![]() ![]() The safety of VIJOICE in patients with type 1 and uncontrolled type 2 diabetes has not been established. Consider consultation with a health care provider with expertise in the treatment of hyperglycemia, and counsel patients on lifestyle changes. ![]() During treatment with antihyperglycemic 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 with VIJOICE, 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 with VIJOICE in patients with risk factors for hyperglycemia, such as obesity (body mass index ≥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 with VIJOICE, 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. In the EPIK-P1 study, grade 1 or 2 hyperglycemia was reported in 12% of patients treated with VIJOICE.īefore initiating treatment with VIJOICE, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar nonketotic syndrome (HHNKS) or fatal cases of ketoacidosis, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. If a SCAR is not confirmed, VIJOICE may require dose modifications, topical corticosteroids, or oral antihistamine treatment. If a SCAR is confirmed, permanently discontinue VIJOICE. Consultation with a dermatologist is recommended. ![]() ![]() If signs or symptoms of SCARs occur, interrupt VIJOICE until the etiology of the reaction has been determined. SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. Severe Cutaneous Adverse Reactions (SCARs). Permanently discontinue VIJOICE in the event of severe hypersensitivity. VIJOICE is not approved for use in the oncology setting. Severe hypersensitivity reactions, including anaphylaxis, angioedema, and anaphylactic shock, have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. VIJOICE is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This indication is approved under accelerated approval based on response rate and duration of response. VIJOICE ® (alpelisib) tablets is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |