Suprefact

Package leaflet: Information for the user

Suprefact Depot 9.45 mg implant

buserelin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Suprefact Depot 9.45 mg implant is and what it is used for
2. What you need to know before using Suprefact Depot 9.45 mg implant
3. How to use Suprefact Depot 9.45 mg implant
4. Possible side effects
5. How to store Suprefact Depot 9.45 mg implant
6. Contents of the pack and other information

1. What Suprefact Depot 9.45 mg implant is and what it is used for

What Suprefact Depot 9.45 mg implant is
Suprefact Depot 9.45 mg implant contains a medicine called buserelin. Buserelin is similar to a hormone
normally released by the brain. Buserelin belongs to a group of medicines known as
“luteinising hormone-releasing hormone analogues” (LHRH analogues).
How Suprefact Depot 9.45 mg implant works
Buserelin works by reducing the levels of hormones that promote the growth of prostate tumours. The prostate is a gland located below the bladder in men.
What Suprefact Depot 9.45 mg implant is used for
Suprefact Depot 9.45 mg implant is used to treat advanced prostate cancer.

2. What you should know before using Suprefact Depot 9.45 mg implant

Do not use Suprefact Depot 9.45 mg implant:

• If you are allergic to buserelin, or to other LHRH analogues (e.g. leuprolide, goserelin, triptorelin), or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue. Do not use this medicine if any of the above apply to you. If you are unsure, ask your doctor or pharmacist before starting treatment with Suprefact Depot 9.45 mg implant.

Warnings and precautions
Talk to your doctor or pharmacist before using Suprefact Depot 9.45 mg implant:

• If you have had your testicles removed.
• If your cancer has worsened (metastatic cancer). At the beginning, it is important that you use other medicines to lower the levels of certain hormones. However, this may cause tumour-related pain; if this occurs, inform your doctor or pharmacist.
• If you are having problems eliminating body fluids (urine).
• If you have risk factors for cardiovascular disease or diabetes.
• If you have any heart or blood vessel disorders, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Suprefact Depot 9.45 mg implant.
• If you have diabetes. Check your blood sugar levels regularly. This is because Suprefact Depot 9.45 mg implant may affect your metabolism and therefore your blood sugar levels.
• If you have high blood pressure. You should visit your doctor or nurse regularly to monitor your blood pressure. This is because blood pressure may be affected by Suprefact Depot 9.45 mg implant.
• If you have experienced episodes of depression. You should carefully monitor your mental state, as depression may recur or worsen.
• If you have a reduced number of red blood cells or feel more tired than usual (anaemia). If you are unsure whether any of the above apply to you, ask your doctor or pharmacist before using Suprefact Depot 9.45 mg implant.

Your doctor should ask you to monitor your bone density and may prescribe appropriate treatment. This is because the use of LHRH analogues may cause decreased bone density, osteoporosis (bone fragility), and an increased risk of bone fractures, particularly if you have risk factors for osteoporosis such as chronic alcohol abuse, smoking, family history of osteoporosis, or long-term therapy with anticonvulsants or corticosteroids.
Cases of depression have been reported in patients taking Suprefact Depot 9.45 mg implant, which may be severe. If you are taking Suprefact Depot 9.45 mg implant and develop depressive mood, inform your doctor.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Other medicines and Suprefact Depot 9.45 mg implant
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines. This is because Suprefact Depot 9.45 mg implant may affect the way some medicines work. Likewise, other medicines may affect the way Suprefact Depot 9.45 mg implant works.
In particular, inform your doctor:

• If you are taking medicines for diabetes. This is because Suprefact Depot 9.45 mg implant may affect how these medicines work, leading to worsening of diabetes.
• If you are taking medicines for heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol).
• If you are taking other medicines that may increase the risk of heart rhythm problems when used with Suprefact Depot 9.45 mg implant (e.g. methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)).

Pregnancy and breastfeeding
Suprefact Depot 9.45 mg implant is a medicine intended for use only in men. It must not be used in women.
Driving and using machines
You may experience certain side effects after taking this medicine. Some of these side effects (e.g. dizziness) may negatively affect your concentration or reaction speed. If this occurs, be cautious when driving, operating tools or machinery, or performing tasks requiring high levels of attention.

3. How to use Suprefact Depot 9.45 mg implant.

The contents of a pre-filled syringe (three cylindrical rod-shaped implants delivering a dose of 9.45 mg of buserelin) must be administered by a subcutaneous injection into the abdominal area every 3 months. This interval may be extended by an additional 3 weeks.
The injection site should be cleaned. The injection should normally be given by a doctor or nurse. The implant must be brought to room temperature before injection. A local anaesthetic may be used to reduce any pain associated with implant insertion.
Follow your doctor's instructions regarding when Suprefact Depot 9.45 mg implant should be administered and the interval between injections.

Blood tests
Your doctor will need to carry out regular blood tests to monitor whether the medicine is working.

If you use more Suprefact Depot 9.45 mg implant than you should
It is unlikely that your doctor or nurse will administer an excessive amount of the medicine. However, receiving more than the intended dose may make you feel weak, nervous, dizzy, or cause nausea.
You may also experience headache, hot flushes, stomach pain, swelling (oedema) in the ankles or lower legs, breast pain, or injection site reactions.
Your doctor can provide appropriate treatment for these side effects.

If you have any questions about the use of Suprefact Depot 9.45 mg implant, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you have experienced any side effects, it is important to inform your doctor before your next treatment.
If you experience severe allergic reactions such as shortness of breath or shock, please contact your doctor immediately, as removal of the implant may be necessary.

Side effects that may occur at the beginning of treatment
At the start of treatment, the amount of sex hormones produced by your body may increase, and you might notice a temporary worsening of symptoms. For example, you might experience bone pain, muscle weakness in the legs, difficulty urinating, fluid retention, or blood clotting disorders in the lungs. To prevent these effects, another medicine, such as cyproterone acetate, is usually given. This additional medicine should be continued for 3–4 weeks after receiving the Suprefact Depot 9.45 mg implant. After this period, testosterone levels normally return to the desired range in response to Suprefact Depot 9.45 mg implant.

Tell your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:

Common (may affect up to 1 in 10 people):

• Loss of sexual desire (libido)
• Inability to maintain an erection
• Headache
• Hot flushes
• Shrinkage of the testicles (called “testicular atrophy”)
• Pain or local reactions at the injection site (such as redness or swelling)
• Mood changes, depression (with long-term treatment)

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

• Allergic reactions such as skin rash, where the skin may appear red and itchy (including hives)
• Drowsiness or fatigue
• Dizziness
• Constipation
• Breast enlargement
• Fluid retention (edema) in the ankles and lower legs
• Increased liver enzymes detectable in blood tests
• Changes in body weight
• Mood changes, depression (with short-term treatment)

Rare (may affect up to 1 in 1,000 patients):

• Severe allergic reactions, such as shortness of breath
• Nervousness, stress, and emotional instability. Also, difficulty sleeping and problems with memory or concentration
• Fast or irregular heartbeat (palpitations), increased blood pressure in patients who already have high blood pressure (hypertension)
• Feeling unwell (nausea), sickness (vomiting), or diarrhoea
• Hair loss or loss of body hair
• Changes in blood lipids and increased bilirubin levels, shown in blood test results

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

• Severe allergic reactions with shock
• Increased thirst, changes in appetite, reduced glucose tolerance (in diabetic patients, this may lead to loss of diabetes control)
• Ringing in the ears (tinnitus), changes in hearing ability
• Vision changes such as blurred vision or a sensation of pressure at the back of the eye
• Discomfort or pain in muscles or the skeletal system
• Worsening of general well-being
• Decrease in blood cells, which may lead to abnormalities in blood tests and/or bruising
• Increase in the size of benign tumours in the pituitary gland or temporary increase in tumour-related pain

Not known (frequency cannot be estimated from available data):

• Changes in ECG pattern (QT prolongation)

With other formulations of buserelin, changes in skin sensations such as tingling have been observed.
This group of medicines (called LHRH analogues) may cause decreased bone density, osteoporosis, and an increased risk of bone fractures. The likelihood of fractures increases with the duration of treatment. LHRH analogues may also increase the risk of cardiovascular diseases (such as heart attack and stroke), diabetes, or anaemia (reduction in red blood cells causing tiredness).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suprefact depot 9.45 mg implant.

