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- RENOVA (tretinoin emollient cream 0.05%) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic use with RENOVA (tretinoin emollient cream 0.05%) are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with RENOVA (tretinoin emollient cream 0.05%) for longer than 48 weeks. The significance of these findings is unknown.
- Safety and effectiveness of RENOVA (tretinoin emollient cream 0.05%) 0.05% in individuals with moderately or heavily pigmented skin have not been established.
- RENOVA (tretinoin emollient cream 0.05%) should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of RENOVA (tretinoin emollient cream 0.05%) because of heightened sunburn susceptibility. Patients should be warned to use sunscreens (minimum SPF of 15) and protective clothing when using RENOVA (tretinoin emollient cream 0.05%) . Patients with sunburn should be advised not to use RENOVA (tretinoin emollient cream 0.05%) until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using RENOVA (tretinoin emollient cream 0.05%) and follow the precautions outlined in the Patient Package Insert.
RENOVA (tretinoin emollient cream 0.05%) should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether, and consider additional appropriate therapy.
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution in patients with this condition.
Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.
RENOVA (tretinoin emollient cream 0.05%) should be used only as an adjunct to a comprehensive skin care and sunlight avoidance program. (See INDICATIONS AND USAGE section.)
Weather extremes, such as wind or cold, may be more irritating to patients using tretinoin containing products.
Information for Patients
RENOVA (tretinoin emollient cream 0.05%) 0.05% is to be used as described below unless otherwise directed by your physician:
- It is for use on the face only.
- Avoid contact with the eyes, ears, nostrils, angles of the nose, and mouth. RENOVA (tretinoin emollient cream 0.05%) may cause severe redness, itching, burning, stinging, and peeling if used on these areas.
- In the evening, gently wash your face with a mild soap. Pat skin dry and wait 20-30 minutes before applying RENOVA (tretinoin emollient cream 0.05%) . Apply only a pea-sized amount of RENOVA (tretinoin emollient cream 0.05%) to your face at one time. This should be enough to cover the entire affected area lightly.
- Do not wash your face for at least one hour after applying RENOVA (tretinoin emollient cream 0.05%) .
- For best results, you are advised not to apply another skin care product or cosmetic for at least one hour after applying RENOVA (tretinoin emollient cream 0.05%) .
- In the morning, apply a moisturizing sunscreen, SPF 15 or greater.
- RENOVA (tretinoin emollient cream 0.05%) is a serious medication. Do not use RENOVA (tretinoin emollient cream 0.05%) if you are pregnant or attempting to become pregnant. If you become pregnant while taking RENOVA (tretinoin emollient cream 0.05%) , please contact your physician immediately.
- Avoid sunlight and other medicines that may increase your sensitivity to sunlight.
- RENOVA (tretinoin emollient cream 0.05%) does not remove wrinkles or repair sun-damaged skin.
Please refer to the Patient Package Insert for additional patient information.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas were observed in some female mice. These concentrations are lower than the concentration of tretinoin in the clinical formulation (0.05%). A dose related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day. These doses are 4 and 8 times the maximum human systemic dose, when adjusted for total body surface area. The biological significance of the neoplastic findings is not clear because they occurred at doses that exceeded the maximally tolerated dermal dose of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (1/5th of the maximum human systemic dose, adjusted for total body surface area). For purposes of comparisons of the systemic animal exposure to the systemic human exposure, the maximum human systemic dose is 1 gram of 0.05% RENOVA applied daily to a 50 kg person (0.01 mg tretinoin/kg body weight, or 0.37 mg/m²total body surface area).
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies in humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
In dermal Segment I fertility studies in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0. 5 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (4 times the maximum human systemic dose adjusted for total body surface area) and above were observed. A dermal Segment III study with RENOVA (tretinoin emollient cream 0.05%) has not been performed in any species. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day ( > 33 times the maximum human systemic dose adjusted for total body surface area).
Teratogenic effects: Pregnancy Category C.
ORAL tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. It was teratogenic and fetotoxic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (17 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which, metabolically, is closer to humans for tretinoin than the other species examined, fetal malformations were reported at doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (167 times the maximum human systemic dose adjusted for total body surface area), although increased skeletal variations were observed at all doses. A dose-related increase in embryolethality and abortion was reported. Similar results have also been reported in pigtail macaques.
TOPICAL tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (17 times the maximum human systemic dose adjusted for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was dermally applied.
There are other reports in New Zealand White rabbits administered doses of greater than 0.2 mg/kg/day (7 times the maximum human systemic dose adjusted for total body surface area) of an increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species.
In contrast, several well-controlled animal studies have shown that dermally applied tretinoin may be fetotoxic, but not overtly teratogenic, in rats and rabbits at doses of 1.0 and 0.5 mg/kg/day, respectively (17 times the maximum human systemic dose adjusted for total body surface area in both species).
With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally-associated congenital malformations have been reported during twenty-five years of clinical use of another formulation of topical tretinoin (Retin-A). Although no definite pattern of teratogenicity and no causal association has been established from these cases, 5 of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.
Dermal tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (17 times the human topical dose normalized for total body surface area). Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death, in rats when administered 2.5 mg/kg/day (42 times the maximum human systemic dose adjusted for total body surface area).
There are, however, no adequate and well-controlled studies in pregnant women. RENOVA (tretinoin emollient cream 0.05%) should not be used during pregnancy.
It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness on the face with RENOVA (tretinoin emollient cream 0.05%) may be postponed in nursing mothers until after completion of the nursing period.
Safety and effectiveness in patients less than 18 years of age have not been established.
Clinical studies of RENOVA (tretinoin emollient cream 0.05%) 0.05% did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/10/2008
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