Hybolin

Approved Indications:

• Anemia of Chronic Illness (including Chronic Renal Failure):
• Used to stimulate erythropoiesis in patients unresponsive to erythropoietin or where erythropoietin is contraindicated.
• Postmenopausal Osteoporosis:
• Improves bone mineral density and reduces fracture risk in postmenopausal women.
• Palliative Treatment of Advanced Breast Cancer (in Women):
• Used in hormone-responsive inoperable breast cancer as supportive therapy.
• Catabolic States and Severe Debilitation:
• Indicated in trauma, burns, surgery, or chronic infections to promote positive nitrogen balance and prevent muscle wasting.

Clinically Accepted Off-Label Uses:

• HIV/AIDS-Associated Wasting Syndrome:
• Helps improve body weight and muscle mass under specialist supervision.
• Cancer Cachexia and Muscle-Wasting Conditions:
• Adjunctive treatment in selected patients to enhance nutritional status and preserve lean body mass.

Note: Nandrolone Phenylpropionate is not approved for performance enhancement or bodybuilding purposes. Misuse is associated with serious health risks and legal consequences.

Route: Intramuscular (IM) injection only (deep gluteal muscle)

Adults:

• Anemia of Chronic Illness or Renal Failure:
• 50–100 mg IM every 1–2 weeks
• Duration: Based on hemoglobin response and clinical condition
• Postmenopausal Osteoporosis:
• 25–50 mg IM every 2–3 weeks
• Minimum duration: 6 months
• Advanced Breast Cancer (Palliative, in Women):
• 50–100 mg IM every 1–2 weeks
• Catabolic or Wasting Conditions:
• 50–100 mg IM every 1–2 weeks depending on severity

Pediatrics:

• Not routinely recommended. If used (e.g., in refractory anemia), dose:
• 1–2 mg/kg IM every 1–2 weeks under close medical supervision

Elderly:

• Use with caution; start at the lower end of the dose range
• Monitor for cardiovascular, hepatic, and prostate-related adverse effects

Renal Impairment:

• No dose adjustment needed, but monitor for fluid retention and hemoglobin levels

Hepatic Impairment:

• Contraindicated in severe hepatic dysfunction
• Use cautiously in mild impairment with regular monitoring of liver enzymes

Nandrolone Phenylpropionate is a synthetic anabolic androgenic steroid (AAS), esterified to allow slow systemic release after intramuscular injection. It is converted to nandrolone, which binds to androgen receptors in various tissues. This receptor binding enhances protein synthesis, nitrogen retention, and bone marrow stimulation, resulting in increased muscle mass, bone density, and red blood cell production. Compared to testosterone, nandrolone has reduced androgenic and enhanced anabolic properties, minimizing masculinizing side effects while providing therapeutic benefits in catabolic and anemic conditions.

• Absorption:
• Slow and sustained absorption following IM injection
• Onset of Action:
• Within 24–48 hours
• Bioavailability:
• 100% via IM route
• Distribution:
• Widely distributed in muscle and fat tissues
• Crosses the placenta
• Protein Binding:
• ~50% bound to plasma proteins
• Metabolism:
• Metabolized in the liver through reduction and conjugation
• Not primarily processed by CYP450 enzymes
• Active Metabolites:
• Includes 5α-dihydronandrolone (less androgenic)
• Half-Life:
• Approximately 3–4.5 days (shorter than nandrolone decanoate)
• Excretion:
• Primarily renal (via urine) as inactive metabolites

• Pregnancy:
• FDA Pregnancy Category X
• Contraindicated due to risk of fetal virilization, particularly in female fetuses
• Lactation:
• Contraindicated during breastfeeding
• Potential for androgenic effects in infants; unknown if excreted into breast milk

• Primary Class: Anabolic Androgenic Steroid (AAS)
• Subclass: 19-Nortestosterone derivative
• Ester Type: Short-acting ester (Phenylpropionate)

• Known hypersensitivity to nandrolone or excipients
• Pregnancy or lactation
• Known or suspected breast or prostate cancer in men
• Severe hepatic impairment
• Hypercalcemia, particularly in immobilized patients
• History of thromboembolic disorders
• Nephrotic syndrome with edema

• Cardiovascular Risks:
• Risk of fluid retention, hypertension, edema, and potential thrombotic events
• Hepatic Toxicity:
• Regular monitoring of liver function is essential, especially during long-term use
• Endocrine Effects:
• Suppression of endogenous testosterone production; potential infertility, especially in men
• Virilization in Women:
• Irreversible effects (voice deepening, hirsutism, acne, clitoral enlargement) may occur
• Behavioral/Psychiatric Changes:
• Risk of mood changes, aggression, irritability, or depression
• Pediatric Use:
• Risk of premature epiphyseal closure and impaired growth; monitor bone age
• Monitoring Requirements:
• CBC, liver enzymes, lipid profile, serum calcium, PSA in men, blood pressure

Common:

• Skin: Acne, oily skin, hirsutism
• Fluid Balance: Edema, weight gain due to sodium and water retention
• Endocrine: Suppression of gonadotropin secretion, testicular atrophy, menstrual irregularities
• Musculoskeletal: Muscle cramps, joint pain

In Women:

• Voice deepening, menstrual irregularity, clitoral enlargement

Serious / Rare:

• Polycythemia (increased red blood cell mass)
• Liver dysfunction or cholestasis (rare)
• Cardiovascular events: thrombosis, myocardial infarction, stroke
• Psychiatric changes: aggression, mania, depression
• Premature closure of growth plates in children

• Oral Anticoagulants (e.g., warfarin):
• May potentiate anticoagulant effects—monitor INR
• Antidiabetic Drugs (e.g., insulin, sulfonylureas):
• May enhance hypoglycemic effect—monitor glucose levels
• Corticosteroids:
• May increase fluid retention and electrolyte imbalance
• Hepatotoxic Agents (e.g., alcohol, isoniazid):
• Additive risk of liver damage
• Cyclosporine:
• May increase risk of nephrotoxicity
• CYP Enzymes:
• Minimal involvement of CYP450; low potential for enzyme-mediated interactions

• WADA Status:
• Classified as a banned substance for performance enhancement
• Regulatory Position (WHO/FDA/EMA):
• Use restricted to clearly indicated medical conditions
• Reinforced warnings for cardiovascular and hepatic monitoring in all guidelines
• Clinical Monitoring Trends:
• Growing emphasis on routine PSA and lipid profile testing during long-term use

• Storage Temperature: 20°C to 25°C (68°F to 77°F)
• Allowable Range: 15°C to 30°C
• Protection from Light: Store in original container away from direct sunlight
• Do Not Freeze
• Handling Instructions:
• Shake gently if crystals form
• Inspect vial before use; discard if discolored or particulate matter present
• Use aseptic technique for administration
• Single-use ampoules must be discarded after opening; multi-dose vials must be used within the recommended timeframe