Prostap SR (Leuprorelin Injection) 3.75 mg dual chamber syringe (DCS) Pack of 1
Prostap SR DCS
Prescription-only medicine (POM)Gonadotrophin-releasing hormone (GnRH) agonist depot injection
Certifications
- MHRA Licensed medicinal product in the UK (PL 16189/0012).
- Manufactured under EU/UK Good Manufacturing Practice (GMP) requirements.
- SmPC and PIL published and regularly updated on the electronic Medicines Compendium (emc).
- Supplied in the UK through MHRA Licensed wholesale dealers (e.g. Alliance Healthcare).
- Medisave UK Ltd registered with MHRA as a wholesale dealer (WDA licence 18935) and certified to ISO 9001 quality management and ISO 14001 environmental management standards.
- MHRA Licensed medicinal product in the UK (PL 16189/0012).
- Manufactured under EU/UK Good Manufacturing Practice (GMP) requirements.
- SmPC and PIL published and regularly updated on the electronic Medicines Compendium (emc).
- Supplied in the UK through MHRA Licensed wholesale dealers (e.g. Alliance Healthcare).
- Medisave UK Ltd registered with MHRA as a wholesale dealer (WDA licence 18935) and certified to ISO 9001 quality management and ISO 14001 environmental management standards.
Gonadotrophin-releasing hormone (GnRH) agonist depot injection
Description
Prostap SR DCS 3.75 mg is a prolonged-release depot formulation of leuprorelin acetate, a gonadotrophin-releasing hormone (GnRH) agonist, supplied as a dual chamber pre-filled syringe containing powder and solvent for suspension for injection. Following reconstitution, it is given as a single subcutaneous or intramuscular injection every month. Chronic administration suppresses gonadotrophin secretion and leads to a reversible reduction in ovarian or testicular steroid production. It is licensed in adults for prostate cancer, endometriosis, endometrial preparation prior to intrauterine surgery, preoperative management of uterine fibroids, preservation of ovarian function during chemotherapy, and hormone-responsive breast cancer, and in children for central precocious puberty. The dual-chamber syringe includes a safety needle device and is for use by healthcare professionals only.
Bnefits
- Monthly depot GnRH agonist injection providing sustained suppression of gonadal steroid production for 30–40 days after a single 3.75 mg dose.
- Wide range of licensed indications across urology, gynaecology, oncology and paediatric endocrinology, including prostate cancer, endometriosis, uterine fibroids, breast cancer and central precocious puberty.
- Dual chamber pre-filled syringe with integrated solvent and powder simplifies reconstitution and reduces risk of handling errors compared with multi-vial systems.
- Includes a safety needle device designed to reduce risk of needlestick injury after injection.
- MHRA-licensed medicinal product with up-to-date SmPC and PIL, ensuring defined quality, safety and efficacy standards.
- Can be administered subcutaneously or intramuscularly (adults) allowing flexibility according to clinical practice and patient factors.
Indications
- Metastatic prostate cancer.
- Locally advanced prostate cancer, as an alternative to surgical castration.
- Adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
- Adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.
- Neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
- Management of endometriosis, including pain relief and reduction of endometriotic lesions.
- Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection.
- Preoperative management of uterine fibroids to reduce their size and associated bleeding.
- Preservation of ovarian function in pre-menopausal women with neoplastic disease undergoing chemotherapy that can cause premature ovarian insufficiency (not a replacement for standard fertility-preservation methods).
- Treatment of pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.
- Adjuvant treatment, in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence.
- Treatment of central precocious puberty in children (girls under 9 years of age, boys under 10 years of age).
Composition
- Active ingredient: Leuprorelin acetate 3.75 mg (equivalent to 3.57 mg leuprorelin base) per single-dose syringe.
- When reconstituted with 1 ml Sterile Solvent, the suspension contains 3.75 mg/ml leuprorelin acetate.
- Powder excipients: Gelatin; Copoly(DL lactic acid/glycolic acid) 72:25 mol%; Mannitol (E421).
- Sterile solvent excipients (per ml): Carmellose sodium 5 mg; Mannitol (E421) 50 mg; Polysorbate 80 1 mg; Acetic acid, glacial (up to 0.05 mg); Water for injections.
Formulation
- Pharmaceutical form: Powder and solvent for prolonged-release suspension for injection in pre-filled dual chamber syringe.
- Powder: Sterile, lyophilised, white, odourless powder.
- Solvent: Colourless, odourless, slightly viscous, sterile solvent.
- Prolonged-release microsphere depot formulation designed for once-monthly subcutaneous or intramuscular administration.
Packaging
- One dual chamber pre-filled syringe containing 3.75 mg leuprorelin acetate powder in the front chamber and 1 ml Sterile Solvent in the rear chamber.
- One 23 gauge syringe needle fitted with safety device.
- One syringe plunger.
- Pack size: 1 dual chamber syringe (DCS) per carton.
Usage
- For subcutaneous or intramuscular injection as a one-month depot, to be prepared and administered only by healthcare professionals familiar with these procedures.
- Attach the plunger rod to the syringe, ensuring it is firmly screwed into the end stopper.
- Without removing the needle cap, tighten the needle by twisting clockwise.
- Holding the syringe upright, slowly push the plunger until the middle stopper reaches the marked blue line, releasing the solvent into the chamber containing the powder.
- Gently tap the syringe to mix until a uniform milky suspension without visible lumps is obtained; avoid vigorous shaking to minimise bubble formation.
- Use immediately after reconstitution, as the suspension settles quickly.
