Package Insert: Information for the User

Decapeptyl Monthly 3.75 mg Powder and Diluent for Long-Acting Suspension Injectable

Triptorelin

Read this entire 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 refer to 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.

6. Contents of the pack and additional information

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

Decapeptyl monthly is indicated in adultsfor the treatment of hormone-dependent locally advanced prostate cancer and hormone-dependent prostate cancer that has spread to other parts of the body (metastatic cancer). It is also used to treat localized high-risk or locally advanced prostate cancer, in combination with radiation therapy.

Decapeptyl monthly is also indicated in women for the treatment ofendometriosis, uterine fibroids, female infertility, andearly-stage hormone-sensitive breast cancer in premenopausal women who have received chemotherapyand in children, for central precocious puberty.

In breast cancer, Decapeptyl monthly is used in combination with other hormonal medications:

Remember to read the prospectus of the medication you are taking along with Decapeptyl monthly.

No use Decapeptyl mensual:

• 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.

• if you are taking Decapeptyl mensual for breast cancer, do not use an aromatase inhibitor (such as exemestane) until you have been treated with Decapeptyl mensual for at least 6 to 8 weeks.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Decapeptyl mensual:

Cases of depression have been reported in patients treated with Decapeptyl mensual, which can be severe. If you are being treated with Decapeptyl mensual and experience depression, inform your doctor.Your doctor may want to monitor your depression during treatment.

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 your doctor may prescribe a bisphosphonate (a medicine 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 medicines that can cause your bones to be less dense for a long time, for example, medicines for epilepsy or steroids (such as hydrocortisone or prednisolone).

If you experience seizures, inform your doctor immediately. Cases of 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 unknown pituitary gland tumor (benign), this may be discovered during treatment with Decapeptyl mensual. Symptoms include headaches, visual problems, and eye paralysis.

If you are taking medicines to prevent blood clotting, as you may experience bleeding at the injection site.

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

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 medicine (an anti-androgen) to prevent symptoms from worsening.
• If you have urinary obstruction or spinal cord compression (nerves in your spine) 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, who will evaluate and treat you appropriately.
• 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 pituitary gland function or sex organs performed during treatment or after stopping treatment with Decapeptyl mensual may be inaccurate.
• If you have vascular or heart problems, including arrhythmia, or are being treated with medicines for this condition, consult your doctor. The risk of arrhythmia may be increased with Decapeptyl mensual.
• Medicines that decrease testosterone may cause changes in the ECG associated with cardiac rhythm anomalies (prolongation of QT).
• Treatment with GnRH analogues like Decapeptyl mensual may increase the risk of anemia (defined as a decrease in red blood cell count).

Women:

Due to the lack of clinical experience in women under 18, triptorelina is not recommended for use in adolescents and young women, as it may cause a decrease in bone density.

You may experience some vaginal bleeding during the first month of treatment. After that, your menstruation will stop. Inform your doctor if you continue to experience bleeding after the first month. After the last injection, you will start menstruating again in approximately 2 months. You should use a non-oral contraceptive method during the first month of treatment and, subsequently, after the last injection, unless the treatment is for infertility.

If you are a woman with submucosal fibroids (benign tumors in the muscle under the uterine lining), triptorelina may cause bleeding when the fibroids rupture within the first 6-10 weeks after starting treatment. Contact your doctor immediately if you experience bleeding or intense or unusual pain.

During infertility treatment, gonadotropins (hormones that stimulate the ovaries) combined with the medicine may cause an increase in ovarian size or hyperstimulation, which may cause pelvic and/or abdominal pain and breathing difficulties. If this occurs, consult your doctor immediately.

If you are using Decapeptyl mensual for adjuvant treatment of breast cancer:

• If you have any bone problems, 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 have a 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 experience depression, inform your doctor. Your doctor may want to monitor your depression during treatment.
• If you interrupt treatment with triptorelina, you must also interrupt treatment with the aromatase inhibitor (such as exemestane).

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 should rule out precocious puberty caused by other diseases.

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

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

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 medicines and Decapeptyl mensual:

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

For men:

Decapeptyl mensual may interfere with some medicines 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 medicines (e.g., methadone (used for pain relief and as part of drug detoxification), moxifloxacine (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy and lactation:

Decapeptyl mensual should not be used during pregnancy or lactation.

Do not use Decapeptyl if you are trying to become pregnant (unless Decapeptyl is part of a treatment for infertility).

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 mensual 3.75 mg contains sodium:

This medicine contains sodium, but less than 1 mmol (23 mg) of sodium per vial; it is essentially "sodium-free".

