Medicinal Products

ANDROTARDYL 250 mg / 1 mL

Generic drug of the therapeutic class: Endocrinology
active ingredients: Testosterone
laboratory: Bayer Healthcare

IM Injectable Solution
Box of 1 ampoule of 1 mL
All forms

Indication

· Male hypogonadism, by documented deficit in testosterone, whatever its etiology.

Dosage ANDROTARDYL 250 mg / 1 mL Solution for injection IM Box of 1 ampoule of 1 mL

The oily solution should be administered very slowly (see Warnings and Precautions ) and immediately after opening the ampoule. It is advisable to use, for injection, a glass syringe.

Dosage

250 mg IM every 2 to 4 weeks

Serum testosterone levels should be measured before starting treatment and occasionally during treatment at the end of the interval between two injections. Below normal serum levels may indicate that it is necessary to shorten the intervals between injections. In case of high serum levels, an increase in the time interval between injections may be considered.

Child and teenager:

ANDROTARDYL is not indicated in children and adolescents (see Warnings and Precautions ).

Elderly patients:

Limited data do not suggest the need for dose adjustment in elderly patients (see Warnings and Precautions section ).

Hepatic insufficiency :

No formal studies have been conducted in patients with hepatic impairment. The use of ANDROTARDYL is contraindicated in patients with hepatic tumors, a history of hepatic tumors or severe hepatic insufficiency (see section 4.3 ).

Renal failure :

No formal studies have been conducted in patients with renal impairment. The use of ANDROTARDYL is contraindicated in patients with severe renal impairment (see section 4.3 ).

Against indications

· Androgen-dependent prostate or breast cancer in humans,

· Prostatic adenoma,

· Hypercalcemia associated with a malignant tumor,

· Liver tumor or history of liver tumor,

· Severe cardiac, renal or hepatic insufficiency,

· Known hypersensitivity to testosterone or to any of the excipients.

Androtardyl side effects

For adverse effects associated with the use of androgens, see also Warnings and Precautions for Use .

The most common adverse reactions observed with ANDROTARDYL therapy are injection site reactions and general administration disorders.

The table below includes adverse reactions from spontaneous reports and scientific literature for which it is not possible to estimate a frequency from the available data.

Class of organ systems

Frequency unknown

Benign and malignant tumors

Benign and malignant liver tumors (section Warnings and precautions for use )

Blood and lymphatic system disorders

Polycythemia (see section Warnings and precautions for use )

Increased hemoglobin

Hematocrit increased

Immune system disorders

hypersensitivity

Hepatobiliary disorders

Abnormal liver function tests

icterus

Skin and subcutaneous tissue disorders

Acne

Alopecia

rash

Urticaria

itching

General disorders and administration site conditions

Various types of injection site reactions *

Disorders of reproductive organs and breast

Augmentation of prostate specific antigens (PSA)

Increased libido

Decreased libido

gynecomastia

The most appropriate MedDRA term to describe a certain adverse reaction and its associated synonyms or diseases is based on MedDRA 13.1.

* Pain, erythema, inflammation at the injection site.

Description of some specific adverse effects

Injections of oily solutions such as ANDROTARDYL have been associated with systemic reactions such as pulmonary micro-embolism that may lead to signs and symptoms such as cough, dyspnoea, chest pain. Other signs and symptoms including vasovagal reactions may occur such as malaise, hyperhidrosis, dizziness, paresthesia or syncope (see Warnings and Precautions section ).

High-dose or long-term treatment with testosterone (especially ANDROTARDYL) increases the tendency for fluid retention and edema (see sections Warnings and Precautions and Contraindications ).

Spermatogenesis is reversibly inhibited by long-term, high-dose treatment with ANDROTARDYL (see Warnings and Precautions ).

Frequent or persistent erections have been reported (see Warnings and Precautions ).

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