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| Product NDC Code | 82111-955 | ||||||
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| Drug Name | Hemady |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 2261802, 2286261 |
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| Application Number | NDA211379 | ||||||
| Labeler Name | Edenbridge Pharmaceuticals LLC. | ||||||
| Packages |
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Overdosage of Hemady
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient’s condition, supportive therapy may include gastric lavage or induced vomiting.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 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.
Hemady Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG 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 ) 7.1 Effect 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 )] . 7.2 Effect 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. 7.3 Laboratory Test Interference Skin Tests Corticosteroids may suppress reactions to skin tests.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Dexamethasone is a corticosteroid with anti-inflammatory effects and low mineralocorticoid activity. The precise mechanism of action in multiple myeloma is unknown. Dexamethasone induces apoptosis of multiple myeloma cells. 12.2 Pharmacodynamics Following oral administration of a single dose of dexamethasone tablet to healthy subjects, the decrease in mean baseline cortisol concentration was maximal by 12 hours post-dose, with mean cortisol concentrations returning to near baseline approximately 3 days after drug administration. 12.3 Pharmacokinetics The pharmacokinetics of oral dexamethasone were dose proportional between single dose of 0.5 to 40 mg. Following a single HEMADY dose of 20 mg, the geometric mean (coefficient of variation, %CV) dexamethasone peak concentrations (C max ) was 247 ng/mL (31%) and area under the curve over time to infinity (AUC inf ) was 1271 ng.hr/mL (31%) in subjects. Absorption Following 20 mg dose of HEMADY, dexamethasone median time to peak concentrations (T max ) was 1 hour (range: 0.5 to 4 hours). Effect of Food A high-fat, high-calorie (total 800-1000 calories: approximately 60% from fat, 25% from carbohydrate and 15% from protein) meal had no effect on AUC inf and decreased C max by 23% of a single 20 mg dose of HEMADY. Distribution Dexamethasone is about 77% bound to human plasma proteins in vitro. Elimination The mean terminal half-life (coefficient of variation) of dexamethasone is 4 hours (18%) and oral clearance (CL/F) was 15.7 L/hr following a single dose of HEMADY. Metabolism Dexamethasone is metabolized by CYP3A4. Excretion Renal excretion of dexamethasone is less than 10% of total body clearance. Less than 10% of dexamethasone is excreted in the urine. Specific Populations The effect of baseline renal and hepatic impairment on the pharmacokinetics of dexamethasone has not been studied. Drug Interactions Studies Effect of Strong and Moderate CYP3A4 Inhibitors Coadministration of itraconazole (strong CYP3A4 inhibitor: 200 mg once daily x 4 days) with a single dose of oral dexamethasone (4.5 mg) increased dexamethasone AUC inf by 3.7-fold [see Drug Interactions ( 7.1 )] . Coadministration of aprepitant (moderate CYP3A4 inhibitor: 125 mg on Day 1, and 80 mg once daily on Days 2 to 5) with oral dexamethasone (20 mg on Day 1, and 8 mg once daily on Day 2-5) increased dexamethasone AUC inf by 2.2 -fold on Day 1 and 5 [see Drug Interactions ( 7.1 )] . Effects of Other Anti-Myeloma Products Coadministration of thalidomide, lenalidomide, pomalidomide, ixazomib, bortezomib or carfilzomib with dexamethasone is not expected to affect the pharmacokinetics of dexamethasone. Effect on Other Anti-Myeloma Products Coadministration of dexamethasone had no effect on the mean AUC inf of lenalidomide, pomalidomide, ixazomib, and bortezomib. Coadministration of dexamethasone with carfilzomib or thalidomide is not expected to affect the pharmacokinetics of these drugs, as these drugs are not primarily metabolized by CYP3A4 in vitro. For additional information on the drug interaction studies with dexamethasone and other anti-myeloma products, refer to the Prescribing Information of the other anti-myeloma products.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Dexamethasone is a corticosteroid with anti-inflammatory effects and low mineralocorticoid activity. The precise mechanism of action in multiple myeloma is unknown. Dexamethasone induces apoptosis of multiple myeloma cells.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Following oral administration of a single dose of dexamethasone tablet to healthy subjects, the decrease in mean baseline cortisol concentration was maximal by 12 hours post-dose, with mean cortisol concentrations returning to near baseline approximately 3 days after drug administration.