Safety Profile

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Grading according to CTCAE version 4.03.              
^aStomatitis, including stomatitis and aphthous ulcer.
^bThe denominator used to calculate the rate varied from 9 to 50 based on the number of patients with a baseline value and at least 1 posttreatment value.
^cGlucose increase is an expected laboratory abnormality of PI3K inhibition.
^dNo CTCAE grade available. For HbA1c, baseline values increasing posttreatment to a value above the upper limit of the normal range (≥5.7%) are considered increased.
^eNo grade 4 laboratory abnormalities were reported.
AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events; NA, not available; PI3K, phosphatidylinositol-3-kinase. 

EPIK-P1

The most commonly reported ARs were diarrhea (16%), stomatitis (16%), and hyperglycemia (12%)¹

• All ARs occurring in ≥10% of patients were mild to moderate (grade 1 or 2)

• Serious ARs occurred in 12% of patients who received VIJOICE. Dehydration (n=2) and cellulitis (n=2) were the only serious ARs that occurred in multiple patients

EPIK-P1 + EPIK-P3

Longer-term follow-up did not show any new safety signals²

• Since initiating VIJOICE, patients (N=57) were exposed to treatment for a median duration of 42.0 months (range: 3.4-74.8 months)

  • 22.8% (n=13) of patients were exposed for >60 months

Most pediatric patients experienced normal growth and development²

Additional safety data¹

• 5% of patients required dose reductions due to ARs. Alopecia, memory impairment, and soft tissue infection were the only ARs that required dose reduction

• Dose interruption due to an AR occurred in 11% of patients. Vomiting (n=2) and dizziness (n=2) were the only ARs that required dose interruption in 2 or more patients

• The following additional adverse reactions and laboratory abnormality have been identified following administration of VIJOICE: hypersensitivity, lipase increased, dermatitis, and abdominal pain

• The following adverse reactions have been identified with VIJOICE use in patients with PROS in an expanded access program for compassionate use. Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure

  • Metabolism and nutrition disorders: Decreased appetite

  • Skin and subcutaneous tissue disorders: Pruritus, rash (including rash maculo-papular, rash erythematous, rash papular, and rash pruritic), acne (including dermatitis acneiform)

ARs caused by targeted therapies are generally reversible^3,4