The most frequent (≥20%) adverse events of any grade observed across the PALOMA clinical trial programme were:^*1

• Severe, life-threatening or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with ET. Across the PALOMA clinical trial programme, 1.4% of patients treated with IBRANCE had ILD/pneumonitis of any grade, 0.1% had Grade 3 and no Grade 4 or fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea)^†1
• VTEs were reported in 3.2% of patients treated with IBRANCE across the PALOMA clinical trial programme.^† Patients should be monitored for signs and symptoms of DVT and PE, and treated as medically appropriate^†1
• Concomitant use of palbociclib with statins which are substrates of CYP3A4 and/or BCRP may increase the risk of rhabdomyolysis due to increased statin plasma concentration. Cases of rhabdomyolysis including fatal cases have been reported following coadministration of palbociclib with simvastatin or atorvastatin^†1

* Pooled analysis from the PALOMA clinical trials involving 872 patients with HR+ HER2− locally advanced or metastatic breast cancer who received IBRANCE in combination with ET (n=527 in combination with letrozole and n=345 in combination with fulvestrant);
† Adverse drug reaction identified post-marketing.