Consumer medicine information

Xiidra

Lifitegrast

BRAND INFORMATION

Brand name

Xiidra

Active ingredient

Lifitegrast

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Xiidra.

What is in this leaflet

This leaflet answers some common questions about XIIDRA.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to-date leaflet from www.novartis.com.au Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using XIIDRA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What XIIDRA is used for

XIIDRA is an eye drop containing the medicine lifitegrast.

It is used to treat moderate to severe dry eye disease in adults for whom prior use of artificial tears has not been sufficient.

Lifitegrast is a type of medicine called an ‘LFA-1 antagonist’ (LFA-1 stands for ‘lymphocyte function-associated antigen-1’)

It works by decreasing inflammation in dry eye disease.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use XIIDRA

When you must not take it

Do not use XIIDRA if you have an allergy to:

  • any medicine containing lifitegrast
  • any of the ingredients listed at the end of this leaflet.

Do not take this medicine after the expiry date printed on the carton, foil and single-dose container or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

XIIDRA should not be used in children and adolescents below 18 years old.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Your doctor can discuss with you the risks and benefits involved.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

If you have not told your doctor about any of the above, tell him/her before you start using XIIDRA.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use XIIDRA

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much to use

The recommended dose is one drop to each affected eye with a single-use container per administration, twice a day.

How to use it

Before you use XIIDRA

  • Wash your hands before each use. This is to make sure you do not contaminate your eyes.
  • If you wear contact lenses, remove them before using XIIDRA. You can put your lenses back in 15 minutes after you use XIIDRA.
  • XIIDRA comes in single-dose containers in an aluminium (foil) pouch. Do not remove the containers from the pouch until you are ready to use XIIDRA.
  • Do not let the tip of the container touch your eye or any other surfaces. This is to help stop contamination.

About the single-dose containers

Each single-dose container of XIIDRA contains enough for one dose in both of your eyes.

  • There is some extra solution in the single-dose container. This is in case you miss getting a drop into your eye.
  • After you have used the drops, throw away the single-dose container and any unused solution.
  • Do not save any unused XIIDRA.

How to use

Step 1

  • Take a foil pouch out of the XIIDRA box.
  • Open the pouch and remove the strip of single-dose containers.

  • Pull off 1 container from the strip.

Step 2

  • Put the remaining strip of containers back in the pouch.

  • Then fold the edge to close the pouch.

Step 3

  • Hold the container upright

  • Tap the top of the container until all of the solution is in the bottom part of the container.

Step 4

  • Twist off the tab to open the container.
  • Make sure that the tip of the container does not touch anything. This is to help stop contamination.

Step 5

  • Tilt your head backwards.
  • If you are not able to tilt your head, lie down.

Step 6

  • Gently pull your lower eyelid downwards, and then look up.

Step 7

  • Place the tip of the container close to your eye, but be careful not to touch your eye with it.

Step 8

  • Gently squeeze the container.
  • Let 1 drop fall into the space between your lower eyelid and your eye.
  • If the drop misses your eye, try again.

Step 9

  • Repeat steps 5 to 8 for your other eye if required.
  • There is enough XIIDRA in one container for both eyes.

After use

  • After you have applied a drop in each affected eye, throw away the opened container, including any remaining solution.
  • If you use contact lenses, wait for at least 15 minutes before placing them back in your eyes.

How long to use it

You may notice improvements 2 weeks after starting treatment with XIIDRA. It is important that you continue to use XIIDRA every day to get the full benefit of this medicine and to stop signs and symptoms of dry eye disease from returning.

If you forget to use it

If you forget to use XIIDRA, wait until your next dose as planned. Do not use double dose to make up for a forgotten dose.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Do not put any more drops in your eyes. Apply your next dose at the next regular time.

While you are using XIIDRA

Things you must do

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not use XIIDRA to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop using your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how XIIDRA affects you. Your sight may be blurred for a short time after using XIIDRA eye drops. If this happens, wait until you can see clearly before you drive, use any tools or machines.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical care immediately if you get any of the following symptoms of an allergic reaction (hypersensitivity) including:

  • wheezing or difficulty breathing
  • swollen tongue.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using XIIDRA.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Eye irritation, pain or discomfort when the drops are used
  • Temporary unpleasant taste in the mouth
  • Headache
  • Blurred vision
  • Itchy or pink eyes caused by allergic reaction
  • Increased tears when the drops are used.
  • Asthma
  • Discomfort when swallowing
  • Swelling of the face, lips, mouth or throat.
  • Skin rash

If you get any side effects that bother you, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

After using XIIDRA

Storage

Keep this medicine in the pack until it is time to use it.

Keep your eye drops in a cool dry place where the temperature stays below 25°C. After opening the foil pouch, the remaining single-dose containers should be kept in the pouch to protect them from light.

Do not store XIIDRA or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

XIIDRA is a clear, colourless to slightly coloured solution.

It is supplied in single-dose containers made of low density polyethylene (LDPE). The single-dose containers are packaged in a sealed laminate aluminium pouch.

Ingredients

Active ingredient: lifitegrast. 1 mL of XIIDRA contains 50 mg lifitegrast.

Inactive ingredients:

  • sodium chloride
  • sodium phosphate dibasic anhydrous
  • sodium thiosulfate pentahydrate
  • sodium hydroxide and/or hydrochloric acid (to adjust pH)
  • water for injection.

Sponsor

XIIDRA is supplied in Australia by:

NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1-800-671-203

This leaflet was prepared in April 2020

Australian Registration Number:
AUST R: 293589

®= Registered Trademark

(xii080420c.doc) based on PI (xii080420i.doc)

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Xiidra

Active ingredient

Lifitegrast

Schedule

S4

 

1 Name of Medicine

Lifitegrast.

2 Qualitative and Quantitative Composition

Xiidra eye drops contains lifitegrast in the concentration of 50 mg/mL (5%), solution. It is preservative-free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, solution.
Xiidra is sterile, preservative-free, clear, colourless to slightly coloured solution with a pH range of 7.0 - 8.0 and an osmolality range of 200 - 330 mOsmol/kg.

4 Clinical Particulars

4.1 Therapeutic Indications

Xiidra is indicated for the treatment of moderate to severe dry eye disease in adults for whom prior use of artificial tears has not been sufficient.

4.2 Dose and Method of Administration

Adults and elderly.

Instil one drop of Xiidra in affected eye(s) using a single-use container per administration, twice a day.

Paediatric population.

There is no relevant use of Xiidra in children and adolescents aged below 18 years old in the treatment of dry eye disease.

Method of administration.

For ophthalmic use only. The single-dose container should be used for one dose only and discarded immediately after use.
Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.

4.3 Contraindications

Xiidra is contraindicated in patients with hypersensitivity to lifitegrast or any of its excipients (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

It is recommended for prescribers to perform a comprehensive eye examination to determine the aetiology of the symptoms and treat any reversible underlying conditions that are not caused by the dry eye disease condition, prior to initiating treatment with lifitegrast.

Hypersensitivity.

Hypersensitivity reactions are possible with Xiidra. Rarely, allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with post-marketing reports for Xiidra. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

Paediatric use.

The safety and efficacy of Xiidra have not been established in paediatric patients. There have been no clinical studies in patients aged less than 18 years.

Use in the elderly.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Due to the low systemic absorption, it is unlikely that lifitegrast contributes to systemic drug interactions. No in vivo interaction studies have been performed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No human data on the effect of lifitegrast on fertility are available. In rats, IV administration of lifitegrast had no effect on male or female fertility at doses yielding systemic exposure (plasma AUC) thousands of times higher than in patients at the maximum recommended human dose.
(Category B1)
There are no or limited amount of data from the use of lifitegrast in pregnant women.
Studies in rats and rabbits, involving IV administration of lifitegrast at doses yielding systemic exposures vastly in excess of that at the maximum recommended human dose, have shown no evidence of teratogenicity or other adverse effects on embryofoetal development.
The use of Xiidra may be considered during pregnancy, if necessary.
 It is not known whether lifitegrast, or any of its metabolites, are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xiidra is administered to a breast-feeding woman.

