Important Safety Information
About HELMD Drive™
HELMD Drive™ is a compounded sublingual tablet containing sildenafil, tadalafil, and apomorphine, prescribed for the treatment of erectile dysfunction (ED). It is dispensed only by a licensed U.S. compounding pharmacy following a consultation with a licensed healthcare provider.
Do not use if you:
- Take any form of nitrate medication (e.g., nitroglycerin, isosorbide) or a guanylate cyclase stimulator (e.g., riociguat). Combining these with sildenafil or tadalafil can cause a severe, life-threatening drop in blood pressure.
- Have severe cardiovascular disease, recent heart attack or stroke, unstable angina, severe heart failure, or have been told by your healthcare provider not to engage in sexual activity.
- Have severe liver impairment or end-stage kidney disease.
- Have a known allergy to sildenafil, tadalafil, apomorphine, or any other ingredient in this product.
Tell your provider before use if you have:
- Any heart condition, low or high blood pressure, irregular heartbeat, or recent cardiovascular surgery.
- A history of priapism (an erection lasting more than four hours) or any condition that may predispose you to it (e.g., sickle cell anemia, multiple myeloma, leukemia).
- A history of sudden vision loss (including non-arteritic anterior ischemic optic neuropathy / NAION) or sudden hearing loss in either eye or ear.
- Any liver or kidney problems.
- A bleeding disorder or active stomach ulcer.
- Any medications or supplements you take — especially alpha-blockers, certain antifungals, HIV protease inhibitors, certain antibiotics, or recreational drugs (especially nitrates, sometimes sold as "poppers").
Possible side effects
Common side effects can include headache, flushing, nasal congestion, indigestion, nausea, dizziness, back pain, or muscle aches. These are generally mild and temporary.
Less common but serious side effects require immediate medical attention:
- Priapism — a painful erection lasting more than four hours. Seek emergency care immediately to avoid permanent injury.
- Sudden vision loss in one or both eyes — stop use and contact your provider immediately.
- Sudden hearing loss or ringing in the ears — stop use and contact your provider.
- Severe allergic reaction (rash, swelling of face/throat, difficulty breathing) — call 911.
- Symptoms of a heart attack or stroke (chest pain, shortness of breath, weakness, slurred speech, irregular heartbeat) — call 911.
How to take HELMD Drive™
Place one tablet under your tongue and allow it to fully dissolve. Do not chew, crush, or swallow whole. Do not take more than one dose in a 24-hour period unless your healthcare provider directs you otherwise. Avoid heavy meals and alcohol around the time of use, as these can affect absorption and increase side effects.
FDA status
HELMD Drive™ is a compounded medication. Compounded medications are not approved by the U.S. Food and Drug Administration (FDA), and the FDA does not verify the safety or effectiveness of compounded drugs. Compounded products are prepared based on a prescription from a licensed healthcare provider for an individual patient.
Pregnancy, breastfeeding, and use in women
HELMD Drive™ is intended for use by adult men diagnosed with erectile dysfunction. It is not intended for use by women or by anyone under 18 years of age.
Emergencies
If you experience an emergency at any time — including chest pain, an erection lasting more than four hours, sudden vision loss, sudden hearing loss, severe allergic reaction, or any other urgent symptom — call 911 or go to the nearest emergency room immediately. Do not rely on telehealth for emergency care.
Questions about your medication
Contact your prescribing provider through the HELMD platform. For general support, email support@helmd.co.