Decapeptyl Semestral 22.5 mg powder and solvent for prolonged-release injectable suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Decapeptyl semestral 22.5 mg powder and solvent for prolonged-release injectable suspension

Triptorelin

Read all of this leaflet carefully before you start using this medicine, as 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 this leaflet

1. What Decapeptyl semestral is and what it is used for
2. What you need to know before using Decapeptyl semestral
3. How to use Decapeptyl semestral
4. Possible side effects
5. How to store Decapeptyl semestral
6. Contents of the pack and other information

1. What Decapeptyl semestral is and what it is used for

Decapeptyl semestral contains triptorelin, which is similar to a hormone called gonadotropin-releasing hormone (GnRH agonist). It is a long-acting formulation designed to slowly release 22.5 mg of triptorelin over a period of 6 months (24 weeks). In men, triptorelin lowers levels of the hormone testosterone. In women, it reduces estrogen levels.

In adult men, Decapeptyl semestral is used to treat 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.

In children, from the age of 2 years, Decapeptyl semestral 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 (precocious puberty).

2. What you need to know before using Decapeptyl semestral

Do not use Decapeptyl semestral

If you are allergic to triptorelin pamoate, to gonadotropin-releasing hormone (GnRH), to other GnRH analogues, or to 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 semestral:

• If you develop depressive behavior. Cases of depression have been reported in patients treated with Decapeptyl semestral, which may be severe. Your doctor may wish to monitor your depression during treatment.
• If you are taking medications to prevent blood clotting, as bruising may occur at the injection site.
• 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 previous medical history of epilepsy.

This product must only be injected into muscle.

In men

• 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 have reduced bone density.

• If you consume excessive amounts of alcohol, and/or are a heavy smoker and/or have a poor diet.

• If you have taken for a long time medications that may reduce your bone density, for example, medicines for epilepsy or steroids (such as hydrocortisone or prednisolone).

• If you have any blood vessel or heart problems, including heart rhythm disorders (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Decapeptyl semestral.

• If you have diabetes or if you have heart or vascular problems.

• At the start of treatment, there will be a temporary increase in the amount of testosterone in your body, which may worsen cancer symptoms. Consult your doctor if this occurs. Your doctor may give you another medicine (an antiandrogen) to prevent worsening of symptoms.

• As with other GnRH analogues, you may experience symptoms due to spinal cord compression (e.g., pain, numbness, or weakness in the legs) or blockage of the urethra (urine outflow tract) during the first weeks of treatment. If any of these symptoms occur, consult your doctor immediately. Your doctor will evaluate you and provide appropriate treatment for these problems.

• If you have undergone surgical castration, triptorelin does not induce any further decrease in serum testosterone levels and therefore should not be used.

• If diagnostic tests of pituitary or gonadal function are to be performed during or after treatment with Decapeptyl semestral, results may be inaccurate.

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

• Medicines that reduce testosterone may cause changes in the ECG associated with heart rhythm abnormalities (QT prolongation).

• Treatment with GnRH analogues such as Decapeptyl semestral may increase the risk of anemia (defined as a decrease in red blood cell count).

In children

• If you have a progressive brain tumor, inform your doctor. This may affect how your doctor decides to treat you.
• Girls with precocious puberty may experience some vaginal bleeding during the first month of treatment.
• If your child has severe or recurrent headaches, vision problems, or ringing or buzzing in the ears, contact a doctor immediately (see section 4).
• When treatment is stopped, signs of puberty will reappear.

In girls, menstrual bleeding will begin 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 stopped.

• 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.

Talk to your doctor if you are concerned about any of these issues.

Other medicines and Decapeptyl semestral

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Decapeptyl semestral may interfere with some medicines 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor before using this medicine.

Do not use Decapeptyl semestral if you are pregnant.

Do not use Decapeptyl semestral if you are breastfeeding.

Driving and using machines

Although administered as directed, Decapeptyl semestral may affect certain reactions to an extent that could impair your ability to drive or operate machinery. This is particularly noticeable when combined with alcohol. You may feel dizzy, tired, or have vision problems such as blurred vision. These are possible adverse effects of treatment or due to the underlying disease. If you experience any of these adverse effects, you must not drive or operate machinery.

Decapeptyl semestral contains sodium but less than 1 mmol (23 mg) of sodium per vial, therefore it is considered “sodium-free” and can be used in a low-sodium diet.

3. How to use Decapeptyl semestral

Decapeptyl semestral 22.5 mg will be administered under the supervision of a physician.

In men

Treatment of prostate cancer with Decapeptyl semestral 22.5 mg requires long-term therapy.

For locally advanced or high-risk localized hormone-dependent prostate cancer in combination with radiotherapy, the recommended treatment duration is 2–3 years.

The usual dose is 1 vial of Decapeptyl semestral injected into the muscle every six months (24 weeks). Decapeptyl semestral is for intramuscular injection only.

Your doctor may perform blood tests to monitor the effectiveness of the treatment.

Use in children

You will normally receive an injection every 6 months (24 weeks). Decapeptyl semestral is for intramuscular injection only. Your doctor will decide when treatment should be discontinued (normally when the child is 12–13 years old in girls and 13–14 years old in boys).

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Seek immediate medical attention if you experience any of the following symptoms:

Difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, or hives. These may be signs of a severe allergic reaction or angioedema, which have been reported in rare cases (may affect up to 1 in 1,000 people).