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics The pharmacokinetics of oral dexamethasone were dose proportional between single dose of 0.5 to 40 mg. Following a single HEMADY dose of 20 mg, the geometric mean (coefficient of variation, %CV) dexamethasone peak concentrations (C max ) was 247 ng/mL (31%) and area under the curve over time to infinity (AUC inf ) was 1271 ng.hr/mL (31%) in subjects. Absorption Following 20 mg dose of HEMADY, dexamethasone median time to peak concentrations (T max ) was 1 hour (range: 0.5 to 4 hours). Effect of Food A high-fat, high-calorie (total 800-1000 calories: approximately 60% from fat, 25% from carbohydrate and 15% from protein) meal had no effect on AUC inf and decreased C max by 23% of a single 20 mg dose of HEMADY. Distribution Dexamethasone is about 77% bound to human plasma proteins in vitro. Elimination The mean terminal half-life (coefficient of variation) of dexamethasone is 4 hours (18%) and oral clearance (CL/F) was 15.7 L/hr following a single dose of HEMADY. Metabolism Dexamethasone is metabolized by CYP3A4. Excretion Renal excretion of dexamethasone is less than 10% of total body clearance. Less than 10% of dexamethasone is excreted in the urine. Specific Populations The effect of baseline renal and hepatic impairment on the pharmacokinetics of dexamethasone has not been studied. Drug Interactions Studies Effect of Strong and Moderate CYP3A4 Inhibitors Coadministration of itraconazole (strong CYP3A4 inhibitor: 200 mg once daily x 4 days) with a single dose of oral dexamethasone (4.5 mg) increased dexamethasone AUC inf by 3.7-fold [see Drug Interactions ( 7.1 )] . Coadministration of aprepitant (moderate CYP3A4 inhibitor: 125 mg on Day 1, and 80 mg once daily on Days 2 to 5) with oral dexamethasone (20 mg on Day 1, and 8 mg once daily on Day 2-5) increased dexamethasone AUC inf by 2.2 -fold on Day 1 and 5 [see Drug Interactions ( 7.1 )] . Effects of Other Anti-Myeloma Products Coadministration of thalidomide, lenalidomide, pomalidomide, ixazomib, bortezomib or carfilzomib with dexamethasone is not expected to affect the pharmacokinetics of dexamethasone. Effect on Other Anti-Myeloma Products Coadministration of dexamethasone had no effect on the mean AUC inf of lenalidomide, pomalidomide, ixazomib, and bortezomib. Coadministration of dexamethasone with carfilzomib or thalidomide is not expected to affect the pharmacokinetics of these drugs, as these drugs are not primarily metabolized by CYP3A4 in vitro. For additional information on the drug interaction studies with dexamethasone and other anti-myeloma products, refer to the Prescribing Information of the other anti-myeloma products.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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 )] . • Patients with hypersensitivity to dexamethasone ( 4 ) • Patients with systemic fungal infections ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION HEMADY (dexamethasone, USP) is an anti-inflammatory, 9-fluoro-glucocorticoid. The chemical name is 9-fluoro-11β,17,21trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular weight is 392.47 g/mol. The molecular formula is C 22 H 29 FO 5. The structural formula is: Dexamethasone is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. HEMADY for oral administration is available as an immediate-release tablet in a strength of 20 mg. Each tablet contains dexamethasone USP and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, povidone NF, and sodium starch glycolate NF. 1
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Tablets: 20 mg white, round, biconvex tablet embossed with “20” on one side. Tablets: 20 mg ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 )
Spl product data elements
Usually a list of ingredients in a drug product.Hemady dexamethasone DEXAMETHASONE DEXAMETHASONE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO 20
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis. Dexamethasone was tested for in vitro and in vivo genotoxic potential and was positive in the following assays: chromosomal aberrations and sister-chromatid exchanges in human lymphocytes, and micronuclei and sister-chromatid exchanges in mouse bone marrow. The Ames/Salmonella assay, with and without S9 mix, did not show an increase in His+ revertants. Published literature identified reduced testicular spermatozoids and reduced spermatogenesis in male mice dosed intraperitoneally for 7 days at doses equivalent to the human dose based on a mg/m 2 body surface area comparison.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis. Dexamethasone was tested for in vitro and in vivo genotoxic potential and was positive in the following assays: chromosomal aberrations and sister-chromatid exchanges in human lymphocytes, and micronuclei and sister-chromatid exchanges in mouse bone marrow. The Ames/Salmonella assay, with and without S9 mix, did not show an increase in His+ revertants. Published literature identified reduced testicular spermatozoids and reduced spermatogenesis in male mice dosed intraperitoneally for 7 days at doses equivalent to the human dose based on a mg/m 2 body surface area comparison.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 1 1 1
