eillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of GnRH-agonists, with a majority occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy was presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention is required.
Precautions
Changes in glucose tolerance have been reported in some patients receiving GnRH agonist therapy. It is advised that diabetic patients are monitored more frequently during treatment with ELIGARD 22.5 mg.
4.5 Interaction with other medicinal products and other forms of interaction
No pharmacokinetic drug-drug interaction studies have been performed with ELIGARD 22.5 mg. There have been no reports of any interactions of leuprorelin acetate with other medicinal products.
4.6 Pregnancy and lactation
Not applicable as ELIGARD 22.5 mg is contraindicated in women.
4.7 Effects on ability to drive and use machines
No studies on the effects of ELIGARD 22.5 mg on the ability to drive and use machines have been performed.
The ability to drive and operate machines may be impaired due to fatigue, dizziness and visual disturbances being possible side effects of treatment or resulting from the underlying disease.
4.8 Undesirable effects
Adverse reactions seen with ELIGARD 22.5mg are mainly subject to the specific pharmacological action of leuprorelin acetate, namely increases and decreases in certain hormone levels. The most commonly reported adverse reactions are hot flashes, nausea, malaise and fatigue and transient local irritation at the site of injection. Mild hot flashes occur in approximately 58% of patients.
The following adverse events were reported during clinical trials with ELIGARD in patients with advanced prostatic carcinoma. Adverse events are classified, by frequency, as very common (1/10), common (1/100, <1/10), uncommon (1/1,000, <1/100), rare (1/10,000, <1/1,000), and very rare (<1/10,000), not known (cannot be estimated from the available data).
Table 1: Undesirable effects in clinical studies with Eligard
Infections and infestations
common
uncommon
nasopharyngitis
urinary tract infection, local skin infection
Metabolism and nutrition disorders
uncommon
aggravated diabetes mellitus
Psychiatric disorders
uncommon
abnormal dreams, depression, decreased libido
Nervous system disorders
uncommon
rare
dizziness, headache, hypoaesthesia, insomnia, taste disturbance, smell disturbance
abnormal involuntary movements
Vascular disorders
very common
uncommon
rare
hot flashes
hypertension, hypotension
syncope, collapse
Respiratory, thoracic and mediastinal disorders
uncommon
rhinorrhoea, dyspnoea
Gastrointestinal disorders
common
uncommon
rare
nausea, diarrhoea,
constipation, dry mouth, dyspepsia ,vomiting
flatulence, eructation,
Skin and subcutaneous tissue disorders
very common
common
uncommon
rare
ecchymoses, erythema
pruritus, night
