Astellas Pharma Co. Ltd

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, nausea, malaise and fatigue and transient local irritation at the site of injection. Mild or moderate hot flashes occur in approximately 58 % of patients.

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include peripheral oedema, pulmonary embolism, palpitations, myalgia, an alteration in the skin sensation, muscle weakness, chills, peripheral vertigo, rash, amnesia, and visual disturbances.

6.5     Nature and contents of container

Two pre-filled cyclic olefin copolymer / polypropylene syringes, one containing powder (Syringe B), and one containing solvent (Syringe A). Together the two syringes comprise a mixing system.

Syringe A has a plunger tip of thermoplastic rubber and is capped with a polyethylene or polypropylene Luer-Lok cover. The syringe tip cap and the two plunger tips of Syringe B are composed of chlorobutyl bromobutyl rubber.

The following pack sizes are available:

·                A kit consisting of one large aluminium outer pouch which contains 2 aluminium pouches, a 18-gauge sterile needle and a desiccant pouch. One pouch contains one pre-filled polypropylene syringe A and a large plunger rod for syringe B. The other pouch contains one pre-filled cyclic olefin copolymer/polypropylene  syringe B.

·                A kit consisting of two thermoformed trays in a cardboard carton. One tray contains pre-filled polypropylene syringe A, a large plunger rod for syringe B and a desiccant pouch. The other tray contains pre-filled cyclic olefin copolymer /polypropylene syringe B, a sterile 18-gauge needle and a desiccant pouch.

·                A bundle pack containing kits of 2 x 2 pre-filled polypropylene/cyclic olefin copolymer syringes (1 x Syringe A; 1 x Syringe B)

Please note that the following sections have changed:

6.5 Nature and contents of container (inclusion of cyclic olefin copolymer and the replacement of bromobutyl with clorobutyl)

10. Date of revision of the text (March 2010)

Change detail

Eligard 45mg SPC

October 2007 in comparison to May 2009

4.2     Posology and method of administration

Administration

Heading changed form Children to Children and adolescents

4.8     Undesirable effects

hot flushes, reworded as hot flashes

Adverse reactions seen with ELIGARD 45 mg are mainly subject to the specific pharmacological action of leuprorelin acetate, namely increases and decreases in certain hormone levels.

Updated to read:

Adverse reactions seen with ELIGARD are mainly subject to the specific pharmacological action of leuprorelin, namely increases and decreases in certain hormone levels.

Undesirable effects in clinical studies with Eligard updated

General Disorders and Administration Site Reaction

Changed from

To

The following has been removed:

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include impotence, decrease in libido (both pharmacological consequences of testosterone deprivation), peripheral oedema, pulmonary embolism, palpitations, muscle weakness, chills, peripheral vertigo, rash, amnesia, visual disturbances and skin sensation. Infarction of pre-existing pituitary adenoma has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

Local adverse events reported after injection of ELIGARD 45 mg are typical of those frequently associated with similar subcutaneously injected products. Mild transient burning following injection is very common. Pain,bruising and “injection site reaction NOS’ are common.

And replaced by:

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include peripheral oedema, pulmonary embolism, palpitations, muscle weakness, chills, peripheral vertigo, rash, amnesia, and visual disturbances. Infarction of pre-existing pituitary apoplexy has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

Local adverse events reported after injection of ELIGARD are similar to the local adverse events associated with similar subcutaneously injected products.

5.3     Preclinical safety data

Sentence updated from:

 

No such effect was observed in mice, which allows to regard the effect in rats as species-specific, having no relevance for humans.

 

To

 

No such effect was observed in mice.

 

 

 

 

 

 

6.1     List of excipients

 

(15:85) changed to (85:15)

 

 

6.3     Shelf life

 

Below paragraph was removed

Chemical and physical in-use stability has been demonstrated for 30 minutes at 25°C. From a microbiological point of view, once reconstituted with sterile vehicle, the product should be administered immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

 

And replaced by:

 

After first opening of the tray or the large outer aluminium pouch, the powder and solvent for solution for injection are to be immediately reconstituted and administered to the patient.

 

Once reconstituted: use immediately, as the viscosity of the solution increases with time.

 

 

6.6     Instructions for use and handling and disposal

 

Inserted:

 

Allow the product to come to room temperature

 

Please prepare the patient for injection first, followed by the preparation of the product, using the instructions below:

 

Mixing instruction and diagrams updated for clarification.

 

 

9.                  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Changed from: Date of first authorisation: 26^th October 2007 to 26^th October 2007

 

 

 

10.     DATE OF REVISION OF THE TEXT

Updated from     October 2007 to May 2009