Camcevi
Italy
Table of Contents
- Package leaflet: Information for the user
- CAMCEVI 42 mg prolonged-release injectable suspension
- 1. What CAMCEVI is and what it is used for
- 2. What you need to know before using CAMCEVI
- 3. How to use CAMCEVI
- 4. Possible side effects
- 5. How to store CAMCEVI
- 6. Package contents and other information
- The following information is intended exclusively for healthcare professionals:
Package leaflet: Information for the user
CAMCEVI 42 mg prolonged-release injectable suspension
leuprorelin
Please read all of this leaflet carefully before you use 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, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What CAMCEVI is and what it is used for
- What you need to know before you use CAMCEVI
- How to use CAMCEVI
- Possible side effects
- How to store CAMCEVI
- Contents of the pack and other information
1. What CAMCEVI is and what it is used for
The active substance of CAMCEVI is leuprorelin, a GnRH agonist (a synthetic version of a natural hormone called gonadotropin-releasing hormone), which acts in the same way as the natural hormone, reducing the level of the sex hormone testosterone in the body.
Prostate cancer is hormone-sensitive, particularly to testosterone, and reducing levels of this hormone helps control tumor growth.
CAMCEVI is used for the treatment of adult men with:
- hormone-dependent metastatic prostate cancer, and
- high-risk hormone-dependent non-metastatic prostate cancer in combination with radiotherapy.
2. What you need to know before using CAMCEVI
Do NOT use CAMCEVI:
- if you are a woman or a person under 18 years of age;
- if you are allergic to leuprorelin or to similar medicines that affect sex hormones (GnRH agonists); your doctor will help you identify these if necessary;
- if you are allergic to any of the other ingredients of this medicine (listed in section 6);
- after surgical removal of the testicles. This medicine cannot further reduce testosterone levels if you no longer have testicles;
- as a single treatment if you have symptoms related to spinal cord compression or if you have a spinal tumour. In this case, CAMCEVI may only be used in combination with other prostate cancer medicines.
Warnings and precautions
Contact your doctor immediately if you experience:
- sudden headache;
- vomiting;
- loss of vision or double vision;
- loss of ability to move muscles inside or near the eyes;
- altered mental state;
- early signs of heart failure such as:
- fatigue;
- swelling of the ankles;
- increased need to urinate at night;
- or more severe symptoms such as shortness of breath, chest pain, and fainting.
These may be signs of a condition called pituitary apoplexy, which involves bleeding into the pituitary gland or impaired blood supply to this gland located at the base of the brain. Pituitary apoplexy can occur due to a pituitary tumour and may rarely occur after starting treatment. Most cases occur within 2 weeks of the first dose; some cases occur within the first hour.
Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported with leuprorelin treatment. Stop treatment with leuprorelin and contact your doctor immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.
Talk to your doctor, pharmacist, or nurse before using CAMCEVI if:
- you have cardiovascular symptoms such as rapid or irregular heartbeat, which may lead to fainting or seizures (convulsions);
- you have heart or blood vessel diseases, including heart rhythm disorders (arrhythmias), or are taking medicines for these conditions. The risk of developing such rhythm disorders may increase when taking CAMCEVI. Your doctor may monitor your heart with an electrocardiogram (ECG);
- you have prostate cancer that has spread to the brain or spinal cord. Your doctor will monitor you more closely during the first weeks of treatment;
- you have diabetes mellitus (high blood sugar). CAMCEVI may worsen existing diabetes, so blood glucose levels should be tested more frequently in diabetic patients;
- you have hepatic steatosis (a condition in which excess fat accumulates in the liver).
Talk to your doctor, pharmacist, or nurse during treatment with CAMCEVI if:
- you have a heart attack. Symptoms include chest pain, shortness of breath, dizziness, and sweating;
- you have a stroke. Symptoms include drooping on one side of the face, inability to lift the arms, and slurred speech;
- you experience a bone fracture. Treatment with CAMCEVI may increase the risk of fractures due to osteoporosis (reduced bone density);
- you have seizures (convulsive seizure);
- you notice an increase in blood sugar. Your doctor will monitor your blood sugar levels during treatment;
- you have difficulty urinating. There may be an obstruction of the urinary tract. Your doctor will monitor you closely during the first weeks of treatment;
- you develop symptoms of spinal cord compression such as pain, numbness, or weakness in the arms, hands, legs, or feet. Your doctor will monitor you closely during the first weeks of treatment.
Conditions that may occur during the first weeks of treatment
During the first few weeks of treatment, there is usually a brief increase in the male sex hormone testosterone in the blood. This may cause a temporary worsening of disease-related symptoms and may also cause new symptoms not previously experienced, including:
- bone pain;
- urinary problems, pain, numbness, or weakness in the arms, hands, legs, or feet, or loss of bladder or bowel control due to spinal cord compression;
- blood in the urine.
These symptoms usually improve as treatment continues. If not, contact your doctor. You may need to take another medicine before starting CAMCEVI to reduce the initial rise in testosterone levels in the blood. You may need to continue taking this other medicine for several weeks after starting CAMCEVI.
