80 mg powder and solvent for injection, solution
degarelix
1. What FIRMAGON is and what it is used for
FIRMAGON contains degarelix.
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult men. Degarelix is similar to a natural hormone (gonadotropin-releasing hormone, GnRH ) and blocks its effects by direct action. Thereby, degarelix immediately reduces the level of the male hormone et testosterone which stimulates prostate cancer.
2. What you need to know before using FIRMAGON
Do not use FIRMAGON
- if you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Tell your doctor if you have any of the following:
- Some cardiovascular conditions or problems with the heart rhythm ( arrhythmia ) or treated with drugs for this condition. The risk of heart rhythm disorders may increase with the use of FIRMAGON.
- Diabetes mellitus. Exacerbation or onset of diabetes may occur. If you have diabetes, you may need to measure your blood sugar more often.
- Liver disease. Liver function may need to be monitored.
- Kidney disease. The use of FIRMAGON has not been studied in patients with severe kidney disease.
- Osteoporosis (osteoporosis) or any other condition that can affect the strength of your bones. A decrease in testosterone levels can reduce calcium in the bone (bone thinning).
- Severe hypersensitivity. The use of FIRMAGON has not been studied in patients with severe hypersensitivity reactions.
Children and young people
Do not give this medicine to children or adolescents.
Other drugs and FIRMAGON
FIRMAGON can affect certain medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or other medicines that can affect the heart rhythm (eg methadone (used for pain relief and detoxification), cisapride, moxifloxacin (an antibiotic ), antipsychotics).
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Driving and using machines
Fatigue and dizziness are common side effects that can impair your ability to drive or use machines. These side effects can be caused by the treatment or be a symptom of the disease.
3. How to use FIRMAGON
This medicine is usually injected by a nurse or doctor.
The recommended starting dose is two injections of 120 mg. You will then receive an injection of 80 mg per month. The injected liquid forms a gel from which degarelix is released for one month.
FIRMAGON should ONLY be injected under the skin ( subcutaneously ). FIRMAGON must NOT be given into a blood vessel ( intravenously ). Precautions must be taken to avoid accidental injection into a vein. The injection site varies within the abdominal area.
If you forget to use FIRMAGON
Talk to your doctor if you think your monthly dose of FIRMAGON has been missed.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very severe allergic reactions are rare with this medicine. If you experience severe rash, itching, and difficulty breathing, this may be a symptom of a severe allergic reaction.
Very common (may affect more than 1 user in 10)
Hot flashes, pain, and redness at the injection site. Side effects at the injection site are more common with the starting dose than with the maintenance dose.
Common (may affect up to 1 in 10 people)
- swelling, nodules, and calluses at the injection site
- chills, fever, or flu-like symptoms after injection one
- sleep problems, fatigue, dizziness, headache
- weight gain, nausea, diarrhea, elevated liver enzyme levels
- increased sweating (including night sweats), skin rash
- anemia ( anemia )
- pain and discomfort in muscles and bones
- decreased testicle size, breast swelling, impotence
Uncommon (may affect up to 1 in 100 people)
- loss of sexual drive, pain in the testicles, pelvic pain, failure to ejaculate, irritation of the genitals, chest pain
- depression, mental deterioration
- skin redness, hair loss, nodules in the skin, loss of sensation
- allergic reactions, hives, itching
- decreased appetite, constipation, vomiting, dry mouth, abdominal pain, stomach upset, high blood sugar/diabetes, increased cholesterol, changes in calcium in the blood, weight loss
- high blood pressure, changes in heart rate, changes in ECG ( QT prolongation), feeling of irregular heartbeat, shortness of breath, swollen hands, and feet
- muscle weakness, muscle twitching, swollen / stiff joints, osteoporosis/bone deficiency, sore joints
- frequent and urgent urination, difficulty urinating, painful urination, nocturnal urination, impaired renal function, incontinence
- dimsyn
- injection discomfort including a drop in blood pressure and slow heart rate (vasovagal reaction)
- feeling sick
Rare (may affect up to 1 in 1,000 people)
- neutropenic fever (a very low white blood cell count in combination with fever), heart attack, and heart failure.
Very rare (may affect up to 1 in 10,000 people)
- infection, abscess, or necrosis (local tissue death) at the injection site
5. How to store FIRMAGON
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 carton, vial, and syringe. The expiration date is the last day of the specified month.
No special storage instructions.
After preparation
This medicine can be stored for 2 hours at 25 ° C.
Due to the risk of microbiological contamination, this medicine should be used immediately. If not used immediately, the use of this medicinal product is the responsibility of the user.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is degarelix. Each vial contains 80 mg of degarelix (as acetate). 1 ml reconstituted solution contains 20 mg degarelix.
- The other ingredient in the powder is mannitol (E421).
- The fluid consists of water for injections.
What the medicine looks like and the contents of the pack
FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The solvent is a clear, colorless solution.
FIRMAGON is available in 2 packaging chairs.
Pack size of 1 tray containing:
1 vial of powder containing 80 mg degarelix, 1 pre-filled syringe with 4.2 ml diluent, 1 syringe plunger, 1 vial adapter, 1 syringe
Pack size of 3 trays containing:
3 vials containing 80 mg degarelix and 3 pre-filled syringes with 4.2 ml of diluent. 3 plungers, 3 adapters to the vial, and 3 needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ferring Pharmaceuticals A / S
Kay Fiskers Square 11
DK-2300 Copenhagen S
Denmark
Tel: +45 88 33 88 34
Manufacturer
Ferring GmBH
Wittland 11
D-24109 Kiel
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienFerring NVTel / Tel: + 32-53 72 92 00ferringnvsa@ferring.be | LithuaniaCentralPharma Communication UABTel .: +370 5 243 0444centralpharma@centralpharma.lt |
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| EestiCentralPharma Communication OÜTel: +372 601 5540centralpharma@centralpharma.ee | NorwayFerring Legmiddel ASTel: +47 22 02 08 80mail@oslo.ferring.com |
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| IrelandFerring Ireland Ltd.Tel: +353 (0) 1 4637355inquiries.ireland@ferring.com | SloveniaSALUS, Veletrgovina, dooTel: +386 1 5899 179regulatory@salus.si |
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| LatviaCentralPharma Communication SIAPhone: +371 674 50497centralpharma@centralpharma.lv | United KingdomFerring Pharmaceuticals LtdTel: +44 844 931 0050contact@ferring.co.uk |