Hemady (dexamethasone)

Common side effects of Hemady include:

• allergic reactions,
• vision changes,
• heart problems,
• acne,
• thin fragile skin,
• thinning scalp hair,
• hives,
• menstrual irregularities,
• fluid retention,
• weight gain,
• bloating,
• increased appetite,
• nausea,
• decreased resistance to infection,
• muscle weakness,
• osteoporosis,
• headache,
• nerve pain,
• numbness and tingling,
• spinning sensation (vertigo),
• mood changes sleep problems (insomnia),
• dry skin,
• bruising or discoloration,
• slow wound healing,
• increased sweating,
• dizziness,
• stomach pain, and
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist)

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.

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.

Strong CYP3A4 Inhibitors

• Coadministration of strong and moderate CYP3A4 inhibitors increased dexamethasone exposure, which may increase the risk of adverse reactions. 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, 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.

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. 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. Closely monitor potassium levels when potassiumdepleting 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. 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.

Nonsteroidal Anti-Inflammatory Agents (NSAIDS)

• Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects.
• 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.

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.

Thalidomide

• Toxic epidermal necrolysis has been reported with concomitant use of thalidomide. Closely monitor for toxicity when thalidomide is coadministered with Hemady.

Laboratory Test Interference

Skin Tests

• Corticosteroids may suppress reactions to skin tests.

• 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.
•  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.