Calcipotriene
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From MedlinePlus, U.S. National Library of Medicine
Vitamin D Analog
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
DOSAGE AND ADMINISTRATION Comb the hair to remove scaly debris and after suitably parting, apply Pellix™ Topical Solution, 0.005% (Scalp Solution), twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Pellix™ Topical Solution, 0.005% (Scalp Solution), have been demonstrated in patients treated for eight weeks.
Keep Pellix™ Topical Solution, 0.005% (Scalp Solution), well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.
Contraindications
Pellix™ Topical Solution, 0.005% (Scalp Solution), is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for calcipotriene. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy Teratogenic Effects Pregnancy Category C Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 μg/kg/day (132 μg/m 2 /day). Rabbits administered 36 μg/kg/day (396 μg/m 2 /day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 μg/kg/day (318 μg/m 2 /day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs.
The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 μg/m 2 /day) and rabbit (17.6 μg/m 2 /day) studies are greater than the expected human systemic exposure level (0.13 μg/m 2 /day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Pellix™ Topical Solution, 0.005% (Scalp Solution), should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation
Nursing Mothers There is evidence that maternal 1,25-dihydroxy vitamin D 3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin. Because many drugs are excreted in human milk, caution should be exercised when Pellix™ Topical Solution, 0.005% (Scalp Solution) is administered to a nursing woman.
Breastfeeding (LactMed)
No information is available on the use of calcipotriene during breastfeeding. Because it is poorly absorbed after topical application, calcipotriene is probably a low risk to the nursing infant and is generally considered acceptable during breastfeeding, although some sources recommend avoiding the nipple area.- Avoid application of the combination products containing betamethasone (Enstilar) to the breast. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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