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 clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] • Thromboembolic Events [see Warnings and Precautions (5.5) ] • Hypersensitivity [see Warnings and Precautions (5.6) ] • Laboratory Abnormalities [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
at 1-800-438-1985 or 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 LITFULO was evaluated in three randomized, placebo-controlled clinical trials and one long-term trial in subjects with alopecia areata, including alopecia totalis and alopecia universalis, who were 12 years of age and older.
A total of 1628 subjects were treated with LITFULO representing 2085 subject-years of exposure.
There were 1011 subjects with at least 1 year of exposure to LITFULO.
In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 subjects were exposed to LITFULO with 130 receiving 50 mg once daily for up to 24 weeks.
The median age of subjects was 33 years, 105 (11.9%) subjects were 12 to <18 years old and 22 (2.5%) subjects were 65 years of age or older.
The majority of subjects were White (70.7%) and female (63.6%).
5 WARNINGS AND PRECAUTIONS • Hypersensitivity: Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs.
( 5.6 ) • Laboratory Abnormalities: Perform ALC and platelet counts prior to LITFULO initiation.
Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities.
( 5.7 ) • Vaccinations: Avoid use of live vaccines during or shortly prior to LITFULO treatment.
( 5.8 ) 5.1 Serious Infections Serious infections have been reported in patients receiving LITFULO.
Like all medications, Litfulo 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: