August Adverse Events Report: FDA Labeling Changes
TAGRISSO (OSIMERTINIB MESYLATE)
Warnings and Precautions added: keratitis
Adverse Reactions updated: AURA3 clinical trial experience:
- Keratitis reported in 0.7% (n = 6) of 833 patients treated with osimertinib in clinical trials.
- Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist.
- Serious adverse reactions were reported in 18% of patients treated with osimertinib and 26% in the chemotherapy group.
- No single serious adverse reaction was reported in 2% or more patients treated with osimertinib. One patient (0.4%) treated with osimertinib experienced a fatal adverse reaction (interstitial lung disease/pneumonitis).
- AURA3 was not designed to demonstrate a statistically significant reduction in adverse reaction rates for osimertinib.
Warnings and Precautions added: benzyl alcohol preservative
- Serious and fatal adverse reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including blinatumomab (with preservative).
- Gasping syndrome is characterized by central nervous syndrome depression, metabolic acidosis, and gasping respirations.
- When prescribing blinatumomab (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources.
- Blinatumomab (with preservative) contains 7.4 mg of benzyl alcohol per mL. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.
JEVTANA KIT (CABAZITAXEL)
Warnings and Precautions added: respiratory disorders
Patient Information added: lung or breathing problems
- Interstitial pneumonia/pneumonitis, interstitial lung disease, and acute respiratory distress syndrome have been reported and may be associated with fatal outcome.
- Patients with underlying lung disease may be at higher risk for these events.
- Acute respiratory distress syndrome may occur in the setting of infection.
- Interrupt cabazitaxel if new or worsening pulmonary symptoms develop.
- Patients should be advised that lung or breathing problems may develop with cabazitaxel and may lead to death.
- People who have lung disease before receiving cabazitaxel may have a higher risk for developing lung or breathing problems with cabazitaxel treatment.
Warnings and Precautions expanded and updated
- Pembrolizumab can cause severe or life-threatening infusion-related
- reactions, including hypersensitivity and anaphylaxis, which have been reported in 6 (0.2%) of 2799 patients receiving pembrolizumab.
- Pembrolizumab can cause immune-mediated pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, type I diabetes mellitus, nephritis, and thyroiditis
- Other clinically important immune-mediated reactions may involve any organ system.