4.7 Effects on Ability to Drive and Use Machines

Xiidra may cause some temporary blurring of vision after drops are administered, which could affect the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

In clinical studies of dry eye disease, 1401 subjects received at least 1 dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of subjects (84%) had ≤ 3 months of treatment exposure. However, 177 subjects were exposed to lifitegrast for > 6 months and 170 subjects were exposed to lifitegrast for approximately 12 months (defined as ≥ 355 days). The lifitegrast population was predominantly female (77%) and white (84%).
The incidence rates of adverse reactions listed in Table 1 below were derived from vehicle-controlled trials of up to one year duration in subjects receiving Xiidra 5% lifitegrast.
The most common ocular adverse reactions were eye irritation (18%), eye pain (12%) and instillation site reactions (12%); the majority of ocular adverse reactions were mild and transient in nature. The most common non-ocular adverse reaction was dysgeusia (14%). See Table 1.

SONATA safety study.

The safety of lifitegrast, administered twice daily, was studied in a randomised, double-masked, vehicle-controlled study in 332 subjects with dry eye disease for one year (defined as ≥ 355 days). Subjects were randomised to lifitegrast 5% or vehicle in a 2:1 ratio (lifitegrast n = 221; vehicle n = 111). After Day 14, subjects were allowed to use artificial tears, topical ophthalmic/nasal antihistamines, steroids and mast cell stabilisers. The safety profile of lifitegrast 5% over the one year period was similar to that seen in the 12-week dry eye disease studies.
Among the subjects in the one year study who responded to a question on artificial tear use, a lower proportion of subjects in the lifitegrast group used artificial tears at any time during the study: 64 out of 195 (32.8%) lifitegrast subjects compared with 43 out of 98 (43.9%) vehicle subjects.

Post-marketing surveillance.

Serious Adverse Drug Reactions from post-marketing experience for which the incidence cannot be determined (see Table 2):

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

There is no information regarding overdose in patients taking lifitegrast.
For more information on the management of overdose, contact the Poisons Information Centre telephone: 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

In vitro evaluation demonstrated that lifitegrast targets the interaction between lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes, and intercellular adhesion molecule-1 (ICAM-1), its cognate ligand. LFA-1 is a heterodimer integrin protein that mediates cell-to-cell interactions essential to immune and inflammatory response mechanisms. Its expression is restricted to leukocytes (neutrophil, eosinophil, basophil, monocyte, T and B lymphocyte), where it functions both as a key adhesion receptor and as a signal-transducing molecule.
ICAM-1 is a member of the immunoglobulin superfamily and is normally expressed in low levels on leukocytes, endothelium and epithelium. Its expression level can greatly increase in response to the presence of inflammatory cytokines. Notably, conjunctival biopsies from patients with dry eye disease (DED) exhibit significant expression of ICAM-1 compared with normal controls.
In vitro studies indicate that T-cells play a critical role in the development of DED. ICAM-1 has been shown to facilitate many T-cell dependent immune functions through its interaction with LFA-1, including adhesion of T-cells to endothelial and epithelial cells, T-cell recruitment and trafficking, proliferation, and the release of inflammatory cytokines. ICAM-1/LFA-1 interaction supports the formation of an immunological synapse between T-cells and antigen presenting cells (APC), such as dendritic cells; inducing T-cell activation and the release of cytokines that promote ocular inflammation, a substantial component of DED pathophysiology.

Clinical trials.

