Tazarotene - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: May cause fetal harm when administered to a pregnant woman.

Obtain a pregnancy test in females of reproductive potential within 2 weeks prior to initiating treatment.

Advise females of reproductive potential to use effective contraception.

Local Irritation: Some individuals may experience excessive pruritus, burning, skin redness, or peeling.

If these adverse reactions occur, discontinue tazarotene cream until the integrity of the skin has been restored or reduce dosing interval.

Avoid using tazarotene cream on eczematous skin, as such use may cause severe irritation.

Photosensitivity and Risk of Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes.

Wear sunscreen daily.

Avoid using tazarotene cream if the patient is also taking drugs known to be photosensitizers.

Lentigo Maligna: Carefully assess facial pigmented lesions of concern before application of tazarotene cream.

5.1 Embryofetal Toxicity Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, tazarotene cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy .

Safety in pregnant females has not been established.

The potential risk to the fetus outweighs the potential benefit to the mother from tazarotene cream use during pregnancy; therefore, discontinue tazarotene cream as soon as pregnancy is recognized.

Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis.

However, limited case reports of pregnancy in females enrolled in clinical trials for tazarotene cream have not reported a clear association with tazarotene and major birth defects or miscarriage risk [see Contraindications , Use in Specific Populations ] .

Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated.

In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in these orally treated animals.

Although there may be less systemic exposure in the treatment of the face alone due to less surface area for application, tazarotene is a teratogenic substance in animals, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology ].

Advise pregnant females of the potential risk to a fetus.

Obtain a pregnancy test within 2 weeks prior to tazarotene cream therapy.

Initiate tazarotene cream therapy during a menstrual period.

Advise females of reproductive potential to use effective contraception during treatment with tazarotene cream [see Dosage and Administration , Use in Specific Populations ] .

5.2 Local Irritation and Hypersensitivity Reactions Local tolerability reactions (including blistering and skin desquamation) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene.

Application of tazarotene cream may cause excessive irritation in the skin of certain sensitive individuals.

Some individuals may experience excessive pruritus, burning, skin redness, or peeling.