Dermatology · By prescription
Compounded clascoterone topical serum
A patient-specific compounded preparation, made by AccuMix Pharmacy on a prescription from a licensed provider. It is supplied as a topical spray in 30 mL and 60 mL bottles.
The preparation
Clascoterone topical serum, compounded to order
Clascoterone topical serum is a non-sterile preparation that AccuMix compounds for an individual patient when a licensed prescriber orders it. It is compounded at the strength your prescriber orders. Available strengths include 5%. It is supplied as a topical spray in 30 mL or 60 mL bottles.
Clascoterone is the active ingredient in Winlevi® (clascoterone cream 1%), a prescription medicine that the FDA has approved for acne. The FDA-approved labeling describes clascoterone as an androgen receptor inhibitor. Our preparation is compounded. It is not an FDA-approved product, and the FDA has not evaluated it for safety or effectiveness for any use.
Whether it is appropriate for a patient is the prescriber’s clinical decision.
What to expect from AccuMix
Made for one patient, checked by a pharmacist
Compounded per prescription
Each bottle is compounded on a prescription for a named patient, verified by a pharmacist and labeled with that patient’s directions.
Pharmacists you can reach
Prescribers, clinic staff and patients can call our pharmacists with questions about the preparation, its ingredients, handling and storage.
Prompt and documented
Our turnaround time is 24 hours. A certificate of analysis is available for every API lot and every batch.
Using it
Using the preparation
- Use it exactly as your prescriber directs, on the area and on the schedule printed on your label.
- Apply to clean, dry skin and let it dry. Wash your hands afterwards.
- Keep it away from your eyes, mouth and broken or irritated skin, and do not breathe in the spray.
- Use only the amount prescribed. Do not cover the area with a tight dressing unless your prescriber tells you to.
- Follow the storage directions and the beyond-use date on your label.
We do not publish dosing schedules. Your directions come from your prescriber and appear on your prescription label.
Safety
What to know before you start
The points below come from the FDA-approved labeling for clascoterone 1% cream. Our compounded preparation has not been reviewed by the FDA.
- Redness, itching and scaling or dryness can occur where it is applied. Tell your prescriber if irritation is severe or does not settle.
- Do not apply it to cuts, scrapes, eczema or sunburned skin.
- Clascoterone can affect the body’s cortisol system (HPA axis suppression). The risk is higher when it is used over large areas, for long periods or under a covering, so use only the amount prescribed.
- Raised potassium levels have been reported in some people using the cream.
- There are no data on use during pregnancy or breastfeeding. Tell your prescriber if you are pregnant, planning a pregnancy or breastfeeding.
- Tell your prescriber about every medicine and every skin or scalp product you use.
- Get emergency care for signs of a serious allergic reaction, such as swelling of the face or throat or trouble breathing.
How to get it
For patients, providers and telehealth platforms
Patients
Ask your provider whether this preparation is appropriate for you. If they prescribe it, they can send the prescription to AccuMix Pharmacy. If your provider has not worked with us before, tell us who they are and we will contact their office.
Providers and clinics
Send prescriptions by e-prescription or by fax to 866-817-5305. Include the patient’s name and date of birth, strength, quantity, directions, refills and allergies. Each provider also receives their own login to our provider portal. A pharmacist verifies every order.
Telehealth platforms
Looking for a partner pharmacy that compounds clascoterone? We fill patient-specific prescriptions written by your licensed prescribers and ship directly to patients. We connect to your platform by HL7, FHIR or webhooks, or work inside the system you already use.
Our turnaround time is 24 hours. We ship to the 37 states and Washington, DC where we hold a pharmacy license. See the states we serve.
How it is made
Compounded to USP standards
The serum is compounded under USP <795>, by a team led by board-certified pharmacists, and dispensed in 30 mL and 60 mL spray bottles. Ingredients come from FDA-registered suppliers and are verified against a certificate of analysis. A pharmacist checks each step, and every preparation is traceable by lot.
Common questions
Compounded clascoterone: questions and answers
Is compounded clascoterone FDA-approved?
No. The only FDA-approved clascoterone product is a 1% cream for acne (Winlevi®). Compounded preparations are not reviewed or approved by the FDA, and our preparation has not been evaluated by the FDA for safety or effectiveness for any use.
Is this the same as Winlevi®?
No. Winlevi® is a commercially manufactured 1% cream that is approved by the FDA. Our preparation is a topical serum compounded on a prescription for one patient, at the strength the prescriber orders. It is a different dosage form, and it is not FDA-approved.
What is it prescribed for?
That is for the prescriber to decide. AccuMix does not recommend this preparation for any particular condition and makes no claims about results. If you want to know whether it is right for you, talk to your provider.
Do I need a prescription?
Yes. We compound clascoterone only after we receive a valid prescription from a licensed provider for a named patient. Nothing is sold through this website.
What strengths are available?
The serum is compounded at the strength your prescriber orders. Available strengths include 5%.
What sizes does it come in?
The serum comes in a spray bottle, in 30 mL and 60 mL sizes. Your prescriber chooses the quantity.
Is it available now?
Yes. We are dispensing compounded clascoterone topical serum now, by prescription, with a 24 hours turnaround time, to patients in the 37 states and Washington, DC where we hold a pharmacy license.
What side effects are possible?
With the FDA-approved 1% cream, the most common reactions are redness, itching and scaling or dryness where it is applied. See the safety section on this page, and ask your prescriber or one of our pharmacists if you have questions.
How do I get it from AccuMix?
Ask your provider to send the prescription to AccuMix Pharmacy by e-prescription or by fax to 866-817-5305. If your provider has not worked with us, use our Refer your provider page and we will contact their office.
AccuMix Pharmacy is a 503A compounding pharmacy. We compound clascoterone only after receiving a valid prescription for an individual patient. Compounded medications are not reviewed or approved by the FDA. This page describes a preparation we compound. It is not medical advice, and it makes no claim that the preparation treats, cures or prevents any condition. Your prescriber decides whether it is right for you.
Talk to a pharmacist about compounded clascoterone
Questions about the preparation, how to prescribe it, or a partnership for your clinic or telehealth platform? Call us Monday to Friday, 8:30 AM to 5:30 PM Central.