The effects of lifitegrast treatment on the signs and/or symptoms of DED were assessed in a total of 2247 subjects in four 12-week, randomised, multi-centre, double-masked, vehicle-controlled studies. In all studies, subjects were randomised to Xiidra 5% or vehicle in 1:1 ratio; Study 1: n = 58, 58; Study 2: n = 293, 295; Study 3: n = 358, 360; and Study 4: n = 355, 356. Study 1 also included 2 lower strengths of lifitegrast; subjects were randomised to the four groups in equal ratios. In these studies, the use of concomitant topical ophthalmic medicinal products including artificial tears, steroids and antihistamines were not permitted.
The majority of subjects were 55 years of age and older (68%), white (85%) and female (76%). Although the number of subjects in subgroup categories were low, there were no apparent differences in age or gender in response to treatment with Xiidra.
Key inclusion criteria: in all studies, subjects reported a history of dry eye in both eyes at study entry. In Studies 1 and 2, subjects were selected for enrolment after exposure to a controlled adverse environment; in Studies 3 and 4 all subjects had a history of artificial tear use and met a minimum symptom threshold (EDS ≥ 40).
Furthermore, subjects were required to have minimum sign thresholds such as Inferior Corneal Staining Score (ICSS) with fluorescein (a score of at least 2.0 on a scale of 0-4 in one eye) and non-anaesthetised Schirmer's Tear Test, STT, (between 1 and 10 mm).
Key exclusion criteria: Patients with dry eye disease not primarily attributable to aqueous deficiency were ineligible to enroll in the lifitegrast clinical trials. For example, patients using ocular or systemic medications that cause ocular drying were excluded from participating, as were patients with ocular conditions such as lid and lid margin disorders (e.g. blepharitis including staphylococcal, demodex, or seborrheic; meibomian gland disease, excessive lid laxity, floppy eyelid syndrome, ectropion, entropion); conjunctival pathology (scarring, xerosis, irradiation, alkali burns, manifestations of Stevens-Johnson syndrome, cicatrical pemphigoid, vitamin A deficiency, advanced conjunctivochalasis, allergic conjunctivitis); corneal disorders (Salzmann's nodular degeneration), disordered ocular sensation (post-LASIK or refractive surgery, postoperative status, advanced keratitis), asthenopia-related conditions, glaucoma, diabetic retinopathy, follicular conjunctivitis, iritis, uveitis, wet-exudative age-related macular, degeneration retinal vein occlusion, tinea versicolor, active ocular inflammation (unrelated to DED), recent ocular infection and/or ocular herpes.

Effects on symptoms of DED.

Eye dryness score (EDS) was rated by patients using a visual analogue scale (VAS) (0 = no discomfort, 100 = maximal discomfort) at each study visit. The average baseline EDS was between 40 and 70. A larger reduction in EDS favouring Xiidra was observed in all studies at Day 42 and Day 84, and an improvement was apparent at Day 14 in a majority of patients studied (see Figure 1).

Effects on signs of DED.

Inferior corneal staining score (ICSS) using fluorescein (0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and countable lesions, 3 = lesions too numerous to count but not coalescent, 4 = coalescent) was recorded at each study visit. The average baseline ICSS was approximately 1.8 in Studies 1 and 2 and 2.4 in Studies 3 and 4. At Day 84, a larger reduction in ICSS favouring Xiidra was observed in three of the four studies (see Figure 2).

Subgroup analysis of patients with moderate to severe dry eye disease.

Study 3 included 413 subjects (209 vehicle-treated and 204 lifitegrast-treated) with moderate to severe DED (baseline EDS ≥ 60 and ICSS > 1.5). In this subgroup, there was a difference between lifitegrast-treated subjects and vehicle-treated subjects that achieved both benchmarks of clinical significance (≥ 30% improvement in EDS and 1 point improvement in ICSS), with 40.7% vs. 25.8% for lifitegrast vs. vehicle respectively (p = 0.0014).
Study 4 included 390 subjects (195 per treatment arm) with moderate to severe DED (baseline EDS ≥ 60 and ICSS > 1.5). In this subgroup, there was a difference between lifitegrast-treated subjects and vehicle-treated subjects that achieved both benchmarks of clinical significance (≥ 30% improvement in EDS and 1 point improvement in ICSS), with 42.6% vs. 29.2% for lifitegrast vs. vehicle respectively (p = 0.0061).

5.2 Pharmacokinetic Properties

Absorption.

Tear.

When administered twice daily for 10 days, tear pharmacokinetic parameters for lifitegrast 5% were: Cmax = 91413 ± 43308 nanogram/mL, AUC0-8 hours = 127697 ± 66418 nanogram.h/mL and Tmax 0.44 ± 0.22 hours. There was no accumulation of lifitegrast in tears during twice daily and three times daily administration of lifitegrast.

Plasma.

