Source: Health Products and Food Branch (CA) Revision Year: 2021
STIEVA-A is contraindicated in patients with known hypersensitivity to retinoids or to any ingredient contained in the preparation or component of the container. For a complete listing, see Composition and Availability of Dosage Forms.
STIEVA-A IS INTENDED FOR EXTERNAL USE ONLY AND SHOULD BE KEPT AWAY FROM AREAS OF BROKEN SKIN, LIPS, EYES, NOSE, MOUTH, AND OTHER MUCOUS MEMBRANES BECAUSE OF ITS IRRITANT EFFECT. IN CASE OF ACCIDENTAL CONTACT RINSE WELL WITH WATER. IN THE CASE OF CONTACT WITH THE EYE, ALSO REFER THE PATIENT TO AN OPHTHALMOLOGIST. IF SENSITIVITY OR CHEMICAL IRRITATION OCCURS, THE MEDICATION SHOULD BE DISCONTINUED.
Do not apply to eyelids or to the skin at the corners of the eyes and mouth. Avoid the angles of the nose, skin fold areas and nasolabial fold (if treatment in these areas is necessary, apply very sparingly with care not to let the medicine accumulate).
Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily or discontinue use altogether.
STIEVA-A should be used with caution in patients using medications that are known photosensitizers (see DRUG INTERACTIONS).
STIEVA-A has been reported to cause severe irritation of eczematous skin and should only be used with utmost caution in patients with this condition.
There are no data on the effect of topical tretinoin on fertility in humans.
Topical tretinoin is not recommended during pregnancy or in women of childbearing years without the proper use of an effective method of contraception.
Observational studies of varying sample size involving a total of 1535 women presumed exposed to topical tretinoin during the first trimester of pregnancy did not detect an increased incidence of congenital abnormalities, including retinoic acid embryopathy or major structural defects.
Cases of temporally associated congenital abnormalities have been reported during clinical use of topical tretinoin during pregnancy, including the rare birth defect category, holoprosencephaly.
Orally administered retinoids are known teratogens, causing a high incidence of severe birth defects, and are contraindicated during pregnancy.
Nonclinical reproductive toxicity studies of topical retinoids have found evidence of developmental toxicity at doses ≥ 80-fold the anticipated clinical dose.
The magnitude of risk to the embryo/fetus from topical use of tretinoin is uncertain. When used in accordance with the prescribing information, there is an approximate 1% to 6% systemic absorption from topically administered tretinoin. However, even though systemic absorption is low from topically administered tretinoin, risk cannot be excluded since there may be other factors that contribute to an increased systemic exposure such as dose used, skin barrier integrity, concurrent use with other products, hypervitaminosis A and dietary intake of vitamin A and/or provitamin A (beta-carotene) or ingestion of these as supplements.
It is not known whether tretinoin is excreted in human milk. A risk to the newborns/infants cannot be excluded. Therefore, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the benefit of breastfeeding to the child and the benefit of the drug to the mother.
Safety and effectiveness in patients below the age of 12 years have not been established, therefore STIEVA-A cream is not recommended for use in this population.
Tretinoin has irritant properties, heightens susceptibility to ultraviolet light radiation, is sensitive to oxidation and is photolabile.
STIEVA-A should be used with caution in patients with:
During early weeks of therapy, an apparent exacerbation of the acne lesions may occur due to an expected drug effect on previously unseen deep lesions. This is an anticipated therapeutic effect and therapy should be continued. Dosing frequency may be reduced or a lower strength of STIEVA-A may be used, if applicable, to help prevent exacerbation of acne lesions.
STIEVA-A contains paraffin (white petrolatum). Patients should be advised not to smoke or go near open flames due to the risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Due to the irritant nature of tretinoin, caution should be used when applying to sensitive areas of skin, such as the neck, abraded or eczematous skin, or in patients with inflammatory skin conditions that coexist with acne.
The skin of certain sensitive individuals, particularly those with fair complexions, may become excessively red, edematous, blistered or crusted when exposed to STIEVA-A.
If skin irritation (redness, peeling or discomfort) or effects of other acne or other treatments with irritating potential are present, this should be resolved before initiating treatment with STIEVA-A.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of severe skin irritation. If severe irritation occurs, interrupt dosing to allow the skin to recover, and re-evaluate the dosing regimen with the patient.
As tretinoin may cause increased sensitivity to ultraviolet radiation, exposure to sunlight and sun lamps should be avoided or minimized during the use of STIEVA-A. When exposure to strong sunlight cannot be avoided (e.g., patients whose occupations require considerable exposure to the sun), patients should be advised to use a broad spectrum sunscreen with an SPF of at least 15, to reapply sunscreen regularly and to wear protective clothing over treated areas.
Due to the potential for photosensitivity, resulting in a greater risk for sunburn, STIEVA-A should be used with caution in patients with a personal or family history of skin cancer.
If a patient has sunburn, this should be resolved before initiating treatment with STIEVA-A. If sunburn occurs while using STIEVA-A, it is advisable to interrupt therapy until the severe erythema and peeling subside.
Weather extremes, such as wind or cold, may be more irritating to patients using tretinoin-containing products.
Carcinogenicity studies with STIEVA-A have not been conducted. Studies in hairless mice suggest that concurrent dermal exposure to isotretinoin, an isomer of tretinoin, may enhance the tumorigenic potential of ultraviolet irradiation.
The following very common adverse drug reactions (≥10%) have been reported in clinical trials involving topical tretinoin-containing products:
Skin and subcutaneous disorders: Pain, burning sensation, tenderness, irritation or pruritus, application site erythema, skin exfoliation, application site stinging and dry skin.
The following adverse drug reactions (<10%) have also been reported in clinical trials involving topical tretinoin-containing products:
Skin and subcutaneous disorders: edematous (1.1%), blistered (1.6%) or crusted skin (0.5%), contact dermatitis (2.2%).
Immune system disorders: allergic reaction
Skin and subcutaneous disorders: skin hyperpigmentation, skin hypopigmentation, photosensitivity reaction, application site rash, application site edema/swelling, skin atrophy.
Concomitant application of oxidising agents, such as benzoyl peroxide, should be avoided since they may reduce the efficacy of topical tretinoin. If combination therapy is required, the products should be applied at different times of the day (e.g., one in the morning and the other in the evening).
Medications known to be photosensitizers (e.g., thiazides, tetracyclines, fluroquinolones, phenothiazines, sulphonamides) should be used with caution with STIEVA-A because augmented photosensitivity may occur.
Concomitant topical acne therapy and other topical medications should be used with caution because cumulative irritation may occur. Particular caution should be exercised during concomitant use of preparations containing a peeling agent (such as sulfur, resorcinol or salicylic acid) with STIEVA-A. If irritation or dermatitis occurs (redness, peeling or discomfort), reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.
In patients whose skin has been subjected to procedures such as depilation, chemical hair treatments, chemical peels, dermabrasion or laser resurfacing, allow the skin to recover before initiating treatment with STIEVA-A is considered.
Cosmetics that have a strong drying effect, including products with high concentrations of alcohol and/or astringents, or that have a potential irritating effect (abrasive agents, products containing spices or limes, etc.) should be used with caution as cumulative irritation may occur.
Patients may use noncomedogenic, hypoallergenic, and oil-free cosmetic products.
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