- Remove the needle cap by pulling straight off, prime the syringe to expel air, then inject the entire contents subcutaneously or intramuscularly as per local practice.
- After injection, activate the safety device until a click is heard or felt and the needle is fully covered; dispose of the device in an appropriate sharps container.
- Adults – prostate cancer: 3.75 mg depot injection every month (30 ± 2 days) by subcutaneous or intramuscular route.
- Adults – endometriosis: 3.75 mg every month for up to 6 months; start during the first 5 days of the menstrual cycle.
- Adults – endometrial preparation prior to intrauterine surgery: a single 3.75 mg injection 5–6 weeks before the procedure, started on days 3–5 of the menstrual cycle.
- Adults – preoperative management of uterine fibroids: 3.75 mg every month, usually for 3–4 months (maximum 6 months).
- Adults – preservation of ovarian function: 3.75 mg injection 2 weeks before starting chemotherapy, then monthly during chemotherapy.
- Adults – advanced or early breast cancer (in combination where indicated): 3.75 mg subcutaneous injection every month.
- Children with central precocious puberty: usual starting dose 3.75 mg subcutaneously once monthly for body weight ≥ 20 kg; 1.88 mg monthly (half dose) may be used for < 20 kg; dose is adjusted individually by the paediatric endocrinologist.
Contraindications
- Hypersensitivity to leuprorelin acetate, any of the excipients, or other synthetic GnRH analogues or GnRH derivatives.
- Women who are pregnant or may become pregnant during treatment.
- Women who are breastfeeding.
- Undiagnosed abnormal vaginal bleeding in women or girls with central precocious puberty.
- Initiation of aromatase inhibitor treatment in pre- or perimenopausal breast cancer patients before adequate ovarian suppression with leuprorelin has been achieved.
- In girls with central precocious puberty: pregnancy and breastfeeding are contraindications.
Adverse Effects
- Very common class-related effects due to hypoestrogenism or hypoandrogenism such as hot flushes, sweating (hyperhidrosis), decreased libido, vaginal dryness, erectile dysfunction and breast tenderness or gynaecomastia.
- Mood changes including depression (which may be severe), insomnia and emotional lability.
- Headache (occasionally severe), dizziness and paraesthesia.
- Injection-site reactions including pain, erythema, induration, swelling, nodules, abscesses, ulcers and necrosis.
- Bone mineral density loss and osteoporosis with an increased risk of fractures, particularly with longer-term use or in patients with additional risk factors.
- Weight fluctuation and metabolic changes, including metabolic syndrome, impaired glucose tolerance, hyperglycaemia and diabetes, and dyslipidaemia.
- Cardiovascular effects including palpitations, hypertension or hypotension and potential QT interval prolongation (with a risk of Torsade de pointes in susceptible patients).
- Gastrointestinal symptoms such as nausea, vomiting and diarrhoea.
- Hepatic enzyme abnormalities, hepatic dysfunction, jaundice and hepatic steatosis.
- Hypersensitivity reactions including rash, pruritus, urticaria, wheezing, fever, chills and rare anaphylactic reactions.
- Musculoskeletal symptoms such as bone pain, arthralgia, myalgia and muscle weakness, including weakness of the lower extremities.
- Severe cutaneous adverse reactions (SCARs) including Stevens–Johnson syndrome and toxic epidermal necrolysis.
- Neurological events including seizures, idiopathic intracranial hypertension (pseudotumour cerebri), pituitary apoplexy (in patients with pituitary adenoma), spinal fracture and, rarely, paralysis in the context of tumour flare.
- In men with prostate cancer: tumour flare at treatment initiation may manifest as urinary obstruction, bone pain, back pain or neurological symptoms due to spinal cord compression.
- In women: vaginal haemorrhage (including withdrawal bleeding or bleeding related to fibroid degeneration), vulvovaginitis, breast atrophy and dyspareunia.
- In children with central precocious puberty: transient flare of pubertal signs, including vaginal bleeding in girls, and injection-site reactions; acne can also occur.
Storage Conditions
- Do not store above 25°C.
- Do not refrigerate or freeze.
- Store in the original container to protect from light.
- Shelf life 3 years unopened; once reconstituted, administer the suspension immediately and do not store.
- Dispose of any unused product or waste material in accordance with local requirements.
Duration
Treatment duration depends on indication: prostate cancer \u2013 long-term continuous monthly therapy, often continued in castrate-resistant disease according to guidelines; endometriosis \u2013 up to 6 months total treatment; endometrial preparation prior to intrauterine surgery \u2013 single dose given 5\u20136 weeks pre-procedure; preoperative management of uterine fibroids \u2013 usually 3\u20134 months, maximum 6 months; preservation of ovarian function during chemotherapy \u2013 for the duration of chemotherapy following an initial dose 2 weeks prior; advanced breast cancer \u2013 as long as clinically beneficial; adjuvant treatment of early breast cancer in combination with tamoxifen or an aromatase inhibitor \u2013 up to 5 years; central precocious puberty \u2013 until an appropriate bone age and pubertal stage are reached, as determined by the paediatric specialist.
Onset
In men with prostate cancer, serum testosterone levels typically increase transiently in the first 4 days (tumour flare) then fall to castrate levels within approximately 2\u20134 weeks and remain suppressed with continued monthly dosing. In premenopausal women, estradiol levels generally decrease to postmenopausal levels within about one month of initiating therapy. Effective plasma levels of leuprorelin acetate from a single 3.75 mg depot persist for around 30\u201340 days.
