Clobex (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2 /day basis).
Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.
Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test. The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 µg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 µg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2 /day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

14 CLINICAL STUDIES

The safety and efficacy of CLOBEX Shampoo, 0.05%, have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either CLOBEX Shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below.

Table 2: Efficacy Results CLOBEX Shampoo, 0.05%N (%) Shampoo Vehiclen (%)
Study A Study B Study A Study B
Total Number of Subjects 95 99 47 49
Success Rate1 at Endpoint2 40 (42.1%) 28 (28.3%) 1 (2.1%) 5 (10.2%)

Subjects with Scalp Psoriasis ParameterClear (None) at EndpointErythema3 Scaling3 Plaque Thickening3

17 (17.9%)21 (22.1%)35 (36.8%) 12 (12.1%)15 (15.2%)34 (34.3%) 3 (6.4%)0 (0%)5 (10.6%) 1 (2.0%)2 (4.1%)5 (10.2%)

1 Success rate defined as the proportion of subjects with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician’s Global Severity Scale for scalp psoriasis.
2 At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available).
3 Subjects with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale.
Clinical studies of CLOBEX Shampoo, 0.05%, did not include sufficient numbers of non-Caucasian subjects to determine whether they respond differently than Caucasian subjects with regards to efficacy and safety.

16 HOW SUPPLIED/STORAGE AND HANDLING

CLOBEX Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.

NDC 0299-3847-04
Storage: Keep tightly closed. Store at USP controlled room temperature 68˚ to 77˚F (20˚ — 25˚C), with excursions permitted between 59˚ and 86˚F (15˚ — 30˚C).

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Information for Patients
Inform the patient using topical corticosteroids to adhere to following instructions:

  • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
  • CLOBEX Shampoo, 0.05%, is for external use only. It should not be used on the face, underarms or groin areas. Avoid contact with the eyes and lips.
  • This medication should not be used for any disorder other than that for which it was prescribed.
  • The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician.
  • Patients should report any signs of local or systemic adverse reactions to their physician.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
  • Patients should wash their hands after applying the medication.
  • Patients should inform their physician(s) that they are using CLOBEX Shampoo, 0.05%, if surgery is contemplated.
  • Do not use other corticosteroid-containing products while using CLOBEX Shampoo, 0.05%.
  • Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of CLOBEX Shampoo, 0.05%.

Patient Information
CLOBEX® (Klo-bex)
(clobetasol propionate)
Shampoo
Important: For use on the scalp only. Do not get CLOBEX Shampoo near or in your eyes, mouth or vagina.
Read the Patient Information that comes with CLOBEX Shampoo before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is CLOBEX Shampoo?

  • CLOBEX Shampoo is a prescription corticosteroid medicine used to treat adults with moderate to severe forms of scalp psoriasis. CLOBEX Shampoo is for use on the scalp only (topical).
  • CLOBEX Shampoo should be used for the shortest amount of time needed to treat your scalp psoriasis.
  • You should not use CLOBEX Shampoo for longer than 4 weeks in a row.
  • You should not use more than 50 mL (1.75 fluid ounces) of CLOBEX Shampoo in one week.


You should not use CLOBEX Shampoo:

  • on your face, underarms (armpits) or groin areas. Avoid getting CLOBEX Shampoo in your eyes or on your lips.


CLOBEX Shampoo should not be used in children under 18 years of age.
What should I tell my doctor before using CLOBEX Shampoo?
Before you use CLOBEX Shampoo, tell your doctor if you:

  • have a scalp infection. You may need medicine to treat the scalp infection before you use CLOBEX Shampoo.
  • have any open sores or cuts on your scalp
  • plan to have surgery
  • have acne vulgaris, rosacea, or a rash around your mouth (perioral dermatitis)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if CLOBEX Shampoo can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if CLOBEX Shampoo passes into your breast milk.

Talk to your doctor about the best way to feed your baby if you use CLOBEX Shampoo.


Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using CLOBEX Shampoo. Ask your doctor or pharmacist if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist if you get a new medicine.
How should I use CLOBEX Shampoo?

  • Use CLOBEX Shampoo exactly as your doctor tells you to use it.
  • Your doctor should tell you how much CLOBEX Shampoo to use and where to apply it.
  • CLOBEX Shampoo is for use on your scalp only (topical).
  • Apply CLOBEX Shampoo on affected areas of your scalp one time each day.
  • Use only enough CLOBEX Shampoo to cover the affected areas of your scalp.
  • Do not use CLOBEX Shampoo on your face, groin, or underarms. Avoid getting CLOBEX Shampoo in your eyes or on your lips.
  • Do not wet your hair before using CLOBEX Shampoo.
  • If CLOBEX Shampoo gets on any part of your body other than your scalp, rinse the area well with water.
  • You should not bandage or cover your head with a shower cap, bathing cap, or a towel, while CLOBEX Shampoo is on your scalp, unless your doctor tells you to.
  • Tell your doctor if your scalp condition is not getting better after 4 weeks of using CLOBEX Shampoo. You should not use CLOBEX Shampoo for more than 4 weeks unless your doctor tells you to.

See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to use CLOBEX Shampoo.
What are the possible side effects of CLOBEX Shampoo?
CLOBEX Shampoo can pass through your skin. Too much CLOBEX Shampoo passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.
The most common side effects of CLOBEX Shampoo include:

  • burning or stinging at the site of application
  • itching
  • swelling
  • inflamed hair follicle
  • acne
  • dry, itchy and reddened skin
  • hair loss
  • rash or hives
  • thinning of the skin
  • widening of small blood vessels in the skin


If you go to another doctor for illness, injury or surgery, tell that doctor that you are using CLOBEX Shampoo.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of CLOBEX Shampoo. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.
How should I store CLOBEX Shampoo?

  • Store CLOBEX Shampoo at room temperature between 68˚F to 77˚F (20˚C to 25˚C).
  • Keep the CLOBEX Shampoo bottle tightly closed.


Keep CLOBEX Shampoo and all medicines out of the reach of children.
General information about CLOBEX Shampoo
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CLOBEX Shampoo for a condition for which it was not prescribed. Do not give CLOBEX Shampoo to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about CLOBEX Shampoo. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX Shampoo that is written for health professionals.
What are the ingredients in CLOBEX Shampoo?
Active ingredient: clobetasol propionate
Inactive ingredients (shampoo base): alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate and sodium laureth sulfate.
Instructions for Use
CLOBEX® (KLO-bex)
(clobetasol propionate)
Shampoo

Important: For use on the scalp only. Do not get CLOBEX Shampoo near or in your eyes, mouth or vagina.


Read the Instructions for Use that comes with CLOBEX Shampoo before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
How to apply CLOBEX Shampoo to your scalp:
Your hair should be dry when you apply CLOBEX Shampoo to your scalp.
Do not get CLOBEX Shampoo on your face, in your eyes or on your lips. If CLOBEX Shampoo does get on these areas, rinse well with water.
Step 1: To apply CLOBEX Shampoo to your scalp, part your hair at the area where it is to be applied.
Step 2: Hold the bottle of CLOBEX Shampoo over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.
Step 3: Gently rub CLOBEX Shampoo into the affected area so that only the affected area is covered with a thin, even layer of CLOBEX Shampoo.
Step 4: Repeat Steps 1 through 3 to apply CLOBEX Shampoo to other affected areas on your scalp as instructed by your doctor.
Step 5: Wash your hands after applying CLOBEX Shampoo.
Step 6: Leave CLOBEX Shampoo on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while CLOBEX Shampoo is on your scalp, unless your doctor tells you to.
Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with CLOBEX Shampoo, such as your hands, face, neck and shoulders.
No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using CLOBEX Shampoo.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
P51352-2
Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada

GALDERMA is a registered trademark.US Patent Nos. 7,316,810 and 7,700,081

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