PAMORELIN POWDER FOR SUSPENSION FOR INJECTION 3.75 MG PER VIAL [SIN14323P]

Product Info

PAMORELIN POWDER FOR SUSPENSION FOR INJECTION 3.75 MG PER VIAL

[SIN14323P]

Therapeutic indications

Pamorelin 3.75 mg, 11.25 mg, and 22.5 mg is indicated for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer.

Pamorelin 3.75 mg, 11.25 mg, and 22.5 mg are indicated as concomitant to and following radiotherapy in patients with high-risk localized or locally advanced prostate cancer.

Pamorelin 3.75 mg is indicated for the treatment of endometriosis.

Pamorelin 3.75 mg is indicated for the pituitary down-regulation in the context of assisted reproduction technology.

Pamorelin 3.75 mg is indicated as adjuvant treatment, in combination with tamoxifen or an aromatase inhibitor, of hormone receptor positive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy.

Pamorelin 22.5 mg is indicated for the treatment of central precocious puberty (CPP) in children of 2 years of age and older with an onset of CPP before 8 years in girls and 10 years in boys.

Posology and method of administration

Pamorelin is administered by a single intramuscular injection.

Dosing schedule depends on the product strength selected (see Table 1).

No dosage adjustment is necessary for patients with renal or hepatic impairment.

Endometriosis:

In women the treatment of endometriosis with Pamorelin 3.75 mg begins during the early follicular phase and should not exceed 6 months.

In patients treated with GnRH analogues for endometriosis, the addition of add-back therapy (an estrogen and progestogen) has been shown to reduce bone mineral density loss and vasomotor symptoms. Therefore, if appropriate, an add-back therapy should be co-administered with GnRH analogue taking into account the risks and benefits of each treatment.

Pituitary down-regulation in the context of medically assisted procreation (IVF, GIFT etc.):

One intramuscular injection of Pamorelin 3.75 mg administered either in the early follicular phase, usually on the 2nd day of the menstrual cycle, or in the mid-luteal phase, usually on the 21st day of the previous cycle. In general, the stimulation by gonadotrophins should be performed when the plasma levels of oestrogens are consistent with ovarian suppression, usually less than 50 pg/ml around the 15th day of the cycle.

Breast cancer:

One intramuscular injection of Pamorelin 3.75 mg every 4 weeks in combination with tamoxifen or an aromatase inhibitor (AI).
Pamorelin 3.75 mg should be commenced after completion of chemotherapy, once pre-menopausal status has been confirmed.
The treatment with Pamorelin 3.75 mg must be initiated at least 6–8 weeks before starting aromatase inhibitor treatment. A minimum of two injections of Pamorelin 3.75 mg (with an interval of 4 weeks between injections) should be administered before commencement of aromatase inhibitor treatment.
During treatment with an aromatase inhibitor, Pamorelin 3.75 mg must not be interrupted to avoid rebound increases in circulating oestrogens.
The recommended treatment duration for adjuvant treatment in combination with other hormonotherapy is up to 5 years.

Prostate cancer:

In high-risk localized or locally advanced hormone-dependent prostate cancer as concomitant to and following radiation therapy, clinical data have shown that radiotherapy followed by long-term androgen deprivation therapy is preferable to radiotherapy followed by short-term androgen deprivation therapy [see Clinical efficacy in men with prostate cancer – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. The treatment duration of androgen deprivation therapy recommended by medical guidances is 2–3 years in these patient populations receiving radiotherapy.

In patients with metastatic castration resistant prostate cancer not surgically castrated receiving a GnRH agonist, such as triptorelin, and eligible for treatment with an inhibitor of androgen biosynthesis (e.g. abiraterone acetate), or an inhibitor of androgen receptor function (e.g. enzalutamide), treatment with the GnRH agonist should be continued.

Central Precocious Puberty:

The treatment of children with Pamorelin 22.5 mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or an endocrinologist with expertise in the treatment of central precocious puberty.

Treatment should be stopped around the physiological age of puberty in boys and girls and should not be continued in girls with a bone maturation of more than 12–13 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 is stopped in boys with a bone maturation age of 13–14 years.

Method of Administration

The lyophilized microgranules are to be reconstituted using 2 mL of sterile water for injection (see Special precautions for disposal and other handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Since Pamorelin is a suspension of microgranules for intramuscular (IM) injection only, inadvertent intravascular injection must be strictly avoided.

As with other medicinal products administered by injection, the injection site should be varied periodically.

Pamorelin must be administered under the supervision of a physician.

Contraindications

Pamorelin is contraindicated in patients with known hypersensitivity to triptorelin, GnRH (Gonadotropin releasing hormone), other GnRH agonist analogues or to any of the excipients of Pamorelin.

Pamorelin is contraindicated in patients with spinal cord compression secondary to prostate cancer metastases.

Pamorelin is contraindicated during pregnancy and breast-feeding.

Pamorelin is contraindicated in patients with unexplained vaginal bleedings.

Initiation of aromatase inhibitor before adequate ovarian suppression with triptorelin has been achieved is contraindicated.