NANDROLONE DECANOATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NANDROLONE DECANOATE (NANDROLONE DECANOATE).
Nandrolone decanoate is an anabolic-androgenic steroid (AAS) that binds to androgen receptors (AR). Upon binding, it activates AR-mediated gene transcription, leading to increased protein synthesis, muscle growth, and bone density. It also exhibits some estrogenic activity via partial aromatization and progestogenic effects. It stimulates erythropoietin production in kidneys, increasing red blood cell mass.
| Metabolism | Primarily hepatic via reduction and hydroxylation, involving 5α-reductase (to dihydronandrolone) and 3α-hydroxysteroid dehydrogenase. Major metabolite is 5α-estran-3β,17β-diol. Excreted in urine as glucuronide and sulfate conjugates. |
| Excretion | Renal: ~90% as metabolites (glucuronide and sulfate conjugates of 19-nortestosterone and its metabolites); fecal: ~6%; due to extensive hepatic metabolism, unchanged drug is not excreted in significant amounts. |
| Half-life | Terminal elimination half-life: approximately 6-7 days (range 4-14 days) after intramuscular injection; this long half-life supports every 2-4 week dosing intervals. |
| Protein binding | Approximately 95% bound to plasma proteins, primarily testosterone-estradiol-binding globulin (TeBG) and albumin. |
| Volume of Distribution | Apparent volume of distribution (Vd/F) is approximately 0.5-1.0 L/kg, indicating distribution into total body water and muscle tissue; crosses placental and blood-brain barriers. |
| Bioavailability | IM: ~100% (depot formulation releases slowly); oral: very low (<5%) due to extensive first-pass hepatic metabolism, thus not used clinically. |
| Onset of Action | Intramuscular (IM): ~1-2 weeks for measurable anabolic effects; full clinical effects may require 4-6 weeks of repeated dosing. |
| Duration of Action | Intramuscular (IM): therapeutic effects persist for 2-4 weeks after a single injection; residual effects may last up to 4-6 weeks due to slow release from the depot. |
| Action Class | Anabolic steroid |
| Brand Substitutes | Nandrolin 25mg Injection, Ndr 25mg Injection, Velbol 25mg Injection, Martilone 25mg Injection, Sensinorm 25mg Injection |
50-200 mg intramuscularly every 2-4 weeks
| Dosage form | Injectable |
| Renal impairment | GFR 30-60: reduce dose by 50%; GFR <30: avoid use |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use |
| Pediatric use | Not recommended for use in children |
| Geriatric use | Use with caution; consider reduced starting dose due to increased risk of fluid retention and cardiovascular effects |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NANDROLONE DECANOATE (NANDROLONE DECANOATE).
| Breastfeeding | Nandrolone decanoate is excreted into breast milk. M/P ratio not determined. Due to potential adverse effects on the infant (androgenic effects, hepatotoxicity), breastfeeding is not recommended during therapy. A 10-day washout period after last dose may be considered. |
| Teratogenic Risk | Nandrolone decanoate is contraindicated in pregnancy. First trimester: Androgenic effects can cause virilization of female fetus, including clitoromegaly, labial fusion, and ambiguous genitalia. Second and third trimesters: Continued risk of fetal masculinization, potential for premature closure of epiphyseal plates, and growth retardation. Placental transfer occurs. |
■ FDA Black Box Warning
None. However, AAS may cause serious cardiovascular, hepatic, and psychiatric adverse effects. Use is contraindicated in pregnancy due to virilization of female fetus.
| Serious Effects |
Hypersensitivity to nandrolone or any component, pregnancy (Category X) and breastfeeding, men with carcinoma of the breast or prostate, prepubertal males (may cause precocious puberty), and patients with severe hepatic or renal impairment.
| Precautions | Monitor liver function, lipid profile, and periodic blood counts. Cholestatic hepatitis and peliosis hepatis reported. Hypercalcemia may occur in immobilized patients. Edema due to fluid retention. Androgenic effects (hirsutism, acne) in women. Prolonged use may cause azoospermia and oligospermia. Use with caution in patients with cardiac or renal disease. |
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| Fetal Monitoring | Monitor maternal: liver function tests (ALT, AST, bilirubin), lipid profile (HDL, LDL), blood pressure, signs of virilization (voice deepening, hirsutism, acne), and edema. Fetal: ultrasound for growth parameters and signs of virilization. Periodic serum nandrolone levels if toxicity suspected. |
| Fertility Effects | Nandrolone decanoate can suppress endogenous gonadotropins (LH, FSH) leading to oligospermia or amenorrhea, impairing fertility. Effects may be reversible upon discontinuation but recovery may be delayed baseline. |