Important Safety Information

01About compounded medication

The medications in our kits are standard prescription products dispensed by a licensed U.S. pharmacy, not compounded preparations.

Individual results vary, and no provider can predict your response in advance.

02Daily tadalafil

Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor. It relaxes smooth muscle in blood vessel walls and increases blood flow. Taken daily at a low dose, it stays at a steady level rather than being timed to an occasion.

Do not use if

• You take any nitrate, in any form, regularly or now and then — nitroglycerin tablets, spray or patches, isosorbide mononitrate or dinitrate — or use “poppers” (amyl or butyl nitrite). Together they can cause a sudden, dangerous drop in blood pressure.
• You take riociguat (Adempas) or another guanylate cyclase stimulator.
• You have had an allergic reaction to tadalafil or any ingredient in the preparation.
• You are under 18.

Tell your provider before starting

Heart and blood vessels

Heart disease, a heart attack, stroke or serious arrhythmia in the last six months, angina, heart failure, low blood pressure or uncontrolled high blood pressure. Sexual activity puts strain on the heart; your provider needs to know whether that is safe for you.

Blood pressure medication and alpha-blockers

Alpha-blockers (such as tamsulosin, doxazosin or terazosin) and other blood-pressure medication can add to tadalafil’s effect and cause dizziness or fainting, especially when standing up.

Kidney or liver disease

Tadalafil clears more slowly. Daily dosing is not recommended with severe kidney or liver impairment.

Eyes and ears

Retinitis pigmentosa, or any previous sudden loss of vision or hearing.

Bleeding and anatomy

A bleeding disorder or active stomach ulcer; a deformed penis (such as Peyronie’s disease) or a condition that raises the risk of priapism, such as sickle cell anemia, multiple myeloma or leukemia.

Interactions

• Strong CYP3A4 inhibitors — ketoconazole, itraconazole, ritonavir and other HIV protease inhibitors, clarithromycin — raise tadalafil levels. Your dose may need to be lower.
• CYP3A4 inducers such as rifampin can make tadalafil ineffective.
• Other PDE5 inhibitors (sildenafil, vardenafil, avanafil, or another tadalafil product): do not combine.
• Alcohol: heavy drinking (about five drinks or more) with tadalafil raises the risk of dizziness, fast heartbeat, headache and low blood pressure.
• Grapefruit juice can raise tadalafil levels.

Possible side effects

Most common: headache, indigestion, back pain, muscle aches, flushing, stuffy nose, and pain in the arms or legs. Back and muscle pain usually appears 12 to 24 hours after a dose and settles within a couple of days.

Get medical help right away for:

• An erection lasting more than 4 hours (priapism), which can cause lasting damage if not treated;
• Sudden decrease or loss of vision in one or both eyes;
• Sudden decrease or loss of hearing, or ringing in the ears with dizziness;
• Chest pain, fainting, or a severe allergic reaction (swelling of the face or throat, difficulty breathing, severe rash).

03Tesamorelin

Tesamorelin is a synthetic analog of growth hormone–releasing hormone. Given by injection under the skin, it prompts the pituitary to release your own growth hormone, which raises insulin-like growth factor 1 (IGF-1). It is not growth hormone itself, and not a steroid. The FDA-approved product is approved only to reduce excess abdominal fat in adults with HIV and lipodystrophy; it is not approved for weight loss, and the compounded preparation is not approved for anything.

Do not use if

• You are pregnant, trying to conceive, or breastfeeding.
• You have a disorder of the pituitary or hypothalamus — a pituitary tumor, hypopituitarism, or a history of pituitary surgery, head radiation or significant head injury.
• You have an active cancer, or a history of cancer without your oncologist’s clearance. Growth hormone and IGF-1 are growth factors.
• You have had an allergic reaction to tesamorelin, mannitol, or any ingredient in the preparation.
• You are critically ill, or recovering from major surgery or trauma.
• You are under 18.

Warnings

Blood glucose

Raised growth hormone can raise blood glucose and reduce insulin sensitivity. Tell your provider about diabetes or prediabetes. Glucose is checked before and during treatment, and diabetes medication may need adjusting. People with diabetes should also have regular eye exams.

IGF-1

IGF-1 is measured on treatment and kept within the normal range for your age. A level that runs high may mean the dose is lowered or treatment is stopped.

Fluid retention and joints

Swelling of the hands and feet, joint pain, stiffness, and tingling or numbness in the hands (carpal tunnel symptoms). These are usually dose-related and settle when the dose is reduced.

Allergic reactions

Rash, hives, flushing, or swelling of the face or throat can occur. Stop and get help for any sign of a serious reaction.

Injection technique

Rotate injection sites in the abdomen, never reuse a needle or syringe, and report redness, warmth or swelling that spreads, or fever.

Interactions

• Growth hormone can change how the liver clears certain medication, including corticosteroids, sex hormones (estrogen, testosterone), anticonvulsants and cyclosporine. Your provider may monitor these.
• Insulin and other diabetes medication may need adjusting.
• Other growth hormone products or peptides (HGH, ipamorelin, CJC-1295, MK-677): do not combine without telling your provider. We do not prescribe them together.

Possible side effects

Most common: injection-site redness, itching, pain or bruising; joint pain; pain in the arms or legs; muscle aches; swelling of the hands or feet; and tingling or numbness in the hands.

Get medical help right away for swelling of the face, lips or throat, difficulty breathing, a fast heartbeat with a widespread rash, or signs of high blood sugar (strong thirst, frequent urination, blurred vision).

04Prescription medical kits

Each kit holds prescription medication for specific situations — depending on the kit, antibiotics, a steroid and other prescription medication, and in some kits epinephrine auto-injectors and a tourniquet — with a plain-language guide that says which to use for which symptoms. A provider reviews your history before the kit ships.

Before you use any kit medication

• Follow your kit guide and your provider. Use a medication only for the situations its guide describes, at the dose on its label. If you are not sure it fits, message your care team first.
• Allergies: tell your provider about any drug allergy before your kit is approved, especially to penicillin, cephalosporins, sulfa drugs or macrolides. Do not take a medication you have reacted to before.
• Antibiotics: they treat bacterial infections only, not colds or flu. Finish the course as directed. Severe or bloody diarrhea during or after a course can mean a serious infection; get care.
• Steroids: can raise blood glucose and blood pressure and affect mood and sleep. Tell your provider about diabetes, high blood pressure, glaucoma, stomach ulcers or a current infection.
• Pregnancy, breastfeeding and children: several kit medications are not suitable. Each kit is prescribed to one adult patient; do not give it to anyone else.
• Your other medication: kit medications can interact with blood thinners, heart rhythm medication and others. Your provider checks the list you give at intake, so keep it current.
• Storage: keep the kit at room temperature, away from children, and replace anything past its expiration date.

05For every treatment

• Give your provider a complete, honest health history and a full list of everything you take — prescriptions, over-the-counter medicine, vitamins, supplements and peptides, whatever the source. Update it if anything changes.
• Fatigue, low energy, weight changes and sexual problems can have causes that need investigating, such as heart disease, diabetes, thyroid disease or low testosterone. A prescription here is not a substitute for that workup.
• Use your medication only as prescribed, and do not share it.
• FoundationRx treats adults 18 and over only.

06Reporting a side effect

Tell your care team about any side effect, even a minor one.