Ibrance

Ibrance Adverse Reactions

palbociclib

Manufacturer:

Pfizer
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
The following clinically significant adverse reactions are described as follows and elsewhere in the labeling: Neutropenia and ILD/Pneumonitis (see Precautions).
Clinical Studies Experience: Because clinical trials are conducted under varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
Study 1: IBRANCE plus Letrozole: Patients with estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine based therapy.
The safety of IBRANCE (125 mg/day) plus letrozole (2.5 mg/day) versus placebo plus letrozole was evaluated in Study 1 (PALOMA-2). The data described below reflect exposure to IBRANCE in 444 out of 666 patients with ER-positive, HER2-negative advanced breast cancer who received at least 1 dose of IBRANCE plus letrozole in Study 1. The median duration of treatment for IBRANCE plus letrozole was 19.8 months while the median duration of treatment for placebo plus letrozole arm was 13.8 months.
Dose reductions due to an adverse reaction of any grade occurred in 36% of patients receiving IBRANCE plus letrozole. No dose reduction was allowed for letrozole in Study 1.
Permanent discontinuation associated with an adverse reaction occurred in 43 of 444 (9.7%) patients receiving IBRANCE plus letrozole and in 13 of 222 (5.9%) patients receiving placebo plus letrozole. Adverse reactions leading to permanent discontinuation for patients receiving IBRANCE plus letrozole included neutropenia (1.1%) and alanine aminotransferase increase (0.7%).
The most common adverse reactions (>10%) of any grade reported in patients in the IBRANCE plus letrozole arm by descending frequency were neutropenia, infections, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, pyrexia, and dysgeusia.
The most frequently reported Grade ≥3 adverse reactions (≥5%) in patients receiving IBRANCE plus letrozole by descending frequency were neutropenia, leukopenia, infections, and anemia.
Adverse reactions (>10%) reported in patients who received IBRANCE plus letrozole or placebo plus letrozole in Study 1 are listed in Table 5. (See Table 5.)


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Additional adverse reactions occurring at an overall incidence of <10.0% of patients receiving IBRANCE plus letrozole in Study 1 included alanine aminotransferase increased (9.9%), aspartate aminotransferase increased (9.7%), epistaxis (9.2%), lacrimation increased (5.6%), dry eye (4.1%), vision blurred (3.6%), and febrile neutropenia (2.5%). (See Table 6.)


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Description of selected adverse reactions: Overall, neutropenia of any grade was reported in patients receiving IBRANCE regardless of the combination, with Grade 3 and Grade 4 neutropenia.
The median time to first episode of any grade neutropenia was 15 days (12-700 days) and the median duration of Grade >3 neutropenia was 7 days across 3 randomised clinical studies.
Febrile neutropenia has been reported in 2.1% of patients receiving palbociclib in combination with letrozole.
The most common adverse reactions (≥20%) of any grade reported in patients in the IBRANCE plus letrozole arm by descending frequency were neutropenia, infections, leukopenia, nausea, fatigue, alopecia, stomatitis, anaemia and diarrhoea.
Dose reductions due to an adverse event of any grade occurred in 36.2% of patients receiving IBRANCE plus letrozole in PALOMA-1 and PALOMA-2. No dose reductions were allowed for the comparator arm. Permanent treatment discontinuation associated with an adverse event occurred in 10.6% patients receiving IBRANCE plus letrozole in PALOMA-1 and PALOMA-2 and in 5.0% of patients in the comparator arm.
In PALOMA-2 patients receiving IBRANCE plus letrozole, the starting dose of IBRANCE was 125 mg once daily. Dose reductions to 100 mg occurred in 36% of patients and dose reductions to 75 mg occurred in 14% of patients due to adverse events.
Neutropenia of any grade was reported in 78.9% of patients receiving IBRANCE plus letrozole in PALOMA-1 and PALOMA-2, with Grade 3 neutropenia reported in 55.2% of patients and Grade 4 neutropenia reported in 9.7% of patients (see Precautions). The most frequently reported Grade >3 adverse reactions (≥5%) in patients receiving IBRANCE plus letrozole by descending frequency were neutropenia, leukopenia, infections and anaemia.
The most frequently (≥ 1%) reported serious adverse drug reactions in patients receiving palbociclib plus letrozole (PALOMA-1 and PALOMA-2) were infections (4.6%) and febrile neutropenia (1.3%).
Cataract was reported in 3.2% of patients receiving IBRANCE plus letrozole and in 0.5% of patients receiving placebo plus letrozole in PALOMA-2.
Postmarketing Experience: The following adverse reactions have been identified during post-approval use of IBRANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Respiratory disorders: Interstitial lung disease (ILD)/non-infectious pneumonitis.
Male patients with HR-positive, HER2-negative advanced or metastatic breast cancer: Based on limited data from postmarketing reports and electronic health records, the safety profile for men treated with IBRANCE is consistent with the safety profile in women treated with IBRANCE.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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