Pamorelin Dosage/Direction for Use

Triptorelin is administered as a single intramuscular (IM) injection. The 3.75 mg format may also be administered as a single subcutaneous (SC) injection.
As with other drugs administered by injection, the injection site should be varied periodically.
Since triptorelin is a suspension of microgranules, inadvertent intravascular injection must be strictly avoided.
Recommended Dosing for Triptorelin: Prostate Cancer: Triptorelin should be prescribed by and administered under the supervision of a qualified physician experienced in the use of hormonal therapy in prostate cancer. (See table.)

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Due to different release characteristics, the different dosage strengths of triptorelin are not additive and must be selected based on the desired dosing schedule. The treatment duration of androgen deprivation therapy recommended by medical guidances for T3 (locally extensive prostate cancer) to T4 (metastatic prostate cancer) patients receiving radiotherapy is 2 to 3 years.
In patients with metastatic castration-resistant prostate cancer not surgically castrated receiving a GnRH agonist, such as triptorelin, and eligible for treatment with abiraterone acetate, an inhibitor of androgen biosynthesis, or enzalutamide, an inhibitor of androgen receptor function, treatment with the GnRH agonist should be continued.
The efficacy of treatment can be monitored by measuring serum levels of testosterone and prostate specific antigen (PSA) and by subjective evaluation (symptomatic improvement, e.g. of urinary symptoms, cancer pain etc.). Testosterone levels can be measured immediately before or after injection.
Breast cancer (For 3.75 mg preparations only): The recommended dose is triptorelin 3.75 mg (1 vial) administered once a month (i.e., every 4 weeks) as an intramuscular injection in combination with tamoxifen or an aromatase inhibitor.
Triptorelin should be commenced after completion of chemotherapy, once premenopausal status has been confirmed.
Treatment with triptorelin must be initiated at least 6 to 8 weeks before starting aromatase inhibitor treatment. A minimum of 2 injections of triptorelin (with an interval of 4 weeks between injections) should be administered before commencement of aromatase inhibitor treatment.
During treatment with an aromatase inhibitor, triptorelin must not be interrupted to avoid rebound increases in circulating estrogens in premenopausal women.
Patients who have discontinued triptorelin treatment should also discontinue aromatase inhibitors within 1 month of the last triptorelin administration.
The recommended treatment duration for adjuvant treatment in combination with other hormonotherapy is up to 5 years.
Pituitary down-regulation in the context of assisted reproduction technology (For 3.75 mg preparations only): Various protocols are proposed for the use of triptorelin 3.75 mg: In the "long protocol", a single injection of triptorelin 3.75 mg causes complete pituitary suppression (down-regulation) prior to the induction of stimulation with exogenous gonadotropins. The extent of the pituitary suppression is measured by the level of circulating estrogens. Stimulation with exogenous gonadotropins is induced only when the E₂ levels is <50 pg/mL.
The "long protocol" is also employed outside medically assisted procreation. The dosage of gonadotropins administered to induce follicular maturation should be adjusted because the aim of treatment is maturation of a single follicle.
In the "short protocol", stimulation with exogenous gonadotropins is induced at the same time as, or very shortly after, the single injection of triptorelin 3.75 mg. In this case, the effect of the GnRH agonists during the first few days of stimulation potentiates the effects of the exogenous gonadotropins ("flare-up"). The "short protocol" should not be used outside medically-assisted procreation.
The extent of pituitary suppression (in the "long protocol") can be evaluated by measuring levels of E₂. Regular biological and endocrinological tests with control ultrasound scans are required during medically assisted procreation. In the event of excessive ovarian stimulation, reduce or discontinue gonadotropin administration.
Endometriosis (For 3.75 mg and 11.25 mg preparations only): Single IM or SC (for 3.75 mg preparation only) injection every 28 days, to be initiated in the first 5 days of the menstrual cycle. The maximum duration of treatment should be 6 months.
Treatment duration depends on the initial severity of the disease and the changes observed in the clinical features (functional and anatomical) during treatment.
Experience in women has been limited to women ≥18 years old treated for 6 months.
Maintaining estradiol suppression is important in the management and relief of chronic pain associated with endometriosis. Missing an appointment by a few days should not disrupt the benefits of treatment, but keeping a consistent schedule of triptorelin injections is an important part of treatment.
An improvement in symptoms (e.g., dysmenorrhea, dyspareunia, tenesmus, pelvic pain) can be expected during treatment. If necessary, therapeutic follow-up can be based on the usual biological parameters (E₂, progesterone).
Precocious puberty (For 22.5 mg preparations only): The treatment of children with triptorelin 22.5 mg should be under the overall supervision of a pediatric endocrinologist, a pediatrician, or an endocrinologist with expertise in the treatment of central precocious puberty.
Treatment should be discontinued around the physiological age of puberty in boys and girls and should not be continued in girls with a bone maturation of more than 12 to 13 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age; however it is advised that treatment be discontinued in boys with a bone maturation age of 13 to 14 years.
The therapy is a long-term treatment, and should be individually adjusted. Triptorelin 22.5 mg should be administered as precisely as possible in regular six-monthly (24 weekly) periods, respectively. An exceptional delay of the injection date for a few days (169 ± 3 days, respectively) does not influence the results of the therapy.
The development of puberty characteristics will occur after discontinuation of treatment. Information with regards to fertility is still limited, but future reproductive function and fertility appears to be unaffected by GnRH treatment. In most girls, regular menses will start on average one year after discontinuation of therapy.
Directions for Reconstitution: The powder should be reconstituted immediately before use. The lyophilized microgranules are to be reconstituted in 2 mL of Sterile Water for Injection only. No other diluents should be used.
Using a syringe fitted with a sterile 21-gauge needle, withdraw 2 mL of Sterile Water for Injection and inject into the vial.
Shake the vial gently and thoroughly to completely disperse the powder to obtain a homogeneous milky suspension.
The suspension should be administered immediately after reconstitution since the product does not contain any preservative. Once reconstituted, the suspension of triptorelin should be injected relatively rapidly and in an uninterrupted manner in order to avoid any potential blockage of the needle.
For single use only. Discard any unused suspension.
Special Populations: Renal and Hepatic Impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.