Travatan Z

Absorption: through the cornea

Peak Plasma Time: within 30 min

Metabolism: hydrolyzed by esterases in the cornea

Excretion: urinary; complete systemic elimination within 1 hr

Mechanism of Action

Prostaglandin F2-alpha analog; incr outflow of aqueous humor

Do not use this medication if you are allergic to travoprost.

Before using travoprost, tell your doctor if you are allergic to any drugs, or if you have swelling or infection of your eye.

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether travoprost is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether travoprost passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The most common adverse reaction observed in controlled clinical studies with TRAVATAN® (travoprost ophthalmic solution) 0.004% and TRAVATAN Z® (travoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus.

Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies with TRAVATAN® or TRAVATAN Z® included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing.

Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections.

In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.

Read the entire FDA prescribing information for Travatan Z (Travoprost Ophthalmic Solution)

This section provides information on the proper use of a number of products that contain travoprost. It may not be specific to Travatan Z. Please read with care.

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

Your doctor may order 2 or more eye drops to be used together. You should wait at least 5 minutes before putting another eye drop in the same eye.

Remove contact lenses before using this medicine. Wait at least 15 minutes after using this medicine before putting the contact lenses back in.

To use:

• The bottle is only partially full to provide proper drop control.
• First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 to 2 minutes to allow the medicine to cover the eye.
• Remove any excess solution around the eye with a clean tissue, being careful not to touch the eye.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For glaucoma or hypertension of the eye:
    • Adults and children 16 years of age and older—Use one drop in the affected eye once a day in the evening.
    • Children younger than 16 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• If you have an allergy to travoprost or any other part of Travatan Z (travoprost).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Travatan Z. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Have your eye pressure checked. Talk with your doctor.
• Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Travatan Z 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 Travatan Z. 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.

Review Date: October 4, 2017

The U.S. Food and Drug Administration (FDA) has approved Travatan Z (travoprost ophthalmic solution) 0.004% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications.

Travatan Z is a new formulation that eliminates benzalkonium chloride (BAK) from Alcon's existing Travatan solution and replaces BAK with SOFZIA(TM), a robust ionic buffered preservative system that is gentle to the ocular surface. Alcon developed this BAK-free version of Travatan because long-term use of topical solutions containing BAK may compromise the ocular surface and exacerbate conditions such as dry eye.

"Because almost 40 percent of glaucoma patients suffer from Ocular Surface Disease, Travatan Z is an advance in therapy which we believe will now enable doctors to address an unmet need of many glaucoma patients," said Kevin Buehler, Alcon's senior vice president, United States and chief marketing officer.

FDA approval of Travatan Z solution was based on a double-masked, multi-center study which has been accepted for publication by the Journal of Glaucoma. The 690 adult patients with open-angle glaucoma or ocular hypertension were randomized to receive Travatan or Travatan Z. Travatan Z reduced IOP up to 8.5 mmHg on average demonstrating statistically equivalent IOP lowering efficacy to the original Travatan. Similar adverse events were noted in both groups.

"These data demonstrate that Travatan Z is equally effective in reducing intraocular pressure in glaucoma patients compared to Travatan with BAK," said Rick Lewis, M.D., Grutzmacher & Lewis, Inc., Sacramento, CA, and lead investigator of this study. "However, chronic use of Travatan Z is less likely to compromise the ocular surface, potentially reducing eye irritation in glaucoma patients also suffering from ocular sensitivities."

Glaucoma, a group of diseases that can damage the eye's optic nerve, is the second leading cause of blindness worldwide. The onset of glaucoma often occurs with no symptoms, but if it remains untreated, gradual loss of peripheral vision may ensue. When diagnosed early, glaucoma can be treated with medicines, laser trabeculoplasty, conventional surgery, or a combination of therapeutic options. While remaining vision may be preserved through treatment, there is currently no cure for glaucoma and lost vision cannot be restored.

Applies to travoprost ophthalmic: ophthalmic solution

Ocular

Very common (10% or more): Ocular hyperemia (up to 50%)
Common (1% to 10%): Decreased visual acuity, eye discomfort, foreign body sensation, eye pain, eyelid pruritus, abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, tearing
Uncommon (0.1% to 1%): Corneal erosion, uveitis, iritis, anterior chamber inflammation, punctate keratitis, eye discharge, erythema of eyelid, periorbital edema, ectropion cataract, eyelid margin crusting, growth of eyelashes, eyelash discoloration, asthenopia
Rare (less than 0.1%): Iridocyclitis, eye inflammation, photopsia, eyelid eczema, conjunctival edema, halo vision, conjunctival follicles, eye hypoesthesia, meibomianitis, anterior chamber pigmentation, mydriasis, eyelash thickening, macular edema, sunken eyes
Postmarketing reports: Periorbital/lid changes (including deepening of the eyelid sulcus)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Skin hyperpigmentation (periocular), skin discoloration, abnormal hair texture, hypertrichosis
Rare (less than 0.1%): Allergic dermatitis, contact dermatitis, erythema, rash, hair color changes, madarosis
Frequency not reported: Pruritus, abnormal hair growth[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris, bradycardia, chest pain, hypertension, hypotension
Uncommon (0.1% to 1%): Palpitations
Rare (less than 0.1%): Irregular heart rate, decreased heart rate, decreased diastolic blood pressure, increased systolic blood pressure
Frequency not reported: Tachycardia[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, gastrointestinal disorder
Rare (less than 0.1%): Reactivated peptic ulcer, constipation, dry mouth
Frequency not reported: Diarrhea, abdominal pain, nausea[Ref]

Genitourinary

Common (1% to 10%): Prostate disorder, urinary incontinence, urinary tract infections
Frequency not reported: Dysuria, increased prostatic specific antigen[Ref]

Musculoskeletal

Common (1% to 10%): Arthritis, back pain
Uncommon (0.1% to 1%): Shoulder pain
Rare (less than 0.1%): Musculoskeletal pain
Frequency not reported: Arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Rare (less than 0.1%): Dysgeusia
Frequency not reported: Vertigo, tinnitus[Ref]

Respiratory

Common (1% to 10%): Bronchitis, cold/flu syndrome, sinusitis
Uncommon (0.1% to 1%): Dyspnea, asthma, nasal congestion, throat irritation
Rare (less than 0.1%): Respiratory disorder, oropharyngeal pain, cough, dysphonia
Frequency not reported: Aggravated asthma[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia[Ref]

Other

Common (1% to 10%): Pain
Uncommon (0.1% to 1%): Asthenia, malaise[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression[Ref]

Immunologic

Rare (less than 0.1%): Herpes simplex, herpetic keratitis[Ref]

General

The most commonly reported side effect was ocular hyperemia.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, seasonal allergy[Ref]

Some side effects of Travatan Z may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.