What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 19255/0016 .


Staladex 10.72 mg Implant (as leuprorelin acetate11.25 mg)

Package leaflet: Information for the patient

Staladex 10.72 mg Implant

leuprorelin acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Staladex is and what it is used for
2. What you need to know before you use Staladex
3. How to use Staladex
4. Possible side effects
5. How to store Staladex
6. Contents of the pack and other information

1. What Staladex is and what it is used for

The active substance in Staladex (leuprorelin acetate) belongs to a group of medicines that inhibit certain sex hormones.

Staladex works by briefly stimulating and then greatly reducing the production of hormones that are made in the pituitary gland and control the production of testosterone in the testicles.

As a result, testosterone concentrations decline to low levels and, with continued treatment, remain in this low range. After stopping Staladex, pituitary hormone and testosterone levels will rise and return to normal.

Staladex is used in adult men to treat prostate cancer that has spread to other parts of the body. Staladex is also used in adult men in combination with radiotherapy to treat prostate cancer that is at high risk of spreading to other parts of the body.

2. What you need to know before you use Staladex

Do not use Staladex:

  • if you are allergic to leuprorelin, any other GnRH analogues, to polylactic acid or to any of the other ingredients of this medicine (listed in section 6).
  • following surgical removal of your testes (as use of Staladex will not lead to a further decrease in testosterone levels).
  • if you are a woman or a child.
  • as the only treatment for prostate cancer if the spinal cord is compressed or the cancer has spread to the spine.

Warnings and precautions

Talk to your doctor or nurse before using Staladex:

  • if you know that you have high blood pressure.
  • if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions, talk to your doctor before using Staladex. The risk of heart rhythm problems may increase when using Staladex.
  • if, before the start of treatment, you already have nervous system symptoms (the spinal cord is compressed or the cancer has spread to the spinal cord) or problems when passing urine due to urinary obstruction. You should tell your doctor without delay; he will monitor you particularly closely for the first few weeks, if possible in hospital.
  • if symptoms of disease (such as pain, difficulty passing urine or weakness in the legs) come back after prolonged use of Staladex. If this happens, your doctor will regularly check the success of the treatment by doing clinical examinations and by running laboratory tests.
  • if you are at an increased risk of thinning of the bones (osteoporosis).
  • if you experience sudden headache, vomiting, altered mental status and sometimes heart collapse, within two weeks of taking [product name], then alert the doctor or medical staff. These are rare cases termed as pituitary apoplexy, which have been reported in other medicines which have a mechanism similar to Staladex.
  • if you suffer from diabetes (elevated blood sugar levels). You should be regularly monitored during treatment.
  • if you develop any of the following after being treated with Staladex, inform your doctor:
  • an abscess at the injection site.
  • yellowing of the skin or whites of the eyes (jaundice) or other liver problems.
  • depressed mood.
  • seizures.

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 Staladex does not help

A proportion of patients will have tumors which are not sensitive to decreased serum testosterone levels. Please talk to you doctor if you have the impression that the effect of Staladex is too weak.

Effects of misuse for doping purposes

The use of Staladex can produce positive results in doping tests.

Other medicines and Staladex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Staladex may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used together with some other medicines such as methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses).

Pregnancy, breast-feeding and fertility

Staladex is not intended for use in women.

Driving and using machines

Fatigue (tiredness) is common, particularly during initiation of therapy, and may also be due to the underlying cancer. Disturbance of vision and dizziness can also occur during treatment. If affected you should not drive or operate machinery.

3. How to use Staladex

Staladex must be given under the supervision of a doctor or a qualified health professional.

Staladex is injected under the skin of the abdomen once every three months.

Treatment of advanced, hormone-dependent tumours of the prostate with Staladex is usually a long-term treatment.

Staladex must not be accidentally injected into an artery (blood vessel that carries oxygen-rich blood).

If you receive more Staladex than you should

This is unlikely as your doctor or nurse will know the correct dosage. However, if you suspect you have received more than you should, let your doctor know about it immediately so appropriate measures can be taken.

If you miss a dose of Staladex

It is important not to miss a dose of Staladex. As soon as you realise you have missed an injection, contact your doctor who will be able to give you your next injection.

If you stop receiving Staladex

Treatment involves administration of Staladex for a long period, so when the treatment is interrupted you may experience a worsening of the symptoms related to the disease. Therefore you must not interrupt the treatment prematurely without your doctor’s permission.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Initially, patients typically experience a brief increase in levels of the male sex hormone (testosterone) in the blood, which may temporarily worsen the following symptoms of disease:

  • Development of or increase in bone pain.
  • Difficulty passing urine due to urinary obstruction.
  • Spinal cord compression.
  • Muscle weakness in the legs.
  • Swelling due to build-up of tissue fluid (lymphoedema).

This increase in symptoms usually subsides spontaneously without the need to discontinue Staladex.

The administration of a suitable male sex hormone blocker (anti-androgen) should be considered for the initial phase of treatment in order to reduce the possible impact of the initial male sex hormone surge.

