Date of preparation: October 2014 TM/946/2014/ECO (1)
Testim
®
gel
50mg
testosterone
TESTIM restores testosterone levels,
producing significant improvement
in sexual function and mood as well
as increased BMD and improved
lean body mass
1
Low testosterone?
Abbreviated Prescribing Information
Prescribing Information: Testim 50mg Gel. Testim is a clear to
translucent gel. One tube of 5 g gel contains 50 mg testosterone.
Indication:
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has been confirmed by clinical features and biochemical
tests.
Dosage and administration:
Recommended starting dose: One tube
of 5 g gel daily. If serum testosterone levels are below the normal range, the
dose may be increased from 50 mg (one tube) to 100 mg (two tubes) once
daily. Once opened apply the entire content of the tube immediately to clean
dry intact skin of the shoulders and/or upper arms, preferably in the morning.
Wash hands immediately after use. Do not apply to the genital area. Not for
use in children. Not clinically evaluated in males less than 18 years of age.
Contraindications:
Androgens are contraindicated in men with carcinoma of
the breast or known or suspected carcinoma of the prostate. Hypersensitivity
to testosterone (synthesised from soy) or to any of the excipients.
Pregnancy
and lactation:
Testim is not indicated for women and must not be used
in pregnant or breastfeeding women. Pregnant women must avoid skin
contact with Testim application sites.
Warnings and precautions:
Prior to
therapy, the risk of prostate cancer must be excluded. Examine breast and
prostate gland at least yearly and twice yearly in elderly or at risk patients
(those with clinical or familial factors). Monitor serum calcium levels in
patients with skeletal metastases at risk of hypercalcaemia/hypercalcuria.
Testosterone may cause oedema with or without congestive cardiac failure
in patients with severe cardiac, hepatic or renal insufficiency. In this case,
stop treatment immediately. Use with caution in patients with hypertension,
ischemic heart disease,epilepsy,and migraine.Possible increased risk of sleep
apnoea in patients who are obese or with chronic respiratory disease. Improved
insulin sensitivity may occur. Irritability, nervousness, weight gain, prolonged
or frequent erections may indicate excessive androgen exposure requiring
dosage adjustment. If severe application site reaction occurs, discontinue
treatment if necessary. Periodically monitor testosterone concentrations, full
blood count, lipid profile, and liver function. Testosterone may produce a
positive reaction in an anti-doping test. Not for use in women. The gel may
be transferred to others by skin to skin contact, which could lead to adverse
reactions (inadvertent androgenisation) by repeated contact. Inform the patient
about the transfer risk, which can be prevented by covering or washing the
site before contact. Testim gel should not be prescribed for patients who
may not comply with safety instructions (e.g. severe alcoholism, drug abuse,
severe psychiatric disorders). The content of the tube is flammable. Testim
contains propylene glycol which may cause skin irritation.
Interactions:
Interactions have been reported with oral anticoagulants,ACTH,corticosteroids
and propranolol. Laboratory tests have shown that androgens may decrease
levels of thyroxine-binding globulin.
Undesirable effects:
Common (1% to
<10%): Application site reactions (rash, erythema, pruritus), increased PSA,
hypertension worsened, acne, headache, increased haematocrit, increased
red blood cell count and increased haemoglobin. Uncommon (0.1% to <1%):
Hot flushes/flushing, pruritus and peripheral oedema. Very rare (<0.01% to
not known): Azoospermia. Gynaecomastia may uncommonly develop and
persist.Other known reactions to testosterone are:Prostate cancer,electrolyte
changes, decreased libido, anxiety, emotional liability, generalized paresthesia,
nausea, jaundice and liver function test abnormalities, hirsutism, alopecia,
seborrhoea,muscle cramps, increased frequency of erections,priapism,prostate
abnormalities,altered blood lipid levels (including reduction of HDL cholesterol),
and weight gain. Please refer to the Summary of Product Characteristics for
the full safety information.
Overdose:
Reports describing overdose have
included doses up to 150 mg testosterone. No dose limiting toxicity has been
reported from these spontaneous cases.
Presentation:
Testim is supplied
as a Carton containing 30 x 5g tubes.
Price:
£32.00.
Legal classification:
POM.
PL Number:
03194/0105.
Please refer to the Summary of Product
Characteristics for full prescribing information. Company name and
address:
Ferring Pharmaceuticals Ltd.,The Courtyard,Waterside Drive,Langley,
Berks, SL3 6EZ.
Date of Preparation:August 2009
Reference:
1. Dean J
et al.
Rev Urol 2004;6(Suppl 6):S22-29.
Prescribing information may differ in each country.
Testim is not approved in all European markets.Testim is a registered
trademark of Auxilium Pharmaceuticals, Inc.
