Decapeptyl Trimestral 11.25 mg powder and solvent for prolonged-release injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Decapeptyl 3-monthly 11.25 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Decapeptyl 3-monthly is and what it is used for.
2. What you need to know before using Decapeptyl 3-monthly.
3. How to use Decapeptyl 3-monthly.
4. Possible side effects.
5. How to store Decapeptyl 3-monthly.

Contents of the pack and other information

1. What Decapeptyl Trimestral 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 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 localized prostate cancer in combination with radiotherapy.

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

2. What you need to know before using Decapeptyl trimestral

Do not use Decapeptyl trimestral:

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

• If you are pregnant or breastfeeding.

Warnings and precautions:

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

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

In adults, triptorelin may cause reduced bone density (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 has reduced bone density.
• If you consume excessive amounts of alcohol and/or are a heavy smoker.
• If you have taken for a long time medications that may reduce bone density, such as antiepileptic drugs or steroids (e.g., hydrocortisone or prednisolone).

If you experience seizures, inform your doctor immediately. Seizures have been reported in patients receiving triptorelin or similar medicines. These occurred in patients with or without a history of epilepsy.

If you have an undiagnosed enlargement (benign tumor) of the pituitary gland, it may be discovered during treatment with Decapeptyl trimestral. Symptoms include headache, visual disturbances, and eye paralysis.

If you are taking medications to prevent blood clotting, bruising at the injection site may occur.

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

In men:

• At the beginning of treatment, testosterone levels will increase, which may worsen cancer symptoms. Consult your doctor if this occurs. Your doctor may prescribe an antiandrogen to prevent worsening of symptoms.
• If you have urinary obstruction or spinal cord compression (nerves of 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 evaluation and appropriate treatment.
• After surgical castration, triptorelin does not cause any further reduction in serum testosterone levels and therefore should not be used after orchiectomy (surgical removal of the testes).
• Diagnostic tests of pituitary gonadal function or genital organs performed during or after discontinuation of Decapeptyl trimestral 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 medications for such conditions, consult your doctor. The risk of heart rhythm problems may increase when using Decapeptyl trimestral.
• Medications that reduce testosterone levels may cause ECG changes associated with heart rhythm abnormalities (QT prolongation).
• Treatment with GnRH analogues such as 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 some vaginal bleeding during the first month of treatment.

When treatment is stopped, signs of puberty reappear.

In girls, menstrual bleeding typically resumes on average one year after stopping treatment.

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

Bone mineral content decreases during treatment but returns to normal levels after treatment is discontinued.

After stopping treatment, a hip disorder (slipped capital femoral epiphysis) may occur. This causes hip stiffness, limping, and/or severe groin pain radiating to the thigh. If this occurs, consult your doctor.

If you have a progressive brain tumor, inform your doctor, as this may affect your treatment plan.

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

Talk to your doctor if you have concerns about any of these issues.

Other medicines and Decapeptyl trimestral

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

For men:

Decapeptyl trimestral 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 with other medicines (e.g., methadone (used for pain relief and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

Pregnancy and breastfeeding

Decapeptyl trimestral must not be used during pregnancy or breastfeeding.

Driving and using 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 trimestral contains sodium

This medicine contains sodium but less than 1 mmol of sodium (23 mg) per vial, i.e., “sodium-free”.

3. How to use Decapeptyl Trimestral

Follow exactly your doctor's instructions for administering this medicine. If in doubt, consult your doctor or pharmacist again.

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

For high-risk or locally advanced localized prostate cancer, in combination with radiotherapy, the recommended treatment duration 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 Trimestral every three months.

Use in children

You will normally receive an injection every 3 months. Decapeptyl Trimestral is for intramuscular injection only. Your doctor will decide when treatment should be discontinued (normally when aged 12–13 years for girls and 13–14 years for boys).

If you feel that the effect 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, contact your doctor or pharmacist immediately.

If you forget to use Decapeptyl Trimestral

As soon as you realize you have missed an injection, consult your doctor, who will decide when your next injection should be administered.

If you stop using Decapeptyl Trimestral

Do not stop treatment with Decapeptyl Trimestral without first discussing it with your doctor.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 (tumor) of the pituitary gland, it may be discovered during treatment with Decapeptyl trimestral. 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 trimestral.

In 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.

With the exception of immunological allergic reactions and injection site reactions, all adverse effects are related to changes in testosterone levels.

Very common adverse effects (may affect more than 1 in 10 patients):

• Hot flushes
• Weakness
• Excessive sweating
• Back pain
• Tingling and numbness sensation in the legs
• Reduced libido
• Impotence

Common adverse effects (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, pain in arms and legs
• Lower abdominal pain
• Allergic reaction
• Weight gain
• Dizziness, headache
• Loss of libido, depression, mood changes
• High blood pressure

Uncommon adverse effects (may affect 1 in 1,000 patients):

• Increased platelet count
• Awareness of heartbeat (palpitations)
• Tinnitus, dizziness
• Blurred vision
• Abdominal pain, constipation, diarrhea, vomiting
• Lethargy, severe chills associated with sweating and fever, somnolence, pain
• Changes in certain laboratory parameters (including elevated 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, elevated blood lipids
• Joint pain, muscle cramps, muscle weakness, muscle pain, swelling of ankles, feet, or fingers, bone pain
• Tingling or numbness
• Insomnia, irritability
• Waking up to urinate, urinary problems
• Breast development in men, breast pain, testicular shrinkage, testicular pain
• Difficulty breathing
• Nosebleeds
• Acne, hair loss, itching, rash, skin redness, urticaria

Rare adverse effects (may affect 1 to 10 in 10,000 patients):

• Red or purple skin discoloration
• Abnormal sensation in the eye, visual disturbances, or blurred vision
• Feeling of fullness in the abdomen, flatulence, dry mouth, altered taste sensation
• Chest pain
• Difficulty standing
• Influenza-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, sensation of euphoria
• Difficulty breathing when lying down
• Blisters
• Low blood pressure

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 edema, anaphylactic shock)
• Changes in ECG (QT prolongation)
• General malaise
• Anxiety
• Rapid formation of papules due to swelling of the skin or mucous membranes
• Urinary incontinence
• If a pituitary tumor is present, there is an increased risk of bleeding in the area
• Anemia (reduced red blood cell count)

Patients receiving long-term treatment with GnRH analogues in combination with radiation may experience additional adverse effects, particularly gastrointestinal, related to radiotherapy.

In children

Very common adverse effects (affect more than 1 in 10):

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

Common adverse effects (affect 1 in 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 1,000 patients):

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

Long-term studies (up to 4 years) did not reveal any new significant safety concerns.

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 edema, anaphylactic shock)
• Seizures
• Elevated blood pressure
• Abnormal vision
• Alterations in certain 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 ringing or buzzing in the ears)

Your doctor will determine the necessary measures to counteract these effects.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Trimestral

Keep this medicine out of sight and reach of children.

Store Decapeptyl Trimestral in its original packaging. Do not store above 25°C.

Do not use Decapeptyl Trimestral after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Decapeptyl trimestral

The active substance is triptorelin (pamoate), 11.25 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 pack

This medicine is a powder and solvent for injectable suspension. The powder is a slightly yellowish lyophilized powder, and the solvent for reconstitution of the suspension is a clear, colourless solution.

Pack containing 1 vial, 1 ampoule, and 1 blister with 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This information is intended exclusively for healthcare professionals:

INSTRUCTIONS FOR RECONSTITUTION

TREATMENT TABLE

LAST NAME

FIRST NAME