LEVULAN KERASTICK- aminolevulinic acid hydrochloride kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Aminolevulinic Acid Hydrochloride (UNII: V35KBM8JGR) (Aminolevulinic Acid - UNII:88755TAZ87)

Available from:

DUSA Pharmaceuticals, Inc.

INN (International Name):

Aminolevulinic Acid Hydrochloride

Composition:

Aminolevulinic Acid Hydrochloride 354 mg in 1.5 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

LEVULAN KERASTICK- AMINOLEVULINIC ACID HYDROCHLORIDE
DUSA PHARMACEUTICALS, INC.
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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
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DOSAGE FORMS AND STRENGTHS
After mixture, topical solution contains 20% aminolevulinic acid
hydrochloride (ALA HCl) by weight in a plastic applicator
device. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
®
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):
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®
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