Degarelix Accord – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Degarelix Accord, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 side effects talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Degarelix Accord is and what it is used for
Degarelix Accord contains degarelix.
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer an d 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 -relasing hormone, GnRH) and directly blocks its effects. By doing so, dega relix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer.
⚠️ 2. What you need to know before you use Degarelix Accord
Do not use Degarelix Accord
if you are allergic to degarelix or any of the other ingredie nts 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 Accord .
- 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 Accord 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 Accord has not been investigated in patients with severe hypersensitivity reactions.
Children and adolescent s Do not give this medicine to children or adolescents.
40 Other medicines and Degarelix Accord Degarelix Accord 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 migh t 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 treatm ent or effects resulting from the underlying disease.
💊 3. How to use Degarelix Accord
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 Accord must be injected under the skin (subcutaneously) ONLY. Degarelix Accord must NOT be give n 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 Accord
If you believe your monthly dose of Dega relix Accord 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 si te 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 sweat s), 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 pai n
- depression, mental impairment 41 – 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, tend erness, 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 side e ffects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V .
By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Degarelix Accord
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.
Store below 25 °C.
After reconstitution :
This medicine is stable for 4 hours at 25°C .
Due to the risk of microbial contamination, this medicine should be used immediately. If not used immediately, the use of this medicine are the responsibility of the user.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw aw ay medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Degarelix Accord contains
- The active substance is degarelix. Each vial contains 120 mg degarelix (as acetate). After reconstitution 1 ml of the reconstituted solution contains 40 mg degarelix.
- The other ingredient of the powder is mannitol
- The solvent is water for injections.
What Degarelix Accord looks like and contents of the pack
42 Degarelix Accord is a powder and solvent for solution for injection. The powder is white or off-white.
The solvent is a colourless , clear solution.
Degarelix Accord is available in 1 pack-sizes.
Pack -size of 2 tray containing:
2 vials with powder containing 120 mg of d egarelix and 2 pre -filled syringe s with 3 ml of solvent.
2 plunger rod s, 2 vial adapter s and 2 injection needle s.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o. ul. Lutomierska 50, 95-200 Pabianice, Poland Or Laboratori Fundació Dau C/ C, 12 -14 Pol. Ind.
Zona Franca, Barcelona, 08040, Spain Or Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht The Netherlands Or Pharmadox Healthcare Limited KW20A Kordin Industrial Park, Paola PLA 3000, Malta
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ .
43 ————————————————————————————————————————
🩺 Information intended for healthcare professionals only
Instructions for proper use NOTE:
- DO NOT SHAKE THE VIALS The pack contains two vials of powder and two pre -filled syringes with solvent that must be prepared for subcutaneous injection. Hence, the procedure described below need to be repeated a second time.
1. Remove the cover from the vial adapter pack. Attach the adapter to the powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place.
2. Prepare the pre -filled syringe by attaching the plunger rod.
3. Remove the cap of the pre -filled syringe. Attach the syringe to the powder vial by screwing it on to the adapter. Transfer all solvent to the powder vial.
4. With the syringe still attached to the adapter, swirl gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly. Avoid shaking to prevent foam formation.
A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure usually takes a few minutes, but may take up to 15 minutes in some cases.
5. Turn the vial upside down and draw up to the line mark on the syringe for injection.
Always make sure to withdraw the precise volume and adjust for any air bubbles.
6. Detach the syringe from the vial adapter and attach the needle for deep subcutaneous injection to the syringe.
7. Perform a deep subcutaneous injection. To do so: grasp the skin of the abdomen, elevate the subcutaneous tissue and insert the needle deeply at an angle of not less than 45 degrees .
Inject 3 ml of Degarelix Accord 120 mg slowly, immediately after reconstitution *.
44 8. No injections should be given in areas where the patient will be exposed to pressure, e.g. around the belt or waistband or close to the ribs.
Do not inject directly into a vein. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the medicinal product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
9. Repeat the reconstitution procedure for the second dose. Choose a different injection site and inject 3 ml.
- Chemical and physical in -use stability has been demonstrated for 4 hours at 25°C . From a microbiological point of view, unless the method of rec onstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in -use storage times and conditions are the responsibility of the user.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Degarelix Accord (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1753).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.