1 mg/ml solution, solution for injection
buserelin
What Suprefact is and what it is used for
Suprefact contains a medicine called buserelin. Buserelin is similar to a naturally occurring hormone released by the brain. It belongs to a group of medicines called “luteinizing hormone-releasing hormone analogs” (LHRH analogs).
Suprefact is used in hormone-dependent prostate cancer. In prostate cancer, Suprefact works by inhibiting the production of testosterone, a male sex hormone. In addition to its normal hormonal effects, testosterone can have a stimulating effect on the growth of certain tumors.
The buserelin contained in Suprefact may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Suprefact
Do not use Suprefact
- if you are allergic to buserelin or any other LHRH analog (eg leuprorelin, goserelin, triptorelin) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Suprefact:
- If your cancer has spread ( metastasized ).
- If you have an increased risk of cardiovascular disease (e.g. heart attack).
- If you have diabetes. Check your blood sugar levels regularly. This is because Suprefact can affect your metabolism and thus your blood sugar levels.
- If you have high blood pressure. Your doctor or nurse should regularly check your blood pressure as blood pressure can be affected by Suprefact.
- If you have ever had depression. You should be vigilant about your mental health because there is a risk that your depression may return or worsen.
- If you have any cardiovascular disease including heart rhythm disorders ( arrhythmia ), or if you are being treated with medicines for this. The risk of suffering from heart rhythm disorders may be increased when using Suprefact.
- If you have risk factors for osteoporosis such as alcohol abuse, are a smoker, have osteoporosis in the family, or if you have been treated for a long time with anti-epileptic drugs or with cortisone.
Suprefact can cause a decrease in bone density, osteoporosis (weakening of the bones), and an increased risk of bone fractures, especially if you have risk factors for osteoporosis according to the last point above. Your doctor should measure your bone density regularly to be able to prescribe preventive measures against osteoporosis if necessary.
At the beginning of prostate cancer treatment, tumor activation may occur due to increased testosterone levels and you may experience a temporary worsening of symptoms (see section 4. Possible side effects ). To counteract this, the addition of a so-called anti-androgenic drug is recommended approximately 5 days before treatment begins and during the first 3-4 weeks of treatment with Suprefact. After this period, testosterone levels have usually decreased to the desired level as a result of the buserelin treatment.
Inform your doctor if you feel down/depressed while taking Suprefact. Depression, which can be severe, has been reported in patients taking Suprefact.
Suprefact can increase the risk of anemia ( lack of blood ). Tell the doctor if you experience symptoms such as tiredness, shortness of breath, and palpitations.
Children and young people
In the absence of information on safety and efficacy in children, Suprefact should not be used in children.
Other medicines and Suprefact
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform the doctor if you use medicines for diabetes. This is because Suprefact can reduce the effect of these medicines.
Suprefact may affect certain other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for serious mental illness).
Pregnancy, breastfeeding, and fertility
Suprefact should not be used in women.
Driving ability and use of machinery
Suprefact can cause side effects (such as drowsiness and dizziness) that can affect your concentration and reaction speed. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effect . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Suprefact contains sodium and the best alcohol
Suprefact contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is almost ‘sodium-free’.
Suprefact contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per ml vial, solution.
Benzyl alcohol can cause allergic reactions.
If you have impaired liver function or impaired kidney function, consult a doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
How to use Suprefact
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
To ensure the desired effect, you must take Suprefact at the appointed times.
The recommended starting dose is 0.5 ml (0.5 mg) of Suprefact given as an injection under the skin every 8 hours for the first seven days. This part of the treatment should, if possible, take place in a hospital. The doctor will then take a blood sample to check levels of testosterone.
A possible worsening of symptoms during the initial phase of treatment can be avoided by taking an antiandrogen at the same time (see also section 4).
If you have used too much Suprefact
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
Too much of this medicine can make you feel weak, anxious, dizzy, or sick (nausea). You may also experience headaches, hot flashes, stomach pain, swelling ( edema ) of the ankles and lower legs, breast tenderness, or reactions at the injection site.
If you have any further questions about this medicine, contact your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you develop symptoms such as a rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue. This could be a serious allergic reaction. This is a rare side effect (which may affect up to 1 in 1,000 users) that can lead to anaphylactic shock.
At the beginning of prostate cancer treatment, the amount of testosterone your body produces may increase and you may experience a temporary worsening of symptoms. Contact a doctor if you experience symptoms such as bone pain, worsening bone pain (in patients with metastases ), muscle weakness in the legs, or problems with urination or fluid retention. These reactions can largely be avoided by treatment with a so-called antiandrogenic drug, see section 2.
Reported side effects are
- Common (may affect up to 1 in 10 users)
- Headache
- Feeling of heat in the skin, sweating
- Pain or other local reactions (eg redness, swelling) at the injection site
- Impotence, reduced testicle size
- Decreased sex drive, mood changes, depression (with long-term use).
- Uncommon (may affect up to 1 in 100 users)
- Influence on liver function values
- Weight loss or weight gain
- Drowsiness, dizziness
- Constipation
- Hypersensitivity reaction (redness, itching, hives)
- Enlargement of the mammary gland (not painful)
- Mood changes, depression (with short-term use)
- Fluid accumulation ( edema ) around the ankles and calves
- Fatigue.
- Rare (may affect up to 1 in 1,000 users)
- Altered blood fat values
- Palpitation
- Sleep disturbances, memory and concentration disorders
- Nausea, vomiting, diarrhea
- Increased or decreased head or body hair
- Increased blood pressure in patients with already high blood pressure
- Emotional instability, anxiety.
- Increase in the substance bilirubin in blood serum.
- Very rare (may affect up to 1 in 10,000 users)
- Changes in the blood picture
- Discomfort and pain in muscles and bones
- Visual impairment (eg, blurred vision) and feeling of pressure behind the eyes
- Tinnitus, hearing disorders
- Decreased bone density, increased risk of fracture
- Increased thirst, change in appetite, reduced glucose tolerance (can lead to impaired control of the disease in diabetics)
- Growth of benign tumor in the pituitary gland
- Mild transitory tumor-related pain
- Deterioration of general well-being.
- Has been reported (occurring in an unknown number of users)
- Changes ( QT prolongation) that can be seen on an electrocardiogram ( ECG )
- Abnormal sensations such as tingling ( paresthesia ) have been observed in connection with other buserelin preparations.
How to store Suprefact
Store at a maximum of 25° C.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the bottle after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is buserelin acetate corresponding to buserelin 1 mg/ml.
- Other ingredients are benzyl alcohol, sodium hydroxide, sodium dihydrogen phosphate, sodium chloride, and water for injections.
Appearance and package sizes of the medicine
Packaging containing 2 vials of 5.5 ml.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Brüningstraße 50
65926 Frankfurt am Main
Germa