final PrograM 13th Congress of the european society for ... - ESSM

TESTOPATCH® SMPC
1. NAME OF THE MEDICINAL PRODUCT. TESTOPATCH® 1.2 mg/24 h transdermal patch.
TESTOPATCH® 1.8 mg/24 h transdermal patch. TESTOPATCH® 2.4 mg/24 h transdermal patch.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION: One transdermal patch of 30 cm² contains 15 mg
of testosterone and delivers 1.2 mg of testosterone per 24 hours. One transdermal patch of 45 cm² contains
22.5 mg of testosterone and delivers 1.8 mg of testosterone per 24 hours. One transdermal patch of 60 cm²
contains 30 mg of testosterone and delivers 2.4 mg of testosterone per 24 hours. For a full list of excipients,
see section 6.1.
3. PHARMACEUTICAL FORM. Transdermal patch. Thin, transparent transdermal patch.
4. CLINICAL PARTICULARS. 4.1 Therapeutic indications. Replacement therapy for male
hypogonadism due to testosterone deficiency confirmed by laboratory and clinical signs (see section 4.4).
4.2 Posology and method of administration. FOR ADULT MEN ONLY. Transdermal route. Posology.
Two transdermal patches must be applied simultaneously to the skin and be replaced every 48 hours.
TESTOPATCH®, transdermal patch is available in three dosage forms: 1.2 mg / 24h, 1.8 mg / 24h and 2.4 mg
/ 24h. Initiation of treatment. The initial dose generally recommended is two TESTOPATCH® 2.4 mg/24 h
transdermal patches, renewed every 48 hours. This dosage may be adjusted as a function of clinical
symptoms and plasma testosterone levels. Dosage adjustment. The plasma testosterone concentration is to
be determined on morning time at the start of treatment and during patient follow-up between 12 and 36 hours
after applying the transdermal patch. The administered dose may be adjusted by the physician on the basis of
clinical and laboratory responses. The testosterone levels have to be regularly monitored after dose adjustment.
If the plasma testosterone concentration is higher than normal values, or in the event of symptoms of
hyperandrogenism, the dosage may be reduced to 2 patches TESTOPATCH® 1.8 mg/24 h or to 2 patches
TESTOPATCH® 1.2 mg/24 h. Method of administration. Take care for the integrity of the pouches before
use. Open the sachet only prior to use and apply immediately after removal from the protective sachet.
TESTOPATCH® must be applied to the arms, lower back or thighs on clean, dry and healthy skin. Avoid areas
of skin that are oily, perspire heavily or are covered with hair, as the patch may not stick tightly to these areas.
If necessary, hair at the application site should be cut and not shave before applying TESTOPATCH®. As well
soaps, oils, lotions or other agents that may irritate the skin or affect it must not be used. A patch should not
be applied twice consecutively to the same site. The transdermal patches are not to be applied to the breasts
or scrotum. The patches may be worn when showering or bathing. In the rare event that a patch becomes
detached from the skin, it is recommended to apply a new patch to another site; the latter should be
removed at the date initially scheduled. If the patient forgets to change the patches, he should replace them
as soon as he remembers. The following patches should be applied on the days initially scheduled. Children
and adolescents. TESTOPATCH® is not for use in children and adolescents below 18 and no clinical study
has been conducted in children and adolescents. Elderly subjects. The experience using TESTOPATCH® is
limited in patients over the age of 65 years. Renal/hepatic impairment. No formal studies have been
conducted in patients with renal or hepatic impairment, but TESTOPATCH® should be used with caution in
these patients (See section4.4). 4.3 Contraindications. • Suspected or confirmed breast carcinoma or
prostatic cancer, • Known hypersensitivity to testosterone or to any other constituent of the transdermal
patch, • Presence or history of liver tumour. 4.4 Special warnings and precautions for use. •
TESTOPATCH® is to be used if hypogonadism (hypo-or hypergonadrotrophic) has been clearly demonstrated
and if other aetiologies that may be responsible for the symptoms have been ruled out before initiating
treatment. Testosterone deficiency must be clearly demonstrated by clinical signs (regression of secondary
sexual characteristics, modification of build, asthenia, decreased libido, erectile dysfunction, etc) and
confirmed by two separate serum testosterone assays. At present, there is no consensus as to normal serum
testosterone values as a function of age. However, account should be taken of the fact that physiological
levels of serum testosterone diminish with age. • Because of the variability of results between different
laboratories, all assays should be performed by the same laboratory for a given patient. • TESTOPATCH® is not
indicated in the treatment of male sterility and impotence. • Androgens can accelerate the development of
infraclinical prostate cancer or of benign prostatic hyperplasia. • Before initiating testosterone-based
therapy, it is essential that patients undergo a detailed examination so as to eliminate any risks related to
pre-existing prostate cancer. • Attentive and regular monitoring of the prostate and breasts is to be
