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Enantone 1-Month DPS 3.75 mg: Endometriosis: Usually, for adults, 3.75 mg of Leuprorelin Acetate is subcutaneously administered once every 4 weeks. However, when the patient's weight is less than 50 kg, 1.88 mg may be used. The administration of this drug should be initiated on the first to fifth day after the start of menstrual period.
Uterine myoma: Usually, for adults, 1.88 mg of Leuprorelin Acetate is subcutaneously administered once every 4 weeks. However, for patients with heavy weight or those with markedly enlarged uterus, 3.75 mg is administered. The administration of this drug should be initiated on the first to fifth day after the start of menstrual period.
Prostate cancer and premenopausal breast cancer: Usually, for adults, 3.75 mg of Leuprorelin Acetate is subcutaneously administered once every 4 weeks.
Central precocious puberty: Usually, a dose of 30 μg/kg of Leuprorelin Acetate is subcutaneously administered once every 4 weeks. Depending upon the patient's condition, the dosage may be increased up to 180 μg/kg.
When using ENANTONE, this drug should be used after suspending it completely by transferring the whole quantity of the vehicle into the powder part, by pressing the plunger rod, with the injection needle held upward, with caution against foaming.
When ENANTONE is used, it becomes impossible to adjust the dosing quantity. Therefore, it should be used only when the patient requires the whole quantity at a time.
Precautions for Dosage and Administration: For all Indications: Since ENANTONE is a sustained release preparation with its action lasting 4 weeks, administration at an interval exceeding 4 weeks may lead to the recurrence of an increase in the serum level of gonadotropic hormone due to the pituitary-gonad system stimulating effect of this drug, resulting in a transient aggravation of the clinical condition. Therefore, the method of administering once every 4 weeks should be observed.
Endometriosis, Uterine Myoma: The incidence of adverse reactions generally tends to increase with an increase in dose. Thus, in setting the dose, careful attention should be paid to the body weight and the extent of enlargement of the uterus as shown previously. (See Pharmacology: Clinical Studies under Actions.)
Before starting treatment with ENANTONE, confirmation should be made that the patient is not pregnant. It is imperative the administration is initiated on the first to fifth day after the start of menstrual period. During the period of treatment with ENANTONE, the patient should be instructed to prevent conception with the use of a non-hormonal method.
A decrease in bone mass may occur owing to estrogen reducing effect of ENANTONE. Therefore, as a rule, this drug should not be administered to patients with endometriosis or uterine myoma for more than 6 months. (The safety of administration for more than 6 months has not been established.) When it is inevitable to administer this drug for a long period or to resume its administration, the drug should be carefully administered after the bone mass is examined as far as possible.
Premenopausal Breast Cancer: Before starting treatment, it should be confirmed that the patient is not pregnant. During the period of treatment with ENANTONE, the patient should be instructed to prevent conception with the use of a non-hormonal method.
A decrease in bone mass may occur owing to estrogen reducing effect of ENANTONE. Therefore, when this drug is administered for a long period, the drug should be carefully administered after bone mass is examined as far as possible.
Central Precocious Puberty: Caution should be exercised not to exceed the dose considered appropriate from the weight and symptoms, etc of the patient.
Enantone 3-Month DPS 11.25 mg: Dosage: Both in male and female the needed dosage is 11.25 mg of active principle (whole content of pre-filled syringe) to be administered once every 3 months.
The duration of the treatment of endometriosis is up to 6 months.
The duration of the treatment of uterine fibroids is up to 6 months.
Paediatric population: The treatment of children with leuprorelin acetate should be done under the general supervision of the paediatric endocrinologist.
The dosage regimen must be adapted individually.
The recommended initial dosage depends on body weight.
Children with body weight ≥20 kg: 1 ml (11.25 mg or the whole content of the prefilled syringe) once every 3 months as a single subcutaneous injection.
Children with body weight <20 kg: In these rare cases, the following dosage must be administered according to the clinical activity of the precocious puberty: 0.5 ml (5.63 mg or the half content of the prefilled syringe) once every 3 months as a single injection. The remainder of the suspension must be discarded. The child's weight gain should be monitored.
Depending to the activity of the central precocious puberty, it may be necessary to increase the dosage in the presence of inadequate suppression (clinical evidence, for example spotting or inadequate suppression of the gonadotropin in the GnRH test). The minimum effective dose to be administered every 3 months should therefore be determined using the GnRH test.
Sterile abscesses often occur at the injection site when leuprorelin acetate has been administered intramuscularly at higher dosages than recommended doses. Therefore, in such cases, the drug must be administered subcutaneously (see Precautions).
