Modeyso Side Effects

6 ADVERSE REACTIONS The following potential clinically significant adverse reactions are described elsewhere in the labelling: • Hypersensitivity [see Warnings and Precautions ( 5.1 )] .

• QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] .

The most common (≥20%) adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain.

The most common (≥2%) Grade 3 or 4 laboratory abnormalities are decreased lymphocytes, decreased calcium, and increased alanine aminotransferase.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chimerix at toll-free phone # 1-866-662-2679 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 WARNINGS AND PRECAUTIONS and below reflects exposure to MODEYSO at the recommended weight-based dose taken until disease progression or unacceptable toxicity in 376 adult and pediatric patients with glioma across four open-label clinical studies (ONC006, ONC013, ONC014, and ONC018) [see Clinical Studies ( 14 )] .

Of the 376 patients who received MODEYSO, 35% were exposed for 6 months, and 17% were exposed for 1 year.

The median age was 23 years (range: 3 to 80): 30% were 2 to 11 years old, 11% were 12 to 17 years old, 55% were 18 to 64 years old, and 3.7% were 65 years or older.

Fifty-two percent (52%) were female;