1. NATURE OF THIS DOCUMENT. This is a legally binding informed consent for the off-label use of three compounded medications: Methylene Blue 5 mg capsules, Rapamycin (Sirolimus) 0.05% topical cream in VersaPro base, and NAD+ injectable solution. Please read every section before signing. Your signature indicates you have read, understood, and agreed to every section. If anything is unclear, stop and contact our office at (818) 570-1640 or dr@nutrabrainclinic.com before signing.
2. PRESCRIBER AND OFF-LABEL DISCLOSURE. I consent to receive these compounded medications prescribed by Farzad David Mahjoubi, MD, through NutraBrain Clinic, Inc. d/b/a Dr. David Wellness, ordered through drdavidwellness.com. I understand that: methylene blue is FDA-approved only as an injection for methemoglobinemia; topical rapamycin is not FDA-approved for cosmetic, dermatologic, or anti-aging use; and injectable NAD+ is not an FDA-approved product. Use of all three for cognitive, energy, mitochondrial, skin, or longevity purposes is OFF-LABEL. Off-label prescribing by a licensed physician is legal but means the FDA has not evaluated these specific uses for safety or efficacy. These are pharmaceutical-grade compounded medications prepared by a U.S.-licensed compounding pharmacy; they are not dietary supplements, not industrial-grade chemicals, and not finished products subject to FDA cGMP manufacturing standards. I will not substitute or supplement my prescription with any non-prescription version purchased elsewhere.
3. TELEHEALTH RELATIONSHIP. This is a telehealth prescribing relationship. Dr. Mahjoubi has not physically examined me and evaluates me only by questionnaire, secure messaging, telephone, or video. Telehealth cannot include a physical examination and depends entirely on the accuracy and completeness of the information I provide. I am responsible for accurately disclosing my full medical history and every medication and supplement I take, and any changes during treatment. Dr. Mahjoubi prescribes only in U.S. states where he is licensed. By providing my state of residence and signing, I confirm I reside in such a state. This treatment does not replace my primary care, mental health care, or any specialist care.
4. METHYLENE BLUE — SPECIFIC RISKS. Methylene blue is a reversible MAO inhibitor and can cause SEROTONIN SYNDROME, a potentially life-threatening condition, when combined with serotonergic medications and supplements (SSRIs, SNRIs, TCAs, MAOIs, linezolid, tramadol, meperidine, fentanyl, methadone, triptans, stimulants, dextromethorphan, ondansetron, St. John's Wort, 5-HTP, L-tryptophan, SAM-e, MDMA, cocaine). It is CONTRAINDICATED in G6PD deficiency (risk of hemolytic anemia), severe kidney or liver impairment, pregnancy/breastfeeding, current MAOI or linezolid use, and age under 18. Side effects include blue-green discoloration of urine/saliva/sweat (harmless and expected), nausea, headache, dizziness, photosensitivity, and at high doses paradoxical methemoglobinemia. If I have surgery or anesthesia within 14 days, I must inform my anesthesiologist, as methylene blue interferes with pulse oximetry readings.
5. RAPAMYCIN TOPICAL — SPECIFIC RISKS. Side effects include local skin irritation, redness, dryness, and potential systemic absorption with theoretical immunosuppression when applied to large surface areas. I will not apply it to broken, infected, or actively inflamed skin. I understand using retinoids or exfoliants at the same site increases absorption. It is contraindicated if I am immunocompromised, taking immunosuppressants, or allergic to sirolimus, macrolide antibiotics, or sorbitol. This service does not substitute for dermatologic evaluation of any suspicious skin lesion.
6. NAD+ INJECTION — SPECIFIC RISKS. I am responsible for following the injection instructions provided. Improper technique may cause pain, bruising, infection, or other complications. I will use sterile technique, never reuse needles, and properly dispose of sharps. Side effects include injection-site redness/bruising/soreness, nausea, flushing, headache, cramping, and rarely allergic reaction. NAD+ therapy is elective and not medically necessary.
7. EMERGENCY ACTION PLAN. I will STOP all products and call 911 or go to the nearest ER if I experience: high fever, severe agitation, confusion, rapid heart rate, muscle stiffness or twitching, severe tremor, sweating, shivering (possible serotonin syndrome); difficulty breathing, swelling of face/lips/tongue/throat, severe chest pain, irregular heartbeat, or fainting (possible allergic/cardiac reaction); or signs of injection-site infection (increasing redness, warmth, swelling, pus). I will then notify Dr. Mahjoubi's office.
8. NO GUARANTEE OF BENEFIT. No guarantee, express or implied, has been made that I will experience any specific benefit. Individual response varies widely. Marketing claims about cognition, energy, mitochondrial function, skin, and aging are based on emerging research and have not been confirmed by the FDA for these off-label uses. No specific outcome has been promised to me.
9. ALTERNATIVES. I understand I am under no obligation to use these products. Alternatives include no treatment, lifestyle interventions, FDA-approved medications for any underlying condition, and evaluation by a primary care physician or specialist. I have had the opportunity to weigh these alternatives.
10. FINANCIAL TERMS AND REFUND POLICY. The Longevity Stack fee is $450, covering physician evaluation, prescription, and the compounded medications with supplies. Because these are custom-compounded prescription medications, they cannot be returned or refunded once dispensed and shipped, in accordance with federal and state law, except for damaged or incorrect orders reported within 7 days. Submission of this form and payment does NOT guarantee a prescription; if the physician determines I am not an appropriate candidate, my order will be canceled and refunded.
11. ADVERSE EVENT REPORTING. Dr. Mahjoubi may report adverse events to the FDA MedWatch program and the compounding pharmacy as permitted by law. I may report directly at www.fda.gov/medwatch or 1-800-FDA-1088.
12. PRIVACY AND HIPAA. NutraBrain Clinic, Inc. d/b/a Dr. David Wellness operates in accordance with HIPAA. The Notice of Privacy Practices and Terms of Service are available at drdavidwellness.com. I authorize communication by email, secure portal, telephone, and text, and accept the inherent privacy risks of email and text.
13. VOLUNTARY CONSENT, RELEASE, AND GOVERNING LAW. My consent is given voluntarily without coercion. I may withdraw and discontinue at any time, subject to non-refundability of medication already shipped. I accept full responsibility for my decision to use these products and to self-administer the NAD+ injection, and I agree to hold Farzad David Mahjoubi, MD, and NutraBrain Clinic, Inc. d/b/a Dr. David Wellness harmless from any adverse outcome resulting from my failure to disclose accurate information or follow instructions, except in cases of gross negligence. This consent and any dispute is governed by the laws of the State of California, except where applicable law requires otherwise (e.g., state medical board complaints). I am at least 18 years old, of sound mind, and legally competent to consent.