Xiidra

Name: Xiidra

Uses of Xiidra

Xiidra is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease (DED).

It is not known if Xiidra is safe and effective in children under 17 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Xiidra

Serious side effects have been reported with Xiidra. See the “Xiidra Precautions” section.

The most common side effects of Xiidra include:

  • eye irritation
  • eye discomfort
  • blurred vision
  • an unusual taste sensation (dysgeusia)

This is not a complete list of Xiidra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Xiidra and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Xiidra. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Xiidra Overdose

If you use too much Xiidra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Xiidra Dosage

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine is usually given as one drop in each eye twice per day (every 12 hours). Follow your doctor's dosing instructions.

Wash your hands before using the eye drops.

Do not use this medicine while wearing contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
  • Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
  • Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.
  • Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Each single-use eye drop container is for only one use in both eyes. Throw away after one use, even if there is still some medicine left in it after using the eye drops

Store the eye drop containers in their original foil pouch. Keep at room temperature away from moisture, heat, and light.

An overdose of lifitegrast ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Commonly used brand name(s)

In the U.S.

  • Xiidra

Available Dosage Forms:

  • Solution

Therapeutic Class: Ophthalmologic Agent

Consumer Information Use and Disclaimer

  • 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 Xiidra, 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 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 Xiidra. 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 Xiidra.

Review Date: October 4, 2017

Dosage Forms and Strengths

Ophthalmic solution containing lifitegrast 5% (50 mg/mL).

Contraindications

None.

Patient Counseling Information

Advise patients to read the FDA-approved patient labeling.

Handling the Single-use Container

Advise patients not to touch the tip of the single-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

Use with Contact Lenses

Advise patients that contact lenses, should be removed prior to administration of Xiidra and can be reinserted 15 minutes after administration [see Dosage and Administration (2)].

Administration

Advise patients that the solution from one single-use container is to be used immediately after opening. It can be used to dose both eyes. The single-use container, including any remaining contents should be discarded immediately after administration [see Dosage and Administration (2)].

Storage Information

Instruct patients to store single-use containers in the original foil pouch until ready to use.

How should I use Xiidra?

Use Xiidra exactly as directed by your health care provider. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Xiidra is usually given as one drop in each eye twice per day (every 12 hours). Follow your doctor's dosing instructions.

Wash your hands before using the eye drops.

Do not use Xiidra eye drops while wearing contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

To apply the Xiidra eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

  • Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

  • Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

  • Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the Xiidra eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Each single-use eye drop container is for only one use in both eyes. Throw away after one use, even if there is still some medicine left in it after using the eye drops

Store the Xiidra eye drop containers in their original foil pouch. Keep at room temperature away from moisture, heat, and light.

What other drugs will affect Xiidra?

It is not likely that other drugs you take orally or inject will have an effect on lifitegrast used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

For the Consumer

Applies to lifitegrast ophthalmic: ophthalmic solution

Along with its needed effects, lifitegrast ophthalmic (the active ingredient contained in Xiidra) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lifitegrast ophthalmic:

More common
  • Changes in vision
  • eye irritation or discomfort
Less common
  • Blurred vision
  • redness of the white part of the eyes or inside of the eyelids

Some side effects of lifitegrast ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Change in taste
  • loss of taste
Less common
  • Cough
  • discomfort or itching of the eyes
  • drainage from the eyes
  • fever
  • headache
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
  • tightness of the chest
  • troubled breathing
  • watering of the eyes

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