conducted, using the recommended methods (rectal touch and determination of prostate-specific antigen
(PSA))at least once a year in any patient under testosterone treatment. In hypogonadal subjects aged over
40 and in patients at risk (clinical or familial factors), a regular monitoring is recommended every 3 months
for the first year, then twice a year subsequently. • In addition to monitoring serum testosterone levels in
patients receiving long-term androgen therapy, the following laboratory parameters should also be
monitored regularly: haemoglobin, hematocrit (to detect any polyglobulia) liver function parameters and
lipid profile. TESTOPATCH® is to be used with caution: • in patients suffering from renal or liver failure. No
efficacy and safety study on this medicinal product has been conducted in these patients, • in patients
presenting with severe heart, liver or kidney failure, or ischemic heart disease, Testosterone treatment may
induce complications, characterized by oedema, which may or may not be accompanied by congestive heart
failure. The treatment must be discontinued immediately if such complications occur. Adapted treatment
may be initiated further to physician’s decision. • in patients presenting with cancer at risk of hypercalcemia
/ hypercalciuria due to bone metastases. Regular serum calcium monitoring is to be conducted in such
patients, • in hypertensive patients, testosterone may induce an increase in blood pressure, • in patients presenting
with epilepsy or suffering from migraine since those disorders may be exacerbated. Enhanced insulin
sensitivity may be observed in patients receiving androgens and in whom normal plasma testosterone levels
have been induced by treatment. Testosterone treatment of hypogonadal subjects may increase the risk of
sleep apnoea, particularly in subjects with risk factors such as obesity or chronic respiratory disease.Certain
clinical signs such as irritability, nervousness, weight gain and prolonged or frequent erections, nausea,
vomiting or ankle swelling, breathing disturbances, including those associated with sleep may reflect
excessive testosterone exposure and require dosage adjustment. The attention of sportsmen and athletes is
to be drawn to the fact that this product contains an active substance (testosterone) liable to induce positive
results to tests for prohibited substances. Androgens are not suitable for enhancing muscular development
in healthy individuals or for increasing physical ability. If the patient develops a severe application site
reaction, treatment should be reviewed and discontinued if necessary. TESTOPATCH® should not be used in
women due to possible virilising effects (see also section 4.6). 4.5 Interaction with other medicinal
products and other forms of interaction. Precautions for use. Interactions studies have only been
performed in adults. + Oral anticoagulants: variation in the anticoagulant effect through modification to
the hepatic synthesis of coagulation factors, with a tendency towards an increase in the effect of the oral
anticoagulant. More frequent controls of the INR, and possible adjustment of the dosage of the oral
anticoagulant during treatment with TESTOPATCH® and for 8 days following its discontinuation, are
recommended. + The concurrent administration of testosterone with ACTH or corticosteroids may increase
the likelihood of oedema; thus these drugs should be administered with caution, particularly in patients with
cardiac, renal or hepatic disease. + Laboratory tests interactions : androgens may decrease levels of
thyroxin-binding globulin, resulting in decreased total T4 serum concentrations and increase resin uptake of
T3 and T4. Free thyroid hormone concentrations remain unchanged, however and there is no clinical
evidence of thyroid dysfunction. 4.6 Pregnancy and lactation. TESTOPATCH® is for men only. It is not
indicated in women. Testosterone may induce virilising effects on the female foetus. Testosterone must not
be administered in women who are pregnant or breastfeeding. 4.7 Effects on ability to drive and use
machines. No studies on the effects on the ability to drive and use machines have been performed. 4.8.
Undesirable effects. During clinical trials performed with different doses of TESTOPATCH®, 47.9% of
patients presented with at least one undesirable effect which was probably treatment-related. The
undesirable effects most frequently observed in clinical trials with the various strengths of TESTOPATCH® are
reactions at the application site, often at the beginning of treatment. Application site reactions occurred in
approximately 23% of patients. At the recommended dosage of two 2.4 mg/24 h patches every 48 hours,
the possibly treatment-related adverse events observed in a total of 253 patients, treated for a maximum of
one year, are indicated in the table below:
Metabolism and nutrition disorders
Psychiatric disorders
Nervous system disorders
Gastrointestinal disorders
Hepato-biliary disorders
Skin and subcutaneous disorders
Musculoskeletal and connective tissue disorders
General disorders and administration site
conditions
COMMON (>1/100,