During post-marketing surveillance, 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 7.5 mg.

4.5 Interaction with other medicinal products and other forms of interaction

 No pharmacokinetic drug-drug interaction studies have been performed with ELIGARD 7.5 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 7.5mg is contraindicated in women.

4.7 Effects on ability to drive and use machines

 No studies on the effects of ELIGARD 7.5 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 are mainly subject to the specific pharmacological action of leuprorelin, namely increases and decreases in certain hormone levels. The most commonly reported adverse reactions are hot flashes, malaise, nausea and fatigue and transient local irritation at the site of injection. Mild or moderate 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
 nasopharyngitis
 
uncommon
 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
 dizziness, headache, hypoaesthesia, insomnia, taste disturbance, smell disturbance
 
rare
 abnormal involuntary movements
 
Vascular disorders
  
very common
 hot flashes
 
uncommon
 hypertension, hypotension
 
rare
 syncope, collapse
 
Respiratory, thoracic and mediastinal disorders
  
uncommon
 rhinorrhoea, dyspnoea
 
Gastrointestinal disorders
  
common
 nausea, diarrh