Rx Safety Information - Finasteride

You must always read this safety information before starting this medication and with every refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider. 

This compounded product has not been approved by the FDA. It is only available if prescribed by a dermatologist  through Tangl who will determine if treatment is suitable. 

What I need to know about topical Finasteride +
5% Minoxidil Roller: 

• Finasteride +
5% Minoxidil is a compounded medication combining topical Finasteride and topical Minoxidil, as well as cetirizine, caffeine. 
• Finasteride is an FDA-approved medication used to treat male pattern baldness due to its DHT blocking effects. Low dose topical finasteride is sometimes used off-label for its anti-androgenic effects in the treatment of hair loss, particularly in women who have a condition called androgenetic alopecia (female pattern hair loss) or other hair loss conditions with an androgenic component. It works by inhibiting the activity of the hormone dihydrotestosterone (DHT), which is a key factor in hair loss in individuals with a genetic predisposition to this condition. 
• Topical minoxidil is a widely used medication for the treatment of hair loss, including androgenetic alopecia. 
• Tretinoin and melatonin are compounded together to be used off-label as supportive topicals aiding in better absorption of the ingredients, creating an optimized scalp environment, and improving the hair growth cycle.

Absolute Contraindications – DO NOT use Finasteride +
5% Minoxidil if you: 

• Are allergic to any of the active ingredients
• Are pre-menopause or are pregnant, breastfeeding, or planning to become pregnant. Finoxidil™ is made for post-menopausal women only.
• Have any present or past cancer, heart problems, kidney problems or liver problems

Drug Interactions – DO NOT use Finasteride +
5% Minoxidil if you take: 

• Lithium
• Guanethidine
• Saw Palmetto 
• Certain blood pressure medications (see a doctor in-person about seeking treatment with Finasteride +
5% Minoxidil) 

Serious Side Effects – STOP treatment and seek emergency medical care or call 911 if you experience:  

• Chest pain, rapid heartbeat, faintness, dizziness, or difficulty breathing  
• Sudden, unexplained weight gain (edema)
• Swelling in the face, hands, legs, feet or ankles
• Tingling or burning sensation of the face, throat hands or feet
• Hypotension, worsening of renal (kidney) function or fluid retention
• Gynecomastia/Breast tenderness/increase in breast size/lump under the arm or breast area
• Lack of libido, sexual dysfunction 
• Mental, psychological or cognitive issues (e.g. depression, confusion, memory loss, etc.)
• Severe scalp irritation 

It’s important to closely and regularly monitor for these side effects while taking Finoxidil™, especially when starting or changing your dose, as they can indicate a severe reaction. If you notice any side effects, stop using Finasteride +
5% Minoxidil and seek immediate medical attention, or call 911. 

Common Side Effects  – Talk to your provider about changing your dose/treatment if you experience:    

• Unwanted hair growth on the face or body (hypertrichosis) 
• Headache    
• Insomnia 
• Nausea 
• Local scalp irritation, including redness or minor swelling
• Hair shedding: It's common to experience increased hair shedding initially. This is typically a temporary phase as hair follicles regenerate. 
• Some may also experience changes in hair texture and color. 

These are not all the possible side effects of Finasteride +
5% Minoxidil. For more information, ask your healthcare provider or pharmacist and refer to the complete prescribing information: Finasteride, Topical Minoxidil, Tretinoin, Melatonin

SERIOUS WARNINGS:

• CARDIAC EFFECTS: In rare cases topical minoxidil, one of the active ingredients in Finoxidil™, can lead to cardiovascular side effects. Pericardial effusions, which is the excessive buildup of fluid in the sac surrounding the heart (pericardium), have been reported in patients taking minoxidil. This can progress to cardiac tamponade, which is a life-threatening condition where the fluid pressure compresses the heart, preventing it from effectively pumping blood. Symptoms encompass sharp chest pain and breathing difficulties. If you notice these symptoms, seek immediate emergency medical care. 
• PREGNANCY RISK: Finasteride, one of the active ingredients in Finoxidil™ is a category X teratogenic medication that can cause birth defects in male fetuses. Finasteride should not be used by women who have child-bearing potential. Women who are planning to get pregnant, are pregnant, or breastfeeding must avoid contact with Finasteride. You must not donate blood while on Finasteride to prevent female recipients from being exposed. This medication should not be used or applied around children, other women of childbearing age, and pets.

Do not let children, pregnant or breastfeeding women, or women who may become pregnant handle this medication. Do not let them touch the area where the medication is applied (such as your scalp). If contact occurs, they should immediately wash the affected skin area with soap and water.Always use Finasteride +
5% Minoxidil under the supervision of a healthcare professional and undergo regular medical assessments during treatment.

WARNING: TOXIC TO PETS  

• Minoxidil, one of the active ingredients in Finasteride +
5% Minoxidil, is highly toxic to animals, especially cats; even trace amounts can be life-threatening. 
• Do not apply minoxidil if pets are in close proximity
• Do not approach your pets until the treated area has thoroughly dried
• Wash hands and surfaces thoroughly after application
• Do not let pets near the application site (i.e. do not hold pets near your face/hair)
• Beware of pillowcases: minoxidil can transfer to pillow cases during sleep. To prevent any risk to your pets, especially cats, consider removing or replacing pillow cases after use. Alternatively, ensure that your pets do not have access to areas where pillows might be.
• Always store Finoxidil™ in a secure location out of reach of pets. 
• If you suspect your pet has come into contact with minoxidil or displays symptoms such as lethargy, rapid breathing, vomiting, or collapse, seek emergency veterinary care immediately.

Always Inform Medical Professionals: Always consult a healthcare provider immediately about any unusual side effects, concerns or changes noticed during treatment. You can message your Tangl dermatologist through your Tangl account (trytangl.com/account) if you have any questions or concerns about your treatment.  

Always Provide Accurate Health Information: Failing to provide accurate information about your health and medical history can lead to severe consequences, including harm or, in some instances, death.

Report Side Effects to the FDA:  Negative side effects should be reported to the FDA at www.fda.gov/medwatch  or call 1-800-FDA-1088.

Instructions For Use:

• Follow your healthcare provider's specific instructions when using this medication
• Do not apply this medication more than the recommended dose; doing so won't enhance results and may raise the likelihood of side effects
• Wash your hands with soap after application
• This product is meant solely for your scalp, repeated contact with other skin areas can potentially result in unwanted hair growth. If the medication accidentally gets on your face, wash it off with soap and water immediately.
• Do not apply on other parts of the body
• Avoid contact with the eyes. In case of accidental contact, rinse eyes with copious amounts of cool tap water 
• Do not use this medication for a condition for which it was not prescribed.
• Never share this medication with others, even if their symptoms are similar to yours. It may be harmful to them. 

Storage Information:

• Keep this medication at a room temperature 
• Dispose of the medication if you are no longer using it. 
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: The FDA has not evaluated all the claims made here. This medication is not guaranteed to diagnose, treat, cure, or prevent any disease. Individual results may vary. This information is not comprehensive. Please see the full prescribing link below for complete safety information: Finasteride, Topical Minoxidil, Tretinoin, Melatonin