Drug Reference
Lotilaner
Other antiinfectives
Rx only
Fact box
- Therapeutic class
- Other antiinfectives
- Action class
- Ectoparasiticide
- Habit forming
- No
- Availability
- Prescription (Rx)
Brand names
CredelioXdemvy
Available as
112.5 MG · Chewable Tablet225 MG · Chewable Tablet450 MG · Chewable Tablet56.25 MG · Chewable Tablet900 MG · Chewable Tablet12 MG · Chewable Tablet48 MG · Chewable Tablet2.5 MG/ML · Ophthalmic Solution
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
1 INDICATIONS AND USAGE XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. ( 1 )
How it works
12.1 Mechanism of Action Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibition of these GABA chloride channels causes a paralytic action in the target organism leading to its death. Lotilaner is not an inhibitor of mammalian GABA mediated chloride channels when tested at up to 30 µM (18 µg/mL) in vitro (approximately 1100 times the RHOD).
How to use / dosing
2 DOSAGE AND ADMINISTRATION Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. If one dose is missed, treatment should continue with the next scheduled dose. Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. ( 2 )
Side effects
6 ADVERSE REACTIONS The most common adverse reaction was instillation site stinging and burning (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the 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. XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment. The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis.
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyUnsafe
8.1 Pregnancy Risk Summary There are no available data on XDEMVY use in pregnant women to inform any drug associated risk; however, systemic exposure to lotilaner from ocular administration is low [see Clinical Pharmacology (12.3) ] . In animal reproduction studies, lotilaner did not produce malformations at clinically relevant doses. Data Animal Data In an oral embryofetal developmental study in pregnant rats dosed during organogenesis from gestation days 6-19, increased post-implantation loss, reduced fetal pup weight, and incomplete skeletal ossification were observed at 50 mg/kg/day (approximately 1390 times the recommended human ophthalmic dose (RHOD) on a body surface area basis) in the presence of maternal toxicity (i.e., decreased body weight and food consumption). A rare malformation of situs inversus of the thoracic and abdominal viscera occurred in 1 fetus from a pregnant rat receiving 50 mg/kg/day; whether this finding was treatment-related could not be excluded. No maternal or embryofetal toxicity was observed at 18 mg/kg/day (approximately 501 times the RHOD on a body surface area basis). In an oral embryofetal development study in pregnant rabbits dosed during organogenesis from gestation days 7-19, no embryofetal toxicity or teratogenic findings were observed at 20 mg/kg/day (approximately 580-times the RHOD on an AUC basis), even in the presence of maternal toxicity (i.e., decreased food consumption and body weight). In an oral two-generation reproductive toxicity study, F0 male and female rats were administered lotilaner at doses up to 40 mg/kg/day for 10 weeks before pairing and during the 2-week pairing period (3 weeks for males). Dosing for F0 females continued through lactation day 22. F1 male and female rats were administered lotilaner at 1 and 5 mg/kg/day post-weaning from day 23 for 10 weeks before pairing and during the 2-week pairing period (3 weeks for males). Dosing for F1 parenteral females continued through lactation day 22. There were no clear adverse effects on the F1 generation, and a slightly lower mean body weight during lactation was noted for F2 pups at 5 mg/kg/day. The no observed adverse effect level (NOAEL) was determined to be 5 mg/kg/day (approximately 139 times the RHOD on a body surface area basis).
BreastfeedingConsult your doctor
…Dosing for F0 females continued through lactation day 22.…
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
5 WARNINGS AND PRECAUTIONS 5.1 Risk of Contamination Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions . 5.2 Use with Contact Lenses Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pediatric use
8.4 Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.