Version July 2025
Duchenne muscular dystrophy:
Note: Administer all appropriate immunizations according to immunization guidelines prior to initiation of therapy; administer live or live-attenuated vaccines ≥4 to 6 weeks prior to initiation of therapy.
Oral: 6 mg/kg once daily preferably with a meal; may decrease to 2 mg/kg once daily based on tolerability. Maximum: 300 mg/day.
Conversion from another oral corticosteroid (eg, deflazacort, prednisone) to vamorolone: Discontinue prior corticosteroid and initiate vamorolone 6 mg/kg once daily (maximum: 300 mg/day); may switch without therapy interruption or dose taper of prior corticosteroid.
Discontinuation of therapy: Gradually taper dose in patients receiving therapy ≥1 week.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Mild to moderate impairment (Child-Turcotte-Pugh class A and B) : Oral: 2 mg/kg once daily preferably with a meal; may decrease dose based on tolerability. Maximum: 100 mg/day.
Severe impairment (Child-Turcotte-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
Refer to adult dosing.
(For additional information see "Vamorolone: Pediatric drug information")
Duchenne muscular dystrophy (DMD): Children ≥2 years and Adolescents: Oral: 6 mg/kg/day once daily; maximum daily dose: 300 mg/day; doses may be titrated down to 2 mg/kg/day once daily based on individual tolerability and response. Note: DMD primarily affects males and rarely females; therefore, clinical trial experience is limited to the male population (Ref).
Conversion to vamorolone: When switching after long-term treatment with other oral steroids (eg, prednisone, deflazacort) to vamorolone, the manufacturer recommends switching without interruption to vamorolone 6 mg/kg/day to minimize risk of adrenal insufficiency.
Discontinuation of therapy: If administered for ≥7 days, a gradual decrease in dose is recommended to avoid acute adrenal insufficiency.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥2 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling.
Children ≥2 years and Adolescents:
Mild to moderate impairment: Oral: 2 mg/kg/day once daily; maximum daily dose: 100 mg/day. Note: Dose may be decreased based on individual tolerability.
Severe impairment: There are no recommendations in the manufacturer's labeling; has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reaction reported in children.
>10%:
Endocrine & metabolic: Cushingoid appearance, vitamin D deficiency, weight gain
Gastrointestinal: Vomiting
Nervous system: Psychiatric signs and symptoms (including aggressive behavior, agitation, anxiety, behavioral changes, irritability, mood changes, sleep disturbance, and stereotypy)
1% to 10%:
Gastrointestinal: Diarrhea, increased appetite
Nervous system: Headache
Respiratory: Cough, rhinitis
Frequency not defined: Endocrine & metabolic: Cushing syndrome, HPA-axis suppression
Hypersensitivity to vamorolone or any component of the formulation.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. HPA axis suppression may lead to adrenal insufficiency (and potentially fatal adrenal crisis) if corticosteroids are withdrawn. Adrenal insufficiency may persist for months following withdrawal of therapy; patients may require systemic corticosteroid supplementation during times of stress (eg, infection, trauma, surgery) (Dineen 2019; manufacturer's labeling).
• Anaphylaxis: Rare cases of anaphylaxis have occurred in patients receiving corticosteroids.
• Hyperglycemia: Corticosteroids may increase blood glucose, predispose patients on chronic therapy to diabetes mellitus, and may decrease effects of antidiabetic agents. Monitor blood glucose and initiate/adjust antidiabetic agents as appropriate.
• Immunosuppression: Corticosteroids suppress the immune system and increase risk of infection with any pathogen. Corticosteroids may increase the incidence of secondary infection, dissemination, and activation of latent infections; corticosteroids may mask acute infection (including fungal infections) or prolong or exacerbate existing infections. Severe and sometimes fatal corticosteroid-associated infections have occurred. Increased corticosteroid doses are associated with increased rates of infectious complications. If infection occurs, consider vamorolone dose reduction or withdrawal of therapy as needed. Tuberculosis reactivation may occur when treating patients with latent tuberculosis or tuberculin reactivity; administer chemoprophylaxis in patients with latent tuberculosis or tuberculin reactivity during prolonged use of vamorolone. Exposure to varicella or measles should be avoided; if exposure occurs, prophylaxis with an appropriate immunoglobulin may be indicated; antiviral treatment may be considered if varicella infection occurs. Avoid use in patients with active ocular herpes simplex. Hepatitis B reactivation can occur (infrequently) in patients who are hepatitis B carriers; screen for hepatitis B prior to vamorolone initiation. For patients who show evidence of hepatitis B infection, consult an infectious disease specialist regarding monitoring and treatment options before initiating vamorolone. Amebiasis reactivation may occur; for patients with recent travel to tropic climates or unexplained diarrhea, asses for latent or active amebiasis prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination, and fatalities have occurred. Avoid use in patients with cerebral malaria.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma; clinical improvement may occur with vamorolone discontinuation.
• Myopathy: Acute generalized myopathy has been reported with high-dose corticosteroids, especially in patients with neuromuscular transmission disorders and/or concomitant neuromuscular blocker therapy. Generalized myopathy may involve ocular and/or respiratory muscles, result in quadriparesis, and/or recovery following corticosteroid discontinuation may be prolonged (eg, months to years).
• Ocular effects: Prolonged use may cause posterior subcapsular cataracts, glaucoma (with possible nerve damage), and increased intraocular pressure.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.
• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and renal function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).
• Thromboembolic events: Higher cumulative doses of corticosteroids have been associated with an increased risk of thromboembolism. Use caution in patients with a history of or increased risk for thromboembolic disorders.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with heart failure and/or hypertension; use of corticosteroids has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute myocardial infarction; corticosteroids have been associated with myocardial rupture.
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production and regulation, leading to hyperglycemia.
• GI disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, ulcerative colitis, active or latent peptic ulcer, abscess or other pyogenic infections) due to perforation risk. Avoid use if there is a probability of impending perforation, abscess, or other pyogenic infection.
• Kidney impairment: Use with caution in kidney impairment; fluid retention may occur.
• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (eg, within first 2 weeks of treatment) (AAN [Narayanaswami 2021]).
• Osteoporosis: Use with caution in patients with or who are at risk for osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss, osteoporotic fractures, and avascular necrosis.
• Pheochromocytoma: Use with caution in patients with pheochromocytoma; cases of pheochromocytoma crisis, which can be fatal, have been reported with corticosteroids.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroidism and decreases in hypothyroidism.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP 1997; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Administer all appropriate immunizations based on current immunization guidelines prior to therapy initiation. Administer any live-attenuated or live vaccines ≥4 to 6 weeks prior to therapy initiation.
In general, corticosteroids may cause osteoporosis (at any age) or inhibition of bone growth in pediatric patients; however, in clinical trials, vamorolone did not affect height trajectories, with no decline in height nor bone marker turnover (Grounds 2023; Guglieri 2022; Smith 2020). Corticosteroids have been associated with myocardial rupture; hypertrophic cardiomyopathy has been reported in premature neonates.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Oral:
Agamree: 40 mg/mL (100 mL) [contains sodium benzoate; orange flavor]
No
Suspension (Agamree Oral)
40 mg/mL (per mL): $120.84
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Oral: Administer preferably with a meal. Shake well for 30 seconds prior to use; measure dose with provided oral syringe and administer directly into patient's mouth.
Oral: Administer with a meal (8 ounces of whole milk or equivalent high-fat/high-calorie meal) (Ref).
Oral suspension: Shake well for 30 seconds prior to use; measure dose with provided oral syringe and administer directly into patient's mouth. After use, rinse oral syringe and barrel with running warm water and let them air dry.
Duchenne muscular dystrophy: Treatment of Duchenne muscular dystrophy in patients ≥2 years of age.
Substrate of CYP2C8 (Minor), CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers), UGT1A3, UGT2B17, UGT2B7; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may increase adverse/toxic effects of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor
Aldesleukin: Corticosteroids (Systemic) may decrease therapeutic effects of Aldesleukin. Risk X: Avoid
Amphotericin B: Corticosteroids (Systemic) may increase hypokalemic effects of Amphotericin B. Risk C: Monitor
Androgens: Corticosteroids (Systemic) may increase fluid-retaining effects of Androgens. Risk C: Monitor
Antacids: May decrease bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider Therapy Modification
Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Antithymocyte Globulin (Equine): Corticosteroids (Systemic) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Baricitinib. Management: The use of baricitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
BCG Products: Corticosteroids (Systemic) may decrease therapeutic effects of BCG Products. Corticosteroids (Systemic) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Bile Acid Sequestrants: May decrease absorption of Corticosteroids (Oral). Risk C: Monitor
Brincidofovir: Corticosteroids (Systemic) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Corticosteroids (Systemic). Risk X: Avoid
Calcitriol (Systemic): Corticosteroids (Systemic) may decrease therapeutic effects of Calcitriol (Systemic). Risk C: Monitor
CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may decrease therapeutic effects of CAR-T Cell Immunotherapy. Corticosteroids (Systemic) may increase adverse/toxic effects of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider Therapy Modification
Cardiac Glycosides: Corticosteroids (Systemic) may increase adverse/toxic effects of Cardiac Glycosides. Risk C: Monitor
Chikungunya Vaccine (Live): Corticosteroids (Systemic) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Corticosteroids (Systemic) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Corticosteroids (Systemic) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider Therapy Modification
Corticorelin: Corticosteroids (Systemic) may decrease therapeutic effects of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor
Cosyntropin: Coadministration of Corticosteroids (Systemic) and Cosyntropin may alter diagnostic results. Risk C: Monitor
COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Vamorolone. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Vamorolone. Management: Reduce the vamorolone dose to 4 mg/kg daily, with a maximum dose of 200 mg daily for patients weighing over 50 kg, when combined with strong CYP3A4 inhibitors. Risk D: Consider Therapy Modification
Deferasirox: Corticosteroids (Systemic) may increase adverse/toxic effects of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Corticosteroids (Systemic) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Corticosteroids (Systemic) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Corticosteroids (Systemic). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and systemic corticosteroids. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Desirudin: Corticosteroids (Systemic) may increase anticoagulant effects of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider Therapy Modification
Desmopressin: Corticosteroids (Systemic) may increase hyponatremic effects of Desmopressin. Risk X: Avoid
Deucravacitinib: May increase immunosuppressive effects of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
Dinutuximab Beta: Corticosteroids (Systemic) may increase immunosuppressive effects of Dinutuximab Beta. Management: Corticosteroids are not recommended for 2 weeks prior to dinutuximab beta, during therapy and for 1 week after treatment. Doses equivalent to over 2 mg/kg or 20 mg/day of prednisone (persons over 10 kg) for 2 or more weeks are considered immunosuppressive Risk D: Consider Therapy Modification
Estrogen Derivatives: May increase serum concentration of Corticosteroids (Systemic). Risk C: Monitor
Etrasimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Etrasimod. Risk C: Monitor
Filgotinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Filgotinib. Management: Coadministration of filgotinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider Therapy Modification
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Gallium Ga 68 Dotatate: Coadministration of Corticosteroids (Systemic) and Gallium Ga 68 Dotatate may alter diagnostic results. Risk C: Monitor
Grapefruit Juice: May increase serum concentration of Vamorolone. Risk C: Monitor
Growth Hormone Analogs: Corticosteroids (Systemic) may decrease therapeutic effects of Growth Hormone Analogs. Growth Hormone Analogs may decrease active metabolite exposure of Corticosteroids (Systemic). Risk C: Monitor
Hyaluronidase: Corticosteroids (Systemic) may decrease therapeutic effects of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider Therapy Modification
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Corticosteroids (Systemic) may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider Therapy Modification
Indium 111 Capromab Pendetide: Coadministration of Corticosteroids (Systemic) and Indium 111 Capromab Pendetide may alter diagnostic results. Risk X: Avoid
Inebilizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider Therapy Modification
Isoniazid: Corticosteroids (Systemic) may decrease serum concentration of Isoniazid. Risk C: Monitor
Leflunomide: Corticosteroids (Systemic) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as systemic corticosteroids. Risk D: Consider Therapy Modification
Licorice: May increase serum concentration of Corticosteroids (Systemic). Risk C: Monitor
Loop Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor
Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may decrease therapeutic effects of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider Therapy Modification
Macimorelin: Coadministration of Corticosteroids (Systemic) and Macimorelin may alter diagnostic results. Risk X: Avoid
MetyraPONE: Coadministration of Corticosteroids (Systemic) and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider Therapy Modification
Mifamurtide: Corticosteroids (Systemic) may decrease therapeutic effects of Mifamurtide. Risk X: Avoid