Lifitegrast 5% solution is rapidly absorbed into the plasma with a mean Tmax of 0.09 ± 0.01 hours (approximately 5.4 minutes) when administered twice daily for 10 days. Lifitegrast is also rapidly eliminated from plasma with lifitegrast concentrations typically being measureable for only up to 30 minutes after administration. Systemic exposure to lifitegrast is extremely low with Cmax = 1.70 ±1.36 nanogram/mL and AUC0-8 hours = 0.69 ± 0.47 nanogram.h/mL when administered twice daily for 10 days; therefore lifitegrast disposition half-life (t1/2) cannot be determined accurately. The overall plasma pharmacokinetic profile demonstrated no systemic accumulation of lifitegrast when administered twice daily over 10 days.

Distribution.

Plasma protein binding by lifitegrast is high in humans (98.9%), and chiefly albumin. Systemically absorbed lifitegrast is subject to hepatic uptake via various transporters.

Metabolism.

An in vitro study in human hepatocytes indicated that lifitegrast is only minimally metabolised by CYP enzymes.

Excretion.

Excretion in rats and dogs was shown to be mostly via the faeces (as unchanged drug) and involve biliary transport. Urinary excretion was only a minor route in laboratory animals.

5.3 Preclinical Safety Data

Pharmacology.

Studies performed in vitro using a human T-cell line have demonstrated that lifitegrast inhibits T-cell adhesion to ICAM-1 with nanomolar potency, and inhibits the secretion of key inflammatory cytokines, including T-cell regulating cytokines IL-2 and IL-4 and several other cytokines associated with the clinical severity of dry eye (IL-1α, IL-1β, IL-10, IFN-γ, MIP-1α and TNF-α). Topical ocular administration of lifitegrast (≥ 0.1%) has also been shown to reduce neutrophil infiltration to the corneal stroma in a mouse model of corneal inflammation. These data suggest that by targeting the LFA-1/ICAM-1 interaction, lifitegrast reduces elevations in cytokines that have been correlated with the development and perpetuation of DED.
Ocular distribution studies in rats, rabbits and dogs showed highest levels of lifitegrast in the conjunctive and cornea following topical administration, with drug levels in posterior ocular tissues and the aqueous and vitreous humour markedly lower.
No relevant inhibition of key CYP isozymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 3A4) was observed with lifitegrast at therapeutic concentrations in vitro. Lifitegrast was identified as a substrate for the OATP1A2 and OATP2B1 transporters, and potentially OATP1B1, but not of OATP2A1, P-glycoprotein or BCRP.

Genotoxicity.

Lifitegrast was not mutagenic in bacteria in the in vitro Ames assay and was not clastogenic in the in vivo mouse micronucleus assay. An increase in chromosomal aberrations was observed with lifitegrast in an in vitro clastogenicity assay using Chinese hamster ovary cells. This occurred only at the highest concentration tested in the absence of metabolic activation, and in the context of significant cytotoxicity.

Carcinogenicity.

Systemic exposure following topical ocular administration of lifitegrast is very low, therefore, long-term animal studies have not been conducted to determine the carcinogenic potential of lifitegrast.

6 Pharmaceutical Particulars

6.1 List of Excipients

Xiidra contains the following inactive ingredients: sodium chloride, dibasic sodium phosphate, sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid (for pH adjustment) and water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

24 months from date of manufacture.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
After opening, store single-dose containers in the original aluminium pouch in order to protect from light.

6.5 Nature and Contents of Container

Xiidra is supplied in low density polyethylene (LPDE) single-use 0.2 mL ampoules, packaged in foil pouches (5 single-use ampoules per pouch). It is available in packs of 60 single-dose ampoules or 20 single-dose ampoules (sample pack).
Each single-use container contains 0.2 mL solution corresponding to 10 mg lifitegrast.

Pack size.

Pack size: 60 single-dose containers; 20 single-dose containers (sample pack).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The active ingredient, lifitegrast, is a white to off-white powder which is soluble in water.

Chemical structure.


Chemical name.

The chemical name for lifitegrast is (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4- tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl) phenyl)propanoic acid.

Formula.

C29H24Cl2N2O7S.

Molecular weight.

615.5.

CAS number.

1025967-78-5.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes