TAZORAC (tazarotene)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Pregnancy
Sunburn

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Skin photosensitivity

There are 0 moderate contraindications.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
Severe erythema Severe pruritus Skin fissure	None.

Rare/Very Rare
Blistering skin Dyschromia Skin photosensitivity

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal desquamation Dry skin Erythema Localized edema Pruritus of skin Skin irritation Stinging of skin	Cheilitis Contact dermatitis

Rare/Very Rare
Exfoliative dermatitis Pain Skin rash

Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered orally to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:28.) Single instances of known retinoid malformations (e.g., spina bifida, hydrocephaly, heart anomalies) have been reported in some species of animals (e.g., rabbits) followingtopical administration of tazarotene during gestation. Abnormal early embryonic development (e.g., decreased litter size, decreased number of live fetuses, decreased fetal body weights) was observed in animals receiving oral tazarotene in dosages 3.4

times the systemic exposure (AUC0-24 h) in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 11 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 6.7

times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area. Developmental delays, teratogenic effects, and postimplantation fetal loss also have been reported in animals receiving oral tazarotene in dosages 1.1-26

or 0.7-13 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream (over 35% of body surface area) or gel (over 20% of body surface area), respectively, 3.5-85

times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream (over 15% of body surface area), or 2.1-52 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1%

cream (over 15% of body surface area). Systemic exposure to tazarotene depends on the extent of body surface area treated. In patients treated topically over sufficient body surface area (over 35 or 20% of body surface area when used as a cream or gel, respectively, in psoriasis patients), systemic exposure to tazarotene could be of the same magnitude as in these orally treated animals.

Although systemic exposure anticipated in the treatment of the face alone may be less as a result of the more limited area of application of the drug, it is not known what level of exposure produces teratogenic effects in humans. There are no adequate and controlled studies to date using tazarotene topical cream or gel in pregnant women. The manufacturer states that the 8 women in clinical trials who were inadvertently exposed to tazarotene during pregnancy subsequently delivered healthy infants.

The importance of these findings is unknown because the exact timing and extent of exposure to the drug in relation to gestation are uncertain. However, tazarotene is contraindicated in women who are or may become pregnant or who intend to become pregnant during treatment. Women of childbearing potential should be warned of the potential risk and should use adequate birth-control measures during treatment with tazarotene.

If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the drug should be discontinued and the patient informed of the potential risks to the fetus. A negative result on a reliable blood pregnancy test (i.e., having a sensitivity of at least 50 mIU/mL for human chorionic gonadotropin (hCG)) should be obtained within 2 weeks prior to beginning tazarotene therapy and therapy should begin during the next normal menstrual period.

It is not known if topically applied tazarotene is distributed into human milk, but the drug appears to distribute into milk following topical application in lactating animals. The manufacturer states that caution should be exercised when tazarotene is administered to a nursing woman.

No enhanced Geriatric Use information available for this drug.