Other adverse effects that may occur:

In men

As observed during treatment with other GnRH agonists or after surgical castration, the most frequent adverse reactions related to triptorelin treatment were due to its expected pharmacological effects. These effects included hot flushes and decreased libido.

An increase in lymphocyte count has been reported in patients receiving GnRH analogues. Except for immunological allergic reactions and injection site reactions, all adverse reactions are related to changes in testosterone levels.

Very common: may affect more than 1 in 10 people:

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

Common: may affect up to 1 in 10 people:

• Nausea, dry mouth
• Pain, bruising, redness and swelling at injection site, muscle and bone pain, pain in arms and legs, oedema (fluid accumulation in body tissues), lower abdominal pain
• High blood pressure
• Allergic reaction
• Weight gain
• Dizziness, headache
• Loss of libido, depression, mood changes

Uncommon: may affect up to 1 in 100 people:

• Increased platelet count
• Awareness of heartbeat (palpitations)
• Tinnitus, dizziness, blurred vision
• Abdominal pain, constipation, diarrhoea, vomiting
• Lethargy, intense shivering associated with sweating and fever, somnolence, 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 blood
• Joint pain, muscle cramps, muscle weakness, muscle pain, swelling and tenderness, bone pain
• Tingling or numbness
• Insomnia, feeling irritable
• Breast development in men, breast pain, reduction in testicular size, testicular pain
• Difficulty breathing
• Acne, hair loss, itching, rash, skin redness, urticaria
• Waking up to urinate, difficulty urinating
• Nosebleeds

Rare: may affect up to 1 in 1,000 people

• Red or purple skin discolouration
• Abnormal sensation in the eye, visual disturbance or blurred vision
• Feeling of fullness in abdomen, flatulence, altered taste sensation
• Chest pain
• Difficulty standing
• Influenza-like symptoms, fever
• Inflammation of nose/throat
• Increased body temperature
• Joint stiffness, joint swelling, musculoskeletal stiffness, osteoarthritis
• Memory loss
• Feeling confused, decreased activity, feeling of euphoria
• Difficulty breathing when lying down
• Blisters
• Low blood pressure

Not known: frequency cannot be estimated from available data

• Changes in ECG (QT prolongation),
• Malaise,
• Anxiety
• Urinary incontinence.
• If a pre-existing pituitary tumour is present, increased risk of bleeding from the area.
• Anaemia (reduced red blood cell count)

In children

Very common: may affect more than 1 in 10 people

• Vaginal bleeding which may occur in girls during the first month of treatment

Common: may affect up to 1 in 10 people

• Abdominal pain
• Pain, redness and swelling at injection site
• Headache
• Hot flushes
• Weight gain
• Acne
• Hypersensitivity reactions

Uncommon: may affect up to 1 in 100 people

• Blurred vision
• Vomiting
• Constipation
• Nausea
• Malaise
• Overweight
• Neck pain
• Mood changes
• Chest pain
• Nosebleeds
• Itching
• Skin rash or urticaria

Not known: frequency cannot be estimated from available data

• High blood pressure
• Abnormal vision
• Severe allergic reaction causing difficulty swallowing, breathing problems, swelling of lips, face, throat or tongue, or hives
• Seizures
• Changes in certain blood tests including hormone levels
• Rapid formation of wheals due to inflammation of the skin or mucous membranes
• Muscle pain
• Mood disturbances
• 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).

Your doctor will determine the measures to be taken to counteract these effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may 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 semestral

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

Do not use Decapeptyl semestral after the expiry date stated on the container and labels 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 medicines and their containers at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

The reconstituted suspension must be used immediately.

Do not store above 25°C.

6. Contents of the pack and other information

Composition of Decapeptyl semestral

The active substance is triptorelin.

One vial contains triptorelin pamoate equivalent to 22.5 mg of triptorelin.

After reconstitution with 2 ml of solvent, 1 ml of reconstituted suspension contains 11.25 mg of triptorelin.

The other components are:

Powder: D,L-lactide-co-glycolide polymer, mannitol, sodium carmellose, and polysorbate 80.

Solvent: water for injections.

Appearance of the product and contents of the pack of Decapeptyl semestral

This medicine is a powder and solvent for injectable suspension; the powder is white to almost white, and the solvent is a clear solution.

Pack containing 1 vial, 1 ampoule, and 1 blister with 1 injection syringe and 2 injection needles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Chemin départemental Nº 402

83870 Signes

France

This medicinal product is authorised in EEA Member States under the following names:

AT, DE: Pamorelin LA 22.5 mg
BE, LU: Decapeptyl Sustained Release 22.5 mg
CZ, PL, SK: Diphereline SR 22.5 mg
DK, FI, NL, NO, SE: Pamorelin 22.5 mg
EL: Arvekap 22.5 mg
ES: Decapeptyl Semestral 22.5 mg powder and solvent for prolonged-release injectable suspension
FR: Decapeptyl LP 22.5 mg
HU: Diphereline SR 22.5 mg por és oldószer retard szuszpenziós injekcióhoz
LV: Diphereline 22.5 mg
SI: Pamorelin 22.5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sprošcanjem

Date of the most recent revision of this leaflet: January 2025

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Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only:

INSTRUCTIONS FOR RECONSTITUTION