Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The active substance of ELIGARD is leuprorelin acetate. It belongs to the group of so-called gonadotropin releasing hormones. These medicines are used to decrease the production of certain sex hormones (testosterone). ELIGARD is used to treat hormone dependent metastatic prostate cancer in adult men and for the treatment of high-risk non-metastatic hormone dependent prostate cancer in combination with radiotherapy.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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• If you have any of the following: any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using ELIGARD. • If you have difficulties urinating. You should be monitored closely during the first weeks of treatment. • If pressure on the spinal cord or difficulties with urinating develops. In connection with other drugs having a similar mechanism of action like ELIGARD, it has been reported that severe cases of pressure effects on the spinal cord and narrowing of the tubes between the kidneys and the urinary bladder may contribute to paralysis like symptoms. If these complications develop, standard therapy should be started. • If you experience sudden headache, vomiting, altered mental status and sometimes heart collapse, within two weeks of taking ELIGARD, then alert the doctor or medical staff. These are rare cases termed as pituitary apoplexy, which have been reported IN OTHER DRUGS which have a mechanism similar to ELIGARD. • If you suffer from diabetes mellitus (elevated blood sugar levels). You should be regularly monitored during treatment. • Treatment with ELIGARD can increase the risk for fractures due to osteoporosis (decrease in bone density). • There have been reports of depression in patients taking ELIGARD. If you are taking ELIGARD and develop depressed mood, inform your doctor. • There have been reports of cardiovascular events in patients taking products similar to ELIGARD of which it is unknown if it is related to these products. If you are taking ELIGARD and develop cardiovascular signs or symptoms, inform your doctor. • There have been reports of seizures in patients after administration of ELIGARD. If you are taking ELIGARD and develop seizures, inform your doctor. • If you suffer from a bad or recurrent headache, problems with your eyesight and ringing or buzzing in the ears, contact your doctor immediately. • If you have fatty liver (a condition where excess fat builds up in the liver) Severe skin rashes including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (SJS/TEN) have been reported in association with leuprorelin. Stop using leuprorelin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Initial treatment complications During the first week of treatment, there is generally a brief increase in the male sex hormone testosterone in the blood. This can lead to a temporary worsening in the disease-related symptoms and also to the occurrence of new symptoms that have not been experienced up to this point. These especially include bone pain, urination disturbances, pressure on the spinal cord, or the secretion of blood in the urine. These symptoms usually subside on continuation of treatment. If the symptoms do not subside, you should contact your doctor. If ELIGARD does not help A proportion of the patients will have tumours, which are not sensitive to decreased serum testosterone levels. Please talk to you doctor if you have the impression that the effect of ELIGARD is too weak. Other medicines and ELIGARD ELIGARD might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug
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addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses). Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding ELIGARD is not intended for women. Driving and using machines Fatigue, dizziness and visual disturbances are possible side effects of the treatment with ELIGARD or might be a result from the disease. If you suffer from these side effects, take care when driving or operating machines.
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Please talk to you doctor if you believe that your three monthly administration of ELIGARD was forgotten. Effects when the treatment with ELIGARD is stopped As a general rule, the therapy of prostate cancer with ELIGARD requires long-term treatment. Therefore, therapy should not be terminated, even if there is an improvement in the symptoms or if they disappear completely. If the treatment with ELIGARD is stopped prematurely, a deterioration of disease-related symptoms can occur. You should not stop the therapy prematurely without previously consulting your doctor. If you have any further question on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, ELIGARD can cause side effects, although not everybody gets them. Side effects that have been observed during treatment with ELIGARD are mainly attributable to the specific effect of the active substance leuprorelin acetate, namely the increase and decrease of certain hormones. The most commonly described side effects are hot flashes (approximately 58 % of patients), nausea, malaise and fatigue, as well as temporary local irritations at the site of injection. Initial side effects During the first weeks of treatment with ELIGARD, disease-specific symptoms may worsen, because in the first instance there is generally a brief increase in the male sex hormone testosterone in the blood. Therefore, your doctor may administer an appropriate anti-androgen (substance that inhibits the effect of testosterone) at the initial phase of the treatment in order to reduce possible after-effects (See also Section 2 Before you use ELIGARD, Initial treatment complications). Local side effects Local side effects that have been described after the injection of ELIGARD are typically those, which are often associated with similar subcutaneously injected preparations (preparations which are injected into the tissue below the skin). Mild burning immediately after the injection is very common. Stinging and pain after the injection are common, as well as a bruise at the injection site. Redness of the skin at the injection site has been reported commonly. Tissue hardening and ulceration are uncommon. These local side effects following subcutaneous injection are mild and described as being of brief duration. They do not occur again in between the individual injections. Very common side effects (may affect more than 1 in 10 people) • Hot flashes • Spontaneous bleeding in skin or mucous membrane, redness of the skin • Fatigue, injection-related side effects (see also local side effects above) Common side effects (may affect up to 1 in 10 people)
