For Multiple Myeloma

Hemady® was designed with your multiple myeloma patients in mind

The most commonly recommended dose of dexamethasone for the treatment of multiple myeloma is 20 or 40 mg once weekly depending on an individual’s treatment regimen, age, and other patient-specific factors.1

Before Hemady®, patients were required to take five or ten tablets of dexamethasone 4 mg to achieve a dose of 20 or 40 mg.2

Hemady® is a proprietary 20 mg tablet strength of dexamethasone, which allows patients to take only one or two tablets to reach the recommended dose.1

Dexamethasone is one of the most frequently used medications in the treatment of multiple myeloma3

Hemady® is the only dexamethasone that is FDA-approved for use in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).1

Anti-myeloma properties of dexamethasone

Dexamethasone is a core component of all primary treatment regimens for multiple myeloma. Along with its anti-myeloma properties, dexamethasone has been shown to enhance clinical response rates to other anti-myeloma agents.3

The efficacy of dexamethasone in multiple myeloma is attributed to its ability to inhibit proliferation and induce apoptosis of multiple myeloma cells in a dose-dependent manner.3,4 This anti-myeloma effect is thought to be mediated via the glucocorticoid receptor and was confirmed in both multiple myeloma cells obtained from patients and in well-established multiple myeloma cell lines.4,5

Although dexamethasone has been well established as an anti-cancer therapy due to its ability to induce cell cycle arrest and cell death, its precise mechanism of action is not completely known.5

High pill burden in multiple myeloma

  • Multiple myeloma regimens are complex and may be associated with a high pill burden, which can result in poor adherence, less effective dosing, and suboptimal treatment and survival outcomes.2
  • Before Hemady®, oral dexamethasone was only available in lower strength formulations (0.5, 0.75, 1, 1.5, 2, 4, and 6 mg tablets), requiring patients to take five or ten 4 mg tablets to achieve the commonly prescribed dose of 20 or 40 mg.4
  • Pill burden in multiple myeloma is a multi-layered concern augmented not only by double and triple therapy combination regimens used to treat multiple myeloma, but also by supportive care needs and individual patient comorbidities. Optimization of dexamethasone therapy can reduce overall pill burden for these patients and help simplify their overall treatment plan.2,7

Optimizing the multiple myeloma regimen with Hemady® may increase patient adherence to multiple myeloma therapy.8

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.1

Indications and Usage

Hemady® (dexamethasone) tablets, 20 mg, is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.

Select Important Safety Information for Healthcare Providers

Contraindications

Hypersensitivity: Hemady® is contraindicated in patients with hypersensitivity to dexamethasone, or to any components of this product. Rare instances of anaphylactic reactions have been reported.

Fungal Infections: Hemady® is contraindicated in patients with systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections.

Warnings and Precautions

Alterations in Endocrine Function: Hemady® can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients for Cushing’s syndrome and hyperglycemia while receiving corticosteroids and adrenal insufficiency and steroid “withdrawal syndrome” after corticosteroid withdrawal.

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. Monitor for the development of infection and consider withdrawal of Hemady® or reduction of the dose of corticosteroids as needed.

Alterations in Cardiovascular/Renal Function: Alterations in cardiovascular and renal function can occur. Monitor for elevated blood pressure and sodium, and decreased potassium levels. Use with caution in patients with congestive heart failure and recent myocardial infarction.

Venous and Arterial Thromboembolism: Thromboembolism is a known adverse reaction of dexamethasone, including Hemady®. When administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib) the risk for venous and arterial thromboembolism increases significantly. Refer to the prescribing information of these anti-myeloma products. Consider using anticoagulant prophylaxis and monitor for evidence of thromboembolism.

Vaccination: Avoid administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.

Ophthalmic Effects: Use of corticosteroids including Hemady® may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Gastrointestinal Perforation: There is an increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders. Avoid corticosteroids such as Hemady® if there is a possibility of impending perforation, abscess, or other pyrogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.

Osteoporosis: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating Hemady®therapy.

Myopathy: An acute myopathy has been observed with the use of high doses of corticosteroids.

Behavioral and Mood Disturbances: Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including Hemady®. Inform patients and caregivers of the potential for behavioral and mood changes and encourage them to seek medical attention if symptoms develop.

Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Embryo-Fetal Toxicity: Hemady® can cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during treatment and for one month after treatment with Hemady®. Refer to the prescribing information of the combination anti-myeloma product for additional Contraindications, Warnings and Precautions.

Adverse Reactions

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.

Please see Full Prescribing Information for Hemady®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). You also may contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336.

Hemady® [Prescribing Information]. Edenbridge Pharmaceuticals, LLC. June 2023.

References
  1. Hemady® [Prescribing Information]. Edenbridge Pharmaceuticals, LLC. June 2023.
  2. Bashir Q, et al. Clin Lymphoma Myeloma Leuk. 2020;20:768-7735.
  3. Rosenberg AS. Leuk Lymphoma. 2023;64(2):283-291.
  4. FDA. Center for Drug Evaluation and Research. Hemady® New Drug Application. 2019.
  5. Sharma S, et al. Blood. 2008;112:1338-1345.
  6. Greenstein S, et al. Clin Cancer Res. 2002;8:1681-1694.
  7. Gupta M, et al. Int J Basic Clin Pharmacol. 2013;2:103-121.
  8. Data on file (Adherence study). Edenbridge Pharmaceuticals, LLC. August 2023.

Select Important Safety Information

Indications and Usage

Hemady® (dexamethasone) tablets, 20 mg, is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.

Select Important Safety Information for Healthcare Providers

Contraindications

Hypersensitivity: Hemady® is contraindicated in patients with hypersensitivity to dexamethasone, or to any components of this product. Rare instances of anaphylactic reactions have been reported.

Fungal Infections: Hemady® is contraindicated in patients with systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections.

Warnings and Precautions

Alterations in Endocrine Function: Hemady® can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients for Cushing’s syndrome and hyperglycemia while receiving corticosteroids and adrenal insufficiency and steroid “withdrawal syndrome” after corticosteroid withdrawal.

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. Monitor for the development of infection and consider withdrawal of Hemady® or reduction of the dose of corticosteroids as needed.

Alterations in Cardiovascular/Renal Function: Alterations in cardiovascular and renal function can occur. Monitor for elevated blood pressure and sodium, and decreased potassium levels. Use with caution in patients with congestive heart failure and recent myocardial infarction.

Venous and Arterial Thromboembolism: Thromboembolism is a known adverse reaction of dexamethasone, including Hemady®. When administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib) the risk for venous and arterial thromboembolism increases significantly. Refer to the prescribing information of these anti-myeloma products. Consider using anticoagulant prophylaxis and monitor for evidence of thromboembolism.

Vaccination: Avoid administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.

Ophthalmic Effects: Use of corticosteroids including Hemady® may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Gastrointestinal Perforation: There is an increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders. Avoid corticosteroids such as Hemady® if there is a possibility of impending perforation, abscess, or other pyrogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.

Osteoporosis: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating Hemady®therapy.

Myopathy: An acute myopathy has been observed with the use of high doses of corticosteroids.

Behavioral and Mood Disturbances: Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including Hemady®. Inform patients and caregivers of the potential for behavioral and mood changes and encourage them to seek medical attention if symptoms develop.

Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Embryo-Fetal Toxicity: Hemady® can cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during treatment and for one month after treatment with Hemady®. Refer to the prescribing information of the combination anti-myeloma product for additional Contraindications, Warnings and Precautions.

Adverse Reactions

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.

Please see Full Prescribing Information for Hemady®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). You also may contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336.

Hemady® [Prescribing Information]. Edenbridge Pharmaceuticals, LLC. June 2023.

References
  1. Hemady® [Prescribing Information]. Edenbridge Pharmaceuticals, LLC. June 2023.
  2. Bashir Q, et al. Clin Lymphoma Myeloma Leuk. 2020;20:768-7735.
  3. Rosenberg AS. Leuk Lymphoma. 2023;64(2):283-291.
  4. FDA. Center for Drug Evaluation and Research. Hemady® New Drug Application. 2019.
  5. Sharma S, et al. Blood. 2008;112:1338-1345.
  6. Greenstein S, et al. Clin Cancer Res. 2002;8:1681-1694.
  7. Gupta M, et al. Int J Basic Clin Pharmacol. 2013;2:103-121.
  8. Data on file (Adherence study). Edenbridge Pharmaceuticals, LLC. August 2023.