Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Consider a diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. In patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis, interrupt PIQRAY immediately and evaluate the patient for pneumonitis.
Pneumonitis was reported in 1.8% of patients treated with PIQRAY. Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, can occur in patients treated with PIQRAY. Advise patients of the signs and symptoms of hyperglycemia (eg, excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss). Closely monitor patients with diabetes.īased on the severity of the hyperglycemia, PIQRAY may require dose interruption, reduction, or discontinuation. Patients with a history of diabetes mellitus may require intensified hyperglycemic treatment. Patients with a medical history of controlled type 2 diabetes were included. The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established as these patients were excluded from the SOLAR-1 trial. Consider consultation with a health care practitioner with expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes. During treatment with anti-hyperglycemic medication, continue monitoring fasting glucose at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. If a patient experiences hyperglycemia after initiating treatment, monitor fasting glucose as clinically indicated, and at least twice weekly until fasting glucose decreases to normal levels. Monitor fasting glucose more frequently for the first few weeks during treatment in patients with risk factors for hyperglycemia such as obesity (BMI ≥30), elevated FPG, HbA1c at the upper limit of normal or above, use of concomitant systemic corticosteroids, or age ≥75. Monitor HbA1c every 3 months and as clinically indicated. After initiating treatment, monitor fasting glucose (FPG or fasting blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY.īefore initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose.
Grade 3 (FPG >250-500 mg/dL) and grade 4 (FPG >500 mg/dL) hyperglycemia were reported in 33% and 3.9% of patients, respectively. Hyperglycemia was reported in 65% of patients treated with PIQRAY. Fatal cases of ketoacidosis have occurred in the postmarketing setting. Hyperglycemia: Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis has occurred in patients treated with PIQRAY.
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If it is not confirmed, PIQRAY may require dose modifications, topical corticosteroids, or oral antihistamine treatment.Īdvise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy). Do not reintroduce PIQRAY in patients who have experienced previous SCARs during PIQRAY treatment. If a SCAR is confirmed, permanently discontinue PIQRAY. Consultation with a dermatologist is recommended. If signs or symptoms of SCARs occur, interrupt PIQRAY until the etiology of the reaction has been determined. DRESS was reported in patients in the postmarketing setting. In the SOLAR-1 study, SJS and EM were reported in 0.4% and 1.1% of patients, respectively. Severe Cutaneous Adverse Reactions (SCARs): SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur in patients treated with PIQRAY. Permanently discontinue PIQRAY in the event of severe hypersensitivity. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Angioedema has been reported in the postmarketing setting in patients treated with PIQRAY. The incidence of grade 3 and 4 hypersensitivity reactions was 0.7%.
Severe hypersensitivity reactions were manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur in patients treated with PIQRAY. PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
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