Abemaciclib Disease Interactions

The dosing frequency of abemaciclib should be reduced to once daily when it is administered to patients with severe hepatic impairment (Child-Pugh C). No dosage adjustments are necessary for patients with mild or moderate hepatic impairment (Child-Pugh A or B). Hepatotoxicity has been reported with the use of abemaciclib. It is recommended to monitor liver function tests prior to the start of therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation.

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Diarrhea, sometimes associated with dehydration and infection, has occurred in patients receiving abemaciclib. Diarrhea incidence was greatest during the first month of abemaciclib dosing. Care should be exercised when treating patients with symptoms of diarrhea. Treatment discontinuation may be required for Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization. Resume treatment at the next lower dose once toxicity resolves to <= Grade 1 diarrhea.

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Patients treated with abemaciclib have reported severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis. It is recommended to monitor patients for pulmonary symptoms indicative of ILD/pneumonitis such as, hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Dose interruption or dose reduction is recommended for patients who develop persistent or recurrent Grade 2 ILD/pneumonitis. Permanently discontinue therapy in all patients with Grade 3 or 4 ILD or pneumonitis.

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Neutropenia, including febrile neutropenia has occurred in patients receiving abemaciclib. Care should be exercised when prescribing this agent to patients with preexisting neutropenia. It is recommended to monitor complete blood counts prior to the start of therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

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Venous thromboembolic events have been reported with the use of abemaciclib. Care should be exercised when using this agent in patients with risk factors or history of venous thromboembolic events. It is recommended to monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.

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The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.

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