clascoterone

Therapeutic Classification: antiacne agents

Pharmacologic Classification: androgen receptor inhibitors

Indications ⬆ ⬇

REMS

Acne vulgaris.

Action ⬆ ⬇

Acts as an androgen receptor inhibitor.

Therapeutic effects:

Reduction in inflammatory and noninflammatory acne lesions.

Pharmacokinetics ⬆ ⬇

Absorption: Does undergo systemic absorption (extent unknown).

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized in liver to several metabolites. Excretion pathway unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(diminution of acne)

ROUTE	ONSET	PEAK	DURATION
Topical	unknown	up to 12 wk	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <12 yr (safety and effectiveness not established); children may be more susceptible to hypothalamic-pituitary-adrenal (HPA) axis suppression.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: dry skin, erythema, pruritus

Endo: HPA axis suppression

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

(Adults and Children ≥12 yr): Apply to affected area(s) twice daily.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess acne lesions prior to and periodically during therapy.
Assess for local skin irritation (itching, burning, skin redness or peeling.) during therapy. Use of medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be limited.

Implementation ⬆ ⬇

Topical Cleanse affected area gently. After skin is dry, apply a thin uniform layer of cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water. Cream is white to almost white. Store cream at room temperature; throw away the unused portion 180 days after date of dispensing or 1 mo after first opening, whichever is sooner.
- For topical use only; not for ophthalmic, oral or vaginal use.

Patient/Family Teaching ⬆ ⬇

Instruct patient in proper technique for applying cream. Avoid applying to cuts, abrasions, eczematous or sunburned skin. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in inflammatory and noninflammatory acne lesions.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

47335- Sun Pharmaceutical Industries, Inc.
- 47335-994- Winlevi
  - 47335-994-36- 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE

47335- Sun Pharmaceutical Industries, Inc.
- 47335-994- Winlevi
  - 47335-994-94- 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE

58175- Wavelength Enterprises Ltd
- 58175-0650-
  - 58175-0650-0- 1 BAG in 1 DRUM (58175-0650-0) / 5 kg in 1 BAG

60722- zhejiang xianju pharmaceutical co., Ltd.
- 60722-3024-
  - 60722-3024-1- 1 kg in 1 DRUM (60722-3024-1)

60722- zhejiang xianju pharmaceutical co., Ltd.
- 60722-3024-
  - 60722-3024-2- 2.5 kg in 1 DRUM (60722-3024-2)

73377- AX Pharmaceutical Corp
- 73377-304-
  73377-304-01- 500 g in 1 JAR (73377-304-01)

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Pronunciation ⬇

Classifications ⬆ ⬇