Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Aminolevulinic Acid Hydrochloride (UNII: V35KBM8JGR) (Aminolevulinic Acid - UNII:88755TAZ87)
DUSA Pharmaceuticals, Inc.
Aminolevulinic Acid Hydrochloride
Aminolevulinic Acid Hydrochloride 354 mg in 1.5 mL
PRESCRIPTION DRUG
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with: Risk Summary Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see Clinical Pharmacology (12.3)]. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancie
The LEVULAN KERASTICK for topical solution, 20%, is supplied in packs of 6 applicators. Each LEVULAN KERASTICK applicator is for single use and consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains 354 mg of aminolevulinic acid HCl. The applicator is covered with a protective cardboard sleeve and cap. Carton of 6 LEVULAN KERASTICK for topical solution, 20% applicators 67308-101-06 Store between 20° - 25 °C (68° - 77 °F); excursions permitted to 15°- 30 °C (59° - 86 °F) [See USP Controlled Room Temperature]. The LEVULAN KERASTICK topical solution should be used immediately following preparation (dissolution). Solution application must be completed within 2 hours of preparation. An applicator that has been prepared must be discarded 2 hours after mixing (dissolving) and a new LEVULAN KERASTICK applicator used, if needed.
New Drug Application
LEVULAN KERASTICK- AMINOLEVULINIC ACID HYDROCHLORIDE DUSA PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVULAN KERASTICK SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVULAN KERASTICK. LEVULAN KERASTICK (AMINOLEVULINIC ACID HCL) FOR TOPICAL SOLUTION, 20% INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Indications and Usage (1) 03/2018 Dosage and Administration (2) 03/2018 Warning and Precautions, Irritation (5.2, 5.3) 03/2018 Warning and Precautions (5.1) 04/2018 INDICATIONS AND USAGE LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities. (1) DOSAGE AND ADMINISTRATION • • • • • • • DOSAGE FORMS AND STRENGTHS After mixture, topical solution contains 20% aminolevulinic acid hydrochloride (ALA HCl) by weight in a plastic applicator device. (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • ® ® LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provide r.(2.1) Apply the drug product to the target lesions. (2.1) Illuminate with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after the incubation time of(2.2): • • ® 14 to 18 hours for scalp or face 3 hours for upper extremities, with occlusion LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks (2.1) For topical use only. (2.1) See full prescribing information for complete dosage and administration instruction. (2) See BLU-U user manual for detailed lamp safety and operating instructions. (2.2) Cutaneous photosensitivity at wavelengths of 400-450 nm. (4) Porphyria or known allergies to porphyrins. (4) Sensitivity to Prečítajte si celý dokument