Andriol TestoCaps40 mg

Andriol TestoCaps is an androgen (testosterone ester) used for testosterone replacement therapy in adult males with confirmed hypogonadism due to an identifiable pathological cause.

Established/Approved Uses

• Primary hypogonadism (congenital or acquired testicular failure, e.g. cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter syndrome, chemotherapy- or radiation-induced testicular damage), confirmed by clinical features and unequivocally low serum testosterone concentrations.
• Hypogonadotropic hypogonadism (congenital or acquired gonadotropin-releasing hormone deficiency, or pituitary-hypothalamic injury from tumours, trauma, or radiation), confirmed with appropriate laboratory testing.

Off-label / Specialist-directed Use

In some settings, Andriol TestoCaps is used under specialist (endocrinology) supervision to induce puberty in adolescent boys with constitutional delay of puberty or organic hypogonadism; this is not a routine, self-directed use.

Important Limitation

Andriol TestoCaps is not indicated for the treatment of age-related decline in testosterone ("age-related hypogonadism" or "low T") in men who do not have a confirmed diagnosis of classical hypogonadism, as the safety and benefit of testosterone therapy for this use have not been established.

Each dosage unit of Testosterone Undecanoate contains testosterone undecanoate, an esterified prodrug of the naturally occurring androgen testosterone, as the active pharmaceutical ingredient.

• Oral soft-gelatin capsules: commonly available as 40 mg testosterone undecanoate per capsule, formulated in an oleic-acid/oil vehicle to aid lymphatic absorption.
• Oil-based intramuscular injection: testosterone undecanoate dissolved in a castor oil/benzyl benzoate vehicle, available in strengths such as 250 mg/mL (1 mL ampoule) or 1000 mg/4 mL (long-acting depot formulation) depending on the specific branded product.

Exact strength and available dosage form vary by specific brand; the prescribing label of the dispensed product should always be checked.

Andriol TestoCaps is a long-acting ester of testosterone, the principal endogenous male sex hormone. Esterification of the 17-beta hydroxyl group with undecanoic acid increases lipid solubility, allowing either enhanced intestinal lymphatic absorption (oral route) or slow release from an intramuscular oil depot (injectable route). Once absorbed, the ester is cleaved by tissue esterases to release active testosterone into the circulation.

Andriol TestoCaps is used clinically for androgen/testosterone replacement therapy in men with confirmed hypogonadism, restoring testosterone to the normal physiological range and thereby supporting development and maintenance of male secondary sexual characteristics, muscle mass, bone density, libido, and overall androgen-dependent function.

Andriol TestoCaps belongs to the therapeutic class of androgens / anabolic-androgenic steroid hormones, used specifically as sex-hormone (testosterone) replacement therapy.

Mechanism of Action

Testosterone Undecanoate is a prodrug. After absorption, esterases hydrolyze the undecanoate side chain to release free testosterone, which binds to the intracellular androgen receptor. The hormone-receptor complex translocates to the nucleus and modulates transcription of androgen-responsive genes, producing:

• Androgenic effects: development and maintenance of male primary and secondary sexual characteristics (genital development, voice deepening, facial/body hair, libido, spermatogenesis support at physiologic levels).
• Anabolic effects: nitrogen retention, increased muscle protein synthesis and lean body mass, increased bone mineral density, and stimulation of erythropoiesis.

Pharmacokinetics

Oral Testosterone Undecanoate is absorbed mainly via intestinal lymphatics (absorption is enhanced when taken with a fat-containing meal) and undergoes some first-pass hepatic conversion; peak testosterone levels are reached within a few hours, with a relatively short duration per dose, necessitating twice-daily dosing. Intramuscular Testosterone Undecanoate forms a slow-releasing oil depot, producing sustained serum testosterone levels over several weeks, allowing dosing intervals of roughly every 10-14 weeks for long-acting depot products after an initial loading phase. Testosterone is metabolized hepatically (partly via 5-alpha-reductase to dihydrotestosterone and via aromatase to estradiol) and excreted mainly as glucuronide/sulfate conjugates in urine, with some biliary/fecal excretion.

Oral Capsules

Andriol TestoCaps oral capsules should be swallowed whole (not chewed or crushed) with a meal containing some fat, which significantly improves absorption via intestinal lymphatics. Doses are usually divided across the day.

Intramuscular Injection

Injectable Andriol TestoCaps must be administered by a qualified healthcare professional as a slow, deep intramuscular injection, typically into the gluteal muscle, strictly following the recommended injection technique. Because oil-based testosterone injections carry a small risk of a pulmonary oil microembolism (POME) reaction and of anaphylaxis occurring during or immediately after injection, administration should take place in a healthcare facility with the capability to manage these emergencies, and patients should be observed for approximately 30 minutes after each injection.

Andriol TestoCaps has the following well-recognized clinically significant interactions:

• Oral anticoagulants (e.g. warfarin): androgens may enhance anticoagulant effect and bleeding risk; INR should be monitored closely, particularly at initiation or discontinuation of Andriol TestoCaps, with anticoagulant dose adjusted as needed.
• Insulin and oral antidiabetic agents: Andriol TestoCaps may improve insulin sensitivity and reduce blood glucose in some patients; glucose monitoring is advised and antidiabetic drug doses may need adjustment.
• Corticosteroids/ACTH: concurrent use with Andriol TestoCaps may increase the risk of fluid retention and edema; concomitant use requires caution, particularly in patients with cardiac, renal, or hepatic disease.
• Other hepatotoxic drugs: caution is advised with concurrent use of other agents known to affect liver function, given the shared hepatic metabolic pathway.

