Important Safety Information

What This Medication Is

The Women’s 3-in-1 Hair Capsule is a prescription compounded medication containing three ingredients in a single oral capsule:

• Minoxidil, a vasodilator that widens blood vessels and increases blood flow to the hair follicle
• GHK-Cu, a copper peptide
• Biotin, a B vitamin, at a dose well above normal dietary intake

It is prepared by a licensed compounding pharmacy for an individual patient. Compounded medications are not FDA approved finished products and are not evaluated by the FDA for safety or effectiveness in the way commercially manufactured products are. This specific combination has not been studied as a finished product.

Minoxidil is separately available as an FDA-approved medication, approved to treat high blood pressure. Using it for hair loss is off-label. Oral GHK-Cu has not been established as a treatment for hair loss, and safety data for copper peptides taken by mouth is limited; most evidence for GHK-Cu concerns topical use.

Do Not Use If You:

This capsule is compounded, so it has no FDA-approved labeling of its own. These are the medical reasons not to take it, drawn from its ingredients:

• Have a pheochromocytoma, a tumor of the adrenal gland (a contraindication for minoxidil)
• Have a copper-metabolism disorder, such as Wilson’s disease or Menkes disease
• Have a known allergy or sensitivity to copper or other heavy metals
• Have had an allergic reaction to minoxidil, biotin, or any other ingredient in this capsule

Belle will also not prescribe this treatment if you:

• Are pregnant, trying to become pregnant, or breastfeeding
• Are under 18

Before Taking This Capsule

Tell your healthcare provider about your full medical history, including if you have:

• Any heart condition, including angina, a previous heart attack, heart failure, or a history of stroke
• Pericarditis or fluid around the heart
• Low blood pressure, or a tendency to feel faint or lightheaded when standing
• Kidney disease, or if you are on dialysis
• Liver disease
• Fluid retention or unexplained swelling
• A thyroid condition, or any scheduled bloodwork (see laboratory testing below)
• Any other medical conditions or allergies

Also tell your provider about every medication you take, including prescription and over-the-counter medicines, vitamins, herbal products, and dietary supplements. In particular:

• Guanethidine should be stopped before starting minoxidil, because taking them together can cause a severe drop in blood pressure.
• Other blood-pressure medications and diuretics, which can add to the effect on your blood pressure.
• Topical or oral minoxidil from any other source. Do not use more than one minoxidil product at a time.
• Other supplements containing biotin, including hair, skin and nail products and multivitamins, so your total biotin intake is known.
• Zinc or copper supplements, because copper and zinc compete for absorption and long-term imbalance in either direction can cause problems.

Withholding information about your health, or giving inaccurate information in order to obtain treatment, can lead to serious harm.

Biotin & Laboratory Testing

This capsule contains biotin at a dose far above what you get from food. High-dose biotin interferes with many common blood tests that use biotin-streptavidin technology, producing results that are falsely high or falsely low depending on the test. The FDA has issued a safety communication about this.

The most serious example is troponin, the blood test used to diagnose a heart attack. Biotin can make a troponin result read falsely low, which can cause a heart attack to be missed. The FDA has reported a death linked to this interference. This matters more for this capsule than it would on its own, because the minoxidil in it carries its own cardiac warning. If you go to an emergency room with chest pain, tell the treating clinician that you take biotin.

Biotin can also distort:

• Thyroid tests (TSH, T3, T4), sometimes closely mimicking an overactive thyroid and leading to unnecessary treatment
• Pregnancy tests (hCG)
• Vitamin D, parathyroid hormone, cortisol, and ferritin

Tell every provider who orders bloodwork for you that you take biotin. Many will ask you to stop it for a period before testing, commonly 48 to 72 hours, but follow the instruction of the provider ordering the test. Do not stop or restart this medication on your own without telling your Belle care team.

Pregnancy & Breastfeeding

Belle does not prescribe this capsule if you are pregnant, trying to become pregnant, or breastfeeding.

