Taclonex Scalp (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

When calcipotriene was applied topically 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 biologically 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.

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 effect in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.

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

Studies in male rats at oral doses of up to 200 mcg/kg/day (1,200 mcg/m2 /day), and in female rats at oral doses of up to 1,000 mcg/kg/day (6,000 mcg/m2 /day) of betamethasone dipropionate indicated no impairment of fertility.

14 CLINICAL STUDIES

14.1 Controlled Clinical Studies

Two multicenter, randomized, double-blind studies were conducted. In Study One, 1,407 subjects were randomized to one of four treatment groups: Taclonex Scalp® Topical Suspension, betamethasone dipropionate in the same vehicle, calcipotriene hydrate in the same vehicle, or the vehicle alone. Study Two did not include a vehicle arm; 1,280 subjects were randomized to one of three treatment groups: Taclonex Scalp® Topical Suspension, betamethasone dipropionate in the same vehicle, or calcipotriene hydrate in the same vehicle. Both studies enrolled subjects with moderate to very severe scalp psoriasis. The majority of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.

Efficacy was assessed as the proportion of patients at Week 8 with absent or very mild disease according to an Investigator’s Global Assessment of Disease Severity. “Clear” was defined as no evidence of redness, thickness or scaling. “Almost clear” was defined as an overall clinical picture of lesions with the presence of minimal erythema. Table 2 contains the response rates in each of these two trials.

Table 2

Percentage of Patients with Clear or Almost Clear Disease

According to the Investigator’s Global Assessment of Disease Severity

Taclonex Scalp ®

Topical

Betamethasone dipropionate in vehicle Calcipotriene in vehicle Vehicle

Study One

(N = 494)

(N = 531)

(N = 256)

(N = 126)

Week 8 70.0% 63.1% 36.7% 19.8%

Study Two

(N = 512)

(N = 517)

(N = 251)

-

Week 8 67.2% 59.6% 41.0% -

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Taclonex Scalp® Topical Suspension is available in bottles of:

16.2 Storage

Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).

Do not refrigerate. Keep the bottle in the outer carton when not in use.

The product should be used within three months after it has been opened.

16.3 Handling

Keep out of reach of children.

Shake before use.

Rx only.

17 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 Taclonex Scalp® Topical Suspension should receive the following information and instructions.

17.1 Instructions for Use

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. This medication should not be used for any disorder other than that for which it has been prescribed. The treated skin area should not be bandaged or otherwise covered as to be occlusive, unless directed by the physician.

17.2 Adverse Reactions

Patients should report any signs of adverse reactions to their physician.

17.3 Concomitant Use of other Corticosteroids

Other products containing calcipotriene or a corticosteroid should not be used with Taclonex Scalp® Topical Suspension without first talking to the physician.

17.4 Excessive Exposure to Light

Patients who use Taclonex Scalp® Topical Suspension 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 Scalp® Topical Suspension.

PATIENT INFORMATION

Taclonex Scalp ® (pronounced TAK-lo-NEKS skalp)

(calcipotriene, 0.005% and betamethasone dipropionate, 0.064%)

Topical Suspension

Read the Patient Information that comes with Taclonex Scalp® Topical Suspension before you start using it and each time you refill your prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

Important information: Taclonex Scalp® Topical Suspension is for use on the scalp only (topical use only). Do not use Taclonex Scalp® Topical Suspension on the face, under arms or on groin area. Do not swallow Taclonex Scalp ® Topical Suspension. Another product, Taclonex® Ointment contains the same medicine that is in Taclonex Scalp® Topical Suspension and is used to treat psoriasis vulgaris of the skin. If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medicines.

What is Taclonex Scalp ® Topical Suspension?

Taclonex Scalp® Topical Suspension is a prescription medicine that is for use on the scalp only (a topical medicine). Taclonex Scalp® Topical Suspension is used to treat psoriasis vulgaris in adults 18 years of age and older. Taclonex Scalp® Topical Suspension is not recommended for use in children. Taclonex Scalp® Topical Suspension has not been studied in patients under the age of 18.

Who should not use Taclonex Scalp ® Topical Suspension?

Do not use Taclonex Scalp ® Topical Suspension if you:

  • have a calcium metabolism disorder
  • have one of the following types of psoriasis:
    • erythrodermic psoriasis
    • exfoliative psoriasis
    • pustular psoriasis
  • have severe kidney or liver disease.

What should I tell my doctor before using Taclonex Scalp ® Topical Suspension?

Tell your doctor about all of your health conditions, including if you:

  • have a skin infection on your scalp. Your skin infection should be treated before you start using Taclonex Scalp® Topical Suspension
  • have thin-skin (atrophy) at the site to be treated. You should not use Taclonex Scalp® Topical Suspension
  • are getting phototherapy treatments (light therapy) for your psoriasis
  • are pregnant or planning to become pregnant. It is not known if Taclonex Scalp® Topical Suspension can harm your unborn baby. You and your doctor will have to decide if Taclonex Scalp® Topical Suspension is right for you while pregnant
  • are breastfeeding. It is not known if Taclonex Scalp® Topical Suspension passes into your milk and can harm your baby.

Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins and herbal supplements.

Taclonex Scalp® Topical Suspension and some other medicines may interact with each other. Especially tell your doctor if you use:

  • other corticosteroid medicines
  • other medicines for your psoriasis.

How should I use Taclonex Scalp ® Topical Suspension?

  • Use Taclonex Scalp® Topical Suspension exactly as prescribed by your doctor.
  • Do not use more than the maximum recommended weekly amount of 100 grams of Taclonex Scalp® Topical Suspension.
  • Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. Do not use Taclonex Scalp® Topical Suspension for more than 8 weeks unless prescribed by your doctor.
  • Taclonex Scalp® Topical Suspension should only be used on the scalp. Do not use Taclonex Scalp® Topical Suspension on the face, under arms or on groin area. If you accidentally get Taclonex Scalp® Topical Suspension on your face or in your eyes wash the area with water right away.
  • If you forget to use Taclonex Scalp® Topical Suspension, use it as soon as you remember. Then go on as before.
  • Wash your hands well after using Taclonex Scalp® Topical Suspension.
  • Do not wash your hair right after applying Taclonex Scalp® Topical Suspension. The medicine will not work as well to treat your psoriasis.

Using Taclonex Scalp ® Topical Suspension:

  • Do not bandage or tightly cover or wrap the treated skin area.
  • Do not apply Taclonex Scalp® Topical Suspension in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your doctor first.
  • Shake the bottle before use.

Remove the cap and apply Taclonex Scalp® Topical Suspension one time each day to the areas of your scalp affected by psoriasis, using the following steps (See the figures below).

3 scalp images
(click image for full-size original)

What should I avoid while using Taclonex Scalp ® Topical Suspension?

Avoid spending a long time in sunlight. Avoid tanning booths and sun lamps. Use sunscreen and wear a hat if you have to be in sunlight. Talk to your doctor if you get a sunburn.

What are the possible side effects of Taclonex Scalp ® Topical Suspension?

Taclonex Scalp ® Topical Suspension may cause serious side effects.

Serious side effects are more likely to happen if you use too much Taclonex Scalp® Topical Suspension, use it for too long, or use it with other topical medicines that contain corticosteroids, calcipotriene, or certain other ingredients. Check with your health care professional before using other topical medicines. Taclonex Scalp® Topical Suspension can pass through your skin and be absorbed into the body.

Serious side effects may include:

  • too much calcium in your blood
  • adrenal gland problems

Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex Scalp® Topical Suspension.

Other side effects include:

  • itching
  • inflamed hair pores (folliculitis)
  • skin pain or irritation
  • skin burning
  • redness of the skin
  • worsening of psoriasis

Call your doctor about any side effect that bothers you or that does not go away.

These are not all of the side effects with Taclonex Scalp® Topical Suspension. Ask your doctor or pharmacist for more information.

How should I store Taclonex Scalp ® Topical Suspension?

  • Store Taclonex Scalp® Topical Suspension between 68-77°F (20-25°C). Do not refrigerate.
  • Keep the bottle in the carton when not in use.
  • Taclonex Scalp® Topical Suspension has an expiration date (exp.) marked on the bottom of the bottle. Do not use the topical suspension after this date.
  • Use Taclonex Scalp® Topical Suspension within three months after it has been opened. After three months, safely throw away the bottle with any leftover Taclonex Scalp® Topical Suspension. If you need to keep using Taclonex Scalp® Topical Suspension or begin using it again, use a new bottle.
  • Keep Taclonex Scalp ® Topical Suspension and all medicines out of the reach of children.

General information about Taclonex Scalp ® Topical Suspension.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex Scalp® Topical Suspension for a condition for which it was not prescribed. Do not give your Taclonex Scalp® Topical Suspension to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Taclonex Scalp® Topical Suspension. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex Scalp® Topical Suspension that is written for health professionals. For more information, please visit www.taclonex.com or call 1-877-494-4536.

What are the ingredients in Taclonex Scalp ® Topical Suspension?

Active ingredients: calcipotriene hydrate, betamethasone dipropionate.

Inactive ingredients: hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Manufactured by:

LEO Pharmaceutical Products Ltd.,
Ballerup, Denmark

LEO ® image of Leo

Distributed by:

LEO Pharma Inc.
1 Sylvan Way, Parsippany, NJ 07054, USA
1-877-494-4536

U.S. Patent Nos. RE39,706 E, 6,753,013 and 6,787,529.

024580-00

December 2009

Relabeling of “Additional Barcode” label by:

Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

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