Ibrance Disease Interactions

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.

Based on a population pharmacokinetic analysis with palbociclib mild hepatic impairment had no effect on the exposure of palbociclib. Close monitoring is recommended when using this agent in patients with moderate or severe hepatic impairment as the pharmacokinetics of palbociclib have not been studied in these patients. Dose modification of concomitant medications may be needed based of hepatic impairment.

The use of palbociclib may cause neutropenia, including febrile neutropenia and neutropenic sepsis. It is recommended to monitor complete blood counts prior to starting treatment and at the beginning of each therapy cycle with palbociclib, as well as on Day 15 of the first 2 cycles, and as clinically indicated thereafter. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Care and close monitoring is recommended, in particular for any episodes of fever.

Pre/perimenopausal women treated with the combination palbociclib plus fulvestrant therapy should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards. Care and close monitoring is recommended.

Based on a population pharmacokinetic analysis with palbociclib mild and moderate renal impairment had no effect on the exposure of palbociclib. Close monitoring is recommended when using this agent in patients with severe renal impairment as the pharmacokinetics of palbociclib in these patients have not been studied.