Side effects of Andriol TestoCaps range from common, generally mild effects to rare but serious reactions.

Common

• Acne, oily skin
• Injection-site pain, induration, or reaction (injectable formulations)
• Mood changes, irritability, increased libido
• Fluid retention/mild edema
• Headache

Less Common / Serious

• Polycythemia (raised hematocrit/hemoglobin) - requires periodic monitoring.
• Gynecomastia and, with prolonged exogenous use, suppressed spermatogenesis/infertility and testicular atrophy.
• Worsening of benign prostatic hyperplasia symptoms.
• Worsening of obstructive sleep apnea.
• Pulmonary oil microembolism (POME) reactions (cough, dyspnea, chest discomfort) and anaphylaxis, occurring during or shortly after intramuscular administration - a boxed-warning-level risk for injectable products in some markets, requiring in-clinic observation after each injection.
• Cardiovascular events (myocardial infarction, stroke) have been reported with testosterone therapy in some studies, particularly in older men or those with existing cardiovascular risk factors.
• Hepatic effects (rare with non-alkylated esters such as this one, but liver function should still be monitored if risk factors are present).

Andriol TestoCaps is not indicated for use in women and is contraindicated in pregnancy because of the risk of virilization of a female fetus. It is also contraindicated during breastfeeding. If exposure occurs during pregnancy, the patient should be counselled on potential fetal risk and evaluated by a physician promptly.

Boxed Warning (Injectable Formulations, Where Applicable)

Intramuscular Andriol TestoCaps formulations carry a risk of serious pulmonary oil microembolism (POME) reactions and anaphylaxis during or immediately after injection. Administration must occur in a healthcare setting equipped to manage these emergencies, with patient observation for approximately 30 minutes post-injection, per the specific product's risk management program where one exists.

Cardiovascular Risk

Some studies suggest an increased risk of myocardial infarction and stroke with testosterone therapy. An individualized risk-benefit discussion is recommended before starting Andriol TestoCaps, particularly in older men or those with existing cardiovascular risk factors.

Polycythemia

Andriol TestoCaps can raise hematocrit/hemoglobin. Hematocrit should be checked before starting therapy and periodically thereafter; therapy may need to be reduced or interrupted if hematocrit rises excessively.

Prostate

Andriol TestoCaps may worsen symptoms of benign prostatic hyperplasia and stimulate growth of subclinical prostate cancer. Periodic prostate monitoring (PSA and, per specialist guidance, digital rectal examination) is recommended, especially in older men.

Other Precautions

• May worsen obstructive sleep apnea.
• May cause gynecomastia and suppressed spermatogenesis/infertility with prolonged exogenous use.
• Not indicated for age-related low testosterone without a confirmed diagnosis of pathological hypogonadism.
• Has recognized potential for misuse for non-medical performance or physique enhancement; Andriol TestoCaps is a controlled substance in many jurisdictions, and such misuse carries additional health risks.

Specific data on acute overdose with Andriol TestoCaps are limited. Excessive dosing may exaggerate androgenic/anabolic effects (e.g. priapism, aggressive behavior, fluid retention) and, with injectable formulations, immediate reactions following administration require urgent evaluation. Anyone who has taken more than the prescribed dose, or who develops symptoms such as severe chest pain, difficulty breathing, prolonged painful erection, or an allergic reaction after an injection, should seek immediate medical attention or contact emergency services / a poison control center rather than attempting home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly

Older men receiving Andriol TestoCaps may be at higher risk of prostate-related effects and cardiovascular events; more frequent monitoring (PSA, hematocrit, cardiovascular risk assessment) is recommended.

Hepatic Impairment

Use with caution; although Andriol TestoCaps is not a 17-alpha-alkylated androgen and carries lower hepatotoxic potential than some other androgens, liver function should be monitored in patients with pre-existing hepatic disease.

Renal Impairment

Use with caution due to the potential for fluid retention; closer monitoring is advised in patients with significant renal impairment.

Pediatric

See Pediatric Use.

Andriol TestoCaps is typically used as long-term, ongoing replacement therapy in confirmed hypogonadism, for as long as clinically indicated and tolerated, under continued specialist supervision. Response (symptoms, serum testosterone trough levels, hematocrit, PSA) is generally reassessed at 3-6 months after initiation or dose change, and at least annually thereafter.

Androgens; Anabolic-androgenic steroids; Sex hormones and modulators of the genital system

Testosterone Undecanoate acts as a prodrug: esterases cleave the undecanoate ester to release free testosterone, which diffuses into target cells and binds the cytosolic androgen receptor. In certain tissues (e.g. skin, prostate) testosterone is first converted by 5-alpha-reductase to the more potent dihydrotestosterone. The hormone-receptor complex enters the nucleus, binds androgen-response elements on DNA, and regulates transcription of genes responsible for male sexual differentiation, secondary sexual characteristics, spermatogenesis support, and anabolic (muscle/bone) effects. Exogenous Testosterone Undecanoate also suppresses hypothalamic-pituitary-gonadal axis output (LH/FSH), which is why prolonged use can suppress endogenous testosterone production and spermatogenesis.

X

Safety and efficacy of Andriol TestoCaps have not been established for general pediatric use. In selected adolescent boys with confirmed constitutional delay of puberty or organic hypogonadism, low-dose, time-limited courses may be used strictly under the supervision of a pediatric endocrinologist, with monitoring of bone age and growth, since androgens can accelerate epiphyseal closure and compromise final adult height if misused. Andriol TestoCaps should not be used in children for growth promotion or any non-approved purpose.