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Safety Information

Important safety information for Keen Testosterone Spray Therapy (Keen T-Spray). Includes warnings, side effects, drug interactions, contraindications, and monitoring requirements.

Effective
March 1, 2026
Last updated
March 1, 2026
Owner
Keen Meds Inc.

Overview

PLEASE READ THIS IMPORTANT SAFETY INFORMATION CAREFULLY BEFORE USING KEEN TESTOSTERONE SPRAY THERAPY (KEEN T-SPRAY) OR ANY PRESCRIPTION PRODUCT OBTAINED THROUGH THE KEEN PLATFORM.

THIS INFORMATION IS PROVIDED FOR EDUCATIONAL PURPOSES AND DOES NOT REPLACE THE ADVICE OF YOUR HEALTHCARE PROVIDER. ALWAYS CONSULT YOUR PRESCRIBING CLINICIAN BEFORE STARTING, STOPPING, OR CHANGING ANY MEDICATION.

IF YOU HAVE A MEDICAL EMERGENCY, CALL 911 OR GO TO YOUR NEAREST EMERGENCY ROOM IMMEDIATELY.

1. About This Page

1.1 This Important Safety Information page provides key safety details about prescription products available through the Keen platform (livekeen.co), operated by Keen Meds Inc. ("Keen," "we," "us," or "our"), a Delaware corporation. "Keen" is the brand name under which Keen Meds Inc. operates.

1.2 Medical services provided through the Platform are delivered by licensed clinicians affiliated with our independent medical practice partner. Prescription medications are compounded and dispensed by our licensed 503A compounding pharmacy partner. The specific medical practice and pharmacy entities are identified in Section 14 (Contact Information) of this page.

1.3 This page focuses primarily on Keen Testosterone Spray Therapy (Keen T-Spray), which utilizes Hypospray technology for transdermal spray delivery of testosterone. Additional safety information for other products may be provided separately or during your clinical consultation.

1.4 This safety information supplements, and should be read in conjunction with, the product-specific information provided with your prescription, the instructions from your prescribing clinician, and the following Keen policies:

2.1 Testosterone therapy is indicated for the treatment of males with conditions associated with a deficiency or absence of endogenous testosterone, including:

  • Primary hypogonadism (congenital or acquired) resulting from testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
  • Hypogonadotropic hypogonadism (congenital or acquired) resulting from idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

2.2 Keen T-Spray delivers testosterone transdermally via Hypospray technology. Your clinician will determine the appropriate dosage based on your lab results, medical history, symptoms, and clinical response.

2.3 Testosterone therapy should only be used under the supervision of a licensed healthcare provider and requires confirmation of low testosterone levels through laboratory testing prior to initiation of therapy.

3. Who Should NOT Use Testosterone Therapy

3.1 Do NOT use testosterone therapy if you:

  • Have known or suspected breast cancer in men.
  • Have known or suspected prostate cancer or a history of prostate cancer.
  • Are pregnant or may become pregnant. Testosterone can cause harm to an unborn baby, including virilization of a female fetus. Women of childbearing potential should not use testosterone products unless specifically prescribed and monitored by their clinician for an approved indication.
  • Have a known hypersensitivity (allergic reaction) to testosterone or any ingredient in the formulation. Allergic reactions may include hives, rash, difficulty breathing, or swelling of the face, lips, tongue, or throat.
  • Have serious cardiac, hepatic (liver), or renal (kidney) disease that, in the judgment of your clinician, makes testosterone therapy inappropriate.

3.2 Always inform your clinician of your complete medical history, including all current medications, supplements, and health conditions, before starting testosterone therapy.

4. Important Warnings

IMPORTANT: Read all warnings before using testosterone therapy.

4.1 Cardiovascular Risk

Testosterone therapy may increase the risk of serious cardiovascular events, including:

  • Heart attack (myocardial infarction)
  • Stroke
  • Elevated blood pressure (hypertension)

Patients with pre-existing cardiovascular disease, risk factors for cardiovascular disease (including smoking, high blood pressure, high cholesterol, diabetes, and obesity), or a history of heart attack or stroke should discuss these risks carefully with their clinician. Report any chest pain, shortness of breath, weakness on one side of the body, or slurred speech to your healthcare provider immediately.