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• Nasopharyngitis (symptoms of common cold) • Alteration in the skin sensation • Nausea, malaise, diarrhoea, inflammation of the stomach and intestines (gastroenteritis/ colitis), dyspepsia (disturbed digestion, with symptoms as full stomach, pain in the stomach, belching, nausea, vomiting, burning feeling in the stomach) • Itching, nightly sweating • Pain in the joints, muscle pain • Irregular trips to the toilet to pass water (also at night), difficulty in starting to pass water, painful urination, reduced urine output • Breast tenderness, swelling of the breast, shrinking of testicles, testicular pain, infertility, erectile dysfunction, reduced penis size • Rigors (episodes of exaggerated shaking with high fevers), weakness • Prolonged bleeding time, changes in blood values, decreased red blood cells/low red blood cell count Uncommon side effects (may affect up to 1 in 100 people) • Urinary tract infection, local skin infection • Worsening of diabetes mellitus • Abnormal dreams, depression, decreased libido • Dizziness, headache, insomnia, taste disturbance, smell disturbance • Hypertension (increased blood pressure), hypotension (decreased blood pressure) • Rhinorrhea, shortness of breath • Constipation, dry mouth, vomiting • Clamminess, increased sweating • Back pain, muscle cramps • Haematuria (blood in the urine) • Bladder spasm, more trips to the toilet to pass water than usual, unable to pass water • Enlargement of male breast tissue, impotence • Lethargy (sleepiness), pain, fever • Increased weight • Loss of balance, light-headedness • Muscle wasting/loss of muscle tissue after prolonged use Rare side effects (may affect up to 1 in 1,000 people) • Abnormal involuntary movements • Sudden loss of consciousness, fainting • Flatulence, belching • Hair loss, skin eruption (pimples on the skin) • Breast pain • Injection site ulceration
Very rare side effects (may affect up to 1 in 10,000 people) • Injection site necrosis Not known (frequency cannot be estimated from the available data) • Changes in ECG (QT prolongation) • Inflammation of lungs, lung disease
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• Idiopathic intracranial hypertension (increased intracranial pressure around the brain characterised by headache, double vision and other visual symptoms and ringing or buzzing in one or both ears) • Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu- like symptoms (Stevens-Johnson syndrome/Toxic Epidermal Necrolysis). • Skin redness and itchy rash (Toxic skin eruption): a skin reaction that causes red spots or patches on the skin, that may look like a target or "bulls-eye" with a dark red centre surrounded by paler red rings (Erythema Multiforme). Other side effects Other side effects that have been described in the literature in relation with treatment with leuprorelin, the active substance of ELIGARD, are oedema (accumulation of fluid in tissue, appearing as swelling of the hands and feet), pulmonary embolism (resulting in symptoms like breathlessness, difficulty in breathing and chest pain), palpitations (awareness of your heartbeat), muscle weakness, chills, rash, impaired memory and impaired vision. Increasing signs of a decrease in bone tissue (osteoporosis) may be expected after long-term treatment with ELIGARD. Due to osteoporosis, the risk for fractures increases. Serious allergic reactions, which cause difficulty in breathing or dizziness, have been reported rarely after administration of products in the same class as ELIGARD. Seizures have been reported after administration of products in the same class as ELIGARD. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
• syringe A pre-filled with the solvent • syringe B pre-filled with the powder • connector with latching button for syringe A and B. • A bundle pack containing kits of 2 pre-connected syringe system Not all pack sizes may be available. Marketing Authorisation Holder and Manufacturer Recordati Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali 1 20148 – Milan Italy This leaflet was last revised in 01/2026
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Figure 1.1 Tray Contents: pre-connected syringe system
Figure 2
The following information is intended for healthcare professionals only: Allow Eligard to come to room temperature by removing from the refrigerator not less than 30 minutes prior to use. Eligard can remain out of the fridge for up to 4 weeks at temperatures below 25 degrees. Please prepare the patient for injection first, followed by the preparation of the product, using the instructions below. If the product is not prepared using the proper technique, it should not be administered as lack of clinical efficacy may occur due to incorrect reconstitution of the product. Step 1 On a clean field, open the tray by tearing off the foil from the corners to remove the contents. Discard the desiccant pouch. Remove the pre-connected syringe system (Figure 1.1) from the tray. Open the safety needle package, available under the tray (Figure 1.2) by peeling back the paper tab. The enclosed safety needle must be used only. Note: Syringe A and Syringe B should not be lined-up yet.
