Vectical - Product Information
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||Calcitriol, Mineral Oil, dl-α-tocopherol, White Petrolatum|
Full prescribing information
Indications and Usage
VECTICAL Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
Limitations of Use
VECTICAL Ointment should not be applied to the eyes, lips, or facial skin.
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.
Dosage Forms and Strengths
Each gram of ointment contains 3 micrograms (mcg/g) of calcitriol.
Warnings and Precautions
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.
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]
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.
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.
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.
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.
Four hundred and nineteen subjects were treated with VECTICAL Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis.
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 elevations were less than 10% above the upper limit of normal [see WARNINGS AND PRECAUTIONS ].
The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with VECTICAL.
Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hypercalciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two.
The following adverse reactions have been identified during world-wide post-approval use of VECTICAL Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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].
Use in Specific Population
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.
Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m2/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies.
It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VECTICAL Ointment is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of VECTICAL Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients
Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects [see WARNINGS AND PRECAUTIONS].
How Supplied/Storage and Handling
VECTICAL Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes:
- 100 g tube (NDC 0299-2012-10)
Store at Controlled Room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). [See USP Controlled Room Temperature.] Do not freeze or refrigerate.
Patient Counseling Information
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients using VECTICAL Ointment should receive the following information:
Instructions for Use
This medication is to be used as directed by the physician. It is for external use only. This medication is to be applied only to areas of the skin affected by psoriasis, as directed. It should be gently rubbed into the skin so that no medication remains visible.
Patients should report any signs of adverse reactions to their physician.
To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
U.S. Patent No. 7,749,986
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada.
GALDERMA is a registered trademark.