Depo-Testosterone

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Testosterone cipionate 100 mg/mL (101mg with manucturers overage.)
Available from:
Pfizer New Zealand Limited
INN (International Name):
Testosterone cipionate 100 mg/mL (101mg with manucturers overage.)
Dosage:
100 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Testosterone cipionate 100 mg/mL (101mg with manucturers overage.) Excipient: Benzyl alcohol Benzyl benzoate Cottonseed oil
Units in package:
Vial, 10 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Pharmacia & Upjohn Company LLC
Therapeutic indications:
DEPO-TESTOSTERONE Sterile Solution is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Product summary:
Package - Contents - Shelf Life: Vial, - 10 mL - 36 months from date of manufacture stored at or below 25°C protect from light
Authorization number:
TT50-4849
Authorization date:
1969-12-31

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NEW ZEALAND DATA SHEET

1. PRODUCT NAME

DEPO-TESTOSTERONE

100mg/mL Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 mL solution for injection contains 100 mg/mL testosterone cypionate.

Excipients with known effects:

Benzyl alcohol

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for Injection

DEPO-TESTOSTERONE is a slightly yellow viscous solution

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

DEPO-TESTOSTERONE

indicated

replacement

therapy

males

conditions

associated with symptoms of deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism,

bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH

deficiency, or pituitary-hypothalamic injury from tumours, trauma, or radiation.

4.2 Dose and method of administration

Prior to initiating DEPO-TESTOSTERONE, confirm the diagnosis of hypogonadism by

ensuring that serum testosterone concentrations have been measured in the morning on at

least two separate days and that these serum testosterone concentrations are below the normal

range.

DEPO-TESTOSTERONE is for intramuscular use only.

It should not be given intravenously. Intramuscular injections should be given deep in the

gluteal muscle.

Dose

The suggested dosage for DEPO-TESTOSTERONE varies depending on the age, sex, and

diagnosis of the individual patient. Dosage is adjusted according to the patient’s response

and the appearance of adverse reactions.

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Various dosage regimens have been used to induce pubertal changes in hypogonadal males;

some experts have advocated lower dosages initially, gradually increasing the dose as puberty

progresses, with or without a decrease to maintenance levels. Other experts emphasise that

higher dosages are needed to induce pubertal changes and lower dosages can be used for

maintenance

after

puberty.

chronological

skeletal

ages

must

taken

into

consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50 mg to 400 mg should be administered every

two to four weeks.

Method of administration

Parenteral drug product should be inspected visually for particulate matter and discoloration

prior to administration, whenever solution and container permit. Warming and shaking the

vial should redissolve any crystals that may have formed during storage at temperatures

lower than recommended.

4.3 Contraindications

Known hypersensitivity to the drug.

Males with carcinoma of the breast.

Males with known or suspected carcinoma of the prostate gland.

Women who are pregnant (see section 4.6).

Patients with serious cardiac, hepatic or renal disease (see section 4.4).

4.4 Special warnings and precautions for use

Hypercalcaemia may occur in immobilised patients. If this occurs, the drug should be

discontinued.

Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been

associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis

hepatis - all potentially life-threatening complications.

There have been post-marketing reports of venous thromboembolic events, including deep

vein

thrombosis

(DVT)

pulmonary

embolism

(PE),

patients

using

testosterone

products, such as DEPO-TESTOSTERONE. Evaluate patients who report symptoms of pain,

oedema, warmth and erythema in the lower extremity for DVT and those who present with

acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue

treatment with DEPO-TESTOSTERONE and initiate appropriate workup and management.

Long

term

clinical

safety

trials

have

been

conducted

assess

cardiovascular

outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and

randomised controlled trials have been inconclusive for determining the risk of major adverse

cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and

cardiovascular death, with the use of testosterone compared to non-use. Some studies, but

not all, have reported an increased risk of MACE in association with use of testosterone

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replacement therapy in men. Patients should be informed of this possible risk when deciding

whether to use or to continue to use DEPO-TESTOSTERONE.

Abuse of testosterone and monitoring of serum testosterone concentrations:Testosterone has

been

subject

abuse,

typically

doses

higher

than

recommended

approved

indication and in combination with other anabolic androgenic steroids. Anabolic androgenic

steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see section

4.8).

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are

within therapeutic range. However, testosterone levels may be in the normal or subnormal

range in men abusing synthetic testosterone derivatives. Counsel patients concerning the

serious adverse reactions associated with abuse of testosterone and anabolic androgenic

steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid

abuse in suspected patients who present with serious cardiovascular or psychiatric adverse

events.

Oedema with or without congestive heart failure, may be a serious complication in patients

with pre-existing cardiac, renal or hepatic disease.

Gynaecomastia

develop

occasionally

persists

patients

being

treated

hypogonadism.

