sunlight (UV) exposure
Tretinoin, ATRA Contraindications and Precautions
Tretinoin should be used cautiously in patients who experience retinoid hypersensitivity reactions to vitamin A or other retinoids because cross-sensitivity between agents is possible. True contact allergy to tretinoin is rare.
Topical tretinoin is classified as FDA pregnancy risk category C and oral tretinoin as FDA pregnancy risk category D. Teratogenic and embryotoxic effects have been demonstrated in animals receiving oral tretinoin or large doses (i.e., many times greater than the normal human dose) of topical tretinoin. Adequate and well-controlled trials have not been performed in humans, but increased spontaneous abortions and major human fetal abnormalities have occurred when pregnant women received other retinoids. There have been 30 case reports of temporally-associated, congenital malformations during 25 years of clinical use of Retin-A®. The significance of these spontaneous reports in terms of risk to the fetus is not known. Avoid use of topical tretinoin over large areas of skin or for prolonged periods. The benefit-risk profile should be considered before prescribing. There is a high risk of birth defects if oral tretinoin is administered during pregnancy. Females of childbearing potential must use two reliable forms of contraception simultaneously during oral tretinoin therapy and for one month following discontinuation of therapy, unless abstinence is the chosen method. Contraception must be used even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Within one week of beginning tretinoin oral therapy, the patient should have a negative pregnancy test; if possible, treatment with tretinoin should be delayed until the results of the pregnancy test are known. Pregnancy testing and counseling should occur monthly during oral tretinoin therapy.
It is unknown whether tretinoin is distributed into breast milk. Breast-feeding should be discontinued in women receiving oral tretinoin. Topical use of tretinoin for photoaging should be discontinued in nursing mothers until after completion of the nursing period.
Topical tretinoin should be avoided, if possible, in patients with eczema because severe irritation of eczematous skin is likely.
Retinoids may cause photosensitivity. Treatment with topical tretinoin should be postponed until sunburn has resolved to avoid exacerbation of the irritation, inflammation, and dryness associated with sunburned skin. Patients with a skin photosensitivity disorder should be closely evaluated prior to receiving tretinoin therapy. If sun exposure cannot be avoided during topical tretinoin therapy, sunscreen products and physical sun blocks (protective clothing, hats) are recommended for protection of treated areas. Sunlight (UV) exposure potentiates the inflammatory effects of tretinoin. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using topical tretinoin. Weather extremes, such as wind or cold, also may be irritating to patients receiving tretinoin.
Tretinoin cream, gel, and liquid are for external use only. Avoid ocular exposure, including eyelids, and contact with the mouth, angles of the nose, and mucous membranes. If eye contact occurs, rinse thoroughly with large amounts of water. Apply only to affected areas; accidental exposure to unaffected skin may cause irritation. Topical tretinoin is flammable; do not use near heat, open flame, or while smoking.
Oral tretinoin should not be administered to patients who have paraben hypersensitivity. Paraben is used as a preservative in the gelatin capsule.
In the treatment of acute promyelocytic leukemia, high initial leukocyte counts or rapidly increasing leukocyte counts (i.e., leukocytosis) during treatment may be predictive of retinoic acid-acute promyelocytic leukemia (RA-APL) syndrome (see Adverse Reactions). Some clinicians routinely add chemotherapy to oral tretinoin therapy when patients present with a WBC count > 5000/mm3 or in the case of a rapid increase in WBC count in leukopenic patients at the start of treatment. Consideration could be given to adding chemotherapy (usually cytarabine and an anthracycline, if not contraindicated) to tretinoin therapy on day 1 or 2 for patients presenting with a WBC count > 5000/mm3 or immediately, for patients presenting with a WBC count of < 5000/mm3, if the WBC count reaches >= 6000/mm3 by day 5, >= 10,000/mm3 by day 10, or >= 15,000/mm3 by day 28. The majority of patients do not require discontinuation of tretinoin therapy during RA-APL syndrome. Close monitoring of WBC and clinical signs during oral tretinoin therapy will aid in the proper management of this syndrome.
Elevated hepatic enzymes has been reported in patients receiving oral tretinoin. Patients with hepatic disease could be more prone to developing this condition. It is recommended that if the serum hepatic enzyme levels are greater than 5-times the upper limit of normal, consideration should be given to temporarily discontinuing oral tretinoin therapy.
The safety and efficacy of topical tretinoin have not been established in children < 12 years of age. Children are prone to developing severe headache and pseudotumor cerebri while receiving oral tretinoin. For relief, some patients may require treatment with analgesics or lumbar puncture. The safety and efficacy of oral tretinoin in infants have not been established.
Oral tretinoin should be used cautiously in patients with hyperlipidemia. Hypercholesterolemia and/or hypertriglyceridemia occurs in as many as 60% of patients receiving oral tretinoin. Monitor the lipid profile while patients are receiving oral tretinoin.
[ Last revised: 8/8/2002 5:02:00 PM ]
Related entries
- Tretinoin, ATRA
- Tretinoin, ATRA capsules
- Tretinoin, ATRA Administration
- Tretinoin, ATRA skin cream, liquid, or gel
- Tretinoin, ATRA Interactions
- Tretinoin, ATRA Indications and Dosage
- Tretinoin Liposomal
- Tretinoin, ATRA Adverse Reactions
- Crema, líquido o gel de tretinoína para la piel, ATRA
- Cápsulas de tretinoína, ATRA
Syndicate
