Verzenios 100 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. Early breast cancer: This drug should be administered continuously for 2 years, or until disease recurrence or unacceptable toxicity occurs. Advanced or metastatic breast cancer: Continue treatment until disease progression or unacceptable toxicity occurs. This drug may be administered 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 initiating treatment with 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 growth factor and until toxicity resolves to Grade 2 or lower. Resume at the next lower dose unless this has already been done for the toxicity that led to use of the growth factor. Use growth factors according to current treatment guidelines. At the first sign of loose stools, start 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 after resuming 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 initiating treatment with 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 no increase in total bilirubin to > 2 x ULN: No dose adjustment is required. Persistent or recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN), with no increase in total bilirubin to > 2 x ULN: Withhold treatment until toxicity resolves to baseline or Grade 1 levels. 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. Treatment with 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. Treatment with 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. For patients whose recommended starting dose is 150 mg twice daily, reduce the dose of this drug to 100 mg twice daily when coadministered with a strong CYP3A inhibitor 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 taking 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 coadministering a moderate CYP3A inhibitor, monitor for adverse reactions and, if necessary, consider reducing the dose of this drug by 50 mg as presented 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 concomitant aromatase inhibitors or fulvestrant in patients with severe hepatic impairment.

This drug may reduce the number of neutrophils in the blood, increasing the risk of infection. Therefore, regular blood tests must be conducted during treatment, and any signs of fever or infection must be reported to a healthcare professional immediately. As it may harm the fetus during pregnancy, contraception is essential, and it is important for women of childbearing potential to take a pregnancy test before starting this medication. This drug can affect liver function, so regular liver function tests should be performed, and the drug should be stopped immediately if signs of serious pulmonary disease such as interstitial lung disease appear. Patients with lactose intolerance should not take this medication. Gastrointestinal side effects such as diarrhea may occur frequently, so appropriate measures should be taken, including maintaining adequate hydration and taking antidiarrheal medication if diarrhea starts; if severe diarrhea occurs, drug administration may be temporarily halted. This drug may increase the risk of thrombosis, so patients must remain vigilant for thrombotic symptoms and consult their healthcare provider if any symptoms arise. Elderly patients can also take this drug, but there should be careful monitoring for the possibility of side effects. In case of overdose, there is no specific antidote, and supportive care should be sought immediately, keeping the drug out of reach of children.

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

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it should be kept away from extreme temperatures, stored at room temperature between 1 to 30 degrees Celsius.

Appearance

White to almost white, oval-shaped film-coated tablet with “Lilly” embossed on one side and “100” embossed on the other side.

Package unit

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