Verenio Tablets 50 mg (Abemaciclib)

Adult dose

The recommended dose of this drug in combination with endocrine therapy is 150 mg orally twice daily. Refer to the prescribing information for the individual endocrine therapy for its recommended dose and administration when used in combination with this drug. This drug should be administered continuously for 2 years, or until disease recurrence or unacceptable toxicity occurs. Continue treatment until disease progression or unacceptable toxicity occurs. This drug may be taken with or without food. Instruct patients to take this drug at approximately the same time each day. If a patient vomits or misses a dose of this drug, instruct the patient to take the next dose at the next scheduled time. Instruct patients to swallow the tablets whole and not to chew, crush, or split them before swallowing. Instruct patients not to take tablets of this drug that are broken, cracked, or otherwise not intact. Discontinue this drug if the patient cannot tolerate a dose of 50 mg twice daily. Recommended starting dose: 150 mg twice daily First dose reduction: 100 mg twice daily Second dose reduction: 50 mg twice daily Third dose reduction: Not applicable Monitor complete blood counts before starting this drug, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Grade 1 or 2: No dose adjustment is required. Grade 3: Withhold treatment until toxicity resolves to Grade 2 or lower. No dose reduction is required. Recurrent Grade 3 or Grade 4: Withhold treatment until toxicity resolves to Grade 2 or lower. Resume treatment at the next lower dose. If hematopoietic growth factors are required, withhold this drug for at least 48 hours after the last dose of the hematopoietic growth factor and until toxicity resolves to Grade 2 or lower. Resume at the next lower dose unless this dose reduction has already been implemented for toxicity that led to growth factor use. At the first sign of loose stools, initiate antidiarrheal treatment and increase fluid intake. Grade 1: No dose adjustment is required. Grade 2: If toxicity does not resolve to Grade 1 or lower within 24 hours, withhold treatment until it resolves. No dose reduction is required. Persistent or recurrent Grade 2 following resumption at the same dose despite optimal supportive care: Withhold treatment until toxicity resolves to Grade 1 or lower. Resume treatment at the next lower dose. Grade 3 or 4, or requiring hospitalization: Withhold treatment until toxicity resolves to Grade 1 or lower. Resume treatment at the next lower dose. Monitor ALT, AST, and serum bilirubin before starting this drug, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Grade 1 (>ULN-3.0 x ULN) Grade 2 (>3.0-5.0 x ULN), with total bilirubin not increased to > 2 x ULN: No dose adjustment is required. Persistent or recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN), with total bilirubin not increased to > 2 x ULN: Withhold treatment until toxicity resolves to baseline or Grade 1. Resume treatment at the next lower dose. Increase in AST and/or ALT >3 x ULN with an increase in total bilirubin >2 x ULN, in the absence of cholestasis: Discontinue this drug. Grade 4 (>20.0 x ULN): Discontinue this drug. Grade 1 or 2: No dose adjustment is required. Persistent or recurrent Grade 2 toxicity that does not resolve to baseline or Grade 1 within 7 days despite optimal supportive care: Withhold treatment until toxicity resolves to baseline or Grade 1 or lower. Resume treatment at the next lower dose. Grade 3 or 4: Discontinue this drug. Early breast cancer, any grade (Grade 1, 2, 3, or 4): Withhold treatment and manage as clinically indicated. This drug may be resumed if the patient is clinically stable. Advanced or metastatic breast cancer, Grade 1 or 2: No dose modification is required. Advanced or metastatic breast cancer, Grade 3 or 4: Withhold treatment and manage as clinically indicated. This drug may be resumed if the patient is clinically stable. Grade 1 or 2: No dose adjustment is required. Persistent or recurrent Grade 2 toxicity that does not resolve to baseline or Grade 1 within 7 days despite optimal supportive care: Withhold treatment until toxicity resolves to baseline or Grade 1 or lower. Resume treatment at the next lower dose. Grade 3 or 4: Withhold treatment until toxicity resolves to baseline or Grade 1 or lower. Resume treatment at the next lower dose. Avoid concomitant use of ketoconazole, a strong CYP3A inhibitor. For patients whose recommended starting dose is 150 mg twice daily, reduce the dose of this drug to 100 mg twice daily when used concomitantly with strong CYP3A inhibitors other than ketoconazole. For patients whose dose was reduced to 100 mg twice daily due to adverse reactions, further reduce the dose of this drug to 50 mg twice daily. If a patient receiving this drug discontinues a CYP3A inhibitor, increase the dose of this drug (after 3-5 half-lives of the inhibitor have elapsed) to the dose used before starting the strong inhibitor. When used concomitantly with moderate CYP3A inhibitors, monitor for adverse reactions and, if necessary, consider reducing the dose of this drug by 50 mg as shown in Table 1. For patients with severe hepatic impairment (Child Pugh-C), reduce the dosing frequency of this drug to once daily. Refer to the prescribing information for dose adjustment requirements for concomitantly administered aromatase inhibitors or fulvestrant in patients with severe hepatic impairment.

This drug can commonly cause a decrease in neutrophil counts in treated patients. Neutropenia can increase the risk of infection, so regular blood tests should be performed to check neutrophil levels. If severe neutropenia occurs, it may be necessary to temporarily suspend treatment or reduce the dosage. This drug can be harmful to the fetus in pregnant women, so women planning a pregnancy or of childbearing potential should use effective contraception during treatment and for at least 3 weeks after the last dose. This drug may cause serious lung diseases such as interstitial lung disease or pneumonitis, so symptoms such as cough, shortness of breath, or hypoxia should be reported to healthcare professionals immediately. If these symptoms are severe, drug administration should be permanently halted. Patients with lactose intolerance should not take this medication. Diarrhea is very commonly seen in patients taking this drug, and if severe diarrhea occurs, fluid intake should be increased, and symptomatic management such as the use of antidiarrheal medication is required. In severe cases, drug administration may need to be temporarily halted or dosages reduced. Liver dysfunction may also occur, so liver function tests should be performed regularly, and if liver enzyme levels significantly rise, treatment should be suspended or dosages adjusted. This drug may increase the risk of thrombosis, so symptoms such as leg pain, swelling, or shortness of breath should be reported to healthcare professionals immediately, and if thrombosis is confirmed, drug administration should be terminated. There may be interactions with other medications, so dosage adjustments are necessary when taking especially with CYP3A4 inhibitors or inducers, and grapefruit products should be avoided. Pregnant or breastfeeding women should avoid taking this drug and should discontinue breastfeeding for at least 3 weeks after taking the medication. Safety in pediatric patients has not been established. It can also be administered to elderly patients, but caution regarding side effects is necessary. Caution is needed when administering to patients with severe kidney or liver dysfunction, and if liver function is severely impaired, the dosing frequency should be reduced. In case of overdose, there is no specific antidote, and general supportive care will be administered. This medication should be kept out of the reach of children and should not be transferred to other containers.

• Neutropenia
• febrile neutropenia
• neutropenic sepsis
• fetal weight loss
• interstitial lung disease
• interstitial pneumonia
• diarrhea
• fatigue
• leukopenia
• infection

This medicine may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it should be stored at room temperature between 1°C and 30°C, away from extremely hot or cold places.

Appearance

Beige oval-shaped film-coated tablets with 'Lilly' embossed on one side and '50' on the other side.

Package unit

70 tablets/box [(14 tablets/blister * 5)]