VECTICAL- calcitriol ointment
Galderma Laboratories, L.P.
INDICATIONS AND USAGE
1.1 Indication
VECTICAL Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
1.2 Limitations of Use
VECTICAL Ointment should not be applied to the eyes, lips, or facial skin.
2 DOSAGE AND ADMINISTRATION
Apply VECTICAL Ointment to affected areas twice daily, morning and evening. The maximum weekly dose should not exceed 200 grams.
VECTICAL Ointment is not for oral, ophthalmic or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS
Each gram of ointment contains 3 micrograms (mcg/g) of calcitriol.
5 Warnings and Precautions
5.1 Effects on Calcium Metabolism
In controlled clinical trails with VECTICAL Ointment, among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal.
If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of VECTICAL Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use.
5.2 Ultraviolet Light Exposure
Animal data suggest that the vehicle of VECTICAL Ointment may enhance the ability of ultraviolet radiation (UVR) to induce skin tumors. [see Carcinogenesis, Mutagenesis, Impairment of Fertility (13.1)]
Subjects who apply VECTICAL Ointment to exposed skin should avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use VECTICAL Ointment.
5.3 Unevaluated Uses
The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.
The safety and effectiveness of VECTICAL Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated.
6 ADVERSE REACTIONS
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
6.1 Clinical Studies Experience
VECTICAL Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to VECTICAL Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year.
7 DRUG INTERACTIONS
VECTICAL Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D [see WARNINGS AND PRECAUTIONS (5.1) ].
8 USE IN SPECIFIC POPULATION
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C.
VECTICAL Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for VECTICAL Ointment in pregnant women. VECTICAL Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.
DESCRIPTION
VECTICAL (calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol.
Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C27 H44 O3 , and the molecular weight is 416.64.
VECTICAL Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum.
12 CLINICAL PHARMACOLOGY
The contribution to efficacy of individual components of the vehicle has not been established.
12.1 Mechanism of Action
The mechanism of action of calcitriol in the treatment of psoriasis has not been established.
