cGMP FDA
NAD+ Injection

NAD+ Injection

100 mg/mL

Size: 10 mL

Nicotinamide adenine dinucleotide (NAD+) is an essential endogenous coenzyme present in virtually all living cells, where it plays a fundamental role in cellular energy metabolism, oxidation-reduction reactions, DNA repair, and intracellular signaling [1][2].

Sterile NAD+ Injection is formulated as a sterile parenteral preparation intended for administration by qualified healthcare professionals in accordance with institution-specific protocols and individualized clinical judgment.

NAD+ is an essential cofactor in numerous enzymatic reactions that support mitochondrial energy production, genomic stability, and cellular metabolic homeostasis. Through its role in oxidation-reduction reactions and enzyme-mediated signaling pathways, NAD+ contributes to normal cellular function and physiological regulation [1][2][3].

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More About This Product

  • • Concentration: 100 mg/mL

    • Volume: 10 mL Multi-Dose Vial

    • Route of Administration: Intravenous (IV) or Intramuscular (IM) Injection.

     

    NAD+ Injection is formulated as a sterile parenteral preparation. It is compounded in an FDA-registered 503B outsourcing facility and undergoes applicable quality testing prior to release. Dosing is individualized according to the underlying treatment protocol and specific clinical objectives.

    Slow intravenous administration is recommended because rapid infusion may be associated with infusion-related intolerance, including flushing, chest discomfort, abdominal cramping, nausea, and anxiety. Infusion rates should be individualized according to patient tolerance, heart rate, blood pressure, and institutional protocol. Intramuscular injections should be administered deep into a large muscle mass. Adherence to strict aseptic technique is required during vial puncture and administration.

  • NAD+ exerts distinct biochemical metabolic functions. It serves as an essential electron acceptor for cellular energy production in glycolysis, the citric acid cycle, and fatty acid oxidation. Through these pathways, it converts to NADH, which subsequently drives ATP production through oxidative phosphorylation. For the DNA damage response, NAD+ is consumed as a required substrate by PARP (poly ADP-ribose polymerase) enzymes, which detect and initiate the repair of damaged DNA, thereby maintaining cellular resilience. Furthermore, it acts as an obligate co-substrate for sirtuin activation (SIRT1-7), a family of deacetylase enzymes that regulate cellular stress responses, mitochondrial function, inflammatory signaling, and metabolic homeostasis [1][2][3].

  • Contraindications: Known hypersensitivity to nicotinamide adenine dinucleotide (NAD+) or any component of the formulation.

     

    Precautions: Rapid intravenous infusion may be associated with uncomfortable physiological symptoms, including severe flushing, nausea, abdominal cramping, and chest tightness; therefore, infusion rates must be carefully titrated based on individual patient tolerance. Because NAD+ participates in multiple cellular metabolic pathways, the clinical significance of exogenous NAD+ administration in patients with active malignancy has not been established. Clinical judgment should guide use in these patients.

  • Formal drug interaction studies have not been conducted for parenteral NAD+. Clinicians should evaluate concomitant therapies based on individual patient characteristics and institutional protocols.

  • Parenteral administration is generally well-tolerated when infused at appropriate, slow rates. Rapid intravenous administration has been reported to be associated with transient infusion-related adverse effects. Reported adverse reactions may include:

    Gastrointestinal: Nausea, vomiting, abdominal cramps.

    Neurological: Lightheadedness, headache.

    Cardiovascular: Chest discomfort, tachycardia.

    Systemic: Flushing, warmth, diaphoresis, anxiety.

    Local/Injection Site: Mild injection site reactions or erythema, particularly with intramuscular administration.

     

    Monitoring Parameters

    Healthcare professionals should monitor:

    Patient tolerance throughout infusion

    Heart rate and blood pressure

    Infusion rate based on clinical tolerance

    Signs and symptoms of infusion-related reactions (flushing, chest discomfort, nausea, abdominal cramping)

    Overall clinical response according to the intended treatment protocol

  • Pregnancy: Adequate and well-controlled studies in pregnant women have not been conducted with high-dose parenteral NAD+. It should be administered during pregnancy only when clearly clinically indicated and the potential benefits outweigh potential risks.

     

    Lactation: It is not known whether exogenous parenteral NAD+ is excreted in human milk. The decision to administer to a nursing individual should carefully weigh the potential benefits against any potential risks.

     

    Pediatric Use: Pediatric use has not been established.

     

    Renal/Hepatic Impairment: Specific dosing guidelines for patients with renal or hepatic impairment have not been formally established; clinical discretion is advised.

  • Follow the storage conditions specified on the product labeling. Store at USP Controlled Room Temperature (20°C–25°C [68°F–77°F]). Protect from light. Do not freeze. Store in the original carton until time of use. Safely discard any unused portion after the designated beyond-use date (BUD) in accordance with standard facility protocols for medical waste. As a 503B product, batch traceability is fully supported via lot-specific Certificates of Analysis (CoAs).

  • [1] Yoshino J, Baur JA, Imai SI. NAD+ Intermediates: The Biology and Therapeutic Potential of NMN and NR. Cell Metab. 2018;27(3):513-528.

    [2] Verdin E. NAD⁺ in aging, metabolism, and neurodegeneration. Science. 2015;350(6265):1208-1213.

    [3] Rajman L, Chwalek K, Sinclair DA. Therapeutic Potential of NAD-Boosting Molecules: The In Vivo Evidence. Cell Metab. 2018;27(3):529-547.

    [4] U.S. Food and Drug Administration. Information for Outsourcing Facilities. Center for Drug Evaluation and Research.

  • This information is intended for healthcare professionals. Refer to the full prescribing information for complete safety and prescribing details.

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