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Levulan Kerastick

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Last Updated: 03 November 2020

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General | Latest Info

LEVULAN KERASTICK is a photosensitizing agent USE to treat warty overgrowths of skin on SUN-expose areas of the face and scalp. Treatment involves application of LEVULAN, followed 14 to 18 hours later by exposure to special Blue Light that causes treated skin cells to die and slough off. Serious side effects of LEVULAN KERASTICK are unlikely. You may experience: tingling, stinging, prickling, itching, swelling, or burning of area treated with LEVULAN during Light treatment. These side effects should improve at the end of Light treatment. Following treatment, you will experience temporary redness, swelling, and scaling of lesions and surrounding skin. These side effects should be completely resolved by 4 weeks after treatment. LEVULAN KERASTICK Dose is determined by a physician and is administered in a medical setting. LEVULAN may interact with griseofulvin, oral diabetes medicines, phenothiazines, sulfa drugs, antibiotics, or diuretics. Tell your doctor all the medications you USE. During pregnancy, LEVULAN should be USE ONLY if prescribe. It is unknown if this drug pass into breast milk. Consult your doctor before breastfeeding. Our LEVULAN KERASTICK side Effects Drug Center provides a comprehensive view of available Drug Information on potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor FOR medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Get emergency medical help if you have signs of allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe stinging or burning that last longer than 4 weeks. Pain, burning, redness, or swelling of treated skin; itching, stinging, tingling, or prickly feeling; scaling or crusting of skin; headache; chills; or puffy eyelids. This is not a complete list of side effects and others may occur. Call your doctor FOR medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Read the entire detailed patient monograph FOR LEVULAN KERASTICK

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

DOSAGE AND ADMINISTRATION

TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy

LEVULAN KERASTICK topical solution applicationTime window 1 for Blue Light Illumination for face or scalpTime window 2 for Blue Light Illumination for upper extremities
6 am8 pm to Midnight9 am
7 am9 pm to 1 am10 am
8 am10 pm to 2 am11 am
9 am11 pm to 3 am12 Noon
10 amMidnight to 4 am1 pm
11 am1 am to 5 am2 pm
12 pm2 am to 6 am3 pm
1 pm3 am to 7 am4 pm
2 pm4 am to 8 am5 pm
3 pm5 am to 9 am6 pm
4 pm6 am to 10 am7 pm
5 pm7 am to 11 am8 pm
6 pm8 am to Noon9 pm
7 pm9 am to 1 pm10 pm
8 pm10 am to 2 pm11 pm
9 pm11 am to 3 pm12 Midnight
10 pmNoon to 4 pm1 am

Apply Topical Solution to Lesions on Scalp or Face; multiple lesions can be treated within the treatment region, but multiple treatment regions should not be treated simultaneously. Application is then followed by photoactivation via Blue Light illumination 14 to 18 hours later. The Recommended frequency is 1 application of Solution and 1 dose of illumination per Treatment region per 8-week Treatment session. Treated Lesions that are not completely resolved after 8 weeks may be treated second time. NOTE: LEVULAN KERASTICK for Topical Solution is not intended for use with any device other than BLU-U Blue Light Photodynamic Illuminator. Apply approximate 1 mm thick layer of Topical Gel to Lesions on Scalp or face, and to 5 mm of surrounding skin. The maximum dose to be applied with each treatment is 20 cm2 or 2 grams of drug. Cover gel with light-blocking occlusive dressing for 3 hours. After 3 hours, remove dressing and any excess gel. Immediately initiate photoactivation via BF-RhodoLED red Light illumination. Patients may undergo retreatment for lesions that DO not completely resolve after 3 months. Apply Topical Solution to Lesions on Upper Extremities; multiple Lesions can be treated within the treatment region, but multiple treatment regions should not be treated simultaneously. Application is then followed by photoactivation via Blue Light illumination 3 hours later. The Recommended frequency is 1 application of Solution and 1 dose of illumination per Treatment region per 8-week Treatment session. Treated Lesions that are not completely resolved after 8 weeks may be treated second time. NOTE: LEVULAN KERASTICK for Topical Solution is not intended for use with any device other than BLU-U Blue Light Photodynamic Illuminator. Various studies describe use of Topical cream or lotion formulations of aminolevulinic acid and exposure to various light sources in treatment of basal cell carcinoma, squamous cell carcinoma and Bowen disease. In one study, 5-aminolevulinic acid 20 % lotion was applied to various non-melanoma skin cancers. Twelve hours later, tumors were exposed to red and infrared irradiation. Complete responses were NOTE in 8084 % of patients with superficial or nodular basal cell carcinoma or superficial squamous cell carcinoma.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

