Zuellig Pharma
Full Prescribing Info
1 disposable syringe with 1 ml injectable solution contains: 100 μg triptorelin acetate (95.6 µg triptorelin) in an pH adjusted aqueous sodium chloride solution.
Pharmacology: Triptorelin, the active ingredient in Decapeptyl, is a synthetic analogue of gonadorelin (GnRH). As a result of the substitution of the 6th amino acid residue in the native molecule, the agonistic effect is more pronounced and the plasma half-life prolonged.
Daily injection of Decapeptyl initially results in a stimulation of the pituitary release of LH and FSH. After prolonged stimulation the pituitary becomes refractory, the gonadotropin release declines, resulting in a decrease of the sex steroids (testosterone or estrogen) to castrate levels. These affects are reversible.
DECAPEPTYL is indicated in situations where lowering of sex steroid serum levels to castrate level is desired. For example: Men: Therapy: Symptomatic treatment of an advanced hormone-dependent prostate carcinoma. As a diagnostic agent: To clarify through differential diagnosis the hormonal dependence of a prostate carcinoma.
Women: Endometriosis, Uterine Myoma, IVF.
Dosage/Direction for Use
Usual dose 0.5 mg s.c. daily for 7 days, after that 0.1 mg daily as maintenance dose. IVF: 7 to 10days with 0.5 mg s.c.; followed by 0.1 mg s.c. daily.
DECAPEPTYL should not be used in prostate carcinoma when this is hormone insensitive or after prostatectomy.
DECAPEPTYL should be discontinued if the patient becomes pregnant.
Special Precautions
Monitoring of the therapy should be performed according to the sex steroid serum levels.
Assisted Reproduction: To prevent hyperstimulation, careful monitoring of follicular growth and luteal phase especially in patients with polycystic ovaries.
Men: The initial transient increase of serum testosterone has, in a few patients, been associated with a temporary aggravation of secondary symptoms of the disease, e.g. urinary obstructions, skeletal pain due to metastasis. Close monitoring during the first weeks of treatment should, in these cases, be carried out. The temporary increase of serum testosterone levels can be avoided by treatment with an antiandrogen during the first treatment period. Symptomatic treatment can also be used in relevant cases.
Women: Prior to treatment, non-pregnancy should be confirmed. During the first month of treatment, patients should use non-hormonal contraceptives. Women should not use preparations containing estrogens during the DECAPEPTYL therapy. During treatment of uterine myoma, uterus and myoma size should be measured regularly by means of, for example, ultrasonography. Unproportionally rapid reduction of uterus volume. In comparison with myoma tissue has, in a few cases, caused bleeding and sepsis.
Use In Pregnancy & Lactation
In animal tests, no teratogenic effects have been detected. In humans, there is insufficient experience.
There are insufficient data relating to the use of DECAPEPTYL during lactation.
Side Effects
The pharmacological side effects owing to the suppression of hormone production include in men: Hot flushes, impotence, loss of libido, and in rare cases, gynaecomastia and testicular atrophy; in women: Hot flushes, bleeding or spotting, vaginal dryness and/or dyspareunia. As a consequence of the lowered estrogen levels, slight trabecular bone loss may occur. However, this is recovered generally within 6-9 months after treatment has been discontinued.
Less frequent side effects reported include: In rare cases, allergic reactions (fever, itching, exanthema, anaphylaxis), headache, tiredness and sleep disturbances. In general, the side effects are mild and disappear after treatment has been stopped.
Drug Interactions
Not yet known.
Store in a refrigerator (2-8°C). Do not freeze. Store in the original package.
The disposable syringes should be stored in package, protected from light.
Shelf Life: 3 years.
ATC Classification
L02AE04 - triptorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Inj 0.1 mg x 7 ready-to-use syringe kit.
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