ELIGARD

What it is

ELIGARD is a sterile polymeric matrix formulation of leuprorelin acetate for subcutaneous injection. It is designed to deliver leuprorelin acetate at a controlled rate over a therapeutic period. Leuprorelin acetate is a synthetic nonapeptide analogue of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis. ELIGARD is administered subcutaneously where it forms a solid drug delivery depot.

Approved indications

— Palliative treatment of advanced prostate cancer. — Treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy. — Treatment of children 2 years of age and older with central precocious puberty (CPP).

Dosing overview

ELIGARD must be administered by a healthcare professional.

Key safety warnings

ELIGARD, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, haematuria, or bladder outlet obstruction. Initiating therapy with a non-steroidal anti-androgen at the same time as leuprorelin acetate therapy has proven benefit in reducing flare reactions in at-risk patients. Additional administration of an appropriate antiandrogen should be considered beginning 3 days prior to leuprorelin therapy and continuing for the first two to three weeks of treatment, which has been reported to prevent the sequelae of an initial rise in serum testosterone. Bone loss can be expected as part of natural aging and can also be anticipated during the hypo-androgenic state caused by long-term use of leuprorelin acetate. In patients with significant risk factors for decreased bone mineral content and/or bone mass such as family history of osteoporosis, chronic use of corticosteroids or anticonvulsants or chronic abuse of alcohol or tobacco, leuprorelin acetate may pose additional risk. In these patients, risk versus benefit must be weighed carefully before initiation of leuprorelin acetate therapy. Post-marketing reports of convulsions have been observed in patients on leuprorelin acetate therapy with or without a history of predisposing factors. These included patients in the female and paediatric populations, patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumours, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Post-marketing reports of idiopathic intracranial hypertension (pseudotumor cerebri) have been reported in paediatric patients receiving GnRH agonists and patients receiving leuprorelin acetate. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, papilledema, vision disturbances including loss of vision, pain behind the eye or pain with eye movement, diplopia, dizziness and nausea, and tinnitus. Severe cutaneous adverse reaction (SCARs), including Steve-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and erythema multiforme occurred in patients receiving ELIGARD. Monitor patients for the development of SCARs.

Contraindications

ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogues or any of the components of ELIGARD. ELIGARD is contraindicated in women who are breastfeeding, pregnant or intending to become pregnant and in paediatric patients. ELIGARD is contraindicated in patients who previously underwent orchiectomy as with other GnRH agonists, ELIGARD does not result in further decrease of serum testosterone in case of surgical castration. ELIGARD is contraindicated as a sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases.

PBS listing

ELIGARD is listed on the PBS in four strengths: 7.5 mg (ex-manufacturer price A$232.55), 22.5 mg (A$625.45), 30 mg (A$833.55), and 45 mg (A$1249.40, listed as 2 items). All presentations are subject to restriction.

Regulatory history

ELIGARD was first registered on the ARTG on 26 November 2003 for the 7.5 mg, 22.5 mg, and 30 mg presentations. The 45 mg presentation was registered on 16 September 2005. In July 2022, the PBAC recommended ELIGARD for the treatment of central precocious puberty. An AusPAR was issued on 6 July 2022 approving ELIGARD 45 mg modified release injection for the treatment of central precocious puberty in children 2 years of age and older, based on demonstrated efficacy and safety profile. In November 2024, the PBAC recommended continuation of ELIGARD with updated injection device for existing listings. ELIGARD is subject to additional monitoring in Australia.