Travoprost

Pharmacologic Category

Ophthalmic Agent, Antiglaucoma; Prostaglandin, Ophthalmic

Dosing: Adult

Ocular hypertension/glaucoma (open-angle): Ophthalmic: Instill 1 drop into affected eye(s) once daily in the evening; do not exceed once-daily dosing (may decrease intraocular pressure-lowering effect).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; dosage adjustments are unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; dosage adjustments are unlikely due to low systemic absorption.

Dosing: Pediatric

Elevated intraocular pressure (IOP): Ophthalmic: Infants ≥2 months, Children, and Adolescents: Limited data available: 1 drop into affected eye(s) once daily in the evening (Dixon 2017; Yanovitch 2008). Note: Do not exceed once-daily dosing (may decrease IOP-lowering effect).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustments are unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustments are unlikely due to low systemic absorption.

Use: Labeled Indications

Ocular hypertension/glaucoma (open-angle): Reduction of elevated intraocular pressure in patients ≥16 years of age.

* See Uses in AHFS Essentials for additional information.

Class and Related Monographs

Ophthalmic Prostaglandin Analogues

Administration: Ophthalmic

May be used with other eye drops to lower intraocular pressure. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Remove contact lenses prior to administration and wait 15 minutes (after administration) before reinserting. Minimize contamination by not touching the eyelids or surrounding areas with the dropper tip; keep bottle tightly closed when not in use. Use eyelid closure or nasolacrimal occlusion when applying topical medications to reduce systemic absorption.

Administration: Pediatric

For ophthalmic use only. Travoprost may be used with other eye drops to lower intraocular pressure. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Apply gentle pressure to lacrimal sac immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration to decrease systemic absorption of ophthalmic drops (Urtti 1993; Zimmerman 1984). Remove contact lenses prior to administration and wait 15 minutes (after administration) before reinserting. Avoid contact of bottle tip with skin or eye; ocular solutions can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may occur from using contaminated solutions

Storage/Stability

Store between 2°C and 25°C (36°F and 77°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat glaucoma.

• It is used to lower high eye pressure.

Frequently reported side effects of this drug

• Itching

• Foreign body sensation of eye

• Eyelash changes

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Vision changes

• Eye pain

• Severe eye irritation

• Eye discharge

• Eye discoloration

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications

Hypersensitivity to travoprost or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy or women attempting to become pregnant.

Warnings/Precautions

Concerns related to adverse effects:

• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.

• Eye color changes: May change/increase brown pigmentation of the iris, the eyelid skin, and eyelashes; length and/or number of eyelashes may also be increased. Pigmentation of the iris is likely to be permanent although iris color change may not be noticeable for months to years; pigmentation of the periorbital tissue and eyelash changes may be reversible following discontinuation of therapy. Long-term consequences and potential injury to eye are not known.

• Ocular inflammation: Intraocular inflammation and exacerbation of inflammation may occur; use with caution in patients with a history of intraocular inflammation (eg, iritis/uveitis) and generally avoid use in patients with active intraocular inflammation.

Disease-related concerns:

• Aphakia or pseudoaphakia: Topical prostaglandin analogues have been associated with the occurrence/exacerbation of macular edema. Carefully examine the macula in these patients especially those with an open posterior capsule.

• Herpetic keratitis: Use with caution in patients with a history of herpes simplex keratitis; reactivation may occur. Avoid use in patients with active herpes simplex keratitis.

• Uveitis: Use cautiously in patients with intraocular inflammation as topical prostaglandins may worsen inflammation.

Special populations:

• Contact lens wearers: Remove contact lens prior to instillation; may reinsert 15 minutes following administration.

• Pediatric: Use in pediatric patients (<16 years of age) is not recommended by the manufacturer due to possible safety issues of increased pigmentation following long-term chronic use.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Evaluate the patient's or caregiver's ability to safely administer the correct dose of ophthalmic medication.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies following systemic administration. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).

