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 serious adverse reactions are described elsewhere in the labeling: Ocular Toxicity [see Warnings and Precautions (5.1) ] Left Ventricular Dysfunction [see Warnings and Precautions (5.2) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Adults: The most common adverse reactions (>25%) were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue.
( 6.1 ) The most common Grade 3 or 4 laboratory abnormality (>2%) was increased creatine phosphokinase.
( 6.1 ) Pediatric patients: The most common adverse reactions (>25%) were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction, and nausea.
( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased neutrophil count and increased creatine phosphokinase.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SpringWorks Therapeutics Inc.
at 1-888-400-7989 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 pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to GOMEKLI in 133 patients (75 adults and 58 pediatric patients) in the ReNeu study [see Clinical Studies (14) ] (n=114) and Study NF-106 (n=19) [NCT-02096471].
Patients received GOMEKLI 2 mg/m 2 orally twice daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity.
Among 133 patients who received GOMEKLI, 62% were exposed for one year or longer, 38% were exposed for 2 years or longer, and 12% were exposed for 3 years or longer.
5 WARNINGS AND PRECAUTIONS Ocular Toxicity : Conduct comprehensive ophthalmic assessments prior to initiating GOMEKLI, at regular intervals during treatment and for new or worsening visual changes or blurred vision.
Continue, withhold, reduce the dose, or permanently discontinue GOMEKLI based on severity.
( 5.1 ) Left Ventricular Dysfunction : Assess ejection fraction by echocardiogram prior to initiating GOMEKLI, every 3 months during the first year, then as clinically indicated thereafter.
Withhold, reduce the dose, or permanently discontinue GOMEKLI based on severity.
( 5.2 ) Dermatologic Adverse Reactions : Initiate supportive care at first signs of dermatologic adverse reactions including rash.
Like all medications, Gomekli 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: