Introduction
Sernivo (betamethasone dipropionate) Spray, 0.05% is a topical corticosteroid formulation approved by the FDA for the treatment of mild to moderate plaque psoriasis in patients 18 years of age and older. This novel spray formulation offers enhanced patient convenience and improved application to difficult-to-reach areas compared to traditional creams and ointments.
Mechanism of Action
Betamethasone dipropionate is a high-potency synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects. Corticosteroids act by binding to cytoplasmic glucocorticoid receptors, forming complexes that translocate to the cell nucleus. These complexes bind to glucocorticoid response elements in DNA, ultimately modifying transcription of specific mRNA. This results in inhibition of inflammatory mediator production, decreased edema, fibrin deposition, capillary dilation, and migration of inflammatory cells to affected areas.
Indications
- Treatment of mild to moderate plaque psoriasis in patients 18 years of age and older
- Not recommended for use on face, groin, or axillae
Dosage and Administration
- Apply a thin film to affected areas twice daily
- Gently rub into the skin until spray is no longer visible
- Shake well before each use
- Treatment duration should not exceed 4 weeks
- Total dosage should not exceed 50 g per week
- Wash hands after application unless being treated
- Hepatic impairment: Use with caution
- Renal impairment: No dosage adjustment required
- Geriatric patients: Use with caution due to increased skin fragility
- Pediatric patients: Not recommended for patients under 18 years
Pharmacokinetics
- Absorption: Systemic absorption varies based on application site, skin integrity, and use of occlusive dressings
- Distribution: Highly protein-bound in circulation
- Metabolism: Primarily hepatic via CYP3A4
- Elimination: Renal excretion of metabolites; elimination half-life approximately 3-5 hours
Contraindications
- Hypersensitivity to betamethasone dipropionate or any component of the formulation
- Viral skin infections (herpes simplex, varicella)
- Fungal skin infections
- Tuberculosis of the skin
- Perioral dermatitis
- Rosacea
- Acne vulgaris
Warnings and Precautions
- Systemic effects: May occur with extensive use, especially under occlusion or on large body surface areas
- HPA axis suppression: Monitor for signs of adrenal insufficiency
- Skin atrophy: May occur with prolonged use, especially on thin skin areas
- Ocular effects: May cause glaucoma or cataracts with periocular use
- Immunosuppression: Increased risk of secondary infections
- Contact dermatitis: Potential for hypersensitivity reactions
- Flammability: Spray is flammable; avoid fire, flame, or smoking during and immediately after application
Drug Interactions
- No formal drug interaction studies conducted
- Theoretical interactions with other topical products applied to same area
- Potential increased systemic absorption when used with other corticosteroids
- Caution with other immunosuppressive agents
Adverse Effects
Most common (>1%):- Application site irritation
- Pruritus
- Burning sensation
- Folliculitis
- Skin dryness
- Hypersensitivity reactions
- Skin atrophy
- Striae
- Telangiectasia
- HPA axis suppression
- Cushing's syndrome
- Hyperglycemia
- Ocular hypertension
Monitoring Parameters
- Clinical response to therapy
- Signs of skin atrophy, striae, or telangiectasia
- Symptoms of HPA axis suppression (fatigue, weakness, nausea, hypotension)
- Blood glucose in diabetic patients
- Signs of secondary infection
- Ophthalmic exams with prolonged periocular use
Patient Education
- Use only as directed by healthcare provider
- Apply only to affected areas
- Avoid use on face, groin, or underarms
- Do not cover with occlusive dressings unless directed
- Shake well before each use
- Report any signs of skin irritation or infection
- Avoid contact with eyes and mucous membranes
- Do not use longer than prescribed (maximum 4 weeks)
- Store at room temperature, away from heat and flame
- Inform all healthcare providers about Sernivo use
References
1. FDA Prescribing Information: Sernivo (betamethasone dipropionate) Spray, 0.05%. Revised 2016. 2. Lebwohl MG, Heymann WR, Coulson IH, et al. Treatment of psoriasis with a new spray formulation of betamethasone dipropionate 0.05%. J Drugs Dermatol. 2015;14(9):1008-1014. 3. Del Rosso JQ, Kircik L. Betamethasone dipropionate spray: a review of its use in the treatment of plaque psoriasis. J Clin Aesthet Dermatol. 2016;9(11):16-22. 4. Kircik LH. Efficacy and safety of betamethasone dipropionate spray in patients with mild to moderate plaque psoriasis. J Drugs Dermatol. 2016;15(3):334-340. 5. Wolverton SE. Comprehensive Dermatologic Drug Therapy. 4th ed. Elsevier; 2020. 6. Lexicomp Online. Betamethasone (Topical). Wolters Kluwer Clinical Drug Information; 2023.