Xiidra (lifitegrast)

Drugs

What is Xiidra?

Xiidra (lifitegrast) is a brand-name prescription medication that’s used to treat dry eye disease. With this condition, your body doesn’t make enough tears, or the tears it does make don’t keep your eyes lubricated (moist).

Xiidra comes as a liquid solution that’s used as eye drops. Xiidra is approved for use in people ages 17 years and older.

Clinical studies looked at how effective Xiidra is at reducing symptoms of dry eye disease. In the studies, people were asked to rate their eye discomfort with something called the eye dryness score (EDS). They scored their symptoms before and after using the drug. Their scores ranged from zero to 100, with zero being no discomfort and 100 being the highest level of discomfort.

Four studies took place, each lasting 12 weeks. At the end of the studies, people using Xiidra had lower EDS by up to 12.3 points than people who received a placebo (treatment with no active drug). This means that people using Xiidra had fewer dry eye symptoms than people using the placebo.

Xiidra generic

Xiidra is available only as a brand-name medication. It’s not currently available in generic form.

Xiidra contains the drug lifitegrast.


Xiidra side effects

Xiidra can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Xiidra. This list does not include all possible side effects.

To learn more about the possible side effects of Xiidra, or how to manage them, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Xiidra can include:

  • blurry vision
  • headache
  • eye irritation
  • itchy eyes
  • metallic taste in mouth (dysgeusia)
  • redness of the eyes
  • sinus infection (sinusitis)
  • watery eyes

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

In clinical studies of Xiidra, no serious side effects caused by Xiidra were reported. However, since the clinical studies took place, some people have reported allergic reactions to Xiidra (see “Allergic reaction” in the “Side effect details” section below).

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on certain side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Xiidra. In clinical studies of Xiidra, no allergic reactions were reported. However, since the clinical studies took place, some people have reported allergic reactions to Xiidra. It isn’t known how often these reactions occur.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • swelling of your tongue, mouth, or throat
  • trouble breathing
  • hives (raised welts on the skin)

Call your doctor right away if you have a severe allergic reaction to Xiidra. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Sinusitis

During clinical studies, about 1 to 5 percent of people using Xiidra had sinusitis. This condition is caused by an infection inside your sinuses (areas behind you nose, cheeks, and forehead). Symptoms of sinusitis can include:

  • yellow or green nasal mucus
  • runny nose
  • cough
  • nasal congestion
  • toothache
  • fever
  • headache
  • pain behind the cheeks and forehead (areas of the sinuses)

If you have symptoms of a sinus infection, call your doctor. You may need treatment with over-the-counter or prescription medication to keep the infection from worsening.

Burning eyes

During clinical studies, up to 25 percent of people using Xiidra had eye irritation. This can happen when first applying the drops into your eyes, but it usually resolves after a few seconds. Eye irritation can cause the following symptoms in the eyes:

  • burning
  • dryness
  • grittiness (feeling like sand is in your eyes)
  • itching

If you have eye irritation that does not go away or worsens while using Xiidra, talk with your doctor. They may recommend that you stop using Xiidra or switch to a different drug.

Headache

Xiidra can cause headaches in people using the drug. During clinical studies, headache occurred in 1 to 5 percent of people using Xiidra.

If you have new or worsening headaches while using Xiidra, talk with your doctor. They may recommend that you stop using Xiidra or switch to a different drug.

Blurred vision

During clinical studies, Xiidra was shown to cause blurred vision in 1 to 5 percent of people using the drug.

Let your doctor know if you have any vision changes (including blurred vision) while using Xiidra. They may recommend that you stop using Xiidra or switch to a different drug.

Itchy eyes

Using Xiidra may cause itchy eyes in some people. During clinical studies, about 1 to 5 percent of people using the drug had itchy eyes.

If you have eye itchiness that doesn’t go away or worsens while using Xiidra, talk with your doctor. They may recommend that you stop using Xiidra or switch to a different drug.

Dry mouth (not a side effect)

In clinical studies, dry mouth was not a side effect in people using Xiidra. Dry mouth can be caused by certain diseases or conditions that Xiidra is often used to treat.

However, up to 5 percent of people in clinical studies had dysgeusia. This condition, which is also called parageusia, causes people to have a metallic or salty taste in their mouth.

If you have changes in taste while using Xiidra, talk with your doctor about ways to help improve the condition.

Xiidra cost

As with all medications, the cost of Xiidra can vary. To find current prices for Xiidra in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance coverage, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Xiidra, or if you need help understanding your insurance coverage, help is available.

Shire US Inc., the manufacturer of Xiidra, offers a program called Xiidra iinsider Savings. For more information and to find out if you’re eligible for support, call 844-694-4747 or visit the program website.


Alternatives to Xiidra

Other drugs are available to treat dry eye disease. Some drugs may be better suited for you than others. If you’re interested in finding an alternative to Xiidra, talk with your doctor to learn more about other medications that may work well for you.

Some treatment options for dry eyes are available over the counter (OTC). Such products are often called eye lubricants or artificial tears. These OTC medications can come in different formulations.

Examples of OTC treatments include:

  • eye drops (Refresh Plus, HypoTears, Systane Complete)
  • eye gels (Systane Gel, Refresh Liquigel)
  • eye ointments (Refresh Lacri-Lube, Sooth Night Time, Systane Nighttime)

Other prescription drugs are also available to treat dry eye disease or other conditions that cause dry eyes. These may also be given as eye drops. Examples of prescription treatments include:

  • eye drops specifically for dry eyes
    • cyclosporine (Restasis)
  • eye drops for burning (inflamed) or itchy eyes
    • azelastine (Optivar)
    • cromolyn (Crolom)
    • ketorolac (Acular)
    • loteprednol (Alrex, Lotemax)
    • prednisolone (Pred Forte, Pred Mild)


Xiidra vs. Restasis

You may wonder how Xiidra compares to Restasis to treat dry eye disease. Here we look at how Xiidra and Restasis are alike and different.

Xiidra contains the drug lifitegrast. Restasis contains the drug cyclosporine. Both drugs are prescription medications.

Uses

Both Xiidra and Restasis are FDA-approved to treat dry eye disease. This condition happens when your body doesn’t make enough tears, or the tears it does make don’t keep your eyes lubricated (moist).

It is not known for sure how these drugs work to treat dry eye disease. Both drugs bind (attach) to certain proteins in the body, which helps reduce inflammation. The symptoms of dry eye disease can be caused by inflammation in the eyes. Xiidra and Restasis may treat dry eye disease by reducing inflammation.

Xiidra and Restasis can be used together, or in combination with other medications to treat dry eye disease. Your doctor will help you decide which drugs are best for treating your condition.

Drug forms and administration

Xiidra comes as a preservative-free liquid solution that’s used as eye drops. It’s packaged in single-dose containers. Xiidra is available in one dosage strength: 5 percent solution.

Restasis comes as a liquid emulsion (oily liquid mixture) that’s used as eye drops. It’s packaged in single-dose containers and also in larger multiple-dose bottles. Restasis is available in one dosage strength: 0.05 percent liquid emulsion.

Both Xiidra and Restasis should be given as one drop in each eye, twice per day. Doses should be taken about 12 hours apart.

Side effects and risks

Xiidra and Restasis contain similar drugs. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Xiidra, with Restasis, or with both drugs (when taken individually).

  • Can occur with Xiidra:
    • headache
    • metallic taste in mouth (dysgeusia)
    • sinus infection (sinusitis)
  • Can occur with Restasis:
    • watery eyes
    • eye pain
    • grittiness in the eyes (feeling of sand in your eyes)
  • Can occur with both Xiidra and Restasis:
    • redness in your eyes
    • blurry vision
    • burning eyes

Serious side effects

The primary serious side effect that can occur with either Xiidra or Restasis is a severe allergic reaction.

Effectiveness

Xiidra and Restasis haven’t been directly compared in clinical studies. But individual studies have shown that both Xiidra and Restasis are effective for treating dry eye disease.

Clinical studies looked at how effective Xiidra is at treating and reducing symptoms of dry eye disease. In the studies, people were asked to rate their eye discomfort with something called the eye dryness score (EDS). They scored their symptoms before and after using the drug. Their scores ranged from zero to 100, with zero being no discomfort and 100 being the highest level of discomfort.

Four studies took place, each lasting 12 weeks. At the end of the studies, people using Xiidra had lowered their EDS by up to 12.3 points compared to people who received a placebo (treatment with no active drug). This means that people using Xiidra had fewer dry eye symptoms than people using the placebo.

Clinical studies have also looked at how effective Restasis is at treating dry eye disease. In these studies, Restasis was compared to a placebo (medication with no active drug). After six months of treatment, people were evaluated using the Schirmer’s test. This test measures how much lubrication or how many tears your eyes make. Four different studies took place, each lasting 6 months.

Study researchers set a treatment goal to measure how well Restasis and the placebo treated dry eye symptoms. The goal was set at being able to measure 10 mm of wetness in the eyes. After treatment, about 15 percent of people using Restasis met this goal. Only 5 percent of people using the placebo met the goal.

Costs

Xiidra and Restasis are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generic medications.

According to estimates on GoodRx.com, Xiidra costs a little less than Restasis costs. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Xiidra dosage

Xiidra is used to treat dry eye disease. The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Xiidra comes as a liquid solution that’s used as eye drops. It’s packaged in single-dose containers. Each container holds 0.2 mL of solution. Xiidra is available in one dosage strength: 5 percent solution.

Dosage for dry eyes

Xiidra should be given as one drop in each eye, twice per day. Doses should be taken about 12 hours apart. Each single-dose container of Xiidra should have enough medication to treat both eyes one time.

If you have solution left over after you’ve used your dose, you should dispose of it. It’s best to use a new single-dose container for each dose.

What if I miss a dose?

If you miss a dose of Xiidra and it’s several hours before your next scheduled dose, use the medication as soon as you remember. But if it’s almost time for your next scheduled dose, just skip the missed dose. You can continue with your next scheduled dose.

You should use Xiidra as prescribed by your doctor. If you have questions about your dose of Xiidra, talk with your doctor.

Will I need to use this drug long term?

When used regularly, Xiidra helps to improve symptoms of dry eye disease. If your dry eye symptoms improve with Xiidra, you may wish to use the medication long term. Your doctor will help you decide if long-term treatment with Xiidra is right for you.

Xiidra for dry eyes

The Food and Drug Administration (FDA) approves prescription drugs such as Xiidra to treat certain conditions.

Xiidra is FDA-approved to treat dry eye disease. With this condition, your body doesn’t make enough tears, or the tears it does make don’t keep your eyes lubricated (moist).

Symptoms of dry eyes can include:

  • itchy eyes
  • redness of eyes
  • burning sensation in your eyes
  • watery eyes
  • blurry vision

Xiidra for children

Xiidra is approved for use in people ages 17 years and older. It hasn’t been confirmed that Xiidra is safe or effective for use in children younger than 17 years.


Xiidra and alcohol

There aren’t any known interactions between alcohol and Xiidra. If you have concerns about drinking alcohol while using Xiidra, talk with your doctor.


Xiidra interactions

Xiidra hasn’t been shown to interact with other medications. However, it’s still important to discuss any prescription medications you take with your doctor and pharmacist before you start treatment with Xiidra.

You should also tell them about any vitamins, supplements, and over-the-counter (OTC) medications you take. Also, don’t forget to mention other topical eye treatments you might be using, such as OTC eye drops.

How Xiidra works

It’s not known for sure how Xiidra works to treat dry eye disease. Xiidra contains the drug lifitegrast, which binds to certain proteins in the body and reduces inflammation. Symptoms of dry eye disease can be caused by inflammation in the eyes.

Xiidra may help improve symptoms of dry eye disease by reducing inflammation. Symptoms of dry eye disease include:

  • itchy eyes
  • redness of eyes
  • burning sensation in the eyes
  • watery eyes
  • blurry vision

How long does it take to work?

After you start taking Xiidra, it will likely take a few weeks for you to notice improvements in your dry eyes. In clinical studies, Xiidra began improving symptoms of dry eye disease in some people after just two weeks of treatment.


Instructions for use of Xiidra

Xiidra is a prescription drug that’s used to treat dry eye disease. It comes as eye drops. It’s packaged in single-dose containers, which hold enough medication for one dose (one drop in each eye).

Below are some basic instructions on how to use Xiidra eye drops. For more information, including a video on how to use Xiidra, visit the manufacturer’s website.

If you wear contact lenses, you’ll need to remove your contacts before using Xiidra. After you’ve used the eye drops, you should wait at least 15 minutes before placing your contacts back into your eyes.

Always be sure to take Xiidra according to your doctor’s instructions.

