HEMADY (Dexamethasone Tablets), for Oral Use Chronic Use
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use • Gastrointestinal Perforation: Avoid use in active or latent peptic ulcers, HEMADYTM safely and effectively. See full prescribing information for diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative HEMADY. colitis, since they may increase the risk of a perforation. (5.7) • Osteoporosis: Increased risk; monitor for changes in bone density with HEMADY (dexamethasone tablets), for oral use chronic use. (5.8) Initial U.S. Approval: 1958 • Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. --------------------------- INDICATIONS AND USAGE ------------------------- Monitor for signs and symptoms and manage promptly. (5.10) HEMADY is a corticosteroid indicated in combination with other anti • Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients myeloma products for the treatment of adults with multiple myeloma. (1) receiving corticosteroid therapy, most often for chronic conditions. (5.11) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of ----------------------- DOSAGE AND ADMINISTRATION --------------------- reproductive potential of the potential risk to a fetus. (5.13, 8.1) Recommended Dosage: 20 mg or 40 mg orally once daily, on specific days depending on the protocol regimen. (2) ------------------------------ ADVERSE REACTIONS ---------------------------- The most common adverse reactions are cardiovascular, dermatologic, --------------------- DOSAGE FORMS AND STRENGTHS ------------------- endocrine, fluid and electrolyte disturbances, gastrointestinal, metabolic, Tablets: 20 mg (3) musculoskeletal, neurological/psychiatric, ophthalmic, abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and ------------------------------ CONTRAINDICATIONS ---------------------------- number of spermatozoa, malaise, moon face, and weight gain. (6) • Patients with hypersensitivity to dexamethasone (4) • Patients with systemic fungal infections (4) To report SUSPECTED ADVERSE REACTIONS, contact Dexcel Pharma Technologies Ltd at 1-720-726-7616 or FDA at 1-800-FDA-1088 ----------------------- WARNINGS AND PRECAUTIONS --------------------- or www.fda.gov/medwatch. • Alterations in Endocrine Function: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur. ------------------------------ DRUG INTERACTIONS ---------------------------- Monitor patients for these conditions with chronic use. (5.1) • Avoid concomitant use of strong CYP3A4 inhibitors or inducers. (7.1) • Immunosuppression and Increased Risk of Infections: Increased risk of • Concomitant therapies such as erythropoietin stimulating agents or new, exacerbation, dissemination, or reactivation of latent infections. (5.2) estrogen containing therapies may have an increased risk of • Alteration in Cardiovascular/Renal Function: Monitor for elevated blood thromboembolism. (7.2) pressure and sodium, and for decreased potassium levels. (5.3) • Venous and Arterial Thromboembolism: Risk increased; consider ----------------------- USE IN SPECIFIC POPULATIONS ---------------------- anticoagulant prophylaxis and monitor for evidence of thromboembolism. Lactation: Advise not to breastfeed. (8.2) (5.4) • Vaccination: Avoid the administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. (5.5) See 17 for PATIENT COUNSELING INFORMATION • Ophthalmic Effects: May include cataracts, infections, and glaucoma. (5.6) Revised: 10/2019 Reference ID: 4500815 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 2 DOSAGE AND ADMINISTRATION 7.1 Effect of Other Drugs on HEMADY 2.1 Recommended Dosage 7.2 Effect of HEMADY on Other Drugs 2.2 Dose Modification for Elderly Patients 7.3 Laboratory Test Interference 3 DOSAGE FORMS AND STRENGTHS 8 USE IN SPECIFIC POPULATIONS 4 CONTRAINDICATIONS 8.1 Pregnancy 5 WARNINGS AND PRECAUTIONS 8.2 Lactation 5.1 Alterations in Endocrine Function 8.3 Females and Males of Reproductive Potential 5.2 Immunosuppression and Increased Risk of Infections 8.4 Pediatric Use 5.3 Alterations in Cardiovascular/Renal Function 8.5 Geriatric Use 5.4 Venous and Arterial Thromboembolism 10 OVERDOSAGE 5.5 Vaccination 11 DESCRIPTION 5.6 Ophthalmic Effects 12 CLINICAL PHARMACOLOGY 5.7 Gastrointestinal Perforation 12.1 Mechanism of Action 5.8 Osteoporosis 12.2 Pharmacodynamics 5.9 Myopathy 12.3 Pharmacokinetics 5.10 Behavioral and Mood Disturbances 13 NONCLINICAL TOXICOLOGY 5.11 Kaposi's Sarcoma 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.12 HEMADY in Combination with Anti-Myeloma Products 16 HOW SUPPLIED/STORAGE AND HANDLING 5.13 Embryo-Fetal Toxicity 17 PATIENT COUNSELING INFORMATION 6 ADVERSE REACTIONS *Sections or subsections omitted from the full prescribing information are not listed. Reference ID: 4500815 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). 2 DOSAGE AND ADMINISTRATION 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. 3 DOSAGE FORMS AND STRENGTHS Tablets: 20 mg white, round, biconvex tablet embossed with “20” on one side. 4 CONTRAINDICATIONS HEMADY is contraindicated in patients with: • Hypersensitivity to dexamethasone, or any of the excipients. Rare instances of anaphylactic reactions have been reported [see Adverse Reactions (6), Description (11)]. • Systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections [see Warnings and Precautions (5.2)]. 5 WARNINGS AND PRECAUTIONS 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 Reference ID: 4500815 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 striae, facial rounding, facial plethora, muscle weakness, easy and frequent bruising with thin fragile skin, posterior neck fat deposition, osteopenia, acne, amenorrhea, hirsutism and psychiatric abnormalities. Using the lowest dose of corticosteroid for the shortest duration possible may reduce the risk. Hyperglycemia Corticosteroids can increase blood glucose, worsen pre-existing diabetes, and predispose those on long-term therapy to diabetes mellitus, and may reduce the effect of the antidiabetic drugs. Monitor blood glucose at regular intervals. For patients with hyperglycemia, anti-diabetic treatment should be initiated or adjusted accordingly. Considerations for Use in Patients with Altered Thyroid Function Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate a dose adjustment of the corticosteroid. When concomitant administration of corticosteroids and levothyroxine is required, administration