HOW SUPPLIED

TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy

LEVULAN KERASTICK topical solution applicationTime window 1 for Blue Light Illumination for face or scalpTime window 2 for Blue Light Illumination for upper extremities
6 am8 pm to Midnight9 am
7 am9 pm to 1 am10 am
8 am10 pm to 2 am11 am
9 am11 pm to 3 am12 Noon
10 amMidnight to 4 am1 pm
11 am1 am to 5 am2 pm
12 pm2 am to 6 am3 pm
1 pm3 am to 7 am4 pm
2 pm4 am to 8 am5 pm
3 pm5 am to 9 am6 pm
4 pm6 am to 10 am7 pm
5 pm7 am to 11 am8 pm
6 pm8 am to Noon9 pm
7 pm9 am to 1 pm10 pm
8 pm10 am to 2 pm11 pm
9 pm11 am to 3 pm12 Midnight
10 pmNoon to 4 pm1 am

LEVULAN KERASTICK For Topical Solution, 20 %, contains hydrochloride salt of aminolevulinic Acid, endogenous 5-carbon aminoketone. Aminolevulinic Acid HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil. The chemical name for ALA HCl is 5-amino-4oxopentanoic Acid hydrochloride. The structural formula is represented below: LEVULAN KERASTICK For Topical Solution applicator is a two component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1. 5 mL of Solution vehicle comprises alcohol USP, water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of ALA HCl as dry solid. The applicator tube is enclose in protective cardboard sleeve and cap. 20 % Topical Solution is prepared just prior to time of use by breaking ampules and mixing contents by shaking the LEVULAN KERASTICK applicator. The term ALA HCl refers to unformulated active ingredient, LEVULAN KERASTICK For Topical Solution refers to drug product in its unmixed state, LEVULAN KERASTICK Topical Solution refers to mixed drug product, and LEVULAN KERASTICK refers to applicator only. LEVULAN KERASTICK For Topical Solution, 20 %, plus Blue Light at 6-10. 9 J / cm2, has been used to treat Actinic Keratoses in 232 patients in six clinical trials. Phase 3 studies were two, identically design, multicenter, Two-arm studies using LEVULAN KERASTICK For Topical Solution applicators plus illumination from BLU-U for 1000 seconds for nominal exposure of 10 J / cm2. Patients were excluded from these studies who had history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, photodermatosis, or inherited or acquired coagulation defects. A minimum of 4 and a maximum of 15 clinically typical, discrete, target Actinic keratosis Lesions were identify. Target Lesions on the face or on the Scalp, but not in both locations in same patient, receive treatment. Patients were randomized to receive treatment either with LEVULAN KERASTICK Topical Solution plus BLU-U or vehicle plus BLU-U. Patients were randomized at 3 to 1 LEVULAN to vehicle ratio. A total of 243 patients were enrol in two Phase 3 studies. Lesions were designated as cleared if lesion had completely clear and adherent scaling plaques of Actinic Keratoses were no longer evident on the surface of treated skin when palpate. Percentage of patients in whom 75 % or more of treated Lesions were clear, and percentage of patients in whom 100 % of treated Lesions were clear, For each study at 8 weeks after treatment are shown in Table 1. Because clinical studies ALA-018 and ALA-019 had identical protocols, combined results from two trials are shown in the following tables.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

PRECAUTIONS

Advise patients that after LEVULAN KERASTICK topical solution has been apply, treatment site will become photosensitive and that they should avoid exposure of photosensitive treatment sites to sunlight or bright indoor light for 40 hours. Exposure may result in stinging and / or burning sensation and may cause erythema and / or edema of lesions. Advise patients to protect treated lesions from the sun by wearing a wide-brim hat or similar head covering of light-opaque material, and / or long-sleeved shirt and / or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin. If for any reason patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call their doctor. Advise patients to continue to avoid exposure of photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and / or burning is note, exposure to light should be reduce. Advise patients to avoid certain medications that may enhance phototoxic reaction to PDT.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

