Hemady

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended Dosage: 20 mg or 40 mg orally once daily, on specific days depending on the protocol regimen. ( ‎2 ) 2.1 Recommended Dosage The recommended dosage of HEMADY is 20 mg or 40 mg, orally, once daily, on specific days depending on the treatment regimen. Refer to the Prescribing Information of the other anti-myeloma products used in combination with HEMADY for specific HEMADY dosing. HEMADY can be administered with or without food. 2.2 Dose Modification for Elderly Patients Dose-reduction for HEMADY is recommended for elderly patients, due to increased toxicity in these patients. Refer to the Prescribing Information of the other anti-myeloma products used as part of a combination regimen with HEMADY, for dosing recommendations in elderly patients. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • Alterations in Endocrine Function: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur. Monitor patients for these conditions with chronic use. ( ‎5.1 ) • Immunosuppression and Increased Risk of Infections: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections. (‎ 5.2 ) • Alteration in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels. (‎ 5.3 ) • Venous and Arterial Thromboembolism: Risk increased; consider anticoagulant prophylaxis and monitor for evidence of thromboembolism. (‎ 5.4 ) • Vaccination: Avoid the administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. ( ‎5.5 ) • Ophthalmic Effects: May include cataracts, infections, and glaucoma. (‎ 5.6 ) • Gastrointestinal Perforation: Avoid use in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. (‎ 5.7 ) • Osteoporosis: Increased risk; monitor for changes in bone density with chronic use. (‎ 5.8 ) • Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Monitor for signs and symptoms and manage promptly. ( ‎5.10 ) • Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. (‎ 5.11 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. (‎ 5.13 , ‎8.1 ) 5.1 Alterations in Endocrine Function Corticosteroids, such as HEMADY, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving HEMADY for adrenal insufficiency after corticosteroid withdrawal and Cushing’s syndrome and hyperglycemia while receiving corticosteroids. In addition, patients with hypopituitarism, primary adrenal insufficiency, or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at risk for adverse endocrine events. Risk of Adrenal Insufficiency Following Corticosteroid Withdrawal Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression, with the potential for the development of secondary adrenal insufficiency after withdrawal of corticosteroid treatment. Acute adrenal insufficiency can occur if glucocorticoids are withdrawn abruptly and can be fatal. The degree and duration of adrenocortical insufficiently produced is variable among patients and depends on the dose, frequency, and duration of glucocorticoid therapy. The risk may be reduced by gradually tapering the corticosteroid dose when withdrawing treatment. This insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstituted. For patients already taking corticosteroids during times of stress, the dosage may have to be increased. A steroid “withdrawal syndrome”, seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, and/or weight loss. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels. Cushing’s Syndrome Cushing’s syndrome (hypercortisolism) may occur with prolonged exposure to exogenous corticosteroids, including HEMADY. Symptoms include hypertension, truncal obesity and thinning of the limbs, purple s