If CAMCEVI does not work
Some patients have tumours that are not sensitive to lower testosterone levels. Contact your doctor if you think that CAMCEVI is not working well enough.
Other medicines and CAMCEVI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. CAMCEVI may interfere with some medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol, dofetilide, and ibutilide) or may increase the risk of developing heart rhythm disorders when used with other medicines such as methadone (used to relieve pain and as a substitute for heroin in treating opioid dependence), moxifloxacin (an antibiotic), and antipsychotic medicines used for severe mental illnesses.
Pregnancy and breastfeeding
This medicine is not intended for use in women.
Driving and using machines
Patients treated with CAMCEVI may experience fatigue, dizziness, and visual disturbances. If you experience any of these side effects, do not drive or operate tools or machinery.
3. How to use CAMCEVI
CAMCEVI is administered by a doctor or nurse as a single injection under the skin (subcutaneous) every 6 months.
This medicine must be given only by a doctor or nurse, who will ensure it is correctly injected under the skin and not into a vein.
After injection, the medicine solidifies and slowly releases leuprorelin into the body over a 6-month period.
In combination with radiotherapy
This medicine may be used before or together with radiotherapy for high-risk localised and locally advanced prostate cancer. "High-risk localised" means that the cancer is likely to spread beyond the prostate gland to nearby tissues and become locally advanced. "Locally advanced" means that the cancer has spread beyond the pelvic area to nearby tissues, such as the lymph nodes.
Monitoring of treatment
Your doctor will monitor your response to treatment with blood tests, including prostate-specific antigen (PSA).
If you use more CAMCEVI than you should
The injection is administered by a doctor or appropriately trained healthcare professional; therefore, overdose is unlikely. If you are accidentally given too high a dose, your doctor will monitor you and provide further treatment if necessary.
If you forget to use CAMCEVI
Contact your doctor if you think you have missed your scheduled 6-monthly dose of CAMCEVI.
If you stop using CAMCEVI
Treatment of prostate cancer with CAMCEVI usually requires long-term therapy; therefore, do not stop treatment too early, even if symptoms improve or disappear completely. If treatment is stopped too early, symptoms may return. Do not stop treatment prematurely without first consulting your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:
- sudden headache;
- vomiting;
- loss of vision or double vision;
- loss of ability to move muscles inside or near the eyes;
- altered mental state;
- early signs of heart failure including:
o fatigue;
o swelling of the ankles;
o increased need to urinate at night;
o more severe symptoms such as shortness of breath, chest pain, and fainting.
These may be signs of a condition called pituitary apoplexy, which involves bleeding into the pituitary gland or impaired blood supply to this gland located at the base of the brain. Pituitary apoplexy may occur due to a pituitary tumour and may rarely occur after starting treatment. Most cases occur within 2 weeks of the first dose; some cases occur within the first hour.
Not known (frequency cannot be estimated from the available data):
- if you develop flat, circular, red skin lesions or lesions resembling a target on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- skin redness and itchy skin rash (toxic skin eruption).
- a skin reaction causing small red spots or patches on the skin, which may look like a target with a dark red center surrounded by lighter red rings (Erythema multiforme).
Initial side effects
During the first week of treatment, there is generally a brief increase in the sex hormone testosterone in the blood. This may cause a temporary worsening of disease-related symptoms and also the appearance of new symptoms you may not have previously experienced, including in particular:
- bone pain;
- urinary problems, pain, numbness or weakness in the arms, hands, legs or feet, or loss of bladder or bowel control due to spinal cord compression;
- blood in the urine.
Your doctor may prescribe another medicine at the beginning of treatment to reduce some of these initial side effects (see also section 2, Conditions you may experience during the first weeks of treatment).
Side effects at the injection site
After injection, you may experience the following side effects near the injection site:
- mild burning and numbness immediately after injection (very common: may affect more than 1 in 10 people)
- pain, bruising and tingling after injection (common: may affect up to 1 in 10 people)
- itching and hardening of the skin at the injection site (uncommon: may affect up to 1 in 100 people)
- skin lesion or soreness at the injection site (rare: may affect up to 1 in 1,000 people);
- dead tissue at the injection site (very rare: may affect up to 1 in 10,000 people).
These side effects are mild and short-lived. They occur only at the time of injection. If you experience any of these side effects, contact your doctor.
Very common side effects (may affect more than 1 in 10 people)
- hot flushes
- bruising and/or redness of the skin
- fatigue
Common side effects (may affect up to 1 in 10 people)
- common cold symptoms (rhinopharyngitis)
- feeling unwell (nausea), malaise, diarrhoea, inflammation of the stomach (gastroenteritis/colitis)
- itching
- night sweats
- joint pain, pain in arms and legs, muscle tenderness and muscle pain
- need to urinate more than normal, including at night, difficulty urinating, pain during urination, insufficient urination or need to urinate less frequently
- tenderness and/or swelling of the breasts, shrinkage of testicles, testicular pain, infertility, erectile dysfunction, reduction in penis size
- episodes of violent shivering with high fever (febrile chills), weakness, general feeling of malaise
- changes in blood laboratory test results (prolonged bleeding time, changes in blood parameters, decreased red blood cells/low red blood cell count).
