Degarelix Ferring 80 mg Powder and solvent for solution for injection

Patient Leaflet Updated 27-May-2025 | Ferring Pharmaceuticals Ltd

Degarelix Ferring 80 mg

Package leaflet: Information for the user

DEGARELIX FERRING 80 mg Powder and solvent for solution for injection

degarelix

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.
  • If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What DEGARELIX FERRING is and what it is used for

DEGARELIX FERRING contains degarelix.

Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer and for the treatment of high-risk prostate cancer prior to radiotherapy and in combination with radiotherapy in adult male patients. Degarelix mimics a natural hormone (gonadotrophin-releasing hormone, GnRH) and directly blocks its effects. By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer.

2. What you need to know before you use DEGARELIX FERRING
Do not use DEGARELIX FERRING

If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Please tell your doctor if you have any of the following:

  • Any cardiovascular conditions or heart rhythm problems (arrythmia) or are being treated with medicines for this condition. The risk of heart rhythm problems may be increased when using DEGARELIX FERRING.
  • Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may have to measure blood glucose more frequently.
  • Liver disease. Liver function may need to be monitored.
  • Kidney disease. Use of DEGARELIX FERRING has not been investigated in patients with severe kidney disease.
  • Osteoporosis or any condition that affects the strength of your bones. Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones).
  • Severe hypersensitivity. Use of DEGARELIX FERRING has not been investigated in patients with severe hypersensitivity reactions.

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and DEGARELIX FERRING

DEGARELIX FERRING might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g. methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics).

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Driving and using machines

Tiredness and dizziness are common side effects that may impair your ability to drive and use machines. These side effects may be due to the treatment or effects resulting from the underlying disease.

3. How to use DEGARELIX FERRING

This medicine is usually injected by a nurse or a doctor.

The recommended starting dose is two consecutive injections of 120 mg. After that, you will receive a monthly 80 mg injection. The injected liquid forms a gel from which degarelix is released over a period of one month.

DEGARELIX FERRING must be injected under the skin (subcutaneously) ONLY. DEGARELIX FERRING must NOT be given into a blood vessel (intravenously). Precautions must be taken to avoid accidental injection into a vein. The site of injection is likely to vary within the abdominal region.

If you forget to use DEGARELIX FERRING

If you believe your monthly dose of DEGARELIX FERRING has been forgotten, please talk to your doctor.

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

4. Possible side effects

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

A very serious allergic reaction to this medicine is rare. Seek medical advice straight away if you develop a severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe allergic reaction.

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

Hot flushes, injection site pain and redness. Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.

Common (may affect up to 1 in 10 people)

  • injection site swelling, node and hardness
  • chills, fever or influenza-like illness after the injection
  • trouble sleeping, tiredness, dizziness, headache
  • increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
  • excessive sweating (including night sweats), rash
  • anaemia
  • musculoskeletal pain and discomfort
  • reduced size of testicles, breast swelling, impotence

Uncommon (may affect up to 1 in 100 people):

  • loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain
  • depression, mental impairment
  • skin redness, loss of hair, skin nodule, numbness
  • allergic reactions, hives, itching
  • decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight
  • high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal heart beat, dyspnoea, peripheral oedema
  • muscular weakness, muscle spasms, joint swelling/ stiffness, osteoporosis/osteopenia, pain in the joint
  • frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence
  • blurred vision
  • discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)
  • malaise

Rare (may affect up to 1 in 1,000 people)

  • febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure
  • unexplained muscular pain or cramps, tenderness, or weakness. The muscle problems can be serious, including muscle breakdown resulting in kidney damage.

Very rare (may affect up to 1 in 10,000 people)

injection site infection, abscess and necrosis

Reporting of side effects

If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about any side effect it can be reported directly via the Yellow Card reporting site www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store and include batch/lot number if available. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DEGARELIX FERRING

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

Do not use this medicine after the expiry date which is stated on the vials, syringes and outer packaging. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

After reconstitution:

This medicine is stable for 2 hours at 25ºC.

Due to the risk of microbial contamination, this medicine should be used immediately. If not used immediately, the use of this medicine is the responsibility of the user.

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 protect the environment.

6. Contents of the pack and other information
What DEGARELIX FERRING contains
  • The active substance is degarelix. Each vial contains 80 mg degarelix (as acetate). After reconstitution 1 ml of the reconstituted solution contains 20 mg degarelix.
  • The other ingredient of the powder is mannitol (E 421).
  • The solvent is water for injections.

What DEGARELIX FERRING looks like and contents of the pack

DEGARELIX FERRING is a powder and solvent for solution for injection.

The powder is white to off-white. The solvent is a clear, colourless solution.

DEGARELIX FERRING is available in 2 pack-sizes.

Pack-size of 1 tray containing:

1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.

1 plunger rod, 1 vial adapter and 1 injection needle.

Pack-size of 3 trays containing:

3 vials with powder containing 80 mg of degarelix and 3 prefilled syringes with 4.2 ml of solvent.

3 plunger rods, 3 vial adapters and 3 injection needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd
Drayton Hall
Church Road
West Drayton
UB7 7PS
United Kingdom

PLGB 03194/0129

Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Ferring Pharmaceuticals Ltd.
Tel: +44 844 931 0050
Email: [email protected]

This leaflet was last revised in September 2024.

FERRING and the FERRING Logo are trademarks of Ferring B.V. © 2022 Ferring B.V.

Company Contact Details
Ferring Pharmaceuticals Ltd
Address

Drayton Hall, Church Road, West Drayton, UB7 7PS, UK

Fax

+44 (0)844 931 0051

WWW

http://www.ferring.co.uk

Telephone

+44 (0)844 931 0050

Medical Information e-mail
Customer Care direct line

0800 111 4125