4.2 Blood Clots (Venous Thromboembolism)

Testosterone therapy may increase the risk of blood clots, including:

  • Deep vein thrombosis (DVT) — blood clots in the legs
  • Pulmonary embolism (PE) — blood clots in the lungs

Seek immediate medical attention if you experience leg pain or swelling, sudden shortness of breath, chest pain, or coughing up blood.

4.3 Polycythemia (Elevated Red Blood Cell Count)

Testosterone can stimulate the production of red blood cells, leading to polycythemia (an abnormally high red blood cell count or elevated hematocrit). This condition increases the risk of blood clots, stroke, and heart attack. Regular blood monitoring is required (see Section 9, Monitoring Requirements). Your clinician may adjust your dose or discontinue therapy if hematocrit levels become elevated.

4.4 Liver Effects

Testosterone therapy, particularly at high doses or with oral formulations, has been associated with:

  • Elevated liver enzymes
  • Hepatic (liver) dysfunction
  • In rare cases, peliosis hepatis (blood-filled cysts in the liver) and hepatic neoplasms (liver tumors)

Report any symptoms of liver problems to your clinician, including yellowing of the skin or eyes (jaundice), dark urine, persistent nausea, abdominal pain, or unusual fatigue.

4.5 Sleep Apnea

Testosterone may worsen obstructive sleep apnea, especially in patients with risk factors such as obesity or chronic lung disease. Inform your clinician if you have a history of sleep apnea or if you develop symptoms such as loud snoring, excessive daytime sleepiness, or episodes of stopped breathing during sleep.

4.6 Prostate Effects

Testosterone therapy may:

  • Increase prostate-specific antigen (PSA) levels
  • Cause or worsen benign prostatic hyperplasia (BPH), leading to urinary symptoms
  • Potentially stimulate growth of undetected prostate cancer

Regular PSA screening and prostate monitoring are required during testosterone therapy (see Section 9). Report any changes in urinary function to your clinician, including difficulty urinating, increased frequency, or weak urine stream.

4.7 Edema (Fluid Retention)

Testosterone may cause fluid retention, which can worsen conditions such as congestive heart failure, kidney disease, or high blood pressure. Report unusual swelling in the ankles, feet, or hands to your clinician.

4.8 Effects on Fertility

Testosterone therapy may suppress spermatogenesis (sperm production) and reduce fertility in men. This effect may or may not be reversible upon discontinuation. If you plan to father children in the future, discuss fertility preservation options with your clinician before starting therapy.

4.9 Mood and Behavioral Changes

Some patients may experience mood changes during testosterone therapy, including:

  • Irritability or aggression
  • Mood swings
  • Depression or anxiety
  • Changes in libido

Report any significant mood or behavioral changes to your clinician.

4.10 Risk of Transfer to Others

Transdermal testosterone products, including sprays, can be transferred to others through direct skin-to-skin contact. This is especially dangerous for women and children, who may experience virilization effects (such as voice deepening, abnormal hair growth, or genital changes in children). To minimize the risk of transfer:

  • Apply the spray only to the recommended application site.
  • Allow the application site to dry completely before covering with clothing.
  • Wash hands thoroughly with soap and water after application.
  • Cover the application site with clothing after the spray has dried.
  • If another person is expected to have direct skin-to-skin contact with the application site, wash the application site thoroughly with soap and water beforehand.
  • 5. Common Side Effects

5.1 The following side effects have been reported with testosterone therapy. Most are mild to moderate and may resolve over time. Contact your clinician if any side effect becomes bothersome or persistent.

Common side effects include:

  • Skin reactions at the application site (redness, irritation, itching)
  • Acne or oily skin
  • Increased body or facial hair growth
  • Headache
  • Changes in libido (increased or decreased)
  • Mood changes (irritability, anxiety)
  • Fluid retention or swelling
  • Increased sweating
  • Gynecomastia (breast tissue enlargement in men)

5.2 For women prescribed testosterone therapy, additional side effects may include voice deepening, facial hair growth, clitoral enlargement, and menstrual irregularities. These virilization effects may be irreversible. Report any such changes to your clinician promptly.

5.3 This is not a complete list of side effects. Other side effects may occur. Report any unusual symptoms to your prescribing clinician or contact us at support@livekeen.co.

6. Drug Interactions

6.1 Tell your clinician about all medications you are currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements, before starting testosterone therapy.