Uncommon side effects (may affect up to 1 in 100 people)
- urinary tract infection (UTI), local skin infection
- worsening of diabetes mellitus
- abnormal dreams, depression, decreased libido (sex drive)
- dizziness, headache, partial or complete loss of sensation in part of the body, insomnia, abnormal alteration of taste and/or smell
- mental confusion and loss of balance (vertigo)
- changes in electrocardiogram (ECG) (prolongation of QT interval)
- heart attack. Symptoms include chest pain, shortness of breath, dizziness and sweating
- high or low blood pressure
- runny nose, shortness of breath
- constipation, dry mouth, digestive disorders with symptoms such as feeling of full stomach, stomach pains, belching, nausea, vomiting, burning sensation in the stomach (dyspepsia), vomiting
- feeling sticky and sweaty
- back pain, muscle cramps
- bladder spasms, blood in the urine, overactive bladder (need to urinate before the bladder is full), inability to urinate
- breast enlargement, impotence, testicular disorders (e.g. swollen, red or hot scrotum, pain or discomfort in the pelvic area)
- drowsiness (lethargy), pain, fever
- changes in blood tests, weight gain
Rare side effects (may affect up to 1 in 1,000 people)
- uncontrollable and involuntary body movements
- fainting, collapse
- flatulence and belching
- hair loss, pustules on the skin
- breast pain
Not known (frequency cannot be estimated from the available data)
- inflammation of the lungs (interstitial lung disease)
- idiopathic intracranial hypertension (increased intracranial pressure around the brain, characterized by headache, double vision and other vision disturbances, and ringing or buzzing in one or both ears).
The following serious allergic reactions have been reported with medicines belonging to the same group as CAMCEVI
- difficulty breathing or dizziness (rarely).
The following side effects have been reported with other medicines containing leuprorelin
- swelling of the hands and feet (oedema)
- symptoms of pulmonary embolism (a blood clot in the vessels leading to the lungs), including chest pain, shortness of breath, difficulty breathing, and coughing up blood
- significantly rapid, strong or irregular heartbeat
- muscle weakness
- chills
- skin rash
- memory changes
- vision disorders
- muscle atrophy/loss of muscle tissue after prolonged use
- a medical condition in which bones become brittle and fragile, called osteoporosis, and consequently an increased risk of bone fractures.
The following side effect has been reported with medicines belonging to the same group as CAMCEVI
- seizures.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 CAMCEVI
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp./EXP".
The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C).
Keep in the original packaging to protect the medicine from light.
Before using CAMCEVI, allow the medicine to reach room temperature (from 15 °C to 25 °C). This will take approximately 15–20 minutes.
Do not dispose of any medicine 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 CAMCEVI contains
- The active substance is leuprorelin. One pre-filled syringe with prolonged-release injectable suspension contains leuprorelin mesilate equivalent to 42 mg of leuprorelin.
- The other components are Poly(D,L-lactide) and N-methylpyrrolidone.
Description of the appearance of CAMCEVI and package contents
CAMCEVI is a prolonged-release injectable suspension. The pre-filled syringe contains a viscous, opalescent suspension, white to slightly yellow in colour.
CAMCEVI is available in a pack containing: 1 pre-filled syringe and 1 sterile safety needle.
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
Accord Healthcare Single Member S.A.
64 Km National Road Athens, Lamia, Schimatari, 32009, Greece
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 7488 821
More detailed information on this medicinal product is available on the European Medicines Agency website:
http://www.ema.europa.eu.
The following information is intended exclusively for healthcare professionals:
Before administering CAMCEVI, follow the instructions provided to ensure
correct preparation of the medicinal product.
Important: before using CAMCEVI, allow the medicinal product to reach room temperature
(between 15 °C and 25 °C). The use of gloves during administration is recommended.
CAMCEVI contains:
- a blister pack containing:
- A sterile, prefilled syringe and a sterile safety needle.
Assembled prefilled syringe:
Step 1 – Preparation of the medicinal product
 | Allow the medicine to reach room temperature and inspect its contents Remove CAMCEVI from the refrigerator. Before using CAMCEVI, allow the medicine to reach room temperature (between 15°C and 25°C). This will take approximately 15–20 minutes. On a clean, flat, dry surface, open the carton and remove the blister pack and the pouch. Remove the CAMCEVI pre-filled syringe (A) from the blister pack. Remove the safety needle (B) from the pouch. Examine all contents of the package. Do not use if any component is damaged. Check the expiration date printed on the syringe. Do not use if the expiration date has passed. Visually inspect the medicine before use. The pre-filled syringe should contain a viscous, opalescent suspension ranging in color from off-white to pale yellow. Do not use if foreign particles are present within the syringe barrel. |
Step 2 – Syringe assembly:
Insert the needle |
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Step 3 - Administration:
| Prepare the injection site Administer the drug   |
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Step 4 – Disposal of the needle and pre-filled syringe
Needle protection Activation with thumb Activation on a flat surface    |
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| Activation with thumb | Activation on a flat surface |
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