FAQs
Frequently Asked Questions About BEPREVE
What is the indication for BEPREVE?
How effective is BEPREVE for relief of ocular itching associated with allergic conjunctivitis?
How does BEPREVE compare in terms of cost?
Does BEPREVE contain a preservative?
Can BEPREVE be used in my patients who wear contact lenses?
What are the adverse reactions associated with BEPREVE?
Are there any contraindications?
Are there any warnings or precautions I should relay to patients?
What is the safety profile for pregnant and nursing patients?
Is BEPREVE approved for pediatric use?
What is the approved dosing for BEPREVE?
What is the indication for BEPREVE?
BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1-receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.1
Bepotastine is a topically active, direct, selective H1-receptor antagonist2 and an inhibitor of the release of histamine from mast cells.3
How effective is BEPREVE for relief of ocular itching associated with allergic conjunctivitis?
As demonstrated in clinical trials, BEPREVE provides powerful first-line therapy for even severe ocular itch.1,4 In a subset of eyes with grading 3.0 ("severe itch with desire to rub"), 3.5 ("severe itch improved with minimal rubbing"), and 4.0 ("incapacitating itch with irresistible urge to rub"), based on the conjunctival allergen challenge (CAC) scale from grade 0 to grade 4.0,5 68% of patients treated with BEPREVE (n=104) vs 3% of patients treated with placebo (n=98) experienced complete relief of ocular itch at 3 minutes.4
Additionally, an analysis of two phase 3 CAC clinical trials found that BEPREVE-treated eyes reached at least a 1.0-unit itching improvement vs baseline across all time points: 95% of eyes at 15 minutes, 90% of eyes at 8 hours after dosing (P≤0.05).6
How does BEPREVE compare in terms of cost?
The convenient 10-mL bottle minimizes the need for additional refills. Patients need just 1 prescription and have only 1 copay for 2 months of therapy. Other prescription antihistamine/mast cell stabilizers are available only in a 1 month supply. The BEPREVE 10-mL bottle provides even greater value compared to potential refill costs of QD drugs.
Does BEPREVE contain a preservative?
As with many other topical ophthalmic solutions, BEPREVE contains 0.005% (0.05 mg/mL) of the preservative benzalkonium chloride (BAK). Due to the risk of absorption of BAK into soft contact lenses, advise patients who wear contact lenses to remove them prior to instillation of BEPREVE and wait at least 10 minutes following administration to reinsert lenses.1
Can BEPREVE be used in my patients who wear contact lenses?
Yes; however, patients should be advised not to wear a contact lens if their eye is red and to consult a healthcare professional to eliminate other causes. Patients should also not use BEPREVE to treat contact lens–related irritation. Advise patients who wear contact lenses to remove them prior to instillation of BEPREVE and wait at least 10 minutes following administration to reinsert lenses.
In a 6-week safety trial of 1534 eyes, it was demonstrated that BEPREVE offers comfort equal to placebo upon instillation and
5 minutes post instillation.8 BEPREVE also did not cause dry mouth or drowsiness.7
What are the adverse reactions associated with BEPREVE?
In clinical trials, BEPREVE was safe and well tolerated.7 The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%-5% of patients were eye irritation, headache, and nasopharyngitis.1
Are there any contraindications?
There are no contraindications to using BEPREVE.1
Are there any warnings or precautions I should relay to patients?
Advise patients to avoid touching the dropper tip of the bottle to any surface in order to minimize the risk of contamination. Patients should also be told that BEPREVE should not be used to treat contact lens–related irritation. If patients wear contact lenses, advise them to remove lenses prior to instillation of BEPREVE.1
What is the safety profile for pregnant and nursing patients?
Pregnant Patients:
BEPREVE is Pregnancy Category C. Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1000 mg/kg/day. An increase in stillborns and decreased growth and development were observed in pups born from rats given oral doses of 1000 mg/kg/day during perinatal and lactation periods. There are no adequate and well-controlled studies of bepotastine besilate in pregnant women. Because animal reproduction studies are not always predictive of human response, BEPREVE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.1
Nursing Mothers:
It is not known if bepotastine besilate is excreted in human milk. Caution should be exercised when BEPREVE is administered to a nursing woman.1
Is BEPREVE approved for pediatric use?
BEPREVE is approved in patients as young as 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.1
What is the approved dosing for BEPREVE?
One drop of BEPREVE should be instilled into the affected eye(s) BID.1
BEPREVE is supplied in a white, low-density, polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in 5-mL (NDC 67425-007-50) and 10-mL sizes (NDC 67425-007-75).1
References: 1. BEPREVE [package insert]. Irvine, CA: ISTA Pharmaceuticals, Inc; 2010. 2. Kato M, Nishida A, Aga Y, et al. Pharmacokinetic and pharmacodynamic evaluation of central effect of the novel antiallergic agent betotastine besilate. Arzneimittelforschung. 1997;47(10):1116-1124. 3. Yato N, Murata T, Saito N, et al. Anti-allergic activity of betotastine besilate (TAU-284), a new anti-allergic drug. Nippon Yakurigaku Zasshi. 1997;110(1):19-29. 4. Clark JC, Williams JI, Gow JA, et al. Bepotastine besilate ophthalmic solution 1.5% rapidly eliminates ocular itching in more severely allergic subjects in the conjunctival allergen challenge model of allergic conjunctivitis. Poster presented at: Eastern Allergy Conference; May 6-9, 2010; Palm Beach, FL. 5. Abelson MB, Spitalny L. Combined analysis of two studies using the conjunctival allergen challenge model to evaluate olopatadine hydrochloride, a new ophthalmic antiallergic agent with dual activity. Am J Ophthalmol. 1998;125(6):797-804. 6. Williams JI, Schooley GL, Gow JA, McNamara TR. Bepreve™ 1.5% provides clinically meaningful reduction in allergen-induced ocular itching for subjects in an analysis of two phase 3 conjunctival allergen challenge (CAC) clinical trials [AAAAI abstract 151]. J Allergy Clin Immunol. 2010;125(2)(suppl 1):AB38. 7. Data on file. ISTA Pharmaceuticals, Inc. 8. Data on file. ISTA Pharmaceuticals, Inc.
IMPORTANT SAFETY INFORMATION: BEPREVE is for topical ophthalmic use only. To minimize risk of contamination, do not touch the dropper tip to any surface. Keep the bottle closed when not in use. BEPREVE should not be used to treat contact lens–related irritation. Remove contact lenses prior to instillation of BEPREVE. The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%-5% of patients were eye irritation, headache, and nasopharyngitis.
For Patients
For Health Care Professionals