3.75 mg powder and solvent for injection, prolonged-release suspension
Triptorelin
What Pamorelin is and what it is used for
Pamorelin works by lowering the levels of male sex hormone ( testosterone ) and female sex hormone ( estrogen ) in the body.
Prostate cancer
Pamorelin is used to treat local advanced hormone-dependent prostate cancer and hormone-dependent prostate cancer that has spread to other parts of the body (metastatic cancer). Pamorelin is also used to treat localized high-risk and locally advanced hormone-dependent prostate cancer in combination with radiation therapy.
Breast cancer
One way to treat hormone-dependent breast cancer is to reduce estrogen levels in the body. Pamorelin is used to treat hormone-dependent breast cancer at an early stage in menopausal women who have received chemotherapy.
Pamorelin is used in combination with hormone replacement therapy. You will also be asked to take:
- a medicine that contains tamoxifen, which you get if you are at high risk of getting your cancer back.
or
- an aromatase inhibitor drug. You will need to be treated with Pamorelin for at least six to eight weeks before you start taking the aromatase inhibitor.
Pamorelin is used to treat premature puberty and relieve symptoms of endometriosis.
What you need to know before using Pamorelin
Do not use Pamorelin
- if you are allergic to triptorelin, gonadotropin-releasing hormone ( GnRH ), other GnRH – like substances, or any of the other ingredients of this medicine (listed in section 6).
Men:
- if you have prostate cancer that is not dependent on hormones.
Women:
- if you are pregnant or breastfeeding.
Warnings and cautions
Everyone treated Pamorelin
Talk to your doctor or pharmacist before using Pamorelin.
- If you have diabetes or any other disease that affects your metabolism. Your doctor will check your blood sugar levels during treatment.
- If you have cardiovascular disease (eg high blood pressure ). . Your doctor will measure your blood pressure during treatment.
- If you have any of the following: Cardiovascular disease including cardiac arrhythmias ( arrhythmia ), or if you are taking medication for this. The risk of heart rhythm disorders may be increased when using Pamorelin.
- Depression, which can be severe, has been reported in patients taking Pamorelin. Tell your doctor if you become depressed while taking Pamorelin.
- If you are taking medicines that inhibit the blood’s ability to coagulate, bruising may occur at the injection site during intramuscular injection.
- Treatment with Pamorelin, as with other GnRH – like substances, can lead to reduced bone mass, which can lead to osteoporosis and increased risk of bone fractures, especially if you drink a lot of alcohol, are a smoker, have osteoporosis, have a poor diet or use antiepileptic drugs (medicines for epilepsy or seizures) or corticosteroids. Your doctor will do a skeletal x-ray before starting treatment to check if you are at risk for osteoporosis and monitor you during treatment.
If you have a sudden headache, vomiting, vision problems, and eye paralysis, it may be a sign of an enlarged pituitary gland (benign tumor ) that you were not aware of. This can be detected during treatment with Pamorelin.
Diagnostic tests of pituitary gland function, performed during or after treatment with Pamorelin, may be misleading.
Men
At the beginning of the treatment, the testosterone level in your body increases. It can aggravate the symptoms of cancer. Contact your doctor if this happens. Your doctor may prescribe you a medicine (antiandrogen) to prevent the symptoms from getting worse.
After surgical castration, triptorelin does not further reduce testosterone levels and therefore Pamorelin should not be used after testicular removal surgery.
During the first weeks of treatment, Pamorelin may occasionally cause bone marrow compression or blockage of the urinary tract. You will be closely monitored by your doctor and receive treatment should this occur.
Women
Pregnancy should be ruled out before starting treatment.
During the first month of your treatment, menstrual-like bleeding may occur. After that, your periods usually end. Talk to your doctor if you experience bleeding after the first month of your treatment.
Your period should start about 2 months after your last injection. You should use a non-hormonal contraceptive throughout the treatment and for one month after the last injection, as birth control pills or other hormone-based contraceptives are not sufficient to prevent pregnancy.
Children and young people
Tell your doctor if your child has a progressive brain tumor.
This can affect how the doctor decides to treat.
Girls with early puberty may experience menstrual-like bleeding during the first month of treatment.
At the end of treatment, your child develops pubertal features.
Information regarding future fertility is still limited. In most girls, regular menstruation begins about a year after the end of treatment.
A disorder in the upper growing part of the femur (femur) at the hip, so-called slippage of the femoral epiphysis, can occur after the end of treatment. This can cause lameness, pain in the knees or hips, stiffness in the hips, outstretched legs, and limited mobility in the hips.
Talk to your doctor if you have any of the above.
Other medicines and Pamorelin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pamorelin may affect certain other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pamorelin should not be used during pregnancy or breastfeeding.
If you are a woman of childbearing potential, you will be carefully examined by a doctor to rule out pregnancy before starting treatment. You should use non-hormonal contraceptives during treatment until menstruation returns. Talk to your doctor for further advice.
Driving and using machines
Even if Pamorelin is used as prescribed, side effects can occur to such an extent that the ability to drive or use machines is impaired. You may feel dizzy, tired, or have vision problems e.g. dimsyn. It may be a side effect of the treatment or the underlying disease. If you experience any of these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Pamorelin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Pamorelin
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The injections of Pamorelin are given by healthcare professionals.
