Decapeptyl Monthly 3.75 mg powder and solvent for prolonged-release injectable suspension
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Decapeptyl monthly is and what it is used for
- 2. What you need to know before using Decapeptyl monthly
- If you are using Decapeptyl monthly for adjuvant treatment of breast cancer:
- 3. How to use Decapeptyl monthly
- 4. Possible adverse effects
- 5. Storage of Decapeptyl monthly
- 6. Package contents and additional information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Decapeptyl monthly 3.75 mg powder and solvent for prolonged-release injectable suspension
Triptorelin
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet
-
What Decapeptyl monthly is and what it is used for.
-
What you need to know before using Decapeptyl monthly.
-
How to use Decapeptyl monthly.
-
Possible side effects.
-
How to store Decapeptyl monthly.
-
Contents of the pack and other information
1. What Decapeptyl monthly is and what it is used for
This medicine contains triptorelin. Triptorelin belongs to a group of medicines known as gonadotropin-releasing hormone (GnRH) analogues. One of its actions is to reduce the levels of sex hormones in the body.
Decapeptyl monthly is indicated in adults for the treatment of locally advanced hormone-dependent prostate cancer and hormone-dependent prostate cancer that has spread to other parts of the body (metastatic cancer). It is also used to treat high-risk localized or locally advanced prostate cancer, in combination with radiotherapy.
Decapeptyl monthly is also indicated in women for the treatment of endometriosis, uterine fibroids, female infertility, and early-stage hormone-sensitive breast cancer in premenopausal women who have received chemotherapy, and in children, for central precocious puberty.
In breast cancer, Decapeptyl monthly is used in combination with other hormonal medicines:
- A medicine called tamoxifen (this medicine will be prescribed if you have a high risk of recurrent cancer), or
- An "aromatase inhibitor" such as exemestane (Decapeptyl monthly will be prescribed for at least 6 to 8 weeks before you start taking this medicine).
Remember to read the package leaflet of the medicine you are taking together with Decapeptyl monthly.
2. What you need to know before using Decapeptyl monthly
Do not use Decapeptyl monthly:
-
if you are allergic (hypersensitive) to triptorelin, gonadotropin-releasing hormone (GnRH), other GnRH analogues, or any of the other components of this medicine (listed in section 6).
-
if you are pregnant or breastfeeding.
-
If you are taking Decapeptyl monthly for breast cancer, do not use an "aromatase inhibitor" (such as exemestane) until you have been treated with Decapeptyl monthly for at least 6 to 8 weeks.
Warnings and precautions:
Talk to your doctor or pharmacist before starting to use Decapeptyl monthly:
Cases of depression, which may be severe, have been reported in patients treated with Decapeptyl monthly. If you are being treated with Decapeptyl monthly and experience depression, inform your doctor. Your doctor may wish to monitor your depression during treatment.
In adults, triptorelin may cause bones to become less dense (osteoporosis), increasing the risk of bone fractures. Therefore, inform your doctor if you have any of the following risk factors, as they may prescribe a bisphosphonate (a medicine used to treat weak bones) to manage bone loss. Risk factors may include:
- if you or a close family member have low bone density.
- if you drink excessive amounts of alcohol, and/or are a heavy smoker.
If you have long-term taken medicines that may cause your bones to become less dense, for example, medicines for epilepsy or steroids (such as hydrocortisone or prednisolone).
In case of seizures, contact your doctor immediately. Cases of seizures have been reported in patients receiving triptorelin or similar medicines. These occurred in patients with or without a previous medical history of epilepsy.
If you have an undiagnosed enlargement (benign tumor) of the pituitary gland, this may be discovered during treatment with Decapeptyl monthly. Symptoms include headache, visual disturbances, and eye paralysis.
If you are taking medicines to prevent blood clotting, as bruising may occur at the injection site.
If you have diabetes or heart problems, inform your doctor.
Men
- At the beginning of treatment, the amount of testosterone in your body will increase, which may worsen cancer symptoms. Consult your doctor if this occurs. Your doctor may give you a medicine (an antiandrogen) to prevent worsening of symptoms.
- If you have urinary obstruction or spinal cord compression (nerves in your spinal column) due to cancer spread, your doctor will closely monitor you during the first weeks of treatment. If you experience difficulty urinating, bone pain, weakness in the lower limbs, or tingling sensations, consult your doctor immediately for proper evaluation and treatment.
- After surgical castration, triptorelin does not induce any additional decrease in serum testosterone levels and therefore should not be used after orchiectomy (surgical removal of the testicles).