MiFEPRIStone: May decrease therapeutic effects of Corticosteroids (Systemic). MiFEPRIStone may increase serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid
Mumps- Rubella- or Varicella-Containing Live Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Corticosteroids (Systemic) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Corticosteroids (Systemic) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Neuromuscular-Blocking Agents (Nondepolarizing): May increase adverse neuromuscular effects of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Risk D: Consider Therapy Modification
Nicorandil: Corticosteroids (Systemic) may increase adverse/toxic effects of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents (Topical): May increase adverse/toxic effects of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor
Ocrelizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Ozanimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Ozanimod. Risk C: Monitor
Pidotimod: Corticosteroids (Systemic) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk X: Avoid
Pneumococcal Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Corticosteroids (Systemic) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Corticosteroids (Systemic) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Corticosteroids (Systemic) may increase adverse/toxic effects of Polymethylmethacrylate. Specifically, the risk for hypersensitivity or implant clearance may be increased. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Quinolones: Corticosteroids (Systemic) may increase adverse/toxic effects of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor
Rabies Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ritodrine: Corticosteroids (Systemic) may increase adverse/toxic effects of Ritodrine. Risk C: Monitor
Ruxolitinib (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Salicylates: May increase adverse/toxic effects of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor
Sargramostim: Corticosteroids (Systemic) may increase therapeutic effects of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Risk C: Monitor
Sipuleucel-T: Corticosteroids (Systemic) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing immunosuppressants, such as systemic corticosteroids, prior to initiating sipuleucel-T therapy. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone given for 2 or more weeks are immunosuppressive. Risk D: Consider Therapy Modification
Sitafloxacin: Corticosteroids (Systemic) may increase adverse/toxic effects of Sitafloxacin. Specifically, the risk of tendonitis and tendon rupture may be increased. Management: Consider alternatives to coadministration of corticosteroids and sitafloxacin unless the benefits of coadministration outweigh the risk of tendon disorders. Risk D: Consider Therapy Modification
Sodium Benzoate: Corticosteroids (Systemic) may decrease therapeutic effects of Sodium Benzoate. Risk C: Monitor
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk C: Monitor
Succinylcholine: Corticosteroids (Systemic) may increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor
Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor
Tacrolimus (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Corticosteroids (Systemic) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Corticosteroids (Systemic) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Tofacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
Typhoid Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects of Typhoid Vaccine. Corticosteroids (Systemic) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Upadacitinib. Management: Coadministration of upadacitinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider Therapy Modification
Urea Cycle Disorder Agents: Corticosteroids (Systemic) may decrease therapeutic effects of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Risk C: Monitor
Vaccines (Live): Corticosteroids (Systemic) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider Therapy Modification
Vaccines (Non-Live/Inactivated/Non-Replicating): Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification
Vitamin K Antagonists: Corticosteroids (Systemic) may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor
Yellow Fever Vaccine: Corticosteroids (Systemic) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Yellow Fever Vaccine. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Corticosteroids (Systemic) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Administration with food increases AUC, decreases Cmax, and delays Tmax. Management: Administer preferably with a meal.
Animal reproduction studies have not been conducted.
Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.
It is not known if vamorolone is present in breast milk.
Systemic corticosteroids are present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Administer preferably with a meal.
BP, blood glucose, electrolytes (at regular intervals).
Following prolonged use (eg, ≥6 weeks): Bone mineral density; assess hypothalamic-pituitary-adrenal axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); signs and symptoms of infection, intraocular pressure; reactivation of tuberculosis in patients with latent tuberculosis or tuberculin reactivity.
Vamorolone is a corticosteroid that acts on the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which vamorolone exerts its effect in patients with Duchenne muscular dystrophy is unknown.
Absorption: Affected by food; administration with a high-fat, high-calorie meal increased AUC by 13%, delayed Tmax by 1 hour, and decreased Cmax by 18%. Administration with a low-fat, low-calorie meal increased AUC by 14%, delayed Tmax by 1 hour, and decreased Cmax by 4%.
Distribution: Vd: 162 L.
Protein binding: 88.1%.
Metabolism: Metabolized via glucuronidation, hydroxylation, and reduction through CYP3A4/5, CYP2C8, UGT1A3, UGT2B7, and UGT2B17.
Half-life elimination: ~2 hours.
Time to peak: With food: Median: ~2 hours (range: 0.5 to 5 hours).
Excretion: Feces: ~30% (15.4% as unchanged drug); urine: 48% (<1% as unchanged drug).
Clearance: 58 L/hour.
Hepatic function impairment: In patients with moderate hepatic impairment (Child-Turcotte-Pugh class B), Cmax and AUC0inf increased by ~1.7- and ~2.6-fold, respectively.