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 after Exp.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). May be stored at a maximum of 25°C for up to 7 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Suprefact Depot 9.45 mg implant contains
The active substance in Suprefact Depot 9.45 mg implant is buserelin. Each pre-filled syringe contains three cylindrical rods delivering 9.9 mg of buserelin acetate, equivalent to 9.45 mg of buserelin.
The excipient is Poly (D,L-lactide-co-glycolide) with a lactide:glycolide ratio of 75:25.

Description of the appearance of Suprefact Depot 9.45 mg implant and contents of the pack
A pack contains 1 or 2 sterile pre-filled syringes.
Each syringe contains 3 cream-coloured cylindrical rods.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Sanofi-Aventis Deutschland GmbH,
Industriepark Höchst, (Bruningstrasse 50),
65926 Frankfurt am Main, Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: Suprefact Depot - Implantat Für 3 Monate
Belgium: Suprefact Depot 9.45 mg Implant
Denmark: Suprefact Depot
Finland: Suprefact Depot 9.45 mg implantaatti
France: Trigonist 9.45 mg implant pour voie sous-cutanée
Germany: Profact Depot 9,45 mg 3-Monatsimplantat
Italy: Suprefact depot 9,45 mg impianto
Luxembourg: Suprefact Depot 9.45 mg Implant
Netherlands: Suprefact Depot 3 Maanden, implantatiestift 9.45 mg
Portugal: Suprefact Depot 3 Meses
Spain: Suprefact Depot 9.45 mg Implante Subcutaneo
Sweden: Suprefact Depot 9.45 mg implantat
The United Kingdom: Suprefact Depot 9.45 mg implant, for subcutaneous route

This Patient Information Leaflet was last approved in December 2023

The following information is intended for healthcare professionals only

1. NAME OF THE MEDICINAL PRODUCT

Suprefact Depot 9.45 mg implant, for subcutaneous use
2 DOSAGE AND ADMINISTRATION
One syringe contains three cylindrical rods which are injected under the skin of the abdomen every three months. It is important to maintain the three-month interval; however, the administration interval may occasionally be extended by up to 3 weeks. A local anesthetic may be used prior to injection.
Allow the implant to reach room temperature before use.
N.B. To prevent the implant (cylindrical rods) from leaking out of the needle (A), keep the syringe in an upright position with the needle pointing upwards until the time of injection.

A: Needle
B: Needle protective cap
C: Plunger
D: Implant
E: Plunger protective cap

1. After opening the package and removing the applicator from its packaging, check that the rods are visible in the inspection window at the base of the needle. If necessary, gently tap the needle protective cap with your fingers to reposition the implants opposite the inspection window. The syringe must be used immediately after opening the packaging.

2. Disinfect the injection site on the lateral abdominal wall area. First remove the plunger protective cap (E), then remove the needle cap (B).

3. Form a skin fold and insert the needle to a depth of approximately 3 cm (a little over one inch) into the subcutaneous tissue. Hold the applicator horizontally or with the needle tip pointing upward before injection. Withdraw the applicator slightly by 1–2 cm before injecting the implant.

4. Fully depress the plunger to inject the cylindrical rods into the subcutaneous tissue. While withdrawing the needle, apply pressure to the injection site to ensure the rods remain within the injected tissue.

5. To confirm that all three rods have been injected, verify that the tip of the plunger is visible at the needle tip.

It is recommended to start administration of an antiandrogen as an adjunctive therapy approximately 5 days before initiating treatment with Suprefact Depot 9.45 mg implant.
3 PHARMACEUTICAL INFORMATION
3.1 List of excipients
Poly (D,L-lactide-co-glycolide)
3.2 Incompatibilities
Not applicable, as the product is supplied in a special applicator.
3.3 Shelf life
3 years.
3.4 Special precautions for storage
Store in a refrigerator (2°C–8°C). May be stored at a maximum temperature of 25°C for up to 7 days.
3.5 Nature and content of container
Pre-filled syringe containing an implant composed of three cylindrical rods, in a cellulose propionate and stainless steel applicator, sealed in a package made of a laminate film composed of polyethylene terephthalate, aluminum, and low-density polyethylene.
Pack sizes: 1 or 2 pre-filled syringes per package.
Not all pack sizes may be marketed.