- Diagnostic tests of pituitary gonadal function or genital organs performed during or after discontinuation of Decapeptyl monthly treatment may yield inaccurate results.
- If you have any blood vessel or heart problems, including heart rhythm disorders (arrhythmias), or if you are being treated with medicines for such conditions, consult your doctor. The risk of heart rhythm problems may be increased with Decapeptyl monthly.
- Medicines that reduce testosterone levels may cause changes in the ECG associated with heart rhythm abnormalities (QT prolongation).
- Treatment with GnRH analogues such as Decapeptyl monthly may increase the risk of anemia (defined as a decrease in red blood cell count).
Women
Due to lack of clinical experience in women under 18 years of age, the use of triptorelin is not recommended in adolescents and young women, as it may cause a decrease in bone density.
During the first month of treatment, you may experience some vaginal bleeding. After this, your menstruation will stop. Inform your doctor if you continue to bleed after the first month. Approximately 2 months after the last injection, your menstruation will return. You should use a contraceptive method other than the pill during the first month of treatment and, subsequently, after the last injection, whenever the treatment is not for infertility.
If you are a woman with submucosal fibroids (benign tumors in the muscle beneath the lining of the uterus), triptorelin may cause bleeding when fibroids degenerate within the first 6–10 weeks after starting treatment. Contact your doctor immediately if you experience bleeding or severe or unusual pain.
During infertility treatment, gonadotropins (hormones that stimulate the ovaries) combined with this medicine may cause an increase in ovarian size or ovarian hyperstimulation, which may lead to pelvic and/or abdominal pain and breathing difficulties. If this occurs, consult your doctor immediately.
If you are using Decapeptyl monthly for adjuvant treatment of breast cancer:
- If you have any bone-related conditions, such as osteoporosis, inform your doctor. This may affect how your doctor decides to treat you. Your doctor will perform a bone scan before starting treatment if you are at risk of osteoporosis and will monitor you during treatment.
- If you have diabetes or high blood pressure, inform your doctor. Your doctor will monitor your blood sugar levels and blood pressure during treatment.
- If you suffer from depression, inform your doctor. Your doctor may wish to monitor your depression during treatment.
- If you interrupt treatment with triptorelin, you must also interrupt treatment with the aromatase inhibitor (such as exemestane) at the same time.
Children
Girls with precocious puberty may experience some vaginal bleeding during the first month of treatment.
If you have a progressive brain tumor, inform your doctor. This may change how your doctor decides to treat you.
Your doctor must rule out precocious puberty caused by other diseases.
Bone mineral content decreases during treatment but returns to normal levels after stopping treatment.
After discontinuation of treatment, a hip disorder (slipped capital femoral epiphysis of the hip) may occur. This causes hip stiffness, limping, and/or severe groin pain radiating to the thigh. If this occurs, you should consult your doctor.
If your child experiences severe or recurrent headaches, vision problems, or tinnitus (ringing or buzzing in the ears), contact a doctor immediately (see section 4).
Talk to your doctor if you are concerned about any of these issues.
Other medicines and Decapeptyl monthly
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
For men
Decapeptyl monthly may interfere with certain medications used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used together with other medicines (e.g. methadone (used for pain relief and in drug detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Pregnancy and breastfeeding
Decapeptyl monthly must not be used during pregnancy or breastfeeding.
Do not use Decapeptyl if you are trying to become pregnant (unless Decapeptyl is part of a fertility treatment).
Driving and use of machines
You may feel dizzy, tired, or have visual disturbances such as blurred vision. These are possible adverse effects of the treatment or due to the underlying disease. If you experience any of these adverse effects, you must not drive or operate machinery.
Decapeptyl monthly 3.75 mg contains sodium
This medicine contains sodium, but less than 1 mmol (23 mg) of sodium per vial; therefore, it is essentially “sodium-free”.
3. How to use Decapeptyl monthly
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Decapeptyl monthly must be administered exclusively by intramuscular route. Your doctor or nurse will administer it to you. See the instructions for use at the end of this leaflet.
For localized high-risk or locally advanced prostate cancer, in combination with radiotherapy, the recommended duration of treatment is 2–3 years.
The dose will be determined by your doctor according to each patient's individual needs. The usual doses are as follows:
Prostate cancer: One deep intramuscular injection of Decapeptyl monthly every four weeks.
Endometriosis: Treatment should be started during the first five days of the cycle. One deep intramuscular injection of Decapeptyl monthly every four weeks.
The duration of treatment depends on the initial severity of endometriosis and on the evolution of its clinical manifestations (functional and anatomical) during treatment. In principle, treatment duration should be four to six months. A second course of treatment with Decapeptyl monthly or with another medicine of the same group is not recommended.
