5 mg implant
leuprorelin
What Leuprorelin Sandoz is and what it is used for
The active substance in Leuprorelin Sandoz (leuprorelin acetate) belongs to the group of inhibitors of certain sex hormones.
Leuprorelin Sandoz affects the pituitary gland. After a short-term stimulation, the production of the hormones that control the production of sex hormones in the testicles is reduced.
This means that the concentration of sex hormones drops and stays at this level during treatment. When treatment with Leuprorelin Sandoz is stopped, the concentration of pituitary hormones and sex hormones returns to normal.
Leuprorelin Sandoz is used to treating the symptoms of advanced hormone-dependent tumors in the prostate ( prostate carcinoma).
Leuprorelin Sandoz is also used for the treatment of locally advanced and localized, hormone-dependent prostate tumors in combination with radiation therapy or after radiation therapy.
Leuprorelin contained in Leuprorelin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Leuprorelin Sandoz
Do not use Leuprorelin Sandoz
- if you are allergic to leuprorelin or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to substances similar to leuprorelin, such as goserelin or buserelin
- if your cancer is not hormone dependent
- if you are a woman or a child.
Warnings and cautions
Talk to your doctor or nurse before receiving Leuprorelin Sandoz:
- if you have been diagnosed with high blood pressure . In that case, your doctor will check you closely.
- if both of your testicles have been removed. In this case, Leuprorelin Sandoz will not cause any further decrease in the concentration of male sex hormone in the blood.
- if you already before the treatment have symptoms from the nervous system (pressure on the spinal cord, metastasize to the spine) or discomfort when urinating due to pressure on the urinary tract. Tell your doctor immediately, he / she will check you especially carefully during the first weeks, if possible you will be hospitalized.
- if the symptoms of the disease return (such as pain, difficulty urinating or weakness in the legs with prolonged use of Leuprorelin Sandoz). In that case, your doctor will check your treatment at regular intervals through clinical examinations (examination of the prostate via the rectum, diagnostic imaging) and by checking your blood levels (phosphatases and prostate- specific antigen (PSA) and the male sex hormone ( testosterone ).
- if you are at risk of developing osteoporosis (osteoporosis). Your doctor will, if possible, give you another medicine to prevent bone breakdown.
- if you have diabetes . In that case, your doctor will check you very carefully.
Depression, which can be severe, has been reported in patients taking Leuprorelin Sandoz. Tell your doctor if you become depressed while taking Leuprorelin Sandoz.
Tell your doctor if you have any of the following:
Cardiovascular disease includes cardiac arrhythmias ( arrhythmia ), or if you are taking medication for this. The risk of suffering from heart rhythm disorders may be increased when using Leuprorelin Sandoz.
Other medicines and Leuprorelin Sandoz
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Leuprorelin Sandoz may affect some 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 certain other medicines (eg methadone [used to treat pain) and in the treatment of drug addiction], moxifloxacin [an antibiotic ], antipsychotics [used for severe mental illness]).
Children and young people
Leuprorelin Sandoz is for adults only.
Pregnancy and breastfeeding
Leuprorelin Sandoz is for men only.
Driving and using machines
This preparation and the cancerous disease can cause fatigue. This is more likely in connection with alcohol consumption.
You should therefore not drive or use machines without your doctor’s permission if this applies to you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
How to use Leuprorelin Sandoz
How to get Leuprorelin Sandoz
- the injection site is washed
- Local anesthesia can be given to reduce the pain when the implant is injected
- Leuprorelin Sandoz is given as an injection under the skin ( subcutaneously ) in the abdominal area
- Leuprorelin Sandoz should only be given by your doctor or nurse who is also prescribing the medicine.
Dosage
The recommended dose is 1 implant with 5 mg leuprorelin every three months.
- follow your doctor’s advice about when to get leuprorelin Sandoz and the time between injection engines
- Leuprorelin Sandoz is injected once every three months. In rare cases, the next injection can be postponed for up to 4 weeks, usually without affecting the treatment effect.
- the contents of a pre-filled syringe are injected
- the syringe contains an implant that gives a dose of 5 mg leuprorelin.
Blood tests
Your doctor will take blood samples regularly to check if the treatment is working. After 3 months of treatment, your doctor will usually check if your prostate cancer can be treated with Leuprorelin Sandoz. Your doctor must therefore check the levels of prostate-specific antigen (PSA) and testosterone.
Duration of treatment
The attending physician decides this. Treatment should be continued even if the cancer symptoms have subsided or cancer has receded.