The labeling for minoxidil tablets does not list pregnancy as a contraindication. It says minoxidil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. That weighing is written for treating high blood pressure, where the benefit can be considerable. Treating hair loss is elective, so there is no comparable benefit to weigh against the risk, and Belle treats that as a reason not to prescribe. Safety data for oral GHK-Cu in pregnancy is not established.

• Minoxidil passes into breast milk.
• Biotin can interfere with hCG pregnancy blood tests, which can make a pregnancy test read incorrectly. Tell your provider you take biotin if a pregnancy test is being run.
• Tell your provider right away if you become pregnant while taking it.

Serious Side Effects: Seek Care Immediately If You Experience:

If you are having a medical emergency, call 911 or go to the nearest emergency room, and tell the treating clinician you take biotin.

• Fluid around the heart (pericardial effusion or tamponade): sharp chest pain, pain spreading to the arm or shoulder, shortness of breath, dizziness, lightheadedness, or fainting
• Worsening chest pain (angina): new chest pain, or chest pain that happens more often or more easily than before
• Rapid heartbeat (tachycardia): an increase of 20 beats per minute or more above your usual resting pulse
• Salt and water retention: rapid weight gain of five pounds or more, or new swelling or puffiness in the face, hands, ankles, or abdomen
• Blood pressure dropping too fast: fainting, severe dizziness, or confusion
• Serious allergic or skin reaction: rash, blistering, peeling skin, or swelling of the face, lips, tongue, or throat

Your provider may ask you to weigh yourself regularly and to check your resting pulse, particularly when you start treatment or change dose.

Unwanted Hair Growth (Hypertrichosis)

The most commonly reported side effect of oral minoxidil is hair growth where you do not want it: longer, thicker, darker hair on the face, arms, back, or legs. It is typically noticed within three to six weeks of starting treatment, is reported more often by women than by men, and becomes more likely at higher doses.

It is generally reversible. Hair growth usually slows and reverses within one to six months of stopping the medication. If it happens, tell your provider rather than adjusting your own dose.

Common Side Effects

• Unwanted hair growth on the face or body
• Salt and water retention, and swelling in the ankles, legs, or face
• Lightheadedness, dizziness, or low blood pressure, especially when standing up
• A faster heartbeat
• Headache, which often eases over time
• Breast tenderness
• Nausea, stomach upset, or a metallic taste
• Changes on an ECG

This is not a complete list. Contact your provider if any side effect persists, worsens, or concerns you.

How to Take It

• Take one capsule daily, exactly as prescribed. It can be taken with or without food.
• Do not change your dose, take extra, or stop and restart without speaking to your provider first.
• Do not use any other minoxidil product, topical or oral, at the same time.
• Check other supplements for biotin so you are not doubling up without knowing.
• Hair regrowth is maintained only while you continue treatment. Hair regrown with minoxidil is usually lost again over several months after stopping.
• Some extra shedding in the first weeks is common and usually settles within about a month. Tell your care team if it continues.

A Note on Compounded Medications

This capsule is prepared by a licensed compounding pharmacy to meet the needs of an individual patient. Compounded medications are not FDA approved finished products and are not evaluated by the FDA for safety or effectiveness. This particular combination of minoxidil, GHK-Cu, and biotin has not been studied as a finished product, and the evidence behind each ingredient is not equivalent: minoxidil has substantial evidence for hair loss, biotin has evidence mainly in people who are deficient in it, and oral GHK-Cu has not been established for this use.

Emergency Information

• In case of a medical emergency, call 911 or go to the nearest emergency room. Tell the treating clinician you take biotin, especially if you are being assessed for chest pain.
• To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
• To reach the Belle care team, text +1-877-359-1724 or call +1-888-541-6003.

This information is not comprehensive. Ask your provider or pharmacist for complete safety information about each ingredient in this capsule.