6.2 Known drug interactions include:

  • Blood thinners (anticoagulants) such as warfarin — Testosterone may increase the effect of blood thinners, raising the risk of bleeding. Dose adjustments and more frequent monitoring of INR/PT may be needed.
  • Insulin and oral diabetes medications — Testosterone may improve insulin sensitivity, which could require adjustments to diabetes medication dosing. Monitor blood glucose levels closely.
  • Corticosteroids — Concurrent use with testosterone may increase the risk of edema (fluid retention), particularly in patients with cardiac, renal, or hepatic disease.
  • Oxyphenbutazone — Concurrent use may increase serum levels of oxyphenbutazone.
  • Propranolol — Testosterone may increase clearance of propranolol.

6.3 This is not a complete list of drug interactions. Your clinician will review your medication list to assess potential interactions before prescribing testosterone therapy.

7. Proper Use and Administration

7.1 Transdermal Spray Application (Keen T-Spray / Hypospray)

Use Keen T-Spray exactly as prescribed by your clinician. Do not use more or less than your prescribed dose, and do not change your dosing schedule without consulting your clinician.

Application Site: Apply the spray to clean, dry, intact skin on the inner forearm or other area as directed by your clinician. Do NOT apply to the genitals, chest, or areas with broken, irritated, or damaged skin.

Application Steps:

Ensure the application area is clean, dry, and free of lotions, oils, or sunscreen.

Hold the spray device at the recommended distance from the skin as indicated in your product instructions.

Actuate the spray to deliver the prescribed number of sprays.

Allow the application site to air dry completely (typically 2–3 minutes) before covering with clothing.

Do NOT rub or wash the application area for at least 2 hours after application, or as directed.

Wash your hands thoroughly with soap and water immediately after applying the spray.

Timing: Apply the spray at the same time each day as directed by your clinician to maintain consistent hormone levels.

Missed Dose: If you miss a dose, apply it as soon as you remember unless it is close to the time for your next dose. Do NOT apply a double dose. Contact your clinician if you are unsure what to do.

Overdose: If you suspect you have used too much testosterone, contact your clinician or Poison Control at 1-800-222-1222. Symptoms of overdose may include persistent erections, excessive acne, or unusual mood changes.

7.2 General Instructions

Do not share your medication with anyone else, even if they have similar symptoms. Testosterone is a Schedule III controlled substance, and sharing or distributing it is illegal (see Section 10).

Keep testosterone products away from women and children at all times.

Do not use the product if the packaging is damaged, opened, or tampered with. Contact us at support@livekeen.co if you receive a damaged product.

8. Storage Information

8.1 Store Keen T-Spray at controlled room temperature, 68°F to 77°F (20°C to 25°C).

8.2 Brief excursions between 59°F and 86°F (15°C and 30°C) are permitted.

8.3 Do NOT store in direct sunlight, extreme heat, or extreme cold.

8.4 Do NOT freeze.

8.5 Keep the spray device in its original packaging when not in use.

8.6 Keep out of the reach of children and pets.

8.7 Disposal: Do not dispose of testosterone products in household trash or flush down the drain. Testosterone is a controlled substance and must be disposed of properly. Contact your local pharmacy or DEA-authorized collector for disposal instructions. You may also visit the DEA's Take Back program at deadiversion.usdoj.gov for authorized disposal locations.

9. Monitoring Requirements

9.1 Testosterone therapy requires regular clinical monitoring. Your prescribing clinician will order periodic laboratory tests to assess your response to therapy and monitor for potential adverse effects.

9.2 Required monitoring includes:

  • Testosterone levels — Measured periodically to ensure levels are within the target therapeutic range. Initial monitoring typically occurs within the first 1–3 months after starting therapy, with follow-up testing at regular intervals thereafter.
  • Hematocrit and hemoglobin (Complete Blood Count / CBC) — Monitored to detect polycythemia (elevated red blood cell count). If hematocrit exceeds the upper limit set by your clinician (commonly above 54%), your dose may be reduced, or therapy may be temporarily suspended.
  • PSA (Prostate-Specific Antigen) — Monitored to screen for prostate abnormalities. Baseline PSA should be obtained before starting therapy, with periodic follow-up per your clinician's protocol.
  • Liver function tests (LFTs) — Periodic monitoring of liver enzymes may be ordered, especially if you have pre-existing liver conditions or risk factors.
  • Lipid panel — Testosterone may affect cholesterol levels. Periodic lipid testing may be ordered.
  • Blood pressure — Regular blood pressure monitoring is recommended during testosterone therapy.
  • Additional tests as deemed appropriate by your clinician based on your individual health status and response to therapy.

