Chew

Important Safety Information (Biotin 2.5mg + Minoxidil 1.5mg Chew)

Your safety is our first priority. Learn more about key medication details, side effects, and other important info about treatment.

The following provides a medication overview of Biotin + Minoxidil chew and how to use it to support hair loss. You will also receive a physical document called a medication guide or patient drug information in the package with your medication when it arrives from the pharmacy which contains full information about Biotin + Minoxidil chew — you should read all of the information that comes with your prescription shipment before taking your medication and at each refill. It’s important to take your medication as directed by your provider and to review the directions on your prescription label.

Read this patient information before you start using this medication and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important safety information
What is the most important information that I should know about oral minoxidil + biotin for the treatment of female pattern hair loss (androgenetic alopecia):

  • Biotin + Minoxidil Chew is a compounded daily medication prescribed off label by your provider to treat female hair loss (androgenetic alopecia). It contains minoxidil 1.5 mg and biotin 2.5 mg.

  • Biotin + Minoxidil Chew is compounded by licensed pharmacists using active pharmaceutical ingredients. However, similar to all compounded medications, Biotin + Minoxidil Chew is not FDA approved. This means that the safety, effectiveness, and quality of this medication have not been verified by the FDA, as the FDA does not verify the safety or effectiveness of any compounded drugs.

  • This tablet was formulated with dermatologists who determined that biotin at a dosage of 2.5 mg is appropriate when combined with oral minoxidil. It is not recommended that you take additional biotin supplements. High doses of biotin (5 mg or higher) may interfere with certain lab tests, including specific tests to aid in heart attack diagnoses

Do not use oral minoxidil for the treatment of your female pattern hair loss if you:

  • Are allergic to minoxidil, biotin, or any of the inactive ingredients in the chewable tablets including: minoxidil, biotin, magnesium stearate, microcrystalline cellulose, dextrose, citric acid, lemon flavor, green coloring, sucralose

  • Are pregnant or breastfeeding

  • Age younger than 18

Minoxidil is suspected to be TOXIC TO CATS AND DOGS. Please do not allow cats, dogs, or other pets to ingest this.

Keep out of reach of children and pets.

If any of the following apply to you, please speak with a healthcare provider in-person about seeking treatment for your female pattern hair loss:

  • Anyone with certain types of heart disease. If you have any heart disease, besides those listed, you must consult with a primary care provider or cardiologist prior to beginning treatment.

    • This does not include abnormal heart beat such as atrial fibrillation (Afib), SVT or long QT syndrome

  • Anyone with a history of stage 3 -5 chronic kidney disease

  • Anyone with a history of liver disease

  • Anyone with uncontrolled high blood pressure

  • Have experienced dizziness or fainting that occurs upon standing after sitting or lying down

  • Have experienced sudden onset of increased muscularity, deepening of the voice, enlargement of the clitoris, or excessive hair growth on the face or body

  • Have pheochromocytoma

  • Anyone with a history of a mini-stroke (TIA) or stroke (CVA). Be sure to completely share details of any previous mini-stroke or stroke with your provider so they can determine if treatment is safe for you.

  • Anyone experiencing hair loss related to having chemotherapy within the last year

These are some of the more common side effects of oral minoxidil:

  • Hypertrichosis, or increased hair growth on the face or body

  • Lightheadedness

  • Palpitations or tachycardia

  • Headaches

  • Leg swelling or fluid retention (edema)

  • Swelling around the eyes

  • Insomnia

  • Nausea and vomiting

  • Rash

If you experience any of the above side effects, contact your provider as you may benefit from a dose adjustment or change in treatment.

Oral minoxidil can cause early hair shedding as beneficial hair cycling is triggered. This is an expected side effect that will improve with continued minoxidil use.

Seek emergency medical care if you experience any of these side effects:

  • New or worsening chest pain

  • Shortness of breath

  • Sudden changes to your vision or hearing

  • Very severe heartburn

  • Symptoms suggestive of a severe allergic reaction (itching, anaphylaxis, rash)

  • Heart problems such as new or worsening chest pain, heart failure, irregular heartbeats, or heart attack.

  • Very low or very high blood pressure

  • Stroke

  • Liver problems

  • Kidney problems or require dialysis

These are not all of the possible side effects of oral minoxidil. For more information, ask your healthcare provider or pharmacist.

Contact your healthcare provider for medical advice about side effects. You can message a healthcare provider through your Hers account if you have any questions about your treatment, including any side effects you may be experiencing. You may report side effects to FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.