LIVE BLOG: LEO Pharma Inc. Dermatology Portfolio Review [Product Theater]
In this live blog from the 11th Annual SDPA conference, Parul Mody, PA-C, discusses a product theater from Leo Pharmceuticals. Ms. Mody covered Picato gel, Taclonex topical suspension, and Leo Quality Care Program.
The US Food and Drug Administration (FDA) has approved a new treatment for actinic keratosis (AK), a common skin precancer that affects 58 million Americans. Leo Pharmaceuticals’ Picato (ingenol mebutate), gel (0.015% and 0.05%) is the first topical therapy to effectively treat AKs in just two or three days.
- 3 day dosing for face and scalp
- 2 day dosing for trunk and extremities
Picato Gel must be refrigerated (do not freeze). Advise patients to wash hands after application and protect periorbital area from exposure. Patients may want to put it on before bed and then wash it off in the morning.
- Indicated for topical treatment of AKs
- Short dosing regimen
- Systemic absorption below the lower limit of quantificaiton
- Efficacy seen at day 57
- The most common side effects of Picato® were skin redness, flaking/scaling, crusting and swelling.
Important Safety Information:
- For topical use only; not for oral, ophthalmic, or intravaginal use.
- Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure.
- Patients should wash hands well after applying Picato®gel, and avoid transfer of the drug to the periocular area during and after application.
- If accidental exposure occurs, flush eyes with water and seek medical care.
- Severe skin reactions in the treated areas on the face/scalp and trunk/extremities, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration can occur after application.
- Administration of Picato® gel is not recommended until the skin is healed from any previous drug or surgical treatment.
- The most common adverse reactions observed in clinical trials on the face and scalp (≥2%) are local skin reactions (94%), application site pain (15%), application site pruritus (8%), application site infection (3%), periorbital edema (3%), and headache (2%).
- The most common adverse reactions observed in clinical trials on the trunk and extremities (≥2%) are local skin reactions (92%), application site pruritus (8%), application site irritation (4%), nasopharyngitis (2%), and application site pain (2%).
- There are no adequate and well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- The safety and effectiveness of Picato® gel for actinic keratosis in patients less than 18 years of age have not been established.
Taclonex Topical Suspension
- Psoriasis affects over 7 million Americans and may affect both the body and scalp in up to 80% of cases
- For patients with plaque psoriasis, the skin’s shedding cycle is too fast, causing skin cells to pile up on the surface
- The patches of affected skin cells are known as plaques and can be found anywhere on the body
- Taclonex Topical Suspension is one topical treatment for both scalp and body plaque psoriasis.
- It is a once-daily treatment indicated for up to 8 weeks
- Combines the efficacy and safety profile of 2 active ingredients
- The most common adverse reactions in clinical studies were folliculitius and burning sensation of the skin
- Non-alcohol containing formulation that allows application on both body and scalp
- The first and only steroid-containing topical product studied with safety as the primary end point for up to 52 weeks.
- Taclonex Topical Suspension is indicated for topical treatment of plaque psoriasis of the scalp and body in patients 18 years or older
- Taclonex Topical Suspension significantly improves IgA score on the body
- Use of one daily, combination product in conjunction with counseling on treatment compliance may improve the patients psoriasis
- Taclonex Topical Suspension is nearly odorless and is an almost clear to slightly off white suspension fluid
- Taclonex Topical Suspension demonstrated efficacy as early as week 2 on the scalp
Important safety information:
- Taclonex Topical Suspension is for topical use only.
- It is not for oral, ophthalmic, or intravaginal use and should not be applied to the face, axillae, or groin.
- Do not use if atrophy is present at the treatment site.
- Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized.
- Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency.
- Use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression and calcium abnormalities. If HPA axis suppression is documented, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid.
- Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
- In clinical trials, the most common adverse reactions that occurred in ≥1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of skin.
- Other less common adverse reactions (<1% but>0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
- Local adverse reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria and may be more likely with occlusive use or more potent corticosteroids.
- Some local adverse reactions may be irreversible.
- Taclonex Topical Suspension may cause eye irritation. Avoid eye exposures.
- Patients who apply Taclonex Topical Suspension to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc.
- There are no adequate and well-controlled studies of Taclonex Topical Suspension in pregnant women. Taclonex Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.
- Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing.
- Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients have not been studied.
The Quality Care Program
LEO Quality Care connects patients to helpful nurses who can answer questions about their treatment. After they enroll, patients will be called twice by a registered nurse who will answer questions they may have about their treatment. Patients may also contact a nurse at 1-855-CARE-LEO (855-227-3536). Additionally, patients may receive helpful communication in the future by mail or e-mail. Encourage your patients to enroll in LEO® Quality Care by calling 1-855-CARE-LEO (855-227-3536).