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Drug overview for XIIDRA (lifitegrast):
Generic name: LIFITEGRAST (LIF-i-TEG-rast)
Drug class: Ophthalmic - Anti-Inflammatory, Immunomodulators
Therapeutic class: Ophthalmic Agents
Lifitegrast, an integrin lymphocyte function-associated antigen-1 (LFA-1) inhibitor, is an anti-inflammatory agent.
No enhanced Uses information available for this drug.
Generic name: LIFITEGRAST (LIF-i-TEG-rast)
Drug class: Ophthalmic - Anti-Inflammatory, Immunomodulators
Therapeutic class: Ophthalmic Agents
Lifitegrast, an integrin lymphocyte function-associated antigen-1 (LFA-1) inhibitor, is an anti-inflammatory agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
XIIDRA 5% EYE DROPS
The following indications for XIIDRA (lifitegrast) have been approved by the FDA:
Indications:
Tear film insufficiency
Professional Synonyms:
Dry eyes syndrome
Indications:
Tear film insufficiency
Professional Synonyms:
Dry eyes syndrome
The following dosing information is available for XIIDRA (lifitegrast):
The recommended dosage of lifitegrast in the management of dry eye disease in adults is 1 drop of a 5% ophthalmic solution in each eye twice daily, administered approximately 12 hours apart.
Lifitegrast is applied topically to the eye as an ophthalmic solution. The ophthalmic solution is for topical ophthalmic use only. Care should be taken to avoid eye injury or contamination of the solution container.
The tip of the single-use container should not touch the eye or any other surface. Contact lenses should be removed prior to administration of lifitegrast ophthalmic solution and may be reinserted 15 minutes after administration. Single-use containers of lifitegrast ophthalmic solution should not be removed from the foil pouch until ready to use.
After removing a single-use container from the foil pouch, the remaining containers should be placed back in the pouch and the edge should be folded to close the pouch. There is a sufficient amount of lifitegrast ophthalmic solution in each single-use container for administration of 1 dose into each eye. The preservative-free solution is for single use only and any unused portion should be discarded immediately after administration.
The tip of the single-use container should not touch the eye or any other surface. Contact lenses should be removed prior to administration of lifitegrast ophthalmic solution and may be reinserted 15 minutes after administration. Single-use containers of lifitegrast ophthalmic solution should not be removed from the foil pouch until ready to use.
After removing a single-use container from the foil pouch, the remaining containers should be placed back in the pouch and the edge should be folded to close the pouch. There is a sufficient amount of lifitegrast ophthalmic solution in each single-use container for administration of 1 dose into each eye. The preservative-free solution is for single use only and any unused portion should be discarded immediately after administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| XIIDRA 5% EYE DROPS | Maintenance | Adults instill 1 drop into both eyes by ophthalmic route 2 times per day approximately 12 hours apart |
No generic dosing information available.
The following drug interaction information is available for XIIDRA (lifitegrast):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for XIIDRA (lifitegrast):
Drug contraindication overview.
Manufacturer states none known.
Manufacturer states none known.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for XIIDRA (lifitegrast):
Adverse reaction overview.
The most common adverse effects of lifitegrast ophthalmic solution (reported in 5-25% of patients) are instillation site irritation, dysgeusia, and reduced visual acuity. Other adverse effects (occurring in 1-5% of patients) include ocular effects such as blurred vision, conjunctival hyperemia, irritation, increased lacrimation, discharge, discomfort, and pruritus as well as nonocular effects such as headache and sinusitis.
The most common adverse effects of lifitegrast ophthalmic solution (reported in 5-25% of patients) are instillation site irritation, dysgeusia, and reduced visual acuity. Other adverse effects (occurring in 1-5% of patients) include ocular effects such as blurred vision, conjunctival hyperemia, irritation, increased lacrimation, discharge, discomfort, and pruritus as well as nonocular effects such as headache and sinusitis.
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acute respiratory distress syndrome Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Pharyngeal edema Tongue swelling |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dysgeusia Ocular irritation Reduced visual acuity |
Blurred vision Conjunctival hyperemia Eye tearing Headache disorder Ocular discharge Ocular itching Ocular pain Sinusitis |
| Rare/Very Rare |
|---|
|
Periorbital edema Skin rash Urticaria |
The following precautions are available for XIIDRA (lifitegrast):
Safety and efficacy of lifitegrast ophthalmic solution have not been established in pediatric patients younger than 17 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no data available regarding the use of lifitegrast ophthalmic solution in pregnant women. In pregnant rats, IV administration of lifitegrast did not result in teratogenic effects at relevant systemic exposures. In pregnant rabbits, IV administration of lifitegrast 3 mg/kg per day (400-fold human plasma exposures at the recommended ophthalmic dosage) increased incidence of omphalocele.
It is not known whether lifitegrast is distributed into human milk following topical application to the eye. There are no data available regarding lifitegrast effects on the breast-fed infant or milk production. Although systemic exposure to lifitegrast after ophthalmic administration is low, the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the infant from lifitegrast.
No overall differences in safety or efficacy have been observed between geriatric patients and younger adults.
The following prioritized warning is available for XIIDRA (lifitegrast):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for XIIDRA (lifitegrast)'s list of indications:
| Tear film insufficiency | |
| H04.12 | Dry eye syndrome |
| H04.121 | Dry eye syndrome of right lacrimal gland |
| H04.122 | Dry eye syndrome of left lacrimal gland |
| H04.123 | Dry eye syndrome of bilateral lacrimal glands |
| H04.129 | Dry eye syndrome of unspecified lacrimal gland |
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