Figure 1.2 Under the Tray: safety needle and cap
Step 2 Press the latching button on the connector with your finger and thumb (Figure 2) until you hear a snapping sound ("Click"). The two syringes will now be lined up. No particular orientation of the syringe system is required to activate the connector. Do not bend the syringe system (please note that this may cause leakage as you may partially unscrew the syringes).
Step 3 Hold the syringes horizontally, gently push the liquid contents of Syringe A into the leuprorelin acetate powder contained in Syringe B. Thoroughly mix the contents by gently pushing the plungers back and forth between the syringes for 60 cycles until a homogenous, viscous solution is obtained (a cycle is
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Figure 3
Figure 4
one push of the plunger for Syringe A and one push of the plunger for Syringe B) (Figure 3). Do not push both plungers at the same time as it may cause leakage. Do not bend the syringe system (please note that this may cause leakage as you may partially unscrew the syringes).
When thoroughly mixed, the viscous solution will appear with a colour in the range of colourless to shades of white or pale yellow Important: After mixing proceed with the next step immediately as the product gets more viscous over time. Do not refrigerate the mixed product. Please note: Product must be mixed as described; shaking WILL NOT provide adequate mixing of the product. Step 4 After mixing, hold the syringes vertically with Syringe B on the bottom. The syringes should remain securely coupled. Draw the entire mixed product into Syringe B (short, wide syringe) by pushing down the Syringe A plunger and slightly withdrawing the Syringe B plunger (Figure 4).
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Step 5 While ensuring Syringe A plunger is fully pushed down, hold the connector and unscrew it from Syringe B. Syringe A will remain attached to the connector (Figure 5). Ensure that no product leaks out as the needle will then not secure properly when attached. Please note: one large or a few small air bubbles may remain in the formulation - this is acceptable. Please do not purge the air bubbles from Syringe B as product may be lost!
Figure 5
Step 6
• Hold Syringe B upright and hold back the white plunger to prevent loss of the product.
• Secure the safety needle to Syringe B by holding the syringe and gently turning the needle clockwise with approximately a three-quarter turn until the needle is secure (Figure 6). Do not over tighten as this may cause cracking of the needle hub resulting in leakage of the product during injection. The safety shield may also be damaged if the needle is screwed with too much force. Should the needle hub crack, appear to be damaged, or have any leakage, the product should not be used. The damaged needle should not be substituted/replaced and the product should not be injected. The entire product should be disposed of securely.
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In the event of damage to the needle hub, use another ELIGARD kit.
Figure 6
Step 7 Move the safety shield away from the needle and pull off the protective needle cover immediately prior to administration (Figure 7). Important: Do not operate the safety needle mechanism before administration. Should the needle hub appear to be damaged, or leak, the product should NOT be used. The damaged needle should NOT be replaced and the product should NOT be injected. In the event of damage to the needle hub, use another ELIGARD kit.
Figure 7
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• Select an injection site on the abdomen, upper buttocks, or another location with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair and has not recently been used. • Cleanse the injection-site area with an alcohol swab (not enclosed). • Pinch the skin around the injection site with your thumb and forefinger.
• Quickly insert the needle at a 90° angle into the skin. Release the skin. • Inject the entire contents of Syringe B using a slow, steady push. Ensure that the full amount of the product in Syringe B is injected before removing the needle. • Withdraw the needle quickly at the same 90° angle used for insertion while maintaining pressure on the plunger.
Step 9 After injection, lock the safety shield using any of the activation methods listed below.
b. Closure with your thumb
Placing your thumb on the safety shield (Figure 9b), cover the needle tip and lock the shield. Verify locked position through audible and tactile "click". Locked position will completely cover needle tip.