Uterine fibroids: Treatment should be started during the first five days of the cycle. The recommended dose is one deep intramuscular injection every four weeks. The duration of treatment depends on the evolution of fibroid volume, as determined by ultrasound. In principle, fibroids should be treated for no more than six months (see adverse reactions). A second course of treatment with Decapeptyl monthly or with another medicine of the same group is not recommended.
Female infertility: One deep intramuscular injection of Decapeptyl monthly administered on the second day of the cycle. In general, stimulation with this medicine should be performed when plasma estrogen levels are below 50 pg/ml (usually around day 15 of the cycle).
Breast cancer
The recommended dose of Decapeptyl monthly is one intramuscular injection every 4 weeks (28 days). Treatment may last up to 5 years.
Decapeptyl monthly is used together with a medicine called tamoxifen or an "aromatase inhibitor", such as exemestane. If you need to take an "aromatase inhibitor", you should be treated with Decapeptyl monthly for at least 6 to 8 weeks before starting the aromatase inhibitor.
Central precocious puberty:
In children: the dose is adjusted according to body weight.
Children weighing more than 30 kg: one intramuscular injection every 4 weeks (28 days).
Children weighing between 20 and 30 kg: two-thirds of the dose by intramuscular route every 4 weeks (28 days), i.e., administer two-thirds of the volume of the reconstituted suspension.
Children weighing less than 20 kg: half of a dose by intramuscular route every 4 weeks (28 days), i.e., administer half of the volume of the reconstituted suspension.
If you use more Decapeptyl monthly than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately.
If you forget to use Decapeptyl monthly
As soon as you realize you have missed an injection, consult your doctor, and he or she will decide when your next injection should be administered.
If you stop treatment with Decapeptyl monthly
Do not stop treatment with Decapeptyl monthly without first talking to your doctor. This is especially important if you are using Decapeptyl monthly together with an aromatase inhibitor. This is because stopping treatment may cause an increase in estrogen levels. Your doctor will monitor your estrogen levels during treatment with Decapeptyl monthly.
If you stop treatment with Decapeptyl monthly, you should also stop treatment with the aromatase inhibitor within one month of stopping Decapeptyl monthly treatment.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In rare cases, you may experience a severe allergic reaction (angioedema, anaphylactic reaction). Inform your doctor immediately if you develop symptoms such as difficulty swallowing or breathing, dizziness, swelling of the lips, face, throat or tongue, or a rash.
If you have an undiagnosed benign enlargement (tumour) of the pituitary gland, it may be discovered during treatment with Decapeptyl monthly. Symptoms include sudden headache, vision problems and eye paralysis.
As with other GnRH analogues, an increase in white blood cell count may occur in patients treated with Decapeptyl monthly.
Men
Many of these adverse effects are expected due to changes in testosterone levels in the body. These effects include hot flushes, impotence and decreased libido.
Very common adverse effects – may affect more than 1 in 10 patients:
- Hot flushes
- Weakness
- Excessive sweating
- Back pain
- Tingling and numbness in the legs
- Reduced libido
- Impotence
Common adverse effects – may affect 1 to 10 in every 100 patients:
- Nausea, dry mouth
- Pain, bruising, redness and swelling at the injection site, muscle and bone pain, pain in arms and legs, oedema (fluid accumulation in body tissues), lower abdominal pain
- Allergic reaction
- Weight gain
- Dizziness, headache
- Loss of libido, depression, mood changes
- High blood pressure
Uncommon adverse effects – may affect 1 to 10 in every 1,000 patients:
- Increased platelet count
- Awareness of heartbeat (palpitations)
- Ringing in the ears, dizziness
- Blurred vision
- Abdominal pain, constipation, diarrhoea, vomiting
- Drowsiness, intense shivering associated with sweating and fever, pain
- Certain blood test parameters affected (including increased liver function tests), increased blood pressure
- Weight loss
- Loss of appetite, increased appetite, gout (severe pain and swelling of joints, usually in the big toe), diabetes, excess lipids in the blood
- Joint pain, muscle cramps, muscle weakness, muscle pain, swelling of ankles, feet or fingers, bone pain
- Tingling or numbness
- Insomnia, feeling irritable
- Waking up to urinate, difficulty urinating
- Breast development in men, breast pain, reduction in testicular size, testicular pain
- Difficulty breathing
- Nosebleeds