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

Decapeptyl monthly should be administered exclusively by intramuscular route. Your doctor or nurse will administer it to you. See the usage instructions at the end of this prospectus.

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 monthly every four weeks.

Endometriosis: Treatment should start during the first five days of the cycle. A deep intramuscular injection of Decapeptyl monthly every four weeks.

The duration of treatment depends on the initial severity of endometriosis and the evolution of its clinical manifestations (functional and anatomical) during treatment. In principle, the treatment duration should be four to six months. It is not recommended to have a second treatment with Decapeptyl monthly or with another medication in the same group.

Uterine fibroids: Treatment should start during the first five days of the cycle. The recommended dose is a deep intramuscular injection every four weeks. The duration of treatment depends on the evolution of the volume of the fibroids, determined by ultrasound. In principle, fibroids should be treated for no more than six months (see adverse reactions). It is not recommended to have a second treatment with Decapeptyl monthly or with another medication in the same group.

Female infertility: A deep intramuscular injection of Decapeptyl monthly administered on the second day of the cycle. In general, stimulation with this medication should be performed when plasma estradiol levels are less than 50 pg/ml (usually around day 15 of the cycle).

Breast cancer

The recommended dose of Decapeptyl monthly is a deep intramuscular injection every 4 weeks (28 days). Treatment may last up to 5 years.

Decapeptyl monthly is used in combination with a medication 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 to take it.

Central precocious puberty:

In children: the dose is adjusted according to body weight.

Children over 30 kg in weight: a deep intramuscular injection every 4 weeks (28 days).

Children between 20 and 30 kg in weight: two-thirds of the dose by intramuscular injection every 4 weeks (28 days), i.e., administer two-thirds of the volume of the reconstituted suspension.

Children under 20 kg in body weight: half a dose by intramuscular injection, every 4 weeks (28 days), i.e., administer half 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 forgot to use Decapeptyl monthly

As soon as you realize you have forgotten a dose, consult with your doctor and he will decide when you should administer the next dose.

If you interrupt treatment withDecapeptyl monthly

Do not interrupt treatment with Decapeptyl monthly without talking to your doctor first. This is especially important if you are using Decapeptyl monthly in combination with an aromatase inhibitor. This is because interrupting treatment may cause an increase in estrogen levels. Your doctor will monitor your estrogen levels during your treatment with Decapeptyl monthly.

If you interrupt treatment with Decapeptyl monthly, you should also interrupt treatment with the aromatase inhibitor, within 1 month of interrupting treatment.

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 enlargement (benign tumor), it may be discovered during treatment with Decapeptyl monthly. 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 monthly.

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.

Side effectsvery common, may affect more than 1 in 10 patients:

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

Side effectscommon, may affect 1 to 10 in 100 patients:

• Nausea, dry mouth
• Pain, bruising, redness, and swelling at the injection site, muscle and bone pain, arm and leg pain, edema (concentration of fluids in the body tissues), lower abdominal pain
• Allergic reaction
• Weight gain
• Dizziness, headache
• Decreased libido, depression, mood changes
• High blood pressure

Side effectsuncommon, may affect 1 to 10 in 1000 patients:

• Increased platelet count
• Feeling heartbeats
• Tinnitus, vertigo,
• Blurred vision
• Abdominal pain, constipation, diarrhea, vomiting
• Modorra, 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 the 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, urinary problems
• Development of breasts in men, chest pain, testicular shrinkage, testicular pain
• Difficulty breathing
• Nasal bleeding
• Acne, hair loss, itching, rash, skin redness, urticaria

Side effectsrare, may affect 1 to 10 in 10,000 patients:

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

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

• Severe allergic reaction that may cause facial, tongue, and neck inflammation, difficulty breathing, or dizziness (Quincke's edema, anaphylactic shock),
• ECG changes (prolongation of QT),
• General discomfort,
• Anxiety
• Rapid formation of papules caused by skin or mucous membrane swelling,
• 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.

Women

Many of the side effects are expected due to the change in estrogen levels in the body.

Side effectsvery common, may affect more than 1 in 10 patients:

• Mood changes, difficulty sleeping,
• Headache,
• Decreased libido,
• Hot flashes,
• Excessive sweating, acne, oily skin,
• Chest changes,
• Pain during or after sex, painful menstruation, genital bleeding,
• Ovarian hyperstimulation syndrome (with increased ovary size and fluid retention),
• Pelvic pain, enlarged ovaries
• Vaginal dryness,
• Weakness

Side effectscommon, may affect 1 to 10 in 100 patients:

• Allergic reaction,
• Depression (long-term treatment), nervousness,
• Dizziness,
• Weight gain, nausea, abdominal pain,
• Chest pain,
• Muscle cramps, joint pain,
• Pain in the arms and legs,
• Reaction at the injection site (including pain, swelling, redness, and inflammation)
• Inflammation of the ankles, feet, and toes.

