Gonapeptyl Depot 3.75 mg - Consumer Medicine Information
|Condition:||Endometriosis, Prostate Cancer, Precocious Puberty, Uterine Cancer (Endometrial Cancer)|
|Class:||Gonadotropin releasing hormones, Hormones/antineoplastics|
|Form:||Intramuscular (IM), Powder|
|Ingredients:||triptorelin, poly-(d,l lactide coglycolide), propylene glycol dicaprylocaprate, dextran 70, polysorbate 80, sodium chloride, sodium hydrogen, phosphate dihydrate, sodium hydroxide, water for injection|
What Gonapeptyl Depot is and What it is Used For
GONAPEPTYL Depot contains triptorelin (as triptorelin acetate). One of its actions is to decrease the production of sex hormones in the body.
It is used
- For the treatment of hormone dependent prostate cancer.
To suppress the levels of ovarian hormones in order to -
- Reduce the size of uterine myomas, (commonly known as fibroids) which are non-cancerous tumours arising from the myometrium (smooth muscle layer) of the uterus.
- Treat endometriosis (the formation of uterine tissue outside the uterus).
- For the treatment of central precocious puberty (puberty that occurs prematurely but with the physical and hormonal changes of normal puberty).
Before You are Given Gonapeptyl Depot
You must not be given GONAPEPTYL Depot:
- If you are allergic to triptorelin or any of the other ingredients of GONAPEPTYL Depot.
- If you have hormone independent prostate cancer.
- If you have had one or both testes removed.
- If you are pregnant or are breast feeding.
- If you have been diagnosed with osteoporosis.
- If you have a progressive brain tumour
You will need to take special care with GONAPEPTYL Depot:
In Men and Women
There have been reports of depression in patients taking Gonapeptyl Depot which may be severe. If you develop depressed mood while taking this product, inform your doctor.
- If you have pains in your bones, or difficulty passing urine.
- If you have a secondary spinal or urinary tract tumour.
- If you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using GONAPEPTYL.
- If you are experiencing bleeding mid-cycle during treatment (except for the first month).
- If you are at an increased risk from loss of bone density.
- For uterine myomas, the size of the uterus and myoma should be monitored using techniques such as ultrasound.
- Non-hormonal methods of contraception should be used until normal periods are resumed.
- Do not use products containing oestrogen during treatment with GONAPEPTYL Depot.
- Pseudo precocious puberty (incomplete premature puberty) and gonadotrophin independent precocious puberty should be excluded prior to treatment.
- Treatment should first be started only in girls under 9 years and boys under 10 years old.
Using Other Medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
GONAPEPTYL Depot might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
How You Will be Given Gonapeptyl Depot
The powder and solvent are normally mixed and injected by a healthcare professional.
Depending on the condition you are being treated for, the appropriate dose will be administered by intramuscular injection (into a muscle) or subcutaneous injection (just under the skin).
- One injection of GONAPEPTYL Depot is normally given every 4 weeks as a long-term therapy.
- One injection of GONAPEPTYL Depot is normally given every 4 weeks for up to six months.
- Treatment must be started during the first 5 days of the menstrual cycle.
- The dose is adjusted according to body weight. Children weighing less than 20kg are given 1.875mg (1/2 dose); children weighing 20 - 30kg are given 2.5mg (2/3 dose); children weighing more than 30kg are given 3.75mg.
- One injection of GONAPEPTYL Depot is normally given every 2 weeks for the first month.
- Thereafter, injections are given every 3 - 4 weeks, according to effect.
Possible Side Effects
Like all medicines, GONAPEPTYL Depot can have side effects.
If you experience these or any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
General (all patients)
- Pain or discomfort may occur at the injection site.
- Although not common, allergic reactions have been reported in adults and children e.g. reaction at the injection site. If you experience swelling of the face, lips, mouth or throat which may cause difficultly in swallowing or breathing, tell your doctor immediately or go to your nearest casualty department.
The symptoms you are being treated for may worsen initially, due to the increased levels of testosterone at the start of treatment.
- Most of the side effects of GONAPEPTYL Depot in men result from lowered testosterone levels.
- Frequent side effects include hot flushes, loss of libido and impotence, headache, nausea, perspiration, tiredness, sleep disorders, muscle and joint pain, breast enlargement, depressed mood, mood changes and depression, and allergic reactions such as itching, skin rash and fever.
- Other possible side effects include, testicular wasting, high blood pressure, recurrence of asthma, increased blood enzymes, thrombo-embolic disorders (blood clots), reduced body hair, injection site reactions, weight changes, loss of appetite, stomach pain and dry mouth.
- Very rare (frequency not known) side effects include changes in ECG (QT prolongation).
- Most of the side effects of GONAPEPTYL Depot in women result from lowered oestrogen levels.
- Frequent side effects include hot flushes, sweating, vaginal dryness and/or pain or difficulty during sexual intercourse, bleeding, spotting, loss of libido, tiredness, nausea, sleep disorders, muscle and joint pain, depressed mood, depression and allergic reactions such as itching, skin rash and fever.
- Other possible side effects include backache, bone mass loss, increased blood enzymes or cholesterol, tingling in the legs, and visual disturbances.
- Frequent side effects include mood changes and depression.
- In girls, vaginal bleeding or discharge may occur.
- Other possible side effects include bone growth changes, nausea and vomiting.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Storing Gonapeptyl Depot
Keep out of the reach and sight of children.
Store at 2°C - 8°C (in a refrigerator). Keep containerin the outer carton.
Do not use after the expiry date stated on the packaging.
GONAPEPTYL Depot 3.75mg Powder and solvent for suspension for injection: PL 03194/0085
Marketing Authorisation Holder
Ferring Pharmaceuticals Limited, Drayton Hall,
Church Road, West Drayton, UB7 7PS , UK.
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.