Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
*The following was added:
- Psychiatric disorders: Abnormal dreams and nightmares
- History of hypersensitivity to Mozobil
- Anaphylactic shock has occurred with use of Mozobil.
WARNINGS AND PRECAUTIONS
Anaphylactic shock and Hypersensitivity reactions
- Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening with clinically significant hypotension and shock, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable following completion of each administration.
- Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- In clinical studies, mild or moderate allergic reactions occurred within approximately 30 minutes after Mozobil administration in less than 1% of patients.
Clinical Trials Experience
- Hyperleukocytosis: In clinical trials, white blood cell counts of 100,000/mcL or greater were observed, on the day prior to or any day of apheresis, in 7% of patients receiving Mozobil and in 1% of patients receiving placebo. No complications or clinical symptoms of leukostasis were observed.
- In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported from post-marketing experience with Mozobil. 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.
- Immune System Disorders: Anaphylactic reactions, including anaphylactic shock