Breast-Feeding Considerations

It is not known if travoprost is present in breast milk. The manufacturer recommends that caution be exercised when administering travoprost to nursing women.

Briggs' Drugs in Pregnancy & Lactation

• Travoprost Ophthalmic

Adverse Reactions

>10%: Ophthalmic: Ocular hyperemia (30% to 50%)

1% to 10%:

Cardiovascular: Angina pectoris (1% to 5%), bradycardia (1% to 5%), chest pain (1% to 5%), hypertension (1% to 5%), hypotension (1% to 5%)

Central nervous system: Foreign body sensation of eye (5% to 10%), anxiety (1% to 5%), depression (1% to 5%), headache (1% to 5%), pain (1% to 5%)

Dermatologic: Hyperpigmentation of eyelashes, increased growth in number of eyelashes

Endocrine & metabolic: Hypercholesterolemia (1% to 5%)

Gastrointestinal: Dyspepsia (1% to 5%), gastrointestinal distress (1% to 5%)

Genitourinary: Prostatic disease (1% to 5%), urinary incontinence (1% to 5%), urinary tract infection (1% to 5%)

Hypersensitivity: Hypersensitivity reaction (1% to 5%)

Infection: Infection (1% to 5%)

Neuromuscular & skeletal: Arthritis (1% to 5%), back pain (1% to 5%)

Ophthalmic: Decreased visual acuity (5% to 10%), eye discomfort (5% to 10%), eye pain (5% to 10%), eye pruritus (5% to 10%), blepharitis (1% to 4%), blurred vision (1% to 4%), cataract (1% to 4%), conjunctivitis (1% to 4%), corneal staining (1% to 4%), crusting of eyelid (1% to 4%), dry eye syndrome (1% to 4%), hyperpigmentation of eyelids (periorbital; 1% to 4%), iris discoloration (1% to 4%), keratitis (1% to 4%), lacrimation (1% to 4%), ophthalmic inflammation (1% to 4%), photophobia (1% to 4%), subconjunctival hemorrhage (1% to 4%), visual disturbance (1% to 4%), increased eyelash length, increased eyelash thickness

Respiratory: Bronchitis (1% to 5%), flu-like symptoms (1% to 5%), sinusitis (1% to 5%)

<1%, postmarketing, and/or case reports: Abdominal pain, arthralgia, asthma, bacterial keratitis (due to solution contamination), cardiac arrhythmia, chest discomfort, corneal edema, cystoid macular edema, diarrhea, dyspnea, dysuria, enophthalmos, epistaxis, erythema of skin, insomnia, iritis, macular edema, musculoskeletal pain, nausea, prostate specific antigen increase, pruritus, tachycardia, tinnitus, uveitis, vomiting

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Monitoring Parameters

Ophthalmic exams (optic nerve and visual field assessment), serial measurement of intraocular pressure (IOP). Frequency of follow up based upon whether target IOP achieved, if there is any progression of damage, and how long disease has been controlled (AAO 2019).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Travatan Z: 0.004% (2.5 mL, 5 mL) [benzalkonium free; contains cremophor el, propylene glycol]

Generic: 0.004% (2.5 mL, 5 mL)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Izba: 0.003% (2.5 mL, 5 mL) [contains propylene glycol]

Travatan Z: 0.004% (2.5 mL, 5 mL) [contains propylene glycol]

Generic: 0.004% (2.5 mL, 5 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• S01EE04

Generic Available (US)

Yes

Pricing: US

Solution (Travatan Z Ophthalmic)

0.004% (per mL): $93.11

Solution (Travoprost (BAK Free) Ophthalmic)

0.004% (per mL): $79.34 - $83.84

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

A selective FP prostanoid receptor agonist which lowers intraocular pressure by increasing trabecular meshwork and outflow

