Abbreviated Prescribing Information

Decapeptyl SR (triptorelin) 3mg, Decapeptyl 3-month (triptorelin) 11.25mg and Decapeptyl 6-month (triptorelin) 22.5mg

See full Summary of Product Characteristics (SmPC) before prescribing. Available at  www.medicines.ie

Presentation: Decapeptyl SR, 3 mg powder and solvent for suspension for injection: 3mg triptorelin (as triptorelin acetate). Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection: 11.25mg triptorelin (as triptorelin pamoate). Decapeptyl 6-month 22.5mg Powder and solvent for prolonged-release suspension for injection: 22.5mg triptorelin (as triptorelin pamoate). Vials for all preparations contain the quantity of triptorelin to ensure the licensed dose is administered. Indications: Decapeptyl SR and Decapeptyl 3-month: Management of advanced prostatic carcinoma, Decapeptyl 6-month: Treatment of locally advanced or metastatic, hormone-dependent prostate cancer. Dosage and administration: Male adults only. Decapeptyl SR: One intramuscular (IM) injection every 28 days. Decapeptyl 3-month:  One IM or subcutaneous (SC) injection every three months. Decapeptyl 6-month: One IM injection every 6 months (24 weeks). Additional dosing information: Vary site of administration periodically. Inadvertent intravascular administration must be avoided. In patients with metastatic castration-resistant prostate cancer not surgically castrated, receiving a GnRH agonist such as triptorelin and eligible to a treatment by abiraterone acetate, an inhibitor of androgen biosynthesis or enzalutamide, an inhibitor of signalling pathway of androgen receptors, the treatment by a GnRH agonist must be continued. No dose adjustment required in the elderly or for patients with renal or hepatic impairment. Please refer to the SmPC for instructions on reconstitution of the medicinal product before administration. Contraindications: Hypersensitivity to GnRH (gonadotropin releasing hormone), its analogues or to any of the excipients. Precautions and Warnings: The product must only be used under the supervision of an appropriate specialist physician having requisite facilities for regular monitoring of response. The use of GnRH agonists may cause a reduction in bone mineral density bone loss and may lead to osteoporosis and increased risk of bone fracture. In men, preliminary data suggest that the use of a bisphosphonate in combination with a GnRH agonist may reduce bone mineral loss. Particular caution in patients with risk factors for, or established osteoporosis is necessary. Treatment should be considered on an individual basis and only be initiated if the benefits of treatment outweigh the risk following a very careful appraisal. Consideration should be given to additional measures in order to counteract loss of bone mineral density. Adjustment of antihypertensive medications may be needed. Rarely treatment with GnRH agonists may reveal presence of gonadotroph cell pituitary adenoma. These patients may present with a pituitary apoplexy characterised by sudden headache, vomiting, visual impairment and ophthalmoplegia. Increased risk of incident depression (which may be severe); inform patients and treat accordingly. Patients with known depression should be monitored closely. Convulsions have been reported with GnRH analogues, particularly in women and children. Some of these patients had risk factors for seizures (such as a history of epilepsy, intracranial tumors or co-medication with drugs known to present a risk of seizure reactions). Convulsions have also been reported in patients in the absence of such risk factors. Caution is required during IM injection in patients treated with anticoagulants, due to the potential risk of haematomas at the site of injection. Like other GnRH agonists, initially triptorelin causes a transient increase in serum testosterone levels.  As a consequence, isolated cases of transient worsening of signs and symptoms of prostate cancer (tumour flare) and cancer related (metastatic) pain may occasionally develop during the first weeks of treatment and can be managed symptomatically. During the initial phase of treatment, consideration should be given to the additional administration of a suitable anti-androgen to counteract the initial rise in serum testosterone levels and the worsening of clinical symptoms. As with other GnRH agonists isolated cases of spinal cord compression or urethral obstruction have been observed. Careful monitoring is indicated in the first few weeks of therapy particularly in patients with vertebral metastases, at risk of spinal cord compression or with urinary tract obstruction. Triptorelin does not further decrease testosterone post-surgical castration. Androgen deprivation therapy (ADT) may prolong the QT interval. In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval, physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating treatment. From epidemiological data, it has been observed that patients may experience metabolic changes (e.g. glucose intolerance), or an increased risk of cardiovascular disease during ADT. Patients at high risk of metabolic or cardiovascular diseases should be carefully assessed before commencing treatment and adequately monitored during ADT.  Increased lymphocyte count has been reported with patients undergoing GnRH agonist treatment. This secondary lymphocytosis is apparently related to GnRH induced castration and seems to indicate gonadal hormone involvement in thymic involution. Triptorelin suppresses pituitary gonadal system; normal function is usually restored on cessation of treatment. Diagnostic tests of pituitary gonadal function conducted during treatment and after discontinuation of therapy with GnRH agonists may therefore be misleading. Due to androgen deprivation, treatment with GnRH analogues can increase the risk of anaemia. This risk should be assessed in treated patients and monitored appropriately. Interactions: Drugs which raise prolactin levels should not be prescribed concomitantly as they reduce the level of GnRH receptors in the pituitary. Exercise caution and supervise patient’s hormonal status if used in combination with drugs affecting pituitary secretion of gonadotropins. Since ADT may prolong the QT interval, the concomitant use of Decapeptyl with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated. Pregnancy and Lactation: Not applicable. Undesirable effects: As seen with other GnRH agonist therapies or after surgical castration, the most commonly observed adverse events related to triptorelin treatment were due to its expected pharmacological effects. These effects included hot flushes and decreased libido. Very common: Asthenia, back pain, lower limb paraesthesia, hyperhidrosis, hot flush, erectile dysfunction (including ejaculation failure, ejaculation disorder), libido decreased. Common: Hypersensitivity, depression, loss of libido, mood change, dizziness, headache, hypertension, nausea, dry mouth, musculoskeletal pain, pain in extremity, pelvic pain, injection site reaction (including erythema, inflammation and pain), oedema, weight increased. Uncommon: includes diabetes mellitus, urinary retention. Rare: includes anaphylactic reaction.  Post-marketing (frequency not known): Anaemia, QT prolongation, anaphylactic shock, pituitary apoplexy, anxiety, angioneurotic oedema, urinary incontinence, malaise. Prescribers should consult the Summary of Product Characteristics in relation to other side effects. Pharmaceutical Precautions: Store below 25ºC.  Decapeptyl SR: Box contains 1 vial, 1 ampoule of solvent, 1 syringe and 2 needles. Decapeptyl 3-month: Box containing 1 vial and 1 ampoule of solvent with 1 syringe and 3 needles. The 38 mm length needle (20 G) with safety device for intramuscular injection in the gluteal muscle. The 25 mm length needle (20 G) with safety device for subcutaneous injection in abdomen or thigh (only patients treated for prostate cancer).  Decapeptyl 6-month: 1 vial, 1 ampoule of solvent and 1 blister containing 1 injection syringe and 2 injection needles. The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of solvent for injection provided. Once reconstituted; Decapeptyl should be use immediately. For single use only. Legal category: POM. Marketing Authorisation Number(s): PA 869/003/001, PA 869/003/002, PA 869/003/003. Marketing Authorisation Holder: Ipsen Pharmaceuticals Limited, Blanchardstown Industrial Park, Blanchardstown, Dublin 15, Ireland. Additional information is available on request. Date of Preparation:  February 2025. Ref: TRI-IE-000568