CLINICAL PHARMACOLOGY

Medically reviewed by drugs. Com. Last updated on Mar 1 2020. LEVULAN KERASTICK FOR TOPICAL Solution plus Blue Light illumination using BLU-U Blue Light Photodynamic Therapy Illuminator is indicated FOR Treatment of minimally to moderately thick Actinic Keratoses of Face, Scalp, or Upper Extremities. After mixing, LEVULAN KERASTICK TOPICAL Solution 20 % is intended FOR direct application to individual Lesions diagnosed as Actinic Keratoses and not to professional skin. This product is not intended FOR application by patients or unqualified medical personnel. Application should involve Lesions on Scalp, Face or Upper Extremities; multiple Lesions can be treated within treatment region, but multiple treatment regions should not be treated simultaneously. The Recommend Treatment frequency is: One application of LEVULAN KERASTICK TOPICAL Solution and One Dose of illumination per Treatment region per 8-Week Treatment session. EACH individual LEVULAN KERASTICK APPLICATOR should be USE FOR ONLY one patient. LEVULAN KERASTICK Photodynamic Therapy FOR Actinic Keratoses is a two-stage process involving application of LEVULAN KERASTICK TOPICAL Solution to target Lesions and then illumination With Blue Light using BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours FOR Upper extremity Lesions or after 14-18 hours FOR Face or Scalp Lesions. If for any reason, a patient cannot be give BLU-U Blue Light Photodynamic Therapy Illuminator Treatment during the prescribed time after applying LEVULAN KERASTICK TOPICAL Solution, he or she may nonetheless experience sensations of stinging and / or burning if photosensitized Actinic Keratoses are exposed to sunlight or prolonged or intense Light at that time. Advise patients to wear appropriate protective apparel to shade Treated Actinic Keratoses from sunlight or other bright light sources until at least 40 hours after application of LEVULAN KERASTICK TOPICAL Solution. Advise patients to reduce light exposure if sensations of stinging and / or burning are experience. LEVULAN KERASTICK Photodynamic Therapy may be repeated second time FOR lesions that have not completely resolved 8 weeks after initial Treatment. Step-Treatment of Actinic Keratoses With LEVULAN KERASTICK TOPICAL Solution Actinic Keratoses target FOR Treatment should be clean and dry prior to application of LEVULAN KERASTICK TOPICAL Solution. LEVULAN KERASTICK APPLICATOR 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 aminolevulinic Acid HCl as dry solid. LEVULAN KERASTICK TOPICAL Solution is prepared by crushing glass ampoules and mixing the contents together. LEVULAN KERASTICK TOPICAL Solution can be prepared either manually, or using an optional KERASTICK Krusher. These methods are illustrated below. 1. Hold LEVULAN KERASTICK APPLICATOR with cap point up. CRUSH bottom ampule containing Solution vehicle by applying finger pressure to position on cardboard sleeve. 2. CRUSH top ampule containing ALA HCl powder by applying finger pressure to Position B on cardboard sleeve. To ensure both ampules are CRUSH continue crushing the APPLICATOR downward, applying finger pressure to position.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What should you Expect?

Photodynamic Therapy is medical Treatment that utilizes photosensitizing molecules and light source to activate administer Drug. Very thin superficial skin cancers called Actinic Keratoses and certain other types of cancer cells can be eliminated this way. Acne can also be treated as well. Procedure is easily performed in a physician's office or outpatient setting. PDT is also referred to as Blue Light Therapy. PDT essentially has three steps. First, light-sensitizing liquid, cream, or intravenous drug is applied or administer. Occasionally, photosensitizing molecules that are already part of the body can be activate. Second, there is an incubation period of minutes to days. Finally, target tissue is then exposed to specific wavelength of light that then activates photosensitizing medication. The mechanism by which tissue is destroyed seems to depend on the presence of activated oxygen molecules. Application of photosensitizer Drug incubation period Light activation, although first used in the early 1900s, PDT in modern sense is a new, evolving science. Current PDT involves a variety of incubation times for different Light-sensitizing drugs and a variety of Light sources depending on target tissue. The basic premise of PDT is selective tissue destruction. At present, primary limitation of available PDT technology for skin is depth of penetration of light and ability to target cells within 1 / 3 of an inch of the light source. Therefore, tumors or atypical growths must be close to the surface of skin for PDT to work. PDT is currently used in a number of medical fields, including oncology, Dermatology, cosmetic surgery, ophthalmology, and oral medicine. In oncology, PDT is FDA approved for non-small cell lung cancer, esophageal cancer, and precancerous changes of Barrett's esophagus. Its use is also being further investigated through clinical trials in general oncology for conditions including cancers of the cervix, prostate gland, brain, and peritoneal cavity. In Dermatology, PDT with photosensitizer LEVULAN KERASTICK is used for treatment of very early, thin skin cancers called Actinic Keratoses. Initial approval was specifically for Treatment of Actinic Keratosis of face and scalp with application of photosensitizer followed by timed exposure to special Blue Light source. PDT has also been used for acne, rosacea, thin nonmelanoma skin cancers, sun damage, enlarge sebaceous glands, wrinkles, warts, hidradenitis suppurativa, psoriasis, and many other skin conditions. It is not used to remove moles or birthmarks. PDT light sources include laser light, intense pulse light, Light-emitting diodes, Blue Light, red Light, and many other visible lights. Photosensitizer drugs may be activated by one or several types of light. The Optimal light source depends on the ideal wavelength for particular drug use and target tissue. Light source needs to be directly applied to the target tissue for an appropriate amount of time.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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