- Acne, hair loss, itching, rash, redness of the skin, urticaria
Rare adverse effects – may affect 1 to 10 in every 10,000 patients:
- Red or purple skin discolouration
- Abnormal sensation in the eye, visual disturbance or blurred vision
- Feeling of fullness in the abdomen, flatulence, altered taste sensation
- Chest pain
- Difficulty standing
- Flu-like symptoms, fever
- Severe allergic reaction that may cause dizziness or difficulty breathing, swelling of the face or throat (angioedema, anaphylactic shock)
- Inflammation of the nose/throat
- Increased body temperature
- Joint stiffness, joint swelling, musculoskeletal stiffness, osteoarthritis (joint disorder affecting cartilage, causing pain, swelling and loss of movement)
- Memory loss
- Feeling confused, decreased activity, feeling of euphoria
- Difficulty breathing when lying down
- Blisters
- Low blood pressure
During post-marketing surveillance, the following adverse effects have also been reported:
- Severe allergic reaction that may cause swelling of the face, tongue and neck, difficulty breathing or dizziness (Quincke's oedema, anaphylactic shock)
- Changes in ECG (QT prolongation)
- General malaise
- Anxiety
- Rapid formation of skin or mucosal swellings (wheals) due to swelling
- Urinary incontinence
- If a pituitary tumour is present, there is an increased risk of bleeding in the area
- Anaemia (reduced red blood cell count)
Patients receiving long-term treatment with GnRH analogues in combination with radiation may experience additional adverse effects, particularly gastrointestinal effects related to radiotherapy.
Women:
Many of the adverse effects are expected due to changes in oestrogen levels in the body.
Very common adverse effects (affect more than 1 in 10 patients):
- Mood changes, difficulty sleeping
- Headache
- Decreased libido
- Hot flushes
- Excessive sweating, acne, oily skin
- Breast disorders
- Pain during or after sexual intercourse, painful menstruation, genital bleeding
- Ovarian hyperstimulation syndrome (with enlarged ovaries and fluid retention)
- Pelvic pain, enlarged ovaries
- Vaginal dryness
- Weakness
Common adverse effects (affect 1 to 10 in every 100 patients):
- Allergic reaction
- Depression (with long-term treatment), nervousness
- Dizziness
- Weight gain, nausea, abdominal pain or discomfort
- Breast pain
- Muscle cramps, painful joints
- Pain in arms and legs
- Injection site reaction (including pain, swelling, redness and inflammation)
- Swelling of ankles, feet and fingers
Uncommon adverse effects (affect 1 to 10 in every 1,000 patients):
- Weight loss, decreased appetite
- Fluid retention
- Mood changes, anxiety, disorientation, depression (with short-term treatment)
- Altered taste
- Loss of sensation
- Temporary loss of consciousness, memory loss, difficulty concentrating
- Tingling or numbness, involuntary muscle movements
- Dry eyes, blurred vision
- Dizziness
- Awareness of heartbeat (palpitations)
- Difficulty breathing, nosebleeds
- Abdominal bloating, vomiting, dry mouth, flatulence, mouth ulcers
- Hair loss, excessive body hair
- Dry skin, brittle nails, itching, skin rash
- Back pain, muscle pain
- Bleeding after sexual intercourse, prolapse, irregular menstruation, painful and heavy periods
- Small ovarian cysts (inflammation) which may cause pain, vaginal discharge
During post-marketing experience, the following adverse effects have also been reported:
- Severe allergic reaction that may cause swelling of the face, tongue and neck, difficulty breathing or dizziness (Quincke's oedema, anaphylactic shock)
- Seizures
- Confusion, abnormal sensations in the eyes and/or visual changes
- Urticaria (rapid formation of wheals due to skin or mucosal inflammation)
- Muscle weakness
- Absence of menstrual periods
- Fever and general malaise
- Abnormal blood test results (including elevated liver function tests)
- Diarrhoea
- Increased blood pressure
- If a pre-existing pituitary tumour is present, there is an increased risk of bleeding in the area.
During infertility treatment, gonadotrophins combined with this product may cause an increase in ovarian size or ovarian hyperstimulation, which may lead to pelvic and/or abdominal pain or difficulty breathing. If this occurs, consult your doctor immediately.
In the treatment of endometriosis, the conditions being treated (pelvic pain, dysmenorrhoea) may worsen at the beginning of treatment, but should resolve within one or two weeks. This may occur even if the treatment is producing a beneficial effect. However, you should inform your doctor immediately about this phenomenon.
Adverse effects when used for breast cancer in combination with tamoxifen or an aromatase inhibitor:
The following adverse effects have been observed when triptorelin is used for breast cancer in combination with tamoxifen or an aromatase inhibitor.