It is recommended that the lowest volumes possible for injections in children to decrease the problem associated with the intramuscular/subcutaneous injection.
The duration of the treatment depends on the clinical parameters at the beginning of or during the course of the treatment (prognosis of final height, rate of growth, bone age and/or bone age acceleration) and is decided by the paediatrician together with the guardian and, if applicable, the child being treated. Bone age should be monitored during treatment at 6-12 month intervals.
In girls over 12 years old with bone maturation and boys over 13 years old with bone maturation, treatment discontinuation should be considered taking into account clinical parameters.
In girls, pregnancy must be ruled out before treatment begins. The occurrence of pregnancy during treatment cannot usually be excluded. In such cases, the doctors should be contacted.
Notes: The dosing interval should be 90 ± 2 days to avoid the recurrence of precocious puberty symptoms.
Mode of administration: Enantone must be prepared, reconstituted and administered only by healthcare professionals familiar with these procedures. Before preparing the syringe, carefully wash the hands and wear protective gloves. Keep the syringe in an upright, vertical position during all preparation stages.
Screw the plunger into the end stopper until the stopper begins to turn.
The needle is free and covered with a regular cap. Do not touch the device around the needle.
Ensure that the needle is secure by screwing the needle cap clockwise. Do not over tighten.
Keeping the syringe upright, SLOWLY push the plunger until the middle stopper reaches the blue line in the centre of the syringe. NOTE: if the plunger is pushed too fast or beyond the blue line, some suspension may be lost out of the needle.
Gently tap the syringe on the palm of the hand while keeping the syringe upright to fully mix the particles and form a uniform suspension. The suspension will appear milky. NOTE: Avoid striking too hard to prevent the formation of bubbles.
If the particles adhere to the stopper, tap the syringe with the finger.
Remove the needle cap and advance the plunger to expel the air from the syringe.
At the time of injection, check the direction of the safety device (the black dot should point upwards).
Inject the contents of the syringe subcutaneously or intramuscularly like a normal injection.
AFTER INJECTION, remove the needle from the patient and immediately activate the safety device to cover the needle, pushing the wing upwards with a finger until it clicks, indicating that the device is fully extended and the needle covered.
Enantone 6-Month DPS 30 mg: Posology: 352.9 mg sustained-release microcapsules containing 30.0 mg leuprorelin acetate suspended in 1 ml suspension medium are administered subcutaneously (s.c.) once every six months.
ENANTONE 6 MONTH DPS can be used as neo-adjuvant or adjuvant therapy in combination with radiotherapy for locally advanced hormone dependent prostate cancer and for localized prostate cancer in patients with intermediate- and high risk.
Paediatric population: There are currently no data available for the use of ENANTONE 6 MONTH DPS in children.
Method of administration: ENANTONE 6 MONTH DPS should be prepared, reconstituted and administered only by healthcare professionals who are familiar with these procedures.
The suspension of ENANTONE 6 MONTH DPS should be prepared fresh each time before administration. (For instructions for the preparation of the dual chamber prefilled syringe before administration, see Special precautions for disposal under Cautions for Usage.)
ENANTONE 6 MONTH DPS is administered subcutaneously once every six months. The application interval should be 168 days to maximum 182 days (24 to 26 weeks).
The injection site should be changed every six months. The subcutaneous injection can be given in the abdominal skin, the buttocks, or the upper thigh, for example.
Generally, the treatment of advanced, hormone-sensitive prostate cancer with ENANTONE 6 MONTH DPS is a long-term treatment.
The treatment with a GnRH (Gonadotropin-Releasing-Hormone) analogous of patients which have a prostate carcinoma, can be continued after a castration resistance has been reached. The relevant guidelines have to be considered.
Clinical data have shown that an androgen withdrawal therapy with 3-year duration and following radiotherapy is preferable to a 6-month treatment of locally advanced hormone dependent carcinoma of the prostate (see also Pharmacology: Pharmacodynamics under Actions). In medical guidelines for patients (T3-T4) who receive radiotherapy an androgen withdrawal therapy with a treatment time of 2-3 years is recommended.
Combination of radiotherapy and 4 - 6 months androgen deprivation therapy with GnRH analogues is recommended for localized prostate cancer with intermediate risk, and for tumours with high-risk profile, a combination with 2 - 3 years androgen deprivation therapy is recommended.
According to animal experimental findings, it is essential to avoid accidental intra-arterial injection (thrombosis of small vessels distal to the administration site).