9.3 You are responsible for completing all required lab work in a timely manner. Failure to complete required laboratory testing may result in the inability to continue or refill prescriptions. If you have questions about your monitoring schedule, contact your clinician through the Platform or email support@livekeen.co.

9.4 Follow-up consultations are a required part of your ongoing care. Your clinician may schedule periodic check-ins to assess your progress, review lab results, and adjust your treatment plan as needed.

10. Controlled Substance Notice

10.1 Testosterone is classified as a Schedule III controlled substance under the Controlled Substances Act (21 U.S.C. Section 801 et seq.) and is regulated by the U.S. Drug Enforcement Administration (DEA).

10.2 Federal law prohibits the transfer, sale, distribution, or sharing of your prescribed testosterone to any other person. Violations of federal controlled substance laws may result in criminal prosecution, including imprisonment and fines.

10.3 Use your prescribed testosterone only as directed by your clinician and only for the condition for which it was prescribed.

10.4 Do not attempt to obtain testosterone from any source other than through a valid prescription from a licensed healthcare provider and a licensed pharmacy.

10.5 If you suspect misuse, abuse, or diversion of controlled substances, report it to the DEA Diversion Tip Line at 1-877-792-2873.

11. When to Seek Immediate Medical Attention

11.1 Call 911 or go to your nearest emergency room immediately if you experience any of the following:

  • Chest pain, pressure, or tightness
  • Sudden severe headache
  • Sudden shortness of breath or difficulty breathing
  • Weakness, numbness, or tingling on one side of the body
  • Slurred speech or difficulty speaking
  • Sudden vision changes
  • Leg pain or swelling, especially if in one leg only
  • Coughing up blood
  • Signs of a severe allergic reaction: hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing
  • Persistent, painful erection lasting more than 4 hours (priapism)

11.2 Contact your clinician promptly (not an emergency but requires medical attention) if you experience:

  • Yellowing of the skin or eyes (jaundice)
  • Dark-colored urine
  • Persistent nausea or vomiting
  • Unusual fatigue or weakness
  • Unexplained weight gain or significant swelling
  • Changes in urinary pattern (difficulty urinating, increased frequency, blood in urine)
  • Persistent mood changes, depression, or suicidal thoughts
  • New or worsening snoring, excessive daytime sleepiness, or observed episodes of stopped breathing during sleep
  • Breast pain, tenderness, or enlargement
  • Persistent skin reactions at the application site
  • Any other unusual or concerning symptom

11.3 Crisis and Mental Health Resources. If you or someone you know is experiencing a mental health crisis, suicidal thoughts, or emotional distress — including as a result of mood changes associated with hormone therapy — please contact one of the following resources immediately:

  • 988 Suicide and Crisis Lifeline: Call or text 988 (available 24/7)
  • Crisis Text Line: Text HOME to 741741
  • SAMHSA National Helpline: 1-800-662-4357

These are free, confidential services available 24 hours a day, 7 days a week.

12. Important Disclaimers

12.1 This information does not replace the advice of your healthcare provider. The safety information provided on this page is for general educational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your prescribing clinician with any questions you may have regarding your medication or medical condition.

12.2 Keen Meds Inc. is a technology platform and does not provide medical advice, diagnosis, or treatment. All medical services are provided by independent, licensed clinicians affiliated with our medical practice partner. All prescriptions are compounded and dispensed by our partner pharmacy, a licensed 503A compounding pharmacy.

12.3 Compounded medications are not FDA-approved. Compounded medications are prepared pursuant to valid, patient-specific prescriptions to meet individual patient needs. The FDA does not verify the safety or efficacy of compounded medications.

12.4 Individual results may vary. Keen Meds does not guarantee any specific health outcome, treatment result, or therapeutic effect. Your response to testosterone therapy depends on multiple factors including genetics, adherence to your treatment plan, lifestyle, and overall health status.

12.5 Reporting Adverse Events. If you experience an adverse reaction to any medication obtained through the Keen platform, discontinue use and contact your healthcare provider immediately. You may also report adverse events to the FDA MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.