Very common adverse effects (affect more than 1 in 10 patients):
- Nausea
- Feeling very tired
- Joint and muscle pain, osteoporosis
- Hot flushes
- Excessive sweating
- Difficulty sleeping, depression
- Decreased libido, vaginal dryness, pain during or after sexual intercourse
- Urinary incontinence
- Increased blood pressure
Common adverse effects (affect 1 to 10 in every 100 patients):
- Diabetes, elevated blood sugar (hyperglycaemia)
- Pain, bruising
- Redness and inflammation at the injection site
- Allergic reaction
- Bone fractures
- Blood clot formation in a blood vessel
Uncommon adverse effects (affect 1 in every 1,000 patients):
- Bleeding in the brain
- Lack of blood supply to the brain or heart
Rare adverse effects (affect 1 to 10 in every 10,000 patients):
- Changes in ECG (QT prolongation)
Children
Very common adverse effects (affect more than 1 in 10 patients):
- Vaginal bleeding, which may occur during the first month in girls.
Common adverse effects (affect 1 to 10 in every 100 patients):
- Abdominal pain
- Painful bruising
- Redness and inflammation at the injection site
- Headache, hot flushes
- Weight gain
- Acne
- Allergic reaction
Uncommon adverse effects (affect 1 in every 1,000 patients):
- Blurred vision
- Vomiting, constipation, nausea
- General malaise
- Overweight
- Neck pain, chest pain
- Mood changes
- Nosebleeds
- Itching, skin rash or urticaria
During post-marketing experience, the following adverse effects have also been reported:
- Severe allergic reaction that may cause difficulty breathing or dizziness and swelling of the face, neck or throat (Quincke's oedema, anaphylactic shock)
- Seizures
- Elevated blood pressure
- Abnormal vision
- Abnormal blood test results, including hormonal levels
- Muscle pain
- Mood changes, depression, nervousness
- Idiopathic intracranial hypertension (increased intracranial pressure around the brain, characterised by headache, double vision and other visual symptoms, and ringing or buzzing in the ears).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Decapeptyl monthly
Keep this medicine out of the sight and reach of children.
Store Decapeptyl monthly in its original packaging. Do not store above 25°C.
Do not use Decapeptyl monthly after the expiry date indicated on the packaging after EXP. The expiry date is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Package contents and additional information
Composition of Decapeptyl monthly
- The active substance is triptorelin (acetate), 3.75 mg per vial.
The other components are:
- Powder: DL-lactide-co-glycolide polymer, mannitol, sodium carmellose, polysorbate 80
- Solvent: mannitol and water for injections.
Appearance of the medicinal product and contents of the container
This medicine is a powder and solvent for injectable suspension. The powder is a white to off-white lyophilized powder and the solvent for reconstitution of the suspension is a clear, colourless solution.
Pack: 1 vial, 1 ampoule, and 1 blister containing 1 syringe and 2 needles for reconstitution and administration.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
IPSEN PHARMA, S.A.U.
Gran Via de les Corts Catalanes 130-136
08038 Barcelona
Spain
Manufacturer:
IPSEN PHARMA-BIOTECH
Parc d'Activité du Plateau de Signes, C.D. 402,
83870 Signes
France
Date of the most recent review of this leaflet: February 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es
This information is intended exclusively for healthcare professionals:
INSTRUCTIONS FOR RECONSTITUTION
1 – PATIENT PREPARATION BEFORE RECONSTITUTION | |
Prepare the patient by disinfecting the injection site in the gluteal muscle. This procedure must be performed first, as the product must be injected immediately once reconstituted. | |
2 – INJECTION PREPARATION | |
The package contains two needles:
| |
The presence of bubbles at the top of the lyophilized product is part of its normal appearance. The following steps must be completed in a continuous sequence. | |
2a
|
|
2b
|
|
2c
|
|
2d
|
|
3 – INTRAMUSCULAR INJECTION | |
|
|
4 – AFTER USE | |
There are two alternative methods to activate the safety system.
Used needles, any unused suspension, and other residual materials must be disposed of in accordance with local regulations. |
Method A
Method B
|
Any incident causing a significant loss of the product to be injected must be reported to the doctor, who will determine whether it is necessary to repeat the injection within a shorter time interval.
|
TREATMENT TABLE
LAST NAME
FIRST NAME
Request Date | Injection Date | |
Injection 1 | ||
Injection 2 | ||
Injection 3 | ||
Injection 4 | ||
Injection 5 | ||
Injection 6 |









