Pfizer announces new safety information added to the labeling for all CDK4/6 inhibitors, including IBRANCE.
On October 20th, 2019
IBRANCE (palbociclib) 125 mg capsules is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based
therapy in postmenopausal women or in men, or
- fulvestrant in patients with disease progression following
endocrine therapy
The 5.2 Warnings and Precautions section
of the label now includes the following information:
Interstitial Lung
Disease (ILD)/Pneumonitis:
Severe, life-threatening, or fatal interstitial
lung disease (ILD) and/or pneumonitis can occur in patients treated
with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including IBRANCE when
taken in combination with endocrine therapy.
Across clinical trials (PALOMA-1, PALOMA-2,
PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade,
0.1% had Grade 3 or 4 and no fatal cases were reported. Additional cases of
ILD/pneumonitis have been observed in the post-marketing setting, with
fatalities reported.
Monitor patients for pulmonary symptoms indicative of
ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or
worsening respiratory symptoms and are suspected to have developed pneumonitis,
interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue
IBRANCE in patients with severe ILD or pneumonitis.
Full updated prescribing
information is available here.
For patients requiring
financial assistance, Pfizer Oncology has support programs that may be able to
help. You can learn more at the product website IBRANCEhcp.com.
IBRANCE (palbociclib) 125 mg capsules is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men, or
- fulvestrant in patients with disease progression following endocrine therapy
The 5.2 Warnings and Precautions section of the label now includes the following information:
Interstitial Lung Disease (ILD)/Pneumonitis:
Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including IBRANCE when taken in combination with endocrine therapy.
Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4 and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.
Full updated prescribing information is available here.
For patients requiring financial assistance, Pfizer Oncology has support programs that may be able to help. You can learn more at the product website IBRANCEhcp.com.
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