Pharmacodynamics/Kinetics

Onset of action: ~2 hours

Peak effect: 12 hours

Absorption: Absorbed via cornea; plasma levels <10 pg/mL within 1 hour

Metabolism: Hydrolyzed by esterases in the cornea to active free acid; systemically; the free acid is metabolized to inactive metabolites

Half-life elimination: 45 minutes (range: 17 to 86 minutes)

Pharmacodynamics/Kinetics: Additional Considerations

Race: The IOP-lowering effect was shown to be 7 to 8 mm Hg in clinical studies. The mean IOP reduction in African-American patients was up to 1.8 mm Hg greater than in non-African-American patients. The reason for this effect is unknown.

Local Anesthetic/Vasoconstrictor Precautions

No significant effects or complications reported

Effects on Dental Treatment

No information available to require special precautions

Effects on Bleeding

No information available to require special precautions

Pharmacotherapy Pearls

The IOP-lowering effect was shown to be 7-8 mm Hg in clinical studies. The mean IOP reduction in African-American patients was up to 1.8 mm Hg greater than in non-African-American patients. The reason for this effect is unknown.

FDA Approval Date

March 16, 2001

References

American Academy of ophthalmology PPP Glaucoma Panel, Hoskins Center for Quality Eye Care. Glaucoma summary benchmarks-2019, October 2019. Available online: https://www.aao.org/summary-benchmark-detail/glaucoma-summary-benchmarks-2019#PrimaryOpen-AngleGlaucoma(InitialEvaluation). Last accessed December 23, 2019

Center for Drug Evaluation and Research. Clinical pharmacology and biopharmaceutics review(s). US Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204822Orig1s000ClinPharmR.pdf. Published August 21, 2013. Accessed December 23, 2019.

Center for Drug Evaluation and Research. Pharmacology review. US Food and Drug Administration website.https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan_pharmr_P1.pdf. Published August 21, 2013. Accessed December 23, 2019.

Dixon ER, Landry T, Venkataraman S, et al. A 3-month safety and efficacy study of travoprost 0.004% ophthalmic solution compared with timolol in pediatric patients with glaucoma or ocular hypertension. J AAPOS. 2017;21(5):370-374.e1.[PubMed 28887006]

European Medicines Academy. Summary of product characteristics - travatan. https://www.ema.europa.eu/en/documents/product-information/travatan-epar-product-information_en.pdf Accessed December 23, 2019.

Gupta N, Aung T, Congdon, Dada R, et al. International Council of Ophthalmology guidelines for glaucoma eye care. 2017. Available online: http://www.icoph.org/downloads/ICOGlaucomaGuidelines.pdf. Last accessed December 13, 2019.

Izba (travoprost) [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; May 2014.

Izba (travoprost) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada; September 2017.

Samples JR and Meyer SM, "Use of Ophthalmic Medications in Pregnant and Nursing Women," Am J Ophthalmol, 1988, 106(5):616-23.[PubMed 2903673]

Travatan Z (travoprost) [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; September 2011.

Travatan Z (travoprost) [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; September 2017.

Travatan Z (travoprost) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; February 2019.

Travoprost ophthalmic solution [prescribing information]. Princeton, NJ: Sandoz Inc; September 2017.

Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456.[PubMed 8100087]

Yanovitch TL, Enyedi LB, Schotthoeffer EO, Freedman SF. Travoprost in children: adverse effects and intraocular pressure response. J AAPOS. 2009;13(1):91-93.[PubMed 19233013]

Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984; 102(4):551-553.[PubMed 6704011 ]

Brand Names: International

Avatan (LK); Avost (BD); Avro (BD); Fredomat (BE); Izba (BE, IE, MY, TH); Tekliva (EG); Trapost (BD); Travatan (AE, AR, AT, AU, BE, BG, BH, BO, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IS, IT, JO, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PR, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VE, VN, ZA, ZW); Travatanz (JP); Travotan (BD); Vizitrav (BE)

Last Updated 2/28/20