syndrome
• intracerebral hemorrhage
• cerebrovascular accident
• COVID-19 infection
• gastrointestinal bleeding
• hyperglycemia
• stomatitis

This medication should be stored in a tightly closed container to prevent air or moisture ingress. Moreover, it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Doing so helps to preserve the drug's efficacy and safety.

Appearance

Round film-coated tablets in reddish-brown to dark reddish-brown color

Package unit

28 tablets/box [7 tablets/PTP x 4]