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Corticosteroid

Hemady

Approved 3 Oct 2019OralTablet

Indications

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 )

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 )] .

Patients with hypersensitivity to dexamethasone (‎ 4 )
Patients with systemic fungal infections (‎ 4 )

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 )

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5.1Alterations 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 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 of corticosteroid should precede the initiation of levothyroxine therapy to avoid adrenal crisis. Pheochromocytoma Crisis There have been reports of pheochromocytoma crisis, which can be fatal, after administration of systemic corticosteroids. In patients with suspected or identified pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering HEMADY.

5.2Immunosuppression and Increased Risk of Infection

Corticosteroids, including HEMADY, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider HEMADY withdrawal or dosage reduction as needed. Tuberculosis If HEMADY is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged HEMADY therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune pediatric and adult patients taking corticosteroids, including HEMADY. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a HEMADY-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated.

If varicella develops, treatment with antiviral agents may be considered. If a HEMADY-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including HEMADY. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with HEMADY. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids, including HEMADY, may exacerbate systemic fungal infections; therefore, avoid HEMADY use in the presence of such infections unless HEMADY is needed to control drug reactions.

For patients on chronic HEMADY therapy who develop systemic fungal infections, HEMADY withdrawal or dosage reduction is recommended. Amebiasis Corticosteroi

Interactions

Avoid concomitant use of strong CYP3A4 inhibitors or inducers. (‎ 7.1 )
Concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thromboembolism. ( ‎7.2 )

7.1Effect of Other Drugs on

HEMADY Strong CYP3A4 inhibitors Coadministration of strong and moderate CYP3A4 inhibitors increased dexamethasone exposure [see Clinical Pharmacology (‎ 12.3 )] , which may increase the risk of adverse reactions [see Warnings and Precautions (‎ 5 ) and Adverse Reactions (‎ 6 )] . Avoid coadministration of strong CYP3A4 inhibitors or consider alternative medication that are not strong CYP3A4 inhibitors. If concomitant use of strong CYP3A4 inhibitors cannot be avoided, closely monitor for adverse drug reactions.

Strong CYP3A4 inducers Coadministration of strong CYP3A4 inducers may decrease dexamethasone exposure [see Clinical Pharmacology (‎ 12.3 )] , which may result in loss of efficacy. Avoid coadministration of strong CYP3A4 inducers or consider alternative medication that are not CYP3A4 inducers. If concomitant use strong CYP3A4 inducers cannot be avoided, consider increasing the dose of HEMADY. Cholestyramine Cholestyramine may increase the clearance of corticosteroids and potentially decrease corticosteroid exposure.

Avoid coadministration of cholestyramine and HEMADY and consider alternative agents. Anticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Ephedrine Ephedrine may decrease dexamethasone exposure. Decreased exposure may result in loss of efficacy.

Consider increasing the dose of HEMADY when used concomitantly with ephedrine. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids and increase exposures, which may increase the risk of adverse reactions [see Warnings and Precautions ( ‎5 ) and Adverse Reactions (‎ 6 )] .

7.2Effect of

HEMADY on Other Drugs CYP3A4 Substrates Coadministration of dexamethasone with drugs that are CYP3A4 substrates may decrease the concentration of these drugs. This may result in loss of efficacy of these drugs. Oral Anticoagulants Coadministration of anticoagulants with corticosteroids may reduce the response to anticoagulants [see Adverse Reactions (‎ 6 )] . Frequently monitor coagulation indices to maintain the desired anticoagulant effect when administered with HEMADY.

Amphotericin B Injection and Potassium-Depleting Agents Sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids [see Warnings and Precautions ( ‎5.3 ), and Adverse Reactions (‎ 6 )] . Closely monitor potassium levels when potassium-depleting agents are coadministered with HEMADY. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antidiabetics Corticosteroids, including HEMADY, may increase blood glucose concentrations [see Warnings and Precautions (‎ 5.1 ) and Adverse Reactions (‎ 6 )] . Consider adjusting the dose of antidiabetic agents, as necessary, when coadministered with HEMADY. Isoniazid Serum concentrations of isoniazid may be decreased with corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.

Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia [ see Warnings and Precautions (‎ 5.3 ) and Adverse Reactions (‎ 6 )] . Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects [see Warnings and Precautions (‎ 5.7 ) and Adverse Reactions (‎ 6 )] .

The clearance of salicylates may be increased with concurrent use of corticosteroids. Monitor for toxicity when aspirin is used in conjunction with HEMADY in hypoprothrombinemia. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone coadministration, leading to alterations in seizure control. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.

Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, defer routine administration of vaccines or toxoids until HEMADY therapy is discontinued [see Warnings and Precautions (‎ 5.5 )] . Concomitant Therapies that May Increase the Risk of Thromboembolism Erythropoietic agents, or other agents that may increase the risk of thromboembolism, such as estrogen containing therapies, coadministered with HEMADY may increase the risk of thromboembolism.

Monitor for risk of thromboembolism in patients with MM receiving anti-myeloma products with HEMADY [see Warnings and Precautions (‎ 5.4 )] . Thalidomide Toxic epidermal necrolysis has been reported with concomitant use of thalidomide. Closely monitor for toxicity when thalidomide is coadministered with HEMADY.

7.3Laboratory Test Interference Skin Tests

Corticosteroids may suppress reactions to skin tests.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Corticosteroids, including HEMADY, readily cross the placenta. Adverse developmental outcomes including orofacial clefts (cleft lip with or without cleft palate), intrauterine growth restriction, and decreased birth weight have been reported with maternal use of corticosteroids, including HEMADY, during pregnancy. In animal developmental and reproductive toxicology studies administration of corticosteroids to pregnant animals during organogenesis resulted in structural abnormalities, embryo-fetal mortality, functional impairment, and alterations to growth at doses equivalent to or below the recommended doses (see Data) .

Advise pregnant women of the potential risk to a fetus. HEMADY is administered in combination with anti-myeloma products that can cause embryo-fetal harm and are contraindicated for use in pregnancy. Refer to the Prescribing Information of the other anti-myeloma products used in combination with HEMADY for additional information. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Human Data HEMADY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Multiple courses of antenatal dexamethasone had been associated with reduced birth weight, susceptibility to infections, and increase blood glucose level in the newborns.

Neonatal hypoglycemia was also reported. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Animal Data In pregnant animals administered dexamethasone during organogenesis, doses equivalent to or below the recommended human dose have caused adverse developmental outcomes including structural abnormalities (cleft palate), alterations to growth (growth restrictions including reduced bone lengths and fetal weights), functional impairment (neurodevelopmental and metabolic effects), and embryo-fetal mortality (reduced number of embryonic implantations and fewer live fetuses).

Adverse reactions

The following clinically significant adverse reactions are described in detail in other labeling sections: Hypersensitivity [see Contraindications ( ‎4 )] Alterations in Endocrine Function [see Warnings and Precautions ( ‎5.1 )] Immunosuppression and Increased Risk of Infections [see Warnings and Precautions (‎ 5.2 ) ] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions (‎ 5.3 )] Venous and Arterial Thromboembolism [see Warnings and Precautions (‎ 5.4 )] Vaccination [see Warnings and Precautions (‎ 5.5 )] Ophthalmic Effects [see Warnings and Precautions (‎ 5.6 )] Gastrointestinal Perforation [see Warnings and Precautions (‎ 5.7 )] Osteoporosis [see Warnings and Precautions (‎ 5.8 )] Myopathy [see Warnings and Precautions ( ‎5.9 )] Behavioral and Mood Disturbances [see Warnings and Precautions ( ‎5.10 )] Kaposi's Sarcoma [see Warnings and Precautions ( ‎5.11 )] HEMADY in Combination with Anti-Myeloma Products [see Warnings and Precautions ( ‎5.12 )] Embryo-Fetal Toxicity [see Warnings and Precautions (‎ 5.13 )] The following adverse reactions associated with the use of HEMADY or other corticosteroids were identified in clinical trials or postmarketing reports.

Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Allergic reactions: Allergic or hypersensitivity reaction, anaphylaxis, angioedema. Blood and Lymphatic System Disorders: Leukocytosis. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, sterile abscess, rash, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and electrolyte disturbances: Fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, increased urinary excretion of calcium, tumor lysis syndrome. Gastrointestinal: Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Infection: Decreased resistance to infection, injection site infections following non-sterile administration. Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Osteonecrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures. Neurological: Convulsions, epidural lipomatosis, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, neuritis, neuropathy, paresthesia, vertigo.

Ophthalmic: Central serous chorioretinopathy, exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, vision blurred. Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. Psychiatric: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychosis.

Reproductive: Alteration in motility and number of spermatozoa. The most common adverse reactions are cardiovascular, dermatologic, endocrine, fluid and electrolyte disturbances, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, ophthalmic, abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, and weight gain.

(‎ 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC, at 877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.