BRIMONIDINE GEL,TOP
Clinical Criteria Summary
Patient Demographics & Diagnosis
- Adult 18 years and older
- Diagnosis of facial rosacea
- Moderate to severe, persistent (nontransient) facial erythema of rosacea (erythematotelangiectatic [ET] rosacea)
- Not more than two facial inflammatory lesions of rosacea
- OR: 3 or more facial inflammatory lesions of rosacea (papulopustular rosacea) in addition to ET rosacea
Exclusion Criteria
- Patients at risk for serious harm from vascular insufficiency, including those with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome
- Patients at risk for serious harm from decrease in blood pressure, such as those with severe, unstable, or uncontrolled cardiovascular disease
- Hypersensitivity to brimonidine tartrate, phenoxyethanol (preservative), or other gel ingredients
Inclusion Criteria
- Inadequate response, intolerance, or contraindication to nonpharmacologic approaches for rosacea (avoidance of triggers of flushing, proper use of sun protection, and use of skin care products for sensitive skin)
- If patient has 3 or more facial inflammatory lesions of rosacea (papulopustular rosacea) in addition to ET rosacea: Documentation of inadequate response, intolerance, or contraindication to a 4-week regimen of:
- Topical metronidazole (0.75% or 1% cream, gel or lotion) or topical azelaic acid (15% gel or 20% cream)
- AND Oral doxycycline (20 to 100 mg twice daily), minocycline (50 to 100 mg twice daily), or tetracycline (250 to 500 mg twice daily)
- Patient must be receiving VA care/consultation and the initial prescription must be from a dermatologist or other locally designated provider
Monitoring & Response Assessment
- High-quality photos should be taken before starting therapy to make an objective assessment of effectiveness (if possible)
- Therapy should be discontinued if there is no clinically meaningful benefit
- Prescriptions may be renewed only if there is documentation that the patient experienced a clinically meaningful benefit after 2 weeks of treatment
Safety, Warnings, & Precautions
- Avoid application to eyes, lips, irritated skin, or open wounds; wash hands immediately after applying
- Not for oral, ophthalmic, or intravaginal use
- Use caution with antihypertensives/cardiac glycosides (alpha-2 agonists may reduce blood pressure)
- Consider potential additive/potentiating effects with CNS depressants (e.g., alcohol, anesthetics, barbiturates, opioids, sedatives)
- Use caution with monoamine oxidase inhibitors (may theoretically impair metabolism and potentially result in increased systemic adverse effects such as hypotension)
- Pregnancy Category B: Use only if potential benefit justifies potential risk to the fetus
- Nursing Mothers: Potential for serious adverse effects in nursing infants; help patient decide whether to discontinue nursing or brimonidine gel
- Geriatric Use: Insufficient data to determine whether patients aged 65 and over respond differently
Prescription Authorization & Limits
- Initial prescriptions limited to one 30-gram tube without refill
- Subsequent prescriptions may be written for larger quantities with refills if medication is effective and tolerated