XIIDRA- lifitegrast solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIFITEGRAST (UNII: 038E5L962W) (LIFITEGRAST - UNII:038E5L962W)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

LIFITEGRAST

Composition:

LIFITEGRAST 50 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). 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)] . Risk Summary There are no available data on Xiidra use in pregnant women to inform any drug-associated risks. Intravenous (IV) administration of lifitegrast to pregnant rats, from pre-mating through gestation Day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level). Since human systemic exposure to lifitegrast following ocular administration of Xiidra at the RHOD is low, the applicability of animal

Product summary:

Xiidra (lifitegrast ophthalmic solution) 5% (50 mg/mL) is supplied in a foil pouch containing 5 low density polyethylene 0.2 mL single-use containers. Carton of 60 single-use containers          NDC 54092-606-01 Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use containers in the original foil pouch.

Authorization status:

New Drug Application

Summary of Product characteristics

XIIDRA- LIFITEGRAST SOLUTION/ DROPS
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XIIDRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XIIDRA.
XIIDRA (LIFITEGRAST OPHTHALMIC SOLUTION), FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
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 AND ADMINISTRATION
One drop twice daily in each eye (approximately 12 hours apart). (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing lifitegrast 50 mg/mL (5%). (3)
CONTRAINDICATIONS
Hypersensitivity. (4)
ADVERSE REACTIONS
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 NOVARTIS
PHARMACEUTICALS CORPORATION
AT 1-888-669-6682 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
®
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Xiidra (lifitegrast ophthalmic solution) 5% is indicated for the
treatment of the signs
and symptoms of dry eye disease (DED).
2 DOSAGE AND ADMINISTRATION
Instill one drop of Xiidra twice d