Xiidra 50 mg/mL
Lifitegrast · SOLUTION/ DROPS · Novartis Pharmaceuticals Corporation
Xiidra is a solution/ drops containing lifitegrast at 50 mg/mL, taken ophthalmic. Manufactured by Novartis Pharmaceuticals Corporation.
Key Facts
- Brand Name
- Xiidra
- Generic Name
- Lifitegrast
- NDC Code (Product)
0078-0911- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 50 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA208073
- Drug Class
- Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]
- Marketing Start
- 07/11/2016
Recall History
Novartis Pharmaceuticals Corporation
Failed Impurities/Degradation Specifications.
Novartis Pharmaceuticals Corporation
Failed Impurities/Degradation Specifications.
Novartis Pharmaceuticals Corporation
Failed Impurities/Degradation Specifications.
Novartis Pharmaceuticals Corporation
Failed Impurities/Degradation Specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container. Discard the single‑use container immediately after using in each eye. Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration. One drop twice daily in each eye (approximately 12 hours apart). ( 2 )
Contraindications
4 CONTRAINDICATIONS Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see Adverse Reactions (6.2) ]. Hypersensitivity. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] The most common adverse reactions (incidence 5%-25%) following the use of Xiidra were instillation-site irritation, dysgeusia, and decreased visual acuity ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In five clinical trials of DED conducted with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had less than or equal to 3 months of treatment exposure. One hundred-seventy patients were exposed to lifitegrast for approximately 12 months. The majority of the treated patients were female (77%). The most common adverse reactions reported in 5%-25%…
Frequently Asked Questions
What is Xiidra used for?
Xiidra contains Lifitegrast. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Xiidra a controlled substance?
Xiidra is not classified as a controlled substance by the DEA.
What is the generic name for Xiidra?
The generic name for Xiidra is Lifitegrast. There are 1 other brand versions of Lifitegrast.
What is the NDC code for Xiidra 50 mg/mL?
The NDC (National Drug Code) for Xiidra 50 mg/mL is 0078-0911, listed by Novartis Pharmaceuticals Corporation.