Enantone L.P. Dosage/Direction for Use

3.75 mg/11.25 mg: Treatment with Prostate cancer: After reconstitution, 3.75 mg/11.25 mg of leuprorelin acetate (ENANTONE L.P. 3.75 mg/11.25 mg) is administered once a month (for 3.75 mg) and ONCE EVERY THREE MONTHS (for 11.25 mg) as a single subcutaneous or intramuscular injection.
The majority of patients will respond to a 3.75 mg/11.25 mg dose. ENANTONE therapy should not be discontinued when remission or improvement occurs. Response to ENANTONE L.P. 3.75 mg/11.25 mg therapy may be monitored by clinical parameters and by measuring serum levels of testosterone and acid phosphatase (for 3.75 mg) and prostate-specific antigen (PSA) serum levels (for 11.25 mg). Clinical studies have shown that testosterone levels increased during the first 4 days of treatment in the majority of non-orchidectomised patients. They then decreased and reached castrate levels by 2-4 weeks. Once attained, castrate levels were maintained as long as drug therapy continued. Transient increases in acid phosphatase levels sometimes occur early in the treatment period but usually return to normal or near normal values by the 4^th week of treatment.
If a patient's response appears to be sub-optimal, then it would be advisable to confirm that serum testosterone levels have reached or are remaining at castrate levels (for 11.25 mg only).
Elderly men: as for adults (for 11.25 mg only).
Treatment with Endometriosis, Uterine Fibroids and Premenopausal breast cancer: Endometriosis: Usually, for adults, 3.75 mg/11.25 mg of leuprorelin acetate (ENANTONE L.P. 3.75 mg/11.25 mg) is subcutaneously or intramuscularly administered once a month (for 3.75 mg) and ONCE EVERY THREE MONTHS (for 11.25 mg) after reconstitution. However, when the patient's weight is less than 50 kg, 1.88 mg preparation (ENANTONE L.P. 1.88 mg) may be used. Treatment should be started during the first five days of the menstrual cycle.
Monotherapy: ENANTONE L.P. 3.75 mg/11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriosis lesions, for up to six months.
Combination therapy: In two clinical studies, 3.75 mg leuprorelin was administered monthly for a period of 12 months with concurrent hormonal replacement therapy (norethindrone acetate 5 mg daily) and calcium supplementation.
These studies demonstrated that concurrent hormonal therapy (norethindrone acetate 5 mg daily) was effective in significantly reducing the loss of bone mineral density loss that occurs with leuprorelin treatment, without comprising the efficacy of leuprorelin in relieving symptoms of endometriosis.
To flatten the endometrium before planned hysteroscopic operative interventions, an injection of ENANTONE L.P. 11.25 mg is administered s.c. or i.m. The success of treatment can be evaluated ultrasonically by measuring the endometrial thickness.
Uterine Fibroids: Usually, for adults, 1.88 mg of leuprorelin acetate (ENANTONE L.P. 1.88 mg) is subcutaneously or intramuscularly administered once a month. However, for patients with heavy weight or those with markedly enlarged uterus, 3.75 mg/11.25 mg (ENANTONE L.P. 3.75 mg/11.25 mg) is administered once a month (for 3.75 mg) and ONCE EVERY THREE MONTHS (for 11.25 mg) The administration of this drug should be initiated on the first to fifth day after the start of menstrual period.
3.75 mg: Recommended duration of therapy with ENANTONE L.P. 3.75 mg is up to 3 months. The symptoms associated with uterine fibroids will recur following discontinuation of therapy. If additional treatment with ENANTONE L.P. 3.75 mg is contemplated, bone density should be assessed prior to initiation of therapy to ensure that values are within normal limits.
11.25 mg: The duration of administration should be restricted to a period of 6 months. Repeated treatments should be carried out only after careful consideration of the risks and benefits by the treating physicians. This includes the measurement of bone density before the start of any treatment.
ENANTONE L.P. 11.25 mg concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine fibroids. The clinician may wish to consider a one-month trial period on iron alone in as much as some of the patients will respond to iron alone.
Premenopausal breast cancer: After reconstitution, 3.75 mg of leuprorelin acetate (ENANTONE L.P. 3.75 mg) is administered once a month as a single subcutaneous or intramuscular injection. Bone density should be assessed prior to initiation of therapy and during therapy to ensure that values are within normal limits.
Usually, for adults, 11.25 mg of Leuprorelin Acetate is subcutaneously or intramuscular administered once every 12 weeks (ONCE EVERY THREE MONTHS).
3.75 mg: Treatment with central precocious puberty: Administer 90-400 μg/kg of leuprorelin acetate subcutaneously or intramuscularly once a month. The dose may be adjusted according to the patient's response.
11.25 mg: Paediatric population: The treatment of children with leuprorelin acetate should be under the overall supervision of the paediatric endocrinologist.
The dosing scheme needs to be adapted individually.
11.25 mg of Leuprorelin Acetate is subcutaneously or intramuscularly administered once every 12 weeks (ONCE EVERY THREE MONTHS).
The duration of treatment depends on the clinical parameters at the start of treatment or during the course of treatment (final height prognosis, growth velocity, bone age and/or bone age acceleration) and is decided by the treating paediatrician together with the legal guardian and, if appropriate, the treated child. The bone age should be monitored during treatment at 6-12 month intervals.
In girls with bone maturation of older than 12 years and boys with bone maturation of older than 13 years discontinuation of treatment should be considered taking into account the clinical parameters.
In girls, pregnancy should be excluded before the start of treatment. The occurrence of pregnancy during treatment cannot be generally excluded. In such cases, medical advice should be sought.
30 mg: ENANTONE L.P. 30 MG DPS containing 30.0 mg leuprorelin acetate suspended in 1 ml sterile vehicle are administered subcutaneously or intramuscularly once every six months.
Treatment with Advanced Prostate cancer: After reconstitution, one DPS administered ONCE EVERY SIX MONTHS as a single subcutaneous or intramuscular injection. The application interval should be 168 days to maximum 182 days (24 to 26 weeks).
The injection site should be changed every six months. Injection sites may include abdominal skin, buttocks, and upper thigh.
Generally, the treatment of advanced prostate cancer with ENANTONE L.P. 30 mg is continued on a long-term basis.
Treatment with ENANTONE L.P. 30 mg should be monitored for success on a regular basis by means of clinical examinations as well as laboratory evaluations of prostate-specific antigen (PSA), and serum testosterone levels, especially in case of potential clinical signs of progression presenting despite adequate treatment.
Note: As animal experimental findings demonstrated, it is crucial to avoid accidental intra-arterial injection, in view of the potential onset of thrombosis of small vessels distal to the injection site.