TAZAROTENE Drug Interactions: What You Need to Know

INTERACTIONS No formal drug-drug interaction studies were conducted with Tazarotene Foam. Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is recommended to postpone treatment until the effects of these products subside before use of Tazarotene Foam is started. Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene. If combination therapy is required, they should be applied at different times of the day (e.g., one in the morning and the other in the evening). The impact of tazarotene on the pharmacokinetics of progestin-only oral contraceptives (i.e., minipills) has not been evaluated. In a trial of 27 healthy female subjects between the ages of 20 to 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle. Avoid concomitant dermatologic medications and cosmetics that have a strong drying effect. ( 7 )

Tazarotene Foam is contraindicated in pregnancy.

Tazarotene

Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1 , 8.3) ]. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ]. Pregnancy. ( 4 , 8.1 )

AND PRECAUTIONS

• Embryofetal Toxicity: Tazarotene gel contains tazarotene, which is a teratogen. Tazarotene gel is contraindicated in pregnancy. Females of child-bearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 )
• Local Irritation: Excessive pruritus, burning, skin redness or peeling can occur. If these reactions occur, discontinue until the integrity of the skin has been restored, or consider reducing dosing frequency or in the case of psoriasis, consider switching to the lower concentration. Tazarotene gel should not be used on eczematous skin, as it may cause severe irritation. ( 5.2 )
• Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. Tazarotene gel should be administered with caution if the patient is also taking drugs known to be photosensitizers. ( 5.3 )

5.1 Embryofetal Toxicity Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, tazarotene gel may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis. 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 orally treated animals. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance and causes fetal malformations in animals, and it is not known what level of exposure is required for teratogenicity in humans <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3)]</span> . There were thirteen reported pregnancies in subjects who participated in the clinical trials for topical tazarotene. Nine of the subjects had been treated with topical tazarotene, and the other four had been treated with vehicle. One of the subjects who was treated with tazarotene cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical tazarotene during the clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown. Females of Child-bearing Potential Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene gel is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test should be obtained within 2 weeks prior to tazarotene gel therapy. Tazarotene gel therapy should begin during a normal menstrual period <span class="opacity-50 text-xs">[see Use in Specific Populations (8.1)]</span> .

5.2 Local Irritation and Hypersensitivity Reactions Application of tazarotene gel may cause excessive irritation in the skin of certain sensitive individuals. Local reactions (including blistering and skin desquamation, pruritus, burning, erythema) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene. If these adverse reactions occur, consider discontinuing the medication or reducing the dosing frequency, as appropriate, until the integrity of the skin is restored. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate treatment. Concomitant topical medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to &quot;rest&quot; a patient&apos;s skin until the effects of such preparations subside before treatment with tazarotene gel is initiated. Tazarotene gel, should not be used on eczematous skin, as it may cause severe irritation. Weather extremes, such as wind or cold, may be more irritating to patients using tazarotene gel.

5.3 Photosensitivity and Risk for Sunburn Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during the use of tazarotene gel. Patients must be warned to use sunscreens and protective clothing when using tazarotene gel. Patients with sunburn should be advised not to use tazarotene gel until fully recovered. 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 tazarotene gel. Tazarotene gel should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.