Men
If you have prostate cancer, the usual dose is 3.75 mg triptorelin (1 vial ), injected into a muscle once a month (every 4 weeks). The injections are given alternately in the right and left gluteal muscles.
Treatment of prostate cancer with Pamorelin requires long-term treatment.
For the treatment of localized high-risk and locally advanced hormone-dependent prostate cancer in combination with radiation therapy, the recommended treatment period is 2-3 years.
Women
Breast cancer
The recommended dose of Pamorelin is an injection into a muscle once a month (every 4 weeks). The treatment can last for up to 5 years.
Pamorelin is used with a medicine that contains tamoxifen or an aromatase inhibitor. If you need to take an aromatase inhibitor, you will need to be treated with Pamorelin for at least six to eight weeks before you start taking the aromatase inhibitor. You will receive at least two injections of Pamorelin (at an interval of 4 weeks between injections ) before you start taking the aromatase inhibitor.
Endometriosis
If you have endometriosis, the usual dose is 3.75 mg triptorelin (1 vial ), injected into a muscle once a month (every 4 weeks). The injections are given alternately in the right and left gluteal muscles.
In women, the treatment of endometriosis should not last longer than 6 months.
Children
In children with premature puberty (before the age of 8 for girls and before the age of 10 for boys) the recommended dose is:
Children over 30 kg: 2 ml suspension (1 vial ), injected into a muscle every 4 weeks (28 days)
Children weighing between 20 and 30 kg: 1.3 ml of suspension one (two-thirds of the volume of the vial), injected into a muscle every 4 weeks (28 days).
Children weighing less than 20 kg: 1 ml of suspension one (half the volume of the vial), injected into a muscle every 4 weeks (28 days).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop using Pamorelin
Do not stop treatment with Pamorelin without talking to your doctor first. This is especially important if you are being treated for your breast cancer and you are taking Pamorelin in combination with an aromatase inhibitor. This is because discontinuation of treatment can cause an increase in estrogen levels. Your doctor will monitor your estrogen levels during treatment with Pamorelin.
If you stop taking Pamorelin, you must stop taking the aromatase inhibitor within one month of receiving your last dose of Pamorelin.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience symptoms that indicate an allergic or anaphylactic reaction, which may include dizziness, swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing ( angioedema ).
For other triptorelin drugs, pressure-sensitive accumulations of substance in tissue have been reported at the injection site following injection under the skin. This is less common.
Men
Very common side effects (affects more than 1 user in 10):
- Hot flashes
- Impotence
- Increased sweating
- Back pain
- An ant crawls, tingling or numbness in the legs
- Decreased sexual desire
- Impotence
Common side effects (affects more than 1 user in 100):
- Nausea, dry mouth
- Pain, bruising, redness and swelling at the injection site, edema (fluid accumulation in body tissues )
- Muscle and skeletal pain, pain in arms and legs, pain in the lower abdomen
- High blood pressure
- Allergic reaction
- Weight gain
- Dizziness, headache
- Lost sexual desire
- Depression, mood swings
Uncommon side effects (affects more than 1 user in 1,000):
- Increased platelet count
- Palpitation
- Earring ( tinnitus ), feeling that the surroundings are moving, visual impairment
- Stomach pain, constipation, diarrhea, vomiting
- Drowsiness chills associated with sweating and fever, drowsiness, pain
- Effects on blood count (including elevated liver function values), high blood pressure
- Weight loss
- Loss of appetite, increased appetite, gout (severe pain and swelling in joints, usually in the big toe), diabetes, high blood fats
- Joint pain, muscle cramps, muscle weakness, muscle pain, swelling and tenderness, skeletal pain
- Ants crawling, tingling, or numbness
- Insomnia, irritability
- Breast augmentation in men, pain in the breasts, decreased size of the testicles, pain in the testicles
- Breathing difficulties
- Acne, hair loss, itching, rash, redness, hives
- Waking up at night to empty the bladder, difficulty emptying the bladder
- Nasal blood
Rare side effects (affects more than 1 user in 10,000):
- Red-purple discolorations on the skin
- Abnormal sensation in the eye, visual disturbances
- Stretched abdomen, gas problems, taste changes
- Chest pain
- Difficulty standing
- Flu-like symptoms, fever
- Anaphylactic reaction (a severe allergic reaction that may cause dizziness or difficulty breathing)
- Inflammation of the nose and throat
- Stiff joints, joint swelling, stiffness in muscles and bones, bone and joint inflammation
- Impaired memory
- Confusion, decreased activity, elation
- Shortness of breath in supine position/rest
- Blisters
- Low blood pressure
- Elevated liver function values
Adverse reactions that have been reported (occurring in an unknown number of users):
Anaphylactic shock ( hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure), changes ( QT prolongation) in ECG ( electrocardiogram ), malaise, anxiety, swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing ( angioedema ), urine leakage.
With an existing pituitary tumor, there is an increased risk of bleeding in the area.
