What Suprefact Depot is and what it is used for
Suprefact Depot 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 Depot is used in the treatment of advanced prostate cancer or premature puberty.
In prostate cancer, Suprefact Depot 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. After 3 – 4 weeks of treatment with Suprefact Depot, the concentration of testosterone has dropped to a very low level.
In premature puberty, Suprefact Depot works by inhibiting sex hormones. In girls, breast development stops or regresses. After initial bleeding, any menstrual bleeding stops in parallel with the decline of the sex hormones in the body. In boys, the growth of the testicles and other signs of puberty stop.
What you need to know before using Suprefact Depot
Do not use Suprefact Depot
- If you are allergic to buserelin or any of the other LHRH analogs (e.g. leuprolide, goserelin, triptorelin) or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Suprefact Depot:
- If you have had your testicles removed.
- If your cancer has spread ( metastasized ).
- If you have an increased risk of cardiovascular disease (e.g. heart attack).
- If you have any cardiovascular disease including heart rhythm disorders ( arrhythmia ) or are being treated with drugs for this. The risk of suffering from heart rhythm disorders may be increased when using Suprefact Depot.
- If you have diabetes. Check your blood sugar levels regularly. This is because Suprefact Depot 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 Depot.
- 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.
Suprefact Depot 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 such as alcohol abuse, are smokers, have a family history of osteoporosis, or if you have been treated for a long time with anti- epilepsy or with cortisone. 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 can occur (see section 4. Possible side effects ), therefore the addition of an antiandrogenic drug is recommended approximately 5 days before treatment begins and during the first 3-4 weeks of treatment with Suprefact Depot. After this period, testosterone levels have usually decreased to the desired level as a result of the buserelin treatment.
At the beginning of treatment for premature puberty, vaginal bleeding is common.
Inform your doctor if you become moody/depressed while taking Suprefact Depot. Depression, which can be severe, has been reported in patients taking Suprefact Depot.
Other medicines and Suprefact Depot
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Suprefact Depot can affect or be affected by certain other medicines.
Talk to your doctor especially if you are using:
- drugs against diabetes. This is because Suprefact Depot can reduce the effect of these medicines.
- medicines to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol).
- other medicines that may increase the risk of heart rhythm disturbances when used together with Suprefact Depot, eg methadone (used as a pain reliever and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used in severe mental illnesses).
Pregnancy and breastfeeding
Suprefact Depot should not be used during pregnancy or breastfeeding.
Driving ability and use of machinery
Suprefact Deopt can cause side effects (such as 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 attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Suprefact Depot
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 pre-filled syringe (2 implants) every two months.
Suprefact Depot is given as an injection under the skin ( subcutaneously ) in the stomach area. Injection one will normally be given by a doctor or nurse. Local anesthesia can be given to relieve the pain when injecting one of the implants ones.
Suprefact Depot is intended for long-term treatment. In case of premature puberty, treatment for 3-4 years may be needed.
If you have used too much Suprefact Depot
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. Inform that you have Suprefact Depot implants, as it may be necessary to remove the implant et.
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, problems with urination, fluid retention, or blood clots in the lungs. 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
- Hot flashes
- Pain or other local reactions at the injection site (such as redness, swelling)
- Impotence, testicular atrophy
- Decreased sex drive ( libido ), mood changes, depression (long-term treatment).
Uncommon (may affect up to 1 in 100 users)
- Influence on certain blood tests due to an increase in enzymes produced in your liver
- Weight loss or weight gain
- Drowsiness, dizziness, fatigue
- Constipation
- Fluid accumulation ( edema ) around the ankles and calves
- Hypersensitivity reactions such as skin rash, redness, and itching as well as hives
- Enlargement of the mammary glands (not painful)
- Mood changes, depression (short-term treatment).
Rare (may affect up to 1 in 1,000 users)
- Influence on certain blood tests due to changes in blood lipids and bilirubin increase
- Fast or uneven heartbeats ( palpitations ), increased blood pressure in people with already high blood pressure ( hypertension )
- Sleep difficulties, memory or concentration disorders
- Nausea, vomiting, diarrhea
- Increased or decreased head or body hair
- Severe allergic reactions such as difficulty breathing
- Anxiety, feeling anxious, emotional instability.
Very rare (may affect up to 1 in 10,000 users)
- Decreased number of blood cells, which can lead to abnormal blood tests and/or bruising
- Visual impairment such as blurred vision and feeling of pressure behind the eyes
- Ringing in the ears ( tinnitus ), hearing disorders
- Discomfort and pain in muscles and bones
- Increased thirst, changes in appetite, decreased glucose tolerance (in diabetics this may lead to impaired diabetic control)
- Enlargement of benign pituitary tumor
- Slight transient increase in tumor pain despite treatment with antiandrogen medication
- Deterioration of general well-being
- Severe allergic reactions with shock.
Has been reported (occurring in an unknown number of users)
- Skin sensations such as tingling have been observed for other pharmaceutical forms of buserelin.
- Changes ( QT prolongation) can be seen on the electrocardiogram ( ECG ).
This group of drugs (so-called LHRH agonists ) can cause reduced bone density and lead to osteoporosis ( osteoporosis ) and an increased risk of bone fractures ( fracture ). The risk of bone fracture increases with the length of the treatment period.
How to store Suprefact Depot
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton 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. Each pre-filled syringe contains two rod-shaped implants, providing a dose of 6.6 mg buserelin acetate. This is equivalent to 6.3 mg of buserelin.
- Other ingredients are Poly (D, L-lactide-co-glycolide) with a molar ratio of lactide: glycolide of 75:25.
Appearance and package sizes of the medicine
One package contains 1 pre-filled syringe. Each syringe contains two cream-colored rod-shaped implants.
Marketing Authorization Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany