TACLONEX (Page 2 of 4)

Information for Patients:

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 Taclonex® Ointment should receive the following information and instructions.

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash hands after application.
  2. This medication should not be used for any disorder other than that for which it has been prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by the physician.
  4. Patients should report any signs of adverse reactions to their physician.
  5. Other products containing calcipotriene or a corticosteroid should not be used with Taclonex® Ointment without first talking to the physician.
  6. Patients who apply Taclonex® Ointment to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients who use Taclonex® Ointment.

Laboratory Tests

See PRECAUTIONS, General.

Carcinogenesis, mutagenesis, impairment of fertility:

When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (corresponding to 9, 30 and 90 mcg/m2 /day), no significant changes in tumor incidence were observed when compared to control.

In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients who apply Taclonex® Ointment to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients that use Taclonex® Ointment.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test.

Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.

Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m2 /day) of calcipotriene demonstrated no impairment of fertility or general reproductive performance.

Studies in rats with oral doses of up to 0.2 mg/kg/day (1,200 mcg/m2 /day) of betamethasone dipropionate demonstrated no impairment of male fertility.

Pregnancy:

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Taclonex® Ointment. Taclonex® Ointment contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex® Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Teratogenicity studies with calcipotriene were performed by the oral route in rats and rabbits. In rabbits, increased maternal and fetal toxicity were noted at dosage of 12 mcg/kg/day (144 mcg/m2 /day); a dosage of 36 mcg/kg/day (432 mcg/m2 /day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (324 mcg/m2 /day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene’s effect upon calcium metabolism. The estimated maternal and fetal no-effect levels in the rat (108 mcg/m2 /day) and rabbit (48 mcg/m2 /day) studies are lower than the estimated maximum topical dose in man (approximately 460 mcg/m2 /day). Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in mice and rabbits when given by the subcutaneous route at doses of 156 mcg/kg/day (468 mcg/m2 /day) and 2.5 mcg/kg/day (30 mcg/m2 /day), respectively. Those dose levels are lower than the estimated maximum topical dose in man (5,948 mcg/m2 /day). The abnormalities observed included umbilical hernia, exencephaly and cleft palates.

Pregnant women were excluded from the clinical trials conducted with Taclonex® Ointment.

Nursing mothers:

Safety of the use of Taclonex® Ointment during lactation has not been established.

Nursing women were excluded from the clinical trials conducted with Taclonex® Ointment.

It is not known whether topically administered calcipotriene is excreted in human milk.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.

Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Ointment is administered to a nursing woman.

Pediatric use:

Safety and effectiveness of Taclonex® Ointment in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.

Geriatric use:

Of the total number of subjects in clinical studies of Taclonex® Ointment, approximately 14% were 65 years and older, while approximately 3% were 75 years and over.

No overall differences in safety or effectiveness of Taclonex® Ointment were observed between these subjects and younger subjects. All other reported clinical experience has not identified any differences in response between elderly and younger patients.

ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to Taclonex® Ointment in 2,448 patients, including 1,992 exposed for 4 weeks, and 289 exposed for 8 weeks. In the trials that included assessment of the effects of Taclonex® Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex® Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known (see PRECAUTIONS). The effects of Taclonex® Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. Taclonex® Ointment was studied primarily in placebo- and active-controlled trials (N = 1,176, and N = 1,272, respectively). The population was 15 — 97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most patients received once daily application, and the median weekly dose was 24.5 g.

The percentage of subjects reporting at least one adverse event was 27.1% in the Taclonex® Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group.

Adverse Events Reported by ≥ 1% of Subjects by Preferred Term

Taclonex®

Ointment

N = 2,448

Calcipotriene

N = 3,197

Betamethasone

dipropionate

N = 1,164

Vehicle

N = 470
Any Adverse Event 663 (27.1) 1055 (33.0) 329 (28.3) 157 (33.4)
Preferred Term # of subjects (%)

Pruritus

Headache

Nasopharyngitis

Psoriasis

Rash scaly

Influenza

Upper respiratory tract infection

Erythema

Application site pruritus

Skin irritation

Pain

75 (3.1)

69 (2.8)

56 (2.3)

30 (1.2)

30 (1.2)

23 (0.9)

20 (0.8)

15 (0.6)

13 (0.5)

11 (0.4)

7 (0.3)

183 (5.7)

75 (2.3)

77 (2.4)

47 (1.5)

40 (1.3)

34 (1.1)

19 (0.6)

54 (1.7)

24 (0.8)

60 (1.9)

12 (0.4)

38 (3.3)

44 (3.8)

34 (2.9)

14 (1.2)

0 (0.0)

14 (1.2)

12 (1.0)

3 (0.3)

10 (0.9)

8 (0.7)

3 (0.3)

43 (9.1)

12 (2.6)

9 (1.9)

5 (1.1)

1 (0.2)

6 (1.3)

3 (0.6)

5 (1.1)

6 (1.3)

5 (1.1)

5 (1.1)

A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.

Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects

Taclonex ®

Ointment

N = 2,448

Calcipotriene

N = 3,197

Betamethasone

dipropionate

N = 1,164

Vehicle

N = 470
Any Adverse Event 213 (8.7) 419 (13.1) 85 (7.3) 76 (16.2)
Preferred Term # of subjects (%)

Pruritus

Rash scaly

Application site pruritus

Erythema

Skin irritation

69 (2.8)

29 (1.2)

12 (0.5)

9 (0.4)

9 (0.4)

170 (5.3)

38 (1.2)

24 (0.8)

36 (1.1)

51 (1.6)

31 (2.7)

0 (0.0)

10 (0.9)

2 (0.2)

8 (0.7)

41 (8.7)

0 (0.0)

6 (1.3)

4 (0.9)

5 (1.1)

For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Taclonex® Ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%).

In a separate study, patients (N = 207) with at least moderate disease severity were given Taclonex® Ointment intermittently on an “as needed” basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Taclonex® Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the patients: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of a serious flare-up of psoriasis was reported.

Development of pustular psoriasis has been reported as an adverse reaction during and following use of Taclonex® Ointment.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.