As treatment is continued, the concentration of the male sex hormone will fall to very low levels, causing some patients to experience one or more of the following side effects:

Very common (may affect more than 1 in 10 people):

  • Hot flushes.
  • Reduction or loss of sexual desire and potency.
  • Testicular atrophy (shrinkage).
  • Bone pain.
  • Increased sweating.
  • Injection site reactions, such as redness, pain, oedema, itching, which have usually resolved also with continued treatment.
  • Weight gain.

Common (may affect 1 to 10 in 100 people):

  • Enlargement of the male breast.
  • Increased appetite.
  • Decreased appetite.
  • Mood swings.
  • Depression.
  • Sleep disorders.
  • Headache.
  • Abnormal sensations (paraesthesia)/numbness.
  • Nausea/vomiting.
  • Joint and/or back pain.
  • Muscle weakness.
  • Increased need to pass urine at night.
  • Problems when passing urine.
  • Frequent need to pass small amounts of urine.
  • Tiredness (fatigue).
  • Build-up of water in tissues.
  • Weight loss.
  • Changes in values for tests of how the liver is working (which may, however, be due to the underlying disease).

Uncommon (may affect 1 to 10 in 1,000 people):

  • Systemic allergic reactions (fever, itching, eosinophilia, rash).
  • Diarrhoea.
  • Dry skin and/or mucous membranes.
  • Night sweats.
  • Inability to void spontaneously when the bladder is full.
  • Testicular pain.

Rare (may affect 1 to 10 in 10,000 people):

  • Change in diabetic control (increase or decrease in blood sugar levels).
  • Dizziness.
  • Temporary changes in the sense of taste.
  • Changes in blood pressure (blood pressure reduction or increase).
  • Hair loss.

Very rare (may affect less than 1 in 10,000 people):

  • Severe hypersensitivity reactions (anaphylactic reactions).
    Contact your doctor immediately if you notice any of the following signs of a severe hypersensitivity reaction, which may very rarely occur with Staladex, because it requires immediate medical treatment: flushing with swelling of the skin and mucous membranes, difficulty breathing because of narrowed airways, drop in blood pressure, rapid heartbeat, seizures, in severe cases: life-threatening failure of the cardiovascular system.
  • As with other medicines in this drug class: pituitary infarction after first dose administration in patients with an existing pituitary lesion.

Not known (cannot be estimated from the available data):

  • Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)
  • Reduction in blood platelets, which increases risk of bleeding or bruising.
  • Reduction in white blood cells which may lead to more frequent infections.
  • Abnormal levels of lipids (shown in a blood test),
  • Inflammation of lungs, lung disease
  • Changes seen on an ECG (prolongation of the QT interval).
  • Seizures.
  • Blurred vision.
  • Palpitations.
  • Yellowing of the skin and whites of the eyes (jaundice).
  • Pulmonary embolism (resulting in symptoms like breathlessness, difficulty in breathing and chest pain.

Special notes:

The response to Staladex therapy should be monitored by measuring blood concentrations of the male sex hormone (testosterone) 28 days after each injection carried out and before each re-administration of Staladex and additionally on the basis of other laboratory tests (acid phosphatase, PSA = prostate specific antigen). For example, testosterone levels show an initial surge upon initiation of therapy, only to decrease thereafter over a period of 2 weeks. After 2 to 4 weeks, testosterone concentrations reach levels similar to those observed following surgical removal of both testicles and remain at that level throughout the treatment period.

An increase in acid phosphatase (detected by a laboratory test) may be seen in the initial phase of treatment and is transient in nature. Acid phosphatase usually returns to normal levels or near-normal levels after a few weeks.

A decrease in the sex hormone testosterone, as is common after removal of the testicles or with treatment with medicines used to inhibit the sex hormones (e.g. Staladex), can cause a reduction in bone mineral density with an increased risk of bone fractures (see section 2 ‘Warnings and precautions’). The reduction in bone mineral density following removal of the testicles is, however, more marked than after administration of Staladex.

Abscesses at the injection site occur rarely. In one report of an abscess at the injection site, the absorption of leuprorelin from the depot appeared to be decreased. It is therefore advised to determine testosterone levels in such cases.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5. How to store Staladex

Do not use this medicine after the expiry date which is stated on the container and the outer packaging.

The pre-filled syringe must be used immediately after opening the sterile pouch.

Do not store above 30°C. Store the pre-filled syringe in the unopened original package.

Keep this medicine out of the sight and reach of children.

6. Contents of the pack and other information

What Staladex contains:

The active substance is leuprorelin acetate. 1 implant contains: 10.72 mg leuprorelin (as leuprorelin acetate).

The other ingredients are polylactic acid and poly(D,L-lactide-co-glycolide) (1:1).

What Staladex looks like and contents of the pack

Plastic pre-filled syringe (with depot chamber) with stainless steel plunger and needle. The pre-filled syringe is packaged together with a desiccant in a sealed sterile plastic/aluminium foil laminate pouch.

Packs of 1 pre-filled syringe containing 1 implant or 2 pre-filled syringes each containing 1 implant for subcutaneous injection.

Marketing Authorisation Holder

Amdeepcha Limited
85 Yarmouth Road
Blofield
Norwich
Norfolk
United Kingdom

Manufacturer

AMW GmbH
Birkerfeld 11
83627 Warngau
Germany

This leaflet was last revised in 09/2019.