Considerations for hyperglycemia: All patients

Before treatment

Test for FPG and HbA1c and optimize the patient's level of blood glucose¹ The PI3K pathway is involved in glucose metabolism, and hyperglycemia is an expected, on-target effect of PI3K inhibition¹

Assess patient's past medical history Patients at higher risk (diabetic, prediabetic, FPG >250 mg/dL, BMI ≥30, or age ≥75 years) need consultation with a health care professional or diabetologist experienced in the treatment of hyperglycemia¹

Monitoring guidance for all patients treated with PIQRAY

Fasting glucose (plasma or blood) Monitor fasting glucose at weeks 1, 2, 4, 6, and 8 after treatment start and monthly thereafter¹

Monitor or self-monitor^* fasting glucose regularly, more frequently in the first 4 weeks and especially within the first 2 weeks of treatment¹

HbA1c monitoring Monitor after 4 weeks of treatment and every 3 months thereafter¹

In case of hyperglycemia, follow thePIQRAY dose modification and management table for hyperglycemia Dose modification and management should only be based on fasting glucose (plasma or blood) values¹

Monitoring schedule changes if hyperglycemia occurs

Monitoring fasting glucose (plasma or blood) during the first 8 weeks of antihyperglycemic treatment Monitor fasting glucose at least 1x per week¹

Monitoring fasting glucose (plasma or blood) after the first 8 weeks of antihyperglycemic treatment Monitor fasting glucose every 2 weeks and as clinically indicated¹ Consider consultation with a health care provider with expertise in the treatment of hyperglycemia¹

BMI, body mass index; HbA1c, glycosylated hemoglobin.
*All glucose monitoring should be performed at the physicians' discretion as clinically indicated.

Considerations for rash

Assess patient's past medical history Do not initiate PIQRAY treatment in patients with a history of Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)¹

Consider prophylaxis with antihistamines prior to onset of rash Antihistamines administered prior to rash onset may decrease incidence and severity of rash based on SOLAR-1 trial¹

Monitor for different forms of rash Rash may present in different forms, including rash maculopapular (the most commonly reported type of rash), macular, generalized, papular and pruritic, dermatitis and dermatitis acneiform^1-3

In case of rash, follow thePIQRAY dose modification and management table for rash

Considerations for diarrhea

Counsel patients on the signs and symptoms of diarrhea Advise patients to speak with their HCP if they experience the following signs and symptoms of diarrhea, including diarrhea (loose stools) lasting more than 2 days, fever of 38.9°C (102°F) or higher, frequent vomiting, six or more loose stools in 24 hours, severe pain in the abdomen or rectum, stools that are black and tarry or contain blood or pus, and symptoms of dehydration (eg, light-headedness)⁴

Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their health care provider if diarrhea occurs while taking PIQRAY¹

In case of diarrhea, follow thePIQRAY dose modification and management table for diarrhea