VERKAZIA- cyclosporine emulsion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Tilgjengelig fra:

Santen Incorporated

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. None Risk Summary There are no adequate and well-controlled studies of Verkazia administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data ] . Data Animal Data Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 320 and 2150 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.015 mg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to

Produkt oppsummering:

Verkazia (cyclosporine ophthalmic emulsion) 0.1% is packaged in low-density polyethylene single-dose vials. Each vial contains 0.3 mL fill; 5 vials are packaged in an aluminum pouch; 24 pouches are packaged in a box of 120 vials. The entire contents of each box of 120 vials must be dispensed intact. 120 Single-Dose Vials 0.3 mL each — NDC 65086-001-12 Storage: Do not freeze Verkazia. Store at 20°C to 25°C (68°F to 77°F). After opening the aluminum pouch, the single-dose vial should be kept in the pouch to protect from light and avoid evaporation. Any opened individual single-dose vial with any remaining emulsion should be discarded immediately after use.

Autorisasjon status:

New Drug Application

Preparatomtale

VERKAZIA- CYCLOSPORINE EMULSION
SANTEN INCORPORATED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERKAZIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERKAZIA.
VERKAZIA® (CYCLOSPORINE OPHTHALMIC EMULSION) 0.1%,
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Verkazia ophthalmic emulsion is a calcineurin inhibitor
immunosuppressant indicated for the treatment of
vernal keratoconjunctivitis in children and adults ( 1)
DOSAGE AND ADMINISTRATION
Instill one drop of Verkazia, 4 times daily (morning, noon, afternoon,
and evening) in each affected eye ( 2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic emulsion: 0.1% (1 mg/mL) cyclosporine ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
To avoid the potential for eye injury and contamination, advise
patient not to touch the vial tip to the eye
or other surfaces ( 5.1)
ADVERSE REACTIONS
The most common adverse reactions following the use of Verkazia were
eye pain (12%) and eye pruritus
(8%) ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANTEN AT
1-855-7-SANTEN (855-772-
6836) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA‑APPROVED PATIENT
LABELING.
REVISED: 6/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Recommended Dosage and Dose Administration
3 DOSAGE FORM AND STRENGTH
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Potential for Eye Injury and Contamination
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
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
*
FULL PRESCRIBING INFORMATION