How to administer

  1. Take a foil pouch from your Xiidra box and open it. Detach one of the single-dose containers from the row of bottles inside the pouch.
  2. Place the remaining containers back into the foil pouch. Fold the foil pouch closed and return it to the medication box.
  3. Hold the single-dose container upright. Tap the top of the container so that all of the liquid solution runs to the bottom of the container.
  4. Open the container by twisting off the top. Make sure the tip of the container does not touch anything. (This will help keep the eye drops free of germs or small particles such as dust.)
  5. Tilt your head backward. If you can’t tilt your head, try lying down or reclining.
  6. Carefully pull your lower eyelid down toward your cheekbone and look up toward your forehead.
  7. Place the tip of the container close to your eye. Be sure to keep it from touching your eye.
  8. Gently squeeze the container and let one drop of liquid solution fall into your eye. If the drop missed your eye, you can it try again.
  9. Repeat steps 5 through 8 for your other eye. You’ll have enough solution in one container to treat both eyes.
  10. After you’ve treated both eyes, throw away the container and any leftover Xiidra solution.

When to take

You can use Xiidra anytime. It doesn’t matter what time of day or night you treat your eyes. But you should try to make sure your doses are spaced about 12 hours apart. You’ll use Xiidra twice each day.

Xiidra and pregnancy

There haven’t been any studies in humans that show whether it’s safe to take Xiidra during pregnancy. Animal studies have shown birth defects in offspring when Xiidra was given to pregnant mothers. In these studies, Xiidra was given by IV (intravenous) infusion. This isn’t how Xiidra is given to humans. Keep in mind that animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor about the risks and benefits of using Xiidra during pregnancy.

Xiidra and breastfeeding

It’s not known if Xiidra is passed into human breast milk. Talk with your doctor if you plan to breastfeed while using Xiidra. They’ll help you decide if this is a healthy choice for you and your child.


Common questions about Xiidra

Here are answers to some frequently asked questions about Xiidra.

Can I use artificial tears with Xiidra?

Yes, you can use artificial tears with Xiidra. Artificial tears are available over the counter at most drug stores. But always check with your doctor before using other medications with Xiidra to treat your condition.

Does Xiidra cause hair loss?

Xiidra hasn’t been shown to cause hair loss or affect the growth of eyelashes in people using the drug. Talk to your doctor if you’re concerned about hair loss while using this medication.

Can I use Xiidra if I wear contact lenses?

Yes, you can use Xiidra if you wear contact lenses. You’ll want to be sure to remove your contacts before placing Xiidra solution in your eyes. After using Xiidra, you’ll need to wait at least 15 minutes before putting your contacts back into your eyes.

You can see detailed instructions on how to use Xiidra in the “Instructions for use of Xiidra” section above. You can also visit the manufacturer’s website for more helpful information about using Xiidra eye drops.

Do I use one dose package for each eye?

You’ll only need to use one single-dose bottle of Xiidra for each dose. This will be enough medication to treat both eyes (one drop in each eye).

You might have a little bit of medication left over. If you do, it’s best to throw the extra solution away. Don’t save it for your next dose. You should start with a new single-dose container for each dose of Xiidra.

Xiidra expiration, storage, and disposal

When you get Xiidra from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Xiidra single-dose containers should be stored in the foil pouch they were packaged in. After opening a foil pouch, fold over the top and keep it closed. This will help keep the rest of the single-dose containers fresh. This medication should be stored at room temperature, which is about 68°F to 77°F (20°C to 25°C).

Disposal

If you no longer need to take Xiidra and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Professional information for Xiidra

The following information is provided for clinicians and other healthcare professionals.

Indications

Xiidra is FDA-approved for the treatment of dry eye disease.

Mechanism of action

The exact mechanism of action of Xiidra is unknown. Xiidra binds to integrin lymphocyte function-associated antigen-1 (LFA-1). This antigen is a cell surface protein found on leukocytes. Xiidra blocks LFA-1 from interacting with cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in people with dry eye disease.

Xiidra has been shown to reduce inflammation by inhibiting T cell adhesion and secretion of inflammatory cytokines in human peripheral blood mononuclear cells.

Pharmacokinetics and metabolism

The plasma trough concentration for most patients using Xiidra was undetectable by assays (0.05 ng/mL limit). In patients whose results were quantifiable, the plasma trough concentration range was 0.55 ng/mL to 3.74 ng/mL.

Xiidra has an osmolality range of 200 to 300 mOsmol/kg. The pH of Xiidra is 7.0 to 8.0. Xiidra is soluble in water. The molecular weight of Xiidra is 615.5 gm/mol.

Contraindications

Xiidra is contraindicated in patients with a known hypersensitivity to lifitegrast or other ingredients within the formulation.

Storage

Xiidra should be stored in its foil packaging at room temperature, between 68°F and 77°F (20°C and 25°C).

Disclaimer: MedicalNewsToday has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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