Safety and efficacy of DEPO-TESTOSTERONE in men with “age-related hypogonadism”

(also referred to as “late-onset hypogonadism”) have not been established. Age-related

hypogonadism refers to men with serum testosterone concentrations below the normal range

for no apparent reason other than age, and who experience signs and symptoms of aging that

overlap with those of hypogonadism.

Androgen therapy should be used cautiously in healthy males with delayed puberty. The

effect on bone maturation should be monitored by assessing bone age of the wrist and hand

every 6 months. In children, androgen treatment may accelerate bone maturation without

producing

compensatory

gain

linear

growth.

This

adverse

effect

result

compromised adult stature. The younger the child, the greater is the risk of compromising

final mature height.

This drug has not been shown to be safe and effective for the enhancement of athletic

performance. Because of the potential risk of serious adverse health effects, this drug should

not be used for such purpose.

The preservative benzyl alcohol has been associated with serious adverse events, including

the “gasping syndrome”, and death in paediatric patients. Although normal therapeutic doses

of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than

those reported in association with the “gasping syndrome”, the minimum amount of benzyl

alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity

depends on the quantity administered and the liver and kidneys’ capacity to detoxify the

chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

General

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism

or excessive sexual stimulation may develop. Oligospermia may occur after prolonged

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administration or excessive dosage. If any of these effects appear, the androgen should be

stopped and if restarted, a lower dosage should be utilised.

Testosterone cypionate should not be used interchangeably with testosterone propionate

because of differences in duration of action.

Testosterone cypionate is not for intravenous use.

Information for patients

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin

colour, ankle swelling, too frequent or persistent erections of the penis.

Paediatric population

Safety and effectiveness in paediatric patients below the age of 12 years have not been

established.

Use in the elderly

Elderly patients treated with androgens may be at an increased risk of developing prostatic

hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is

lacking (see section 5.3).

4.5 Interaction with other medicines and other forms of interaction

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may

require reduction in order to maintain satisfactory therapeutic hypoprothrombinaemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum

levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and,

therefore, insulin requirements.

Effect on laboratory tests

Haemoglobin

haematocrit

levels

detect

polycythaemia)

should

checked

periodically in patients receiving long-term androgen administration.

Serum cholesterol may increase during androgen therapy.

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4

serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain

unchanged, however, and there is no clinical evidence of thyroid dysfunction.

4.6 Fertility, pregnancy and lactation

Fertility

See pregnancy section

Pregnancy

The use of testosterone in women who are pregnant is contraindicated. (see section 4.3).

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Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause

virilization of the female fetus when administered to pregnant women. A study has shown the

degree of virilization of the genitalia of the female fetus following treatment with androgens

is directly related to the amount of hormone given between the 8th and 13th weeks of

pregnancy, which is the sensitive period.

Benzyl alcohol can cross the placenta (see section 4.4).

Lactation

DEPO-TESTOSTERONE is not recommended for use in nursing mothers.

4.7 Effects on ability to drive and use machines

No information supplied.

4.8 Undesirable effects

The following adverse reactions in the male have occurred with some androgens:

Blood and lymphatic system disorders

Haematologic: Suppression of clotting factors II, V, VII and X, bleeding in patients on

concomitant anticoagulant therapy, and polycythaemia.

Endocrine disorders

Endocrine and urogenital: Gynaecomastia and excessive frequency and duration of penile

erections. Oligospermia may occur at high dosages.

Nervous system disorders

Increased or decreased libido, headache, anxiety, depression, and generalised paraesthesia.

Eye disorders

Rare cases of central serous chorioretinopathy (CSCR).

Cardiac disorders

Myocardial infarction, stroke.

Fluid and electrolyte disturbances

Retention of sodium, chloride, water, potassium, calcium and inorganic phosphates.

Vascular disorders

Venous thromboembolism.

Gastrointestinal disorders

Nausea,

cholestatic

jaundice,

alterations

liver

function

tests,

rarely

hepatocellular

neoplasms and peliosis hepatis (see section 4.4)

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Skin and subcutaneous tissue disorders

Skin and appendages: Hirsutism, male pattern of baldness, seborrhoea, and acne.

Allergic

Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Miscellaneous

Inflammation and pain at the site of intra-muscular injection.

Drug abuse and dependence

Abuse

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding

psychological and physiological effects. Abuse and misuse of testosterone are seen in male

and female adults and adolescents. Testosterone, often in combination with other anabolic

androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be

abused by athletes and bodybuilders. There have been reports of misuse by men taking

higher doses of legally obtained testosterone than prescribed and continuing testosterone

despite adverse events or against medical advice.

Abuse-related adverse reactions

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic

steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy,

congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric

manifestations,

including

major

depression,

mania,

paranoia,

psychosis,

delusions,

hallucinations, hostility and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks,

convulsions,

hypomania,

irritability,

dyslipidemias,

testicular

atrophy,

subfertility,

infertility.

following

additional

adverse

reactions

have

been

reported

women:

hirsutism,

virilisation, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness,

and menstrual irregularities.

following

adverse

reactions

have

been

reported

male

female

adolescents:

premature closure of bony epiphyses with termination of growth, and precocious puberty.

