*If further dose reduction below 75 mg/day is required, discontinue the treatment¹

Example

Example

Additional Monitoring

Management of Interstitial Lung Disease (ILD)/Pneumonitis, Venous Thromboembolism and Febrile Neutropenia¹

ILD/Pneumonitis

Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/Pneumonitis of any grade. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new of worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.¹

Venous Thromboembolism

Any grade VTEs were reported in 3.2% of patients treated with IBRANCE across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3). Patients should be monitored for signs and symptoms of DVT and PE, and treated as medically appropriate.¹

Febrile Neutropenia

Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients experienced febrile neutropenia of any grade. In cases of febrile neutropenia, IBRANCE should be withheld until recovery of neutropenia to Grade <2 and then resumed at the next lower dose at the beginning of the following cycle.¹

The overall safety profile of IBRANCE is based on pooled data from 872 patients who received palbociclib in combination with endocrine therapy (N=527 in combination with letrozole and N=345 in combination with fulvestrant) in randomised clinical studies in HR+ HER2-negative advanced or metastatic breast cancer.

For the most up-to-date safety profile information, please refer to the full IBRANCE® Summary of Product Characteristics.