Side effectsuncommon(affect 1 to 10 in 1000 patients):

• Weight loss, loss of appetite,
• Fluid retention,
• Mood changes, anxiety, disorientation, depression (short-term treatment)
• Abnormal taste,
• Numbness or tingling,
• Temporary loss of consciousness, memory loss, lack of concentration,
• Numbness or tingling, involuntary muscle movement,
• Dry eyes, blurred vision,
• Dizziness,
• Feeling heartbeats,
• Difficulty breathing, nasal bleeding,
• Abdominal swelling, vomiting, dry mouth, flatulence, mouth ulcers,
• Hair loss, excessive body hair,
• Dry skin, brittle nails, itching, skin rash,
• Back pain, muscle pain,
• Bleeding after sex, prolapse, irregular menstruation, painful menstruation,
• Small cysts (inflammation) in the ovaries that may cause pain, vaginal discharge,

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

• Severe allergic reaction that may cause facial, tongue, and neck inflammation, difficulty breathing, or dizziness (Quincke's edema, anaphylactic shock)
• Convulsions

• Confusion, abnormal sensations in the eyes and/or changes in vision
• Urticaria (rapid formation of papules due to skin or mucous membrane inflammation),
• Muscle weakness,
• Amenorrhea,
• Fever and general discomfort,
• Affected blood tests (including elevated liver function tests),
• Diarrhea,
• Increased blood pressure,
• If there is a pre-existing pituitary tumor, there is an increased risk of bleeding in the area.

During fertility treatment, gonadotropins combined with the product may induce an increase in ovarian size or ovarian hyperstimulation, which may cause pelvic or abdominal pain or difficulty breathing. If this occurs, consult your doctor immediately.

In the treatment of endometriosis, the disorders for which treatment has been justified (pelvic pain, dysmenorrhea) may worsen at the beginning of treatment, but should disappear in one or two weeks. This may occur even if the treatment has a favorable effect. However, you should inform your doctor immediately of this phenomenon.

Side effects when used for breast cancer in combination with tamoxifen or an aromatase inhibitor:

The following side effects have been observed when triptorelin is used for breast cancer in combination with tamoxifen or an aromatase inhibitor.

Side effects very common (affect more than 1 in 10 patients):

• Nausea,
• Feeling very tired,
• Joint and muscle pain, osteoporosis,
• Hot flashes,
• Excessive sweating,
• Difficulty sleeping, depression,
• Decreased libido, vaginal dryness, pain during or after sex,
• Incontinence,
• Increased blood pressure.

Side effects common (affect 1 to 10 in 100 patients):

• Diabetes, elevated blood sugar (hyperglycemia),
• Pain, bruising,
• Redness and inflammation at the injection site,
• Allergic reaction,
• Fractures,
• Formation of blood clots in a blood vessel.

Side effects uncommon (affect 1 in 10 patients in 1000):

• Brain hemorrhage,
• Lack of blood supply to the brain or heart.

Side effects rare (affect 1 to 10 in 10,000 patients):

• ECG changes (prolongation of QT).

Children

Side effectsvery common(affect more than 1 patient in 10):

• Vaginal bleeding, which may occur during the first month in girls.

Side effects common(affect 1 to 10 in 100 patients):

• Abdominal pain,
• Severe bruising,
• Redness and inflammation at the injection site,
• Headache, hot flashes,
• Weight gain,
• Acne,
• Allergic reaction.

Side effects uncommoncommon (affect 1 in 10 patients in 1000):

• Blurred vision,
• Vomiting, constipation, nausea,
• General discomfort,
• Weight gain,
• Neck pain, chest pain,
• Mood changes,
• Nasal bleeding,
• Itching, skin rash, or urticaria.

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

• Severe allergic reaction that may cause difficulty breathing or dizziness and facial, neck, or throat inflammation (Quincke's edema, anaphylactic shock)
• Convulsions
• High blood pressure,
• Abnormal vision,
• Affected 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).

Reporting of 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano.www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use Decapeptyl monthly after the expiration date shown 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 monthly

-The active principle is triptorelin (acetate), 3.75 mg per vial.

The other components are:

• Powder: DL lactide-co-glycolide polymer, mannitol, sodium carmellose, polisorbate 80
• Solvent: mannitol and water for injectable preparations.

Aspect of the product and contents of the package

This medication is a powder and solvent for injectable suspension, the powder is a white lyophilized powder 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 this leaflet:February 2025

The detailed and updated information of this medication 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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