Package Insert: Information for the User

Decapeptyl Trimestral 11.25 mg Powder and Diluent for Long-Acting Suspension Injectable

Triptorelin

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the Package and Additional Information

This medication contains triptorelin. Triptorelin belongs to a group of medications called gonadotropin-releasing hormone (GnRH) analogs. One of its actions is to decrease the levels of sex hormones in the body.

Decapeptyl trimestral 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 or locally advanced prostate cancer located in the prostate, in combination with radiation therapy.

In children, starting from 2 years of age, Decapeptyl trimestral is used to treat precocious puberty that appears at a very young age, before 8 years in girls and 10 years in boys (central precocious puberty).

No use Decapeptyl trimestral:

• If you are allergic (hypersensitive) to triptorelin, gonadotropin-releasing hormone (GnRH), other GnRH analogs, or any of the other components of this medication (listed in section 6).

• If you are pregnant or breastfeeding.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Decapeptyl trimestral.

Cases of depression have been reported in patients treated with Decapeptyl trimestral, which can be severe. If you are being treated with Decapeptyl trimestral and experience depression, inform your doctor.

In adults, triptorelin can cause bones to be less dense (osteoporosis) with an increased risk of bone fractures. Therefore, inform your doctor if you have any of the following risk factors, as they may prescribe a bisphosphonate (a medication used to treat weak bones) to treat bone loss. The risk factors may include:

• If you or a close relative have less dense bones.
• If you drink excessive amounts of alcohol, and/or are a heavy smoker.
• If you have taken medications that can cause your bones to be less dense for a long time, for example, medications for epilepsy or steroids (such as hydrocortisone or prednisolone).

In case of seizures, inform your doctor immediately. Cases of seizures have been reported in patients receiving triptorelin or similar medications. These occurred in patients with or without a history of epilepsy.

If you have an unknown benign tumor of the pituitary gland, it may be discovered during treatment with Decapeptyl trimestral. Symptoms include headache, visual problems, and paralysis of the eyes.

If you are using medications to prevent blood clotting, as they may cause hematomas at the injection site.

If you have diabetes or heart problems, inform your doctor.

In men:

• Starting treatment will increase the amount of testosterone in your body, which may worsen cancer symptoms. Consult your doctor if this happens. Your doctor may give you a medication (an anti-androgen) to prevent symptoms from worsening.
• 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, lower limb weakness, or numbness, consult your doctor immediately.
• 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 testicles).
• Diagnostic tests for gonadal pituitary function or sex organs performed during treatment or after treatment interruption with Decapeptyl trimestral may be inaccurate.

• If you have any vascular or heart problems, including arrhythmia, or if you are being treated with medications for this condition, consult your doctor. The risk of arrhythmia may be increased when using Decapeptyl trimestral.
• Medications that decrease testosterone levels may cause changes in the ECG associated with cardiac rhythm anomalies (prolongation of QT).
• Treatment with GnRH analogs like Decapeptyl trimestral may increase the risk of anemia (defined as a decrease in red blood cell count).

In children:

Girls with precocious puberty may experience vaginal bleeding during the first month of treatment.

When treatment is interrupted, puberty signs appear.

Girls will start menstruating on average one year after treatment interruption.

Your doctor should rule out precocious puberty caused by other diseases.

The amount of minerals in bones decreases during treatment but returns to normal levels after treatment is stopped.

After treatment interruption, you may experience hip pathology (slipping of the femoral head epiphysis in the hip joint). This causes hip stiffness, limp, and/or intense pain in the groin that radiates to the thigh. If this occurs, consult your doctor.

If you have a progressive brain tumor, inform your doctor. This may affect how your doctor decides to treat you.

If your child experiences intense or recurrent headaches, visual problems, and/or ringing or buzzing in the ears, contact a doctor immediately (see section 4).

Consult your doctor if you are concerned about any of these topics.

Other medications and Decapeptyl trimestral:

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

For men:

Decapeptyl trimestral may interfere with some medications used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., methadone (used for pain relief and as part of drug detoxification), moxifloxacino (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy and lactation:

Decapeptyl trimestral should not be used during pregnancy or lactation.

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Driving and operating machinery:

You may feel dizzy, tired, or experience visual problems, such as blurred vision. These are possible side effects of treatment or due to the underlying disease. If you experience any of these side effects, you should not drive or operate machinery.

Decapeptyl trimestral contains sodium:

This medication contains sodium but less than 1 mmol of sodium (23 mg) per vial, which is "sodium-free."

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Decapeptyl Trimestral must be administered exclusively by intramuscular route. Your doctor or nurse will administer it. See the Use Instructions at the end of this leaflet.

For localized high-risk or locally advanced prostate cancer, in combination with radiation therapy, the recommended treatment duration is 2-3 years.

The dose will be established by the doctor according to the needs of each patient. The normal doses are as follows:

Prostate Cancer: A deep intramuscular injection of Decapeptyl Trimestral every three months.

Use in children

You will normally receive an injection every 3 months. Decapeptyl Trimestral is only for injection into the muscle. Your doctor will decide when to stop treatment (usually when you are 12 to 13 years old, in the case of girls, and 13-14 years old in boys).

If you feel that the action of Decapeptyl Trimestral is too strong or too weak, inform your doctor or pharmacist.

If you use more Decapeptyl Trimestral than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately.

If you forgot to use Decapeptyl Trimestral

As soon as you realize you have forgotten an injection, consult with your doctor and he will decide when to administer the next injection.

If you interrupt treatment with Decapeptyl Trimestral

Do not stop treatment with Decapeptyl Trimestral without first talking to your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side 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 unknown pituitary gland tumor, it may be discovered during treatment with Decapeptyl trimestral. Symptoms include sudden headache, vision problems, and eye paralysis.

Like other GnRH analogs, an increase in white blood cell count may occur in patients treated with Decapeptyl trimestral.

In men

Many of these side effects are expected due to the change in testosterone levels in your body. These side effects include hot flashes, impotence, and decreased libido.

Except for allergic reactions and injection site reactions, all side effects are related to changes in testosterone levels.

Side effects that are very frequent, may affect more than 1 in 10 patients:

• Hot flashes
• Weakness
• Excessive sweating
• Back pain
• Leg numbness and tingling
• Reduced libido
• Impotence

Side effects that are frequent, may affect 1 to 10 in 100 patients:

• Nausea, dry mouth
• Pain, bruising, redness, and swelling at the injection site, edema (fluid accumulation in body tissues),
• Muscle and bone pain, arm and leg pain
• Lower abdominal pain
• Allergic reaction
• Weight gain
• Dizziness, headache
• Reduced libido, depression, mood changes
• High blood pressure

Side effects that are infrequent, may affect 1 in 10 in 1000 patients:

• Increased platelet count
• Feeling heartbeats
• Ringing in the ears, dizziness,
• Blurred vision
• Abdominal pain, constipation, diarrhea, vomiting
• Drowsiness, intense shivering associated with sweating and somnolence, pain
• Certain analytical parameters affected (including increased liver function tests), increased blood pressure
• Weight loss
• Loss of appetite, increased appetite, gout (severe pain and swelling in joints, usually in the big toe), diabetes, high blood lipids
• Joint pain, muscle cramps, muscle weakness, muscle pain, swelling of the ankles, feet, or toes, bone pain
• Numbness or tingling
• Inability to sleep, irritability
• Waking up to urinate, difficulty urinating
• Development of breasts in men, chest pain, testicular shrinkage, testicular pain
• Difficulty breathing,
• Nosebleed
• Acne, hair loss, itching, rash, skin redness, urticaria

Side effects that are rare, may affect 1 to 10 in 10,000 patients:

• Red or purple discoloration of the skin
• Abnormal sensation in the eye, altered vision or blurred vision
• Abdominal fullness, flatulence, dry mouth, abnormal taste
• Chest pain
• Difficulty standing
• Flu-like symptoms, fever
• Severe allergic reaction that may cause dizziness or difficulty breathing, facial or throat swelling)
• Nasal or throat inflammation
• Increased body temperature
• Joint stiffness, joint swelling, muscle stiffness, osteoarthritis (joint alteration that affects cartilage and causes pain, swelling, and loss of movement)
• Memory loss
• Confusion, decreased activity, feeling of euphoria
• Difficulty breathing while lying down
• Blisters
• Low blood pressure

During post-marketing experience, the following side effects have also been reported:

• Severe allergic reaction that may cause facial, tongue, or neck swelling, difficulty breathing, or dizziness (Quincke's edema, anaphylactic shock)
• ECG changes (prolongation of QT)
• General discomfort
• Anxiety
• Rapid formation of papules due to skin or mucous membrane swelling,
• Urinary incontinence
• If there is a pituitary tumor, there is a higher risk of bleeding in the area
• Anemia (decreased red blood cell count)

Patients receiving long-term treatment with GnRH analogs in combination with radiation may experience more side effects, especially gastrointestinal, related to radiation.

In children

Frequent side effects (affect more than 1 in 10):

• Vaginal bleeding that may occur during the first month in girls

Frequent side effects (affect 1 in 10 in 1000 patients):

• Abdominal pain
• Painful, bruised, red, and swollen injection site
• Headache, hot flashes
• Weight gain
• Acne
• Allergic reaction

Infrequent side effects (affect 1 in 10 in 1000 patients):

• Blurred vision
• Vomiting, constipation, nausea
• General discomfort
• Overweight
• Neck pain, chest pain
• Mood changes
• Nosebleed
• Itching, rash, or urticaria on the skin

The long-term study (up to 4 years) did not provide any new significant safety problems.

During post-marketing experience, the following side effects have also been reported:

• Severe allergic reaction that may cause difficulty breathing or dizziness and facial, neck, or throat swelling (Quincke's edema, anaphylactic shock)
• Seizures
• High blood pressure
• Abnormal vision
• Affecting some blood tests, including hormone levels
• Muscle pain
• Mood changes, depression, nervousness.
• Idiopathic intracranial hypertension (increased intracranial pressure around the brain characterized by headache, double vision, and other visual symptoms, and tinnitus or ringing in the ears).

Your doctor will determine the measures to be taken to counteract them.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store Decapeptyl quarterly in its original packaging. Do not store at a temperature above 25°C.

Do not use Decapeptyl quarterly after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Decapeptyl Trimestral

The active ingredient is triptorelin (pamoate), 11.25 mg per vial.

The other components are:

• Dry powder:DL-lactide-co-glycolide polymer, mannitol, sodium carmellose, polisorbate 80
• Vehicle: mannitol and water for injection.

Appearance of the product and contents of the package

This medicine is a powder and solvent for injectable suspension, the powder is a lyophilized powder of a slightly yellowish color and the solvent for reconstitution of the suspension is a colorless transparent solution.

Package with 1 vial, 1 ampoule and 1 blister with 1 syringe and 2 needles for its reconstitution and administration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136

08038 Barcelona

Spain

Responsible for manufacturing:

IPSEN PHARMA-BIOTECH

Parc d'Activité du Plateau de Signes, C.D. 402,

83870 Signes

France

Last review date of thisleaflet:February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es
This information is intended solely for healthcare professionals:INSTRUCTIONS FOR RECONSTITUTION

TREATMENT TABLE

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