Patients receiving long-term treatment with GnRH analog in combination with radiation may have more side effects, especially gastrointestinal side effects, related to radiation therapy.
Women
Breast cancer
The following side effects have been observed when Pamorelin is used for breast cancer in combination with either tamoxifen or an aromatase inhibitor:
Very common side effects (affects more than 1 user in 10):
- nausea
- strong fatigue
- joint and muscle pain
- osteoporosis
- hot flashes
- increased sweating
- difficulty sleeping
- Depression
- decreased sexual desire, vaginal dryness, pain during or after intercourse
- urinary incontinence
- increased blood pressure
Common side effects (affects more than 1 user in 100):
- diabetes
- high blood sugar ( hyperglycemia )
- pain, bruising, redness, and swelling at the injection site
- allergic reaction
- bone fractures
- blood clot in a blood vessel
Uncommon side effects (affects more than 1 user in 1,000):
- bleeding in the brain
- lack of blood supply to the brain or heart.
Rare side effects (affects more than 1 user in 10,000):
- change in ECG ( QT prolongation)
Endometriosis
Very common side effects (affects more than 1 user in 10):
- sleep disorders, mood swings
- headache
- hot flashes
- increased sweating, acne, oily skin
- changes in the breasts, pain during intercourse, genital bleeding, decreased sexual desire, overproduction in the ovaries, enlargement of the ovaries, pelvic pain, vaginal dryness
Common side effects (affects more than 1 user in 100):
- nausea, abdominal pain, stomach upset
- joint pain, muscle twitching, pain in arms and legs
- chest pain
- pain, bruising, redness, and swelling at the injection site
- swelling and tenderness
- fatigue
- allergic reaction
- weight gain
- depression, nervousness
- dizziness
Uncommon side effects (affects more than 1 user in 1,000):
- palpitation
- feeling that the environment is moving
- dry eyes, visual impairment
- distended abdomen, vomiting, gas problems, dry mouth, cold sores
- weight loss
- decreased appetite, accumulation of fluid in the body
- back pain, muscle pain
- altered taste perception, decreased sensation, fainting, impaired memory, difficulty concentrating, an ant crawling, tingling or numbness, involuntary tremors
- mood swings, anxiety, confusion
- bleeding after intercourse, bulging anterior vaginal wall, irregular menstruation, menstrual cramps and heavy menstruation, small cysts (fluid-filled blisters) on the ovaries that can cause pain, discharge
- difficulty breathing, nosebleeds
- hair loss, increased body hair
- dry skin, brittle nails, itching, rash
Adverse reactions that have been reported (occurring in an unknown number of users):
Anaphylactic shock ( hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure), confusion, visual disturbances, diarrhea, swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema ), hives, muscle weakness, weakness, menstrual weakness, altered blood levels (including elevated liver function values), high blood pressure. With an existing pituitary tumor, there is an increased risk of bleeding in the area.
With endometriosis treatment, the symptoms for which the treatment has been justified (pelvic pain, menstrual pain) may worsen at the beginning of the treatment but should disappear within one to two weeks. This can occur even if the treatment has a beneficial effect. However, you should tell your doctor immediately about this phenomenon.
Children
Very common side effects (affects more than 1 user in 10):
- Vaginal bleeding may occur in girls during the first month of treatment
Common side effects (affects more than 1 user in 100):
- Allergic reaction
- Headache
- Hot flashes
- Stomach pain
- Pain, bruising, redness, and swelling at the injection site
- Weight gain
- Acne
Uncommon side effects (affects more than 1 user in 1,000):
- Dimsyn
- Vomiting, constipation, nausea
- Feeling sick
- Overweight
- Neck pain
- Mood swings
- Chest pain
- Nasal blood
- Itching, rash, or hives
Adverse reactions that have been reported (occurring in an unknown number of users): Anaphylactic shock ( hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure), mood swings, depression, nervousness, visual disturbances, swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing ( angioedema ), muscle pain, altered blood levels including hormone levels, high blood pressure.
How to store Pamorelin
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton and the EXP label. The expiration date is the last day of the specified month.
Ready-mixed suspension should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is triptorelin.
One vial contains triptorelin embonate equivalent to 3.75 mg of triptorelin.
After reconstitution with 2 ml of diluent, 1 ml of reconstituted suspension contains 1,875 mg of triptorelin.
Other ingredients are:
Powder: poly (d, l-lactide-coglycolide), mannitol, carmellose sodium, polysorbate 80.
Diluent: water for injections.
What the medicine looks like and the contents of the pack
The powder is a white to off-white powder and the diluent is a clear solution.
Pamorelin 3.75 mg is available in pack sizes:
1 vial, 1 ampoule, and 1 blister containing 1 syringe and 2 syringes.
3 vials, 3 ampoules, and 3 blisters containing 1 syringe and 2 syringes.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Institut Synthesis Institute (IPSEN) AB
Kista Science Tower
Färögatan 33
164 51 Kista
Manufacturer
Ipsen Pharma Biotech
Plateau de Signes Activity Park
Departmental Road No. 402
83870 Signes
France