Xiidra

Generic name: lifitegrast ophthalmic
Drug class: Ophthalmic anti-inflammatory agents

Medically reviewed by  A Ras MD.

What is 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.

Description

ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula:

Abacavir sulfate is a white to off-white solid and is soluble in water.

ZIAGEN tablets are for oral administration. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, polysorbate 80, synthetic yellow iron oxide, titanium dioxide, and triacetin.

ZIAGEN oral solution is for oral administration. Each milliliter (1 mL) of ZIAGEN oral solution contains abacavir sulfate equivalent to 20 mg of abacavir (i.e., 20 mg per mL) as active ingredient and the following inactive ingredients: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), sorbitol solution, and water.

In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir.

Who should not take Xiidra?

Do not use Xiidra:

• If you are allergic to lifitegrast or any of the other ingredients in Xiidra, see “What are the ingredients in Xiidra?”

What should I tell my healthcare provider before taking Xiidra?

Before you use Xiidra, tell your doctor if you:

• are using any other eye drops
• wear contact lenses
• are pregnant or plan to become pregnant. It is not known if Xiidra will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Xiidra passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Xiidra.

How should I use Xiidra?

See the instructions for use that comes with Xiidra.

• Use Xiidra as your doctor tells you.
• Use one drop of Xiidra in each eye, two times each day, about 12 hours apart.
• Use Xiidra right away after opening. Throw away the single-use container and any unused solution after you have applied the dose to both eyes. Do not save any unused Xiidra for later.

What are the possible side effects of Xiidra?

The most common side effects of Xiidra include:

• eye irritation
• discomfort
• blurred vision when the drops are applied to the eyes
• an unusual taste sensation (dysgeusia)

Seek medical care immediately if you get any symptoms of wheezing, difficulty breathing, or swollen tongue.

These are not all the possible side effects of Xiidra.

Tell your doctor if you have any side effects that bother you. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Xiidra

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about Xiidra that is written for health professionals. Do not use Xiidra for a condition for which it was not prescribed. Do not give Xiidra to other people, even if they have the same symptoms you have. It may harm them.

How should I store Xiidra?

• Store Xiidra at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Xiidra in the original foil pouch to protect it from light.
• Do not open the Xiidra foil pouch until you are ready to use the eye drops.
• Return unused single-use containers to their original foil pouch to protect from excessive light exposure.

Keep Xiidra and all medicines out of the reach of children.

What are the ingredients in

Active ingredient: lifitegrast

Inactive ingredients: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid (to adjust pH).

Label

PRINCIPAL DISPLAY PANEL

• NDC 0078-0911-12
• Rx Only
• 60 Single-Use
  Containers:
  12 pouches x 5 single-use
  containers (0.2 mL each)
• xiidra®
  (lifitegrast
  ophthalmic solution) 5%
• NOVARTIS

SRC: NLM .