Step 8 It is not necessary to purge the air bubbles as it poses no risks for the subcutaneous injection. Purging air bubbles might cause product loss. Inject the product subcutaneously whilst keeping the safety shield away from the needle. Administration Procedure:
Figure 8
a. Closure on a flat surface Press the safety shield, lever side down, onto a flat surface (Figure 9a) to cover the needle and lock the shield. Verify locked position through audible and tactile "click". Locked position will completely cover needle tip.
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Figure 9a Closure on a flat surface
Once safety shield is locked, immediately dispose of the needle and syringe in an approved sharps container. '{QR code} to be included' Latest approved information of the educational materials on this medicine is available by scanning the QR code included in the Package Leaflet and outer carton with a smartphone/device. The same information is also available on the following URL: www.Eligard.eu
Figure 9b Closure with your thumb
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ELIGARD 22.5 mg powder and solvent for solution for injection comes as powder containing 22.5 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in ELIGARD 22.5 mg powder and solvent for solution for injection is leuprorelin acetate.
Medicines with the same active substance include: Prostap 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Prefilled Syringe, Prostap PD DCS 1.88 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe, Prostap SR DCS 3.75 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe, Staladex 11.25mg Implant. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for ELIGARD 22.5 mg powder and solvent for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
ELIGARD 22.5 mg is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
Posology
Adult Males
ELIGARD should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment.
ELIGARD 22.5 mg is administered as a single subcutaneous injection every three months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a three-month period.
As a rule, therapy of advanced prostate cancer with ELIGARD 22.5 mg entails long-term treatment and therapy should not be discontinued when remission or improvement occurs.
ELIGARD 22.5 mg may be used as neoadjuvant or adjuvant therapy in combination with radiotherapy in high-risk localised and locally advanced prostate cancer.
Response to ELIGARD 22.5 mg should be monitored by clinical parameters and by measuring prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone levels increased during the first 3 days of treatment in the majority of non-orchiectomised patients and then decreased to below medical castration levels within 3 - 4 weeks. Once attained, castrate levels were maintained as long as medicinal product therapy continued (< 1% testosterone breakthroughs). In case the patient's response appears to be sub-optimal, it should be confirmed that serum testosterone levels have reached or are remaining at castrate levels. As lack of efficacy may result from incorrect preparation, reconstitution, or administration, testosterone levels should be evaluated in cases of suspected or known handling errors (see section 4.4).
In patients with metastatic castration resistant prostate cancer not surgically castrated receiving a GnRH agonist, such as leuprorelin, and eligible for treatment with androgen biosynthesis inhibitors or androgen receptor inhibitors, treatment with a GnRH agonist may be continued.
Paediatric population
The safety and efficacy of ELIGARD 22.5 mg in children aged 0 to 18 years have not been established (see also section 4.3).
Specific Patient Populations
No clinical studies were performed in patients with either liver or kidney impairment.
Method of administration
ELIGARD 22.5 mg should be prepared, reconstituted and administered only by healthcare professionals who are familiar with these procedures. Instructions for reconstitution and administration must be strictly followed (see section 4.4 and 6.6.). If the product is not prepared appropriately, it should not be administered.
The contents of the two pre-filled sterile syringes must be mixed immediately prior to administration of ELIGARD 22.5 mg by subcutaneous injection.
Based on data from animal experience, intra-arterial or intravenous injection, respectively, has to be strictly avoided.
As with other medicinal products administered by subcutaneous injection, the injection site should be varied periodically.
ELIGARD 22.5 mg is contraindicated in women and in paediatric patients.
Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients listed in section 6.1.
In patients who previously underwent orchiectomy (as with other GnRH agonists, ELIGARD 22.5 mg does not result in further decrease of serum testosterone in case of surgical castration).
As sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases (see also section 4.4)
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.
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of ELIGARD 22.5 mg 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 (see section 4.4).
ELIGARD 22.5 mg is contraindicated in women (see section 4.3).
Preclinical studies with leuprorelin acetate revealed in both sexes effects on the reproductive system, which were shown to be reversible after discontinuation of the treatment (see section 5.3).
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.
ELIGARD 22.5mg does not have the potential for abuse, and deliberate overdose is unlikely. There are no reports of abuse or overdose having occurred in clinical practice with leuprorelin acetate, but in the event that excessive exposure becomes a reality, observation and symptomatic supportive treatment are recommended.
Ask anything about ELIGARD 22.5 mg powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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