Table 4.
Adverse event | Incidence in SPRINT | Recommended monitoring | Recommended management |
---|---|---|---|
Rash | 91% | Monitor for rash at each encounter | Withhold treatment, reduce dose, or discontinue selumetinib |
Diarrhea | 77% | Monitor for diarrhea at each encounter |
Loperamide Increase fluid intake Withhold treatment, reduce dose, or discontinue selumetinib |
Increased CPK | 76% | Measure CPK at baseline |
Evaluate patients for rhabdomyolysis if CPK is increased Withhold treatment, reduce dose, or discontinue selumetinib |
LVEF ≥ 10% below baseline (and below institutional lower limit) | 23% | Echocardiogram at baseline, q3 months during the first year, and q6 months thereafter |
Perform echocardiogram Withhold treatment, reduce dose, or discontinue selumetinib |
Ocular toxicity (blurred vision, photophobia, cataracts, and ocular hypertension) | 15% |
Ophthalmic exam at baseline, and at regular intervals thereafter Optical coherence tomography q3 weeks until resolution in patients with RPED |
Perform ophthalmic exam Withhold treatment, reduce dose, or discontinue selumetinib depending on severity Withhold selumetinib in patients with RPED, resume once resolved Discontinue selumetinib in patients with RVO |
CPK Creatine phosphokinase, LVEF Left ventricular ejection fraction, q3 every 3, q6 every 6, RPED Retinal pigment epithelial detachment, RVO Retinal vein occlusion