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PRODUCT MONOGRAPH

Andriol (testosterone undecanoate)
40 mg capsules
ANDROGEN

Organon Canada Ltd./Ltee
Scarborough, Ontario

Date of Preparation-
5HN855633 March 26th, 1992

NAME OF THE DRUG
ANDRIOL

PHARMACOLOGICAL CLASSIFICATION
Androgen

ACTIONS AND CLINICAL PHARMACOLOGY

Andriol (testosterone undecanoate), an orally active testosterone preparation, is a fatty acid ester of the
natural androgen testosterone. Unlike other oral testosterone preparations, testosterone undecanoate is able to by-pass the liver via the lymphatic system and is therefore orally bioavailable.

Therapy with Andriol increases plasma levels of testosterone and its active metabolites, leading to a regular therapeutic effect. In eugonadal men, peak testosterone levels are reached in approximately 4-5 hours after ingestion returning to basal levels after about 10 hours. In volunteers and hypogonadal men, 77-93% of an orally administered dose of testosterone undecanoate was excreted in the urine and faeces within 3 to 4 days.

Indications and Clinical Use

Andriol (testosterone undecanoate) is indicated for replacement therapy in males in conditions associated
with symptoms of deficiency or absence of endogenous testosterone: for the management of congenital or
acquired primary hypogonadism and hypogonadotropic hypogonadism; to develop and maintain secondary
sexual characteristics in males with testosterone deficiency.

Andriol is also indicated to stimulate puberty in carefully selected males with clearly delayed puberty not secondary to pathological disorder. It is also used as replacement therapy in impotence or for male climacteric symptoms when the conditions are due to a measured or documented androgen deficiency.

Dosage and Administration

The dosage should be adjusted according to the response of the individual patient. Usually, an initial dosage of 120-160 mg daily in two divided doses for 2-3 weeks is adequate, followed by a maintenance dosage of 40-120 mg daily.
Andriol capsules should be taken after meals and swallowed without chewing.

Pharmaceutical Information

Drug Substance
Testosterone undecanoate
17 beta-undecanoyloxy-androst-4-en-3-one

Ô
O
O-C-(CH2)9-CH3

Formula: C30H48O3

Molecular Weight: 456.7
Melting point: 63°C

Solubility: -in water - insoluble

-in oleic acid - m 160 mg/mL

Testosterone undecanoate is a creamy-white crystalline powder.

Composition:
Capsule contents: testosterone undecanoate, oleic acid
Capsule shell: Glycerol 85%, an aqueous solution of partially hydrogenated hydrolyzed starch (containing total solids consisting of 27- 35% of sorbitol, 2- 4% of mannitol and 61- 71% of not hydrogenated hydrolyzed starch), sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, titanium dioxide, iron oxide red, gelatin

Stability and Storage Recommendations

Pharmacist: refrigerated at 2°C - 8°C. Protect from light and moisture. Do not freeze.
Patient: store between 15°C and 25°C. Protect from light and moisture. Use within 90 days.

Availiability

Each Andriol Capsule contains 40 mg of testosterone undecanoate in oleic acid. Each Andriol Capsule is an
oval reddish-brown soft gelatin capsule marked D3V.
Andriol 40 mg is available in bottles of 60 and 100 capsules.

References

1. Franchi, F. Luisi, M. and Kicovic, P.M. Longterm study of oral testosterone undecanoate in hypogonadal males. Int J Androl 1978; 1 -.270-278.
2. Franchimont, P., Kicovic, P.M., Mattel, A. and Roulier, R. Effects of oral testosterone undecanoate in hypogonadal male patients. Clin Endocrinol 1978; 9:313-320.
3. Gooren, L.J.G. Long-term safety of the oral androgen testosterone undecanoate. Int J Androl 1986; 9:21-26.
4. Horst, H.J., Holtje, W.J., Dennis, M., Coert, A. Geelan, J. and Voigt, K.D. Lymphatic absorption and metabolism of orally
administered testosterone undecanoate in man. Klin Woch 1976:54:875-879.
5. Luisi, M. and Franchi, F. Double-blind group comparative study of testosterone undecanoate and mesterolone in hypogonadal male patients. J Endocrinol Invest 1980;
3:305-308.
6. Maisey, N.M., Bingham, J. Marks, V., English, J. and Chakraborty, J. Clinical efficacy of testosterone undecanoate in male hypogonadism. Clin Endocrinol 1981; 14:625-629.
7. Nieschlag, E., Mauss, H., Coert, A. and Kicovic, P. Plasma androgen levels in men after oral administration of testosterone or testosterone undecanoate. Acta Endocrinol
1975:79:366-374.
8. Romanelli, R., Cini, F., Barletta, D., Romoli, P., Franchi, F., Alicicco, E., Kicovic, P.M. and Luisi, M. Un nuovo tipo di terapia androgenica nel climaterio maschile. In: Giornate endocrinologiche pisane. Pacini, 779-88 (1978).
9. Skakkebaek, N.E., Bancroft, J., Davidson, D.W. and Warner, P. Androgen replacement with oral testosterone undecanoate in hypogonadal men: a double-blind controlled study. Clin endocrinol 1981; 14:49-61.
10. Well, J., Bidlingmaier, F., Butenandt, 0., Sippell, W.G., Baumgartner, W. and Knorr, D. Treatment of anorchia with oral testosterone undecanoate: pharmacodynamics and clinical effectiveness. Acta Endocrinol 1980; 95:244- 250.
11. Wu, F.C.W, Bancroft, J., Davidson, D.W. and Nicol, K. The behavioural effects of testosterone undecanoate in adult men with Klinefelter's Syndrome. Clin Endocrinol 1982; 16:489-497.
12. IARC Monographs on the evaluation of the carcinogenic risk of chemicals in humans. 1979:21:519-547.
13. Pusch, H.H. Oral treatment of oligozoospermia with testosterone-undecanoate: Results of a double-blind-placebo-controlled trial. Andrologia 1989; 21(1):76-82.