Hemady: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Discuss the following with patients prior to treatment with HEMADY: Administration HEMADY is administered as part of combination regimens with anti-myeloma products; instruct patients to take HEMADY exactly as prescribed in the Prescribing Information of the anti-myeloma products administered with HEMADY [see Dosage and Administration ( 2.1 ) and Warning and Precautions ( 5.12 )] . Inform elderly patients regarding dose-reduction, if needed [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.5 )] . Warn patients to not stop taking HEMADY abruptly or without first checking with their healthcare providers as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency [see Warnings and Precautions ( 5.1 )] . HEMADY may be taken with or without food. Alterations in Endocrine Function Advise patients to inform any medical attendants that they are taking corticosteroids, as prolonged use may cause adrenal insufficiency, Cushing's syndrome and make patients dependent on corticosteroids. Instruct patients to notify their healthcare provider if they have diabetes, or thyroid gland problems as the dose of medications used to control these other conditions may need to be adjusted while they are taking HEMADY [see Warnings and Precautions ( 5.1 )] . Advise the patient that, following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including myalgia, arthralgia, and malaise. Advise patients to not discontinue use of HEMADY abruptly or without medical supervision [see Warnings and Precautions ( 5.1 )] . Immunosuppression and Increased Risk of Infections Advise patients that they are at increased risk of infection. Tell patients to inform their healthcare provider if they have had recent or ongoing infections or if they have recently received a vaccine. Medical advice should be sought immediately if the patient develops fever or other signs of infection. Patients should be made aware that some infections can potentially be severe and fatal [see Warnings and Precautions ( 5.2 )] . Warn patients who are on corticosteroids to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed [see Warnings and Precautions ( 5.2 )] . Alterations in Cardiovascular/Renal Function Inform patients that HEMADY can cause an increase in blood pressure and water retention. If this occurs, dietary salt restriction and potassium supplementation may be needed [see Warnings and Precautions ( 5.3 )] . Venous and Arterial Thromboembolism Inform patients of the potential risk of developing venous and arterial thromboembolism and discuss the need for appropriate prophylactic treatment [see Warnings and Precautions ( 5.4 )] . Vaccination Inform patients that they may receive concurrent vaccinations with use of HEMADY, except for live-attenuated or live vaccines [see Warnings and Precautions ( 5.5 )] . Ophthalmic Effects Inform patients that HEMADY may cause cataracts or glaucoma and advise monitoring if corticosteroid therapy is continued for more than 6 weeks [see Warnings and Precautions ( 5.6 )] . Gastrointestinal Perforation HEMADY may increase the risk of developing gastrointestinal perforation. Advise patients to promptly seek medical attention if they develop unusually severe, persistent or worsening abdominal pain. Warn patients to avoid corticosteroids if there is a possibility of gastrointestinal perforation [see Warnings and Precautions ( 5.7 )] . Osteoporosis Advise patients about the risk of osteoporosis with prolonged use of HEMADY, which can predispose the patient to vertebral and long bone fractures [see Warnings and Precautions ( 5.8 )] . Myopathy Advise patients to contact their healthcare provider if they experience new or worsening symptoms of myopathy such as unexplained muscle pain, tenderness or weakness [see Warnings and Precautions ( 5.9 )] . Behavioral and Mood Disturbances Advise patients about the potential for severe behavioral and mood changes with HEMADY and encourage them to seek medical attention if psychiatric symptoms develop [see Warnings and Precautions ( 5.10 )] . Kaposi’s Sarcoma Advise patients about the risk of Kaposi’s sarcoma in patients receiving corticosteroid therapy. Advise patients to discontinue HEMADY in case Kaposi’s sarcoma is diagnosed [see Warnings and Precautions ( 5.11 )] . HEMADY in Combination with Anti-Myeloma Products Advise patients about the risk of adverse reactions which may occur when HEMADY is taken in combination with anti-myeloma products. Inform patients of the possible adverse reactions that could occur with the prescribed combination regimen, as detailed in the Prescribing Information of these products [see Warnings and Precautions ( 5.12 )] . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with HEMADY [see Warnings and Precautions ( 5.13 ) and Use in Specific Populations ( 8.1 )] . Drug Interactions Certain medications can cause an interaction with HEMADY. Advise patients to inform their healthcare provider of all the medicines the patient is taking, including over-the-counter medicines, dietary supplements, and herbal products. Inform patients that alternate therapy, dosage adjustment, and/or special test(s) may be needed during the treatment [see Drug Interactions ( 7.1 , 7.2 )] . Females and Males of Reproductive Potential Advise patients of reproductive potential to use effective contraception during treatment with HEMADY and for at least one month after the last dose [see Use in Specific Populations ( 8.3 )] . Lactation Advise women not to breastfeed during treatment with HEMADY and for 2 weeks after the last dose [see Use in Specific Populations ( 8.2 )] . Manufactured for: Dexcel Pharma Technologies Ltd Nahum Haftzadi 21, Givat Shaul Jerusalem, Israel 9548402 Distributed by: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience with dexamethasone has not identified differences in responses between the elderly and younger patients. However, the incidence of corticosteroid-induced adverse reactions may be increased