Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Neutropenia and Severe Infections [see Warnings and Precautions ( 5.1 )] .
Adrenal Insufficiency [see Warnings and Precautions ( 5.2 )] Exacerbation of Conditions Treated with Glucocorticoids [see Warnings and Precautions ( 5.3 )].
Most common adverse reactions (incidence > 20%), including laboratory abnormalities, that occurred in patients treated with LIFYORLI in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Corcept Therapeutics at 1-855-844-3270 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of LIFYORLI in combination with nab-paclitaxel was evaluated in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in ROSELLA [see Clinical Studies ( 14 )] .
Patients received LIFYORLI (150 mg orally on the day before, the day of, and the day after each administration of nab-paclitaxel 80 mg/m 2 intravenous infusion on Days 1, 8 and 15 of each 28-day cycle (n=188) or nab-paclitaxel 100 mg/m 2 intravenous infusion (n=190) until disease progression or unacceptable toxicity.
LIFYORLI dosing was interrupted whenever nab-paclitaxel was interrupted.
The median duration of LIFYORLI treatment was 4.7 months (range: 0.2 to 24).
Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel.
5 WARNINGS AND PRECAUTIONS Neutropenia and Severe Infections : Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated.
Withhold, reduce the dose, or permanently discontinue LIFYORLI based on severity.
( 2.3 , 5.1 ) Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency.
( 5.2 ) Exacerbation of Conditions Treated with Glucocorticoids: LIFYORLI makes systemic glucocorticoids less effective in patients who have an ongoing requirement for systemic glucocorticoids.
( 5.3 ) Embryo-Fetal Toxicity : LIFYORLI can cause fetal harm.
Like all medications, Lifyorli can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: