FABIOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FABIOR (FABIOR).
Retinoid that binds to retinoic acid receptors (RARs) and retinoid X receptors (RXRs), inducing differentiation and apoptosis of keratinocytes.
| Metabolism | Metabolized via CYP450 enzymes (primarily CYP2C8, CYP3A4) to active metabolites; further glucuronidation. |
| Excretion | Primarily hepatic metabolism via CYP450; renal excretion of metabolites accounts for <1% of dose as unchanged drug. Fecal elimination is the major route (approximately 90%). |
| Half-life | Terminal elimination half-life is approximately 24-26 hours, supporting once-daily dosing. |
| Protein binding | >99% bound to plasma proteins, primarily albumin and lipoproteins. |
| Volume of Distribution | Approximately 2.5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Topical: Systemic absorption is minimal (approximately 2-4% of the applied dose) following topical application to the face. |
| Onset of Action | Topical: Clinical improvement (reduction in inflammatory and non-inflammatory lesions) typically observed within 4-8 weeks of continued use. |
| Duration of Action | Duration of therapeutic effect is sustained with continued once-daily application; effects diminish upon discontinuation. |
FABIOR (tazarotene) foam, 0.1%: Apply a thin layer once daily in the evening to affected areas of the face, scalp, or trunk.
| Dosage form | AEROSOL, FOAM |
| Renal impairment | No dose adjustment required for renal impairment; use caution in severe renal disease due to lack of studies. |
| Liver impairment | Contraindicated in patients with hepatic impairment; no dose adjustment defined due to lack of safety data. |
| Pediatric use | Safety and efficacy in pediatric patients below 12 years have not been established; for ages 12 years and older, same as adult dosing. |
| Geriatric use | No specific dose adjustment recommended; use caution due to potential increased sensitivity and higher risk of skin irritation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FABIOR (FABIOR).
| Breastfeeding | Contraindicated during breastfeeding. Tazarotene is excreted in rat milk; potential for serious adverse reactions in nursing infants. M/P ratio not established in humans. |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in pregnancy due to high risk of severe fetal malformations including CNS, cardiovascular, and craniofacial defects, as well as increased risk of miscarriage. Avoid in women of childbearing potential without effective contraception. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not for use in pregnant women or women planning pregnancy; animal studies show teratogenicity.
| Serious Effects |
Pregnancy or women of childbearing potential not using contraception; hypersensitivity to any component.
| Precautions | Avoid excessive sun exposure; use sunscreen. Minimize use on eczematous or sunburned skin. Discontinue if hypersensitivity occurs. |
| Food/Dietary | Avoid excessive intake of vitamin A-rich foods (e.g., liver, fortified cereals) as tazarotene is a retinoid and may increase risk of hypervitaminosis A. No other significant food interactions. Grapefruit and grapefruit juice have no known interaction with topical tazarotene. |
Loading safety data…
| Negative pregnancy test within 2 weeks prior to therapy initiation; monthly pregnancy tests during treatment. Immediate discontinuation if pregnancy occurs. Monitor for fetal development if inadvertent exposure. |
| Fertility Effects | No human data on fertility effects. In animal studies, no impairment of fertility observed at subtoxic doses. |
| Clinical Pearls |
| Fabior (tazarotene) foam is a potent topical retinoid approved for acne vulgaris. Due to increased percutaneous absorption compared to gel formulations, apply only a pea-sized amount for the entire face. Avoid application to eczematous or sunburned skin. Concomitant use of photosensitizing agents (e.g., tetracyclines, thiazides) may increase phototoxicity. Advise strict photoprotection with SPF 30+ and avoid prolonged sun exposure. Can cause transient burning, stinging, or erythema; if severe irritation occurs, reduce frequency to every other day or discontinue. Teratogenic potential: contraindicated in pregnancy (Pregnancy Category X); verify negative pregnancy test before initiation and counsel on effective contraception. |
| Patient Advice | Use only a pea-sized amount for the entire face; more does not improve efficacy and increases irritation. · Apply once daily in the evening to clean, dry skin; wait 20 minutes after washing. · Avoid contact with eyes, mouth, and mucous membranes. If contact occurs, rinse with water. · Minimize sun exposure; use sunscreen and wear protective clothing daily. · Do not use on broken, eczematous, or sunburned skin. · Worsening of acne may occur during the first 2-4 weeks; continue use as directed. · This medication can cause severe birth defects; do not use if pregnant or planning pregnancy. Use two forms of effective contraception. · Inform your doctor if you are breastfeeding; it is unknown if topical tazarotene passes into breast milk. · Avoid products that dry the skin (e.g., harsh cleansers, alcohol-based astringents). · Report persistent redness, blistering, or peeling to your healthcare provider. |