ALPHAGAN® 0.2%® (brimonidine tartrate ophthalmic solution)
ALPHAGAN® 0.2% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or
ocular hypertension:1
− as monotherapy in patients in whom topical beta-blocker therapy is contraindicated
− as adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single agent
ALPHAGAN® 0.2% (brimonidine ophthalmic solution)
ALPHAGAN® 0.2% offers an established tolerability profile1
The most commonly reported adverse drug reactions are oral dryness, ocular hyperemia and burning/stinging, all occurring in 22–25% of patients. They are usually transient and not commonly of a severity requiring discontinuation.1
As monotherapy:
In a pooled analysis of two 12-month RCTs, there were no serious treatment-associated adverse events in any patients treated with ALPHAGAN® 0.2% (n=466 over 12 months).*,2
With the exception of ocular allergy, dry mouth, fatigue/drowsiness, and headache, less than 1% of patients treated with ALPHAGAN® 0.2% withdrew treatment prematurely as a result of a specific adverse event in two 12-month RCTs (n=466).*,2
*Pooled results of two 12-month, multicenter, randomized, double-masked, parallel- group, active-controlled comparisons conducted in the US (40 sites), Canada (7 sites), Australia (2 sites), and Israel (2 sites). These studies included patients with POAG or OHT and compared the long-term efficacy and safety of ALPHAGAN® 0.2% twice daily (n=466) vs. timolol maleate 0.5% (n=371).2
Monotherapy is only licensed in patients in whom topical beta-blockers are contraindicated.
This list is not exhaustive, please refer to the ALPHAGAN® 0.2% Summary of Product Characteristics for additional information on adverse events and safety.
Although ALPHAGAN® 0.2% is not contraindicated in patients with cardiac or pulmonary dysfunction, caution should still be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease. In addition, upper respiratory symptoms are common adverse events, and limited data are available in bronchial asthma showing no adverse events.1,2
As adjunctive therapy:
The most commonly reported adverse reactions were oral dryness, ocular hyperemia and burning/stinging, all occurring in 22–25% of patients. They were usually transient and not commonly of a severity requiring discontinuation of treatment.1
Symptoms of ocular allergic reactions occurred in 12.7% of subjects (causing withdrawal in 11.5% of subjects) in clinical trials with onset between 3–9 months in the majority of patients. Adverse events listed as very common included, but were not limited to, headache, drowsiness, ocular irritation, blurred vision, oral dryness, and fatigue.1
*Pooled results of two 12-month, multicenter, randomized, double-masked, parallel- group, active-controlled comparisons conducted in the US (40 sites), Canada (7 sites), Australia (2 sites), and Israel (2 sites). These studies included patients with POAG or OHT and compared the long-term efficacy and safety of ALPHAGAN® 0.2% twice daily (n=466) vs. timolol maleate 0.5% (n=371).2
ALPHAGAN® 0.2% is licensed as adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single agent.1
| Organ system | Frequency | Adverse reaction |
|---|---|---|
| Nervous system disorders | Very common | headache, drowsiness |
| Common | dizziness, abnormal taste | |
| Eye disorders | Very common | ocular irritation (hyperemia, burning and stinging, pruritus, foreign body sensation, conjunctival follicles), blurred vision, allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reaction, and follicular conjunctivitis |
| Common | local irritation (eyelid hyperemia and edema, blepharitis, conjunctival edema and discharge, ocular pain and tearing), photophobia, corneal erosion and staining, ocular dryness, conjunctival blanching, abnormal vision, conjunctivitis | |
| Respiratory, thoracic, and mediastinal disorders | Common | upper respiratory symptoms |
| Gastrointestinal disorders | Very common | oral dryness |
| Common | gastrointestinal symptoms | |
| General disorders and administration site conditions | Very common | fatigue |
| Common | asthenia |
Adapted from ALPHAGAN® 0.2% Summary of Product Characteristics. 2020.1
Please refer to ALPHAGAN® 0.2% Summary of Product Characteristics for full safety information and precautions for use.
This list is not exhaustive, please refer to the ALPHAGAN® 0.2% Summary of Product Characteristics for additional information on adverse events.
Reporting of suspected adverse reactions
ALPHAGAN® 0.2% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.1
- as monotherapy in patients in whom topical beta-blocker therapy is contraindicated
- as adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single agent
The most commonly reported ADRs are oral dryness, ocular hyperemia and burning/stinging, all occurring in 22 to 25% of patients. They are usually transient and not commonly of a severity requiring discontinuation of treatment. Symptoms of ocular allergic reactions occurred in 12.7% of subjects (causing withdrawal in 11.5% of subjects) in clinical trials with the onset between 3 and 9 months in the majority of patients.1
ADR, adverse drug reaction; IOP, intraocular pressure; OAG, open-angle glaucoma; OHT, ocular hypertension; RCT, randomized
controlled trial.
1. ALPHAGAN® (brimonidine tartrate ophthalmic solution) 0.2%. Summary of Product Characteristics. 2020.
2. Katz L. Am J Ophthalmol 1999; 127: 20–26.