in geriatric patients and are dose-related. Osteoporosis is the most frequently encountered complication, which occurs at a higher incidence rate in corticosteroid-treated geriatric patients as compared to younger populations and in age-matched controls. Losses of bone mineral density appear to be greatest early on in the course of treatment and may recover over time after steroid withdrawal or use of lower doses. Higher doses increase the relative risk of both vertebral and nonvertebral fractures, even in the presence of higher bone density compared to patients with involution osteoporosis. Perform routine screening of geriatric patients, including regular assessments of bone mineral density and institution of fracture prevention strategies, along with regular review of the dose of and need for continued dexamethasone therapy [see Warnings and Precautions ( 5.8 )] . HEMADY is used in combination with other anti-myeloma products. Refer to the Prescribing Information of the other anti-myeloma products used as part of a combination regimen with HEMADY, for information on the use of those products in elderly patients.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Lactation Risk Summary Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Advise women not to breastfeed during treatment and for 2 weeks after the last dose.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.8.3 Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating HEMADY [see Use in Specific Populations ( 8.1 )] . HEMADY is used in combination with other anti-myeloma products that require pregnancy testing in females of reproductive potential. Refer to the Prescribing Information for the products used in combination with HEMADY. Contraception Advise patients of reproductive potential to use effective contraception during treatment with HEMADY and for at least one month following the final dose of HEMADY. HEMADY is used in combination with other anti-myeloma products that require contraception in females and males of reproductive potential. Refer to the Prescribing Information for the products used in combination with HEMADY. Infertility Males Steroids may increase or decrease motility and number of spermatozoa in some patients. In animals, dexamethasone affects male spermatogenesis [see Nonclinical Toxicology ( 13.1 )] .
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy 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).
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy 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). 8.2 Lactation Risk Summary Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Advise women not to breastfeed during treatment and for 2 weeks after the last dose. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating HEMADY [see Use in Specific Populations ( 8.1 )] . HEMADY is used in combination with other anti-myeloma products that require pregnancy testing in females of reproductive potential. Refer to the Prescribing Information for the products used in combination with HEMADY. Contraception Advise patients of reproductive potential to use effective contraception during treatment with HEMADY and for at least one month following the final dose of HEMADY. HEMADY is used in combination with other anti-myeloma products that require contraception in females and males of reproductive potential. Refer to the Prescribing Information for the products used in combination with HEMADY. Infertility Males Steroids may increase or decrease motility and number of spermatozoa in some patients. In animals, dexamethasone affects male spermatogenesis [see Nonclinical Toxicology ( 13.1 )] . 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience with dexamethasone has not identified differences in responses between the elderly and younger patients. However, the incidence of corticosteroid-induced adverse reactions may be increased in geriatric patients and are dose-related. Osteoporosis is the most frequently encountered complication, which occurs at a higher incidence rate in corticosteroid-treated geriatric patients as compared to younger populations and in age-matched controls. Losses of bone mineral density appear to be greatest early on in the course of treatment and may recover over time after steroid withdrawal or use of lower doses. Higher doses increase the relative risk of both vertebral and nonvertebral fractures, even in the presence of higher bone density compared to patients with involution osteoporosis. Perform routine screening of geriatric patients, including regular assessments of bone mineral density and institution of fracture prevention strategies, along with regular review of the dose of and need for continued dexamethasone therapy [see Warnings and Precautions ( 5.8 )] . HEMADY is used in combination with other anti-myeloma products. Refer to the Prescribing Information of the other anti-myeloma products used as part of a combination regimen with HEMADY, for information on the use of those products in elderly patients.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 20 mg tablet: white, round, biconvex tablets embossed "20" on one side. NDC 82111-955-01: Bottle of 24, NDC 82111-955-02: Bottle of 100 Storage Store at 20°C to 25°C (68°F to 77°F) excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child resistant container.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API