Because these reactions are reported voluntarily from a population of uncertain size and may

include abuse of other agents, it is not always possible to reliably estimate their frequency or

establish a causal relationship to drug exposure.

Dependence

Behaviours associated with addiction

Continued

abuse

testosterone

other

anabolic

steroids,

leading

addiction

characterised by the following behaviours:

Taking greater dosages than prescribed

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Continued drug use despite medical and social problems due to drug use

Spending significant time to obtain the drug when supplies of the drug are interrupted

Giving a higher priority to drug use than other obligations

Having difficulty in discontinuing the drug despite desires and attempts to do so

Experiencing withdrawal symptoms upon abrupt discontinuation of use

Physical

dependence

characterised

withdrawal

symptoms

after

abrupt

drug

discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic

doses of testosterone may experience withdrawal symptoms lasting for weeks or months

which include depressed mood, major depression, fatigue, craving, restlessness, irritability,

anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.

Drug

dependence

individuals

using

approved

doses

testosterone

approved

indications has not been documented.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued

monitoring

benefit/risk

balance

medicine.

Healthcare

professionals

asked

report

suspected

adverse

reactions

https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

There have been no reports of acute overdosage with the androgens.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Endogenous androgens are responsible for normal growth and development of the male sex

organs and the maintenance of secondary sex characteristics. These effects include growth

and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male

hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal

cord thickening, and alterations in body musculature and fat distribution. Drugs in this class

also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary

excretion of calcium. Androgens have been reported to increase protein anabolism and

decrease protein catabolism. Nitrogen balance is improved only when there is sufficient

intake of calories and protein.

Androgens are responsible for the growth spurt of adolescence and the eventual termination

on linear growth, brought about by fusion of the epiphyseal growth centres. In children,

exogenous

androgens

accelerate

linear

growth

rates,

cause

disproportionate

advancement in bone maturation. Use over long periods may result in fusion of the

epiphyseal growth centres and termination of the growth process. Androgens have been

reported to stimulate production of red blood cells by enhancing production of erythropoietic

stimulation factor.

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During exogenous administration of androgens, endogenous testosterone release is inhibited

through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of

exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition

of pituitary follicle stimulating hormone (FSH).

There is a lack of substantial evidence that androgens are effective in fractures, surgery,

convalescence, and functional uterine bleeding.

5.2 Pharmacokinetic properties

Absorption

Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected

intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate can be

given at intervals of two to four weeks.

Distribution

Testosterone in plasma is 98 percent bound to a specific testosterone-oestradiol binding

globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding

globulin in the plasma will determine the distribution of testosterone between free and bound

forms, and the free testosterone concentration will determine its half-life.

Excretion

About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulphuric

acid conjugates of testosterone and its metabolites; about 6 percent of a dose is excreted in

the faeces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in

the liver. Testosterone is metabolised to various 17-keto steroids through two different

pathways.

The half-life of testosterone cypionate when injected intra-muscularly is approximately eight

days.

many

tissues

activity

testosterone

appears

depend

reduction

dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex

is transported to the nucleus where it initiates transcription events and cellular changes

related to androgen action.

5.3 Preclinical safety data

Carcinogenicity

Animal Data: Testosterone has been tested by subcutaneous injection and implantation in

mice and rats. The implant induced cervical-uterine tumours in mice, which metastasised in

some cases. There is suggestive evidence that injection of testosterone into some strains of

female mice increases their susceptibility to hepatoma. Testosterone is also known to

increase the number of tumours and decrease the degree of differentiation of chemically-

induced carcinomas of the liver in rats.

Human Data: There are rare reports of hepatocellular carcinoma in patients receiving long-

term therapy with androgens in high doses. Withdrawal of the drugs did not lead to

regression of the tumours in all cases.

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Elderly patients treated with androgens may be at an increased risk of developing prostatic

hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is

lacking.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl benzoate,

Cottonseed oil,

Benzyl alcohol.

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store at controlled room temperature (20°C - 25°C) and protect from light.

6.5 Nature and contents of container

DEPO-TESTOSTERONE is available in 10 mL multi-dose vials.

6.6 Special precautions for disposal and other handling

None stated.

7. MEDICINE SCHEDULE

Prescription Medicine.

8. SPONSOR

Pfizer New Zealand Limited

P O Box 3998

Auckland, New Zealand, 1140.

Toll Free Number: 0800 736 363.

9. DATE OF FIRST APPROVAL

31 December 1969

10. DATE OF REVISION OF THE TEXT

14 January 2019

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SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

The statement ‘Women who are or may become pregnant has been

amended to Women who are pregnant.

The text under subsection Pregnancy has been updated to include

teratogenicity

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