Prostate cancer can be treated with Leuprorelin Sandoz for several years. If its effect is good and you tolerate the treatment well, the treatment can continue without interruption. Your doctor will perform certain tests at regular intervals to determine the effect of treatment, especially if you experience recurrent symptoms, such as
- pain
- urination difficulties
- weakness in the legs.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or see your nearest hospital if you get any of the following serious side effects:
- Allergic reactions (anaphylactic reactions). The symptoms may come on suddenly and be:
- feeling of heat, rash, itching or hives in the skin and / or mucous membranes
- swelling of the face, lips or tongue or other parts of the body
- shortness of breath, wheezing / wheezing or difficulty breathing
- drop in blood pressure, increased heart rate , seizures and in the most severe cases life-threatening cardiovascular failure
- Swelling and pain in any part of the body caused by a blood clot in a vein
- Difficulty breathing, chest pain, fainting, rapid pulse , bluish skin and discoloration due to blood clots in the lungs.
These side effects are rare (may affect up to 1 in 1,000 people).
At the beginning of the treatment, the level of male sex hormone ( testosterone ) in the blood normally rises for a short time. As a result, the following symptoms may temporarily worsen:
- Skeletal pain may occur or worsen
- it can be difficult to urinate due to pressure on the urinary tract
- pressure against the spinal cord
- muscle weakness in the legs
- swelling due to fluid in the tissues that is prevented from being transported away (lymphedema).
The worsening symptoms usually go away without the need to stop treatment with Leuprorelin Sandoz.
When starting treatment, consider giving a drug that counteracts male sex hormone (an antiandrogen) to reduce the effects of the initial increase in male sex hormone.
During treatment, the concentration of male sex hormone drops to a very low level, which can lead to the following side effects in some patients:
Very common (may affect more than 1 user in 10):
- hot herds
- increased sweating
- skeletal pain
- impaired or lost sexual desire or erection problems
- reduced testicle size
- weight gain
- local skin reactions, e.g. redness or hardening, pain, swelling and itching at the injection site, which usually resolve with continued treatment; in some cases, abscesses have formed.
Common (may affect up to 1 in 10 people):
- breast augmentation in men
- decreased appetite
- increased appetite
- depression, mood swings
- disturbed sleep
- headache
- abnormal sensations, e.g. feeling of tingling and / or numbness
- nausea / vomiting
- joint or back pain
- muscle weakness
- increased need to urinate at night
- need to urinate much more often during the day
- difficulty urinating and pain when urinating
- fatigue
- swelling of the ankles, feet or fingers (peripheral edema )
- weight loss
- increased levels of certain liver enzymes ( ALT , AST , GGT) and other enzymes (LDH, alkaline and acid phosphatase) in the blood.
Uncommon (may affect up to 1 in 100 people):
- allergic reactions involving the whole body, e.g. fever, itching , increased white blood cell count , rash
- diarrhea
- dry skin or dry mucous membranes
- pain in the testicles
- inability to empty the bladder spontaneously
- increased sweating at night.
Rare (may affect up to 1 in 1,000 people):
- decreased or increased blood sugar levels
- dizziness
- transient changes in the sense of taste
- decreased or increased blood pressure
- hair loss.
Very rare (may affect up to 1 in 10,000 people):
- As with other drugs in this class: infarction in pituitary one after the first injection the patients with tumor of the pituitary a.
Has been reported (occurs in the unknown number of users):
- lung disease without infection ( pneumonia ) (mainly reported in Japan)
- inflammation of the lungs, lung disease
- in rare cases, abscesses have appeared at the injection site
- changes ( QT prolongation) in ECG ( electrocardiogram )
- cramps.
Special information
The effect of Leuprorelin Sandoz can be controlled by measuring the level of male sex hormone ( testosterone ) in the blood and by other blood tests (acid phosphatase, PSA = prostate-specific antigen ). Testosterone levels first rise at the beginning of treatment and then decrease for two weeks. After 2-4 weeks, the testosterone concentration has reached the level seen after surgery of both testicles and is then constant throughout the treatment period.
At the beginning of treatment, the level of acid phosphatase in the blood may rise temporarily. Normal or almost normal levels are reached again after a few weeks.
When the level of the male sex hormone testosterone decreases, which occurs after removal of the testicles or during treatment with drugs that inhibit the sex hormones (eg Leuprorelin Sandoz), bone density may decrease and the risk of fracture may increase (see “Warnings and Precautions”). However, the reduced bone density is more marked after removal of the testicles than after treatment with Leuprorelin Sandoz. Your doctor will consider giving you an additional medicine to regulate calcium metabolism (a so-called bisphosphonate).
How to store Leuprorelin Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, sterile bag, and syringe label after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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 leuprorelin (as leuprorelin acetate).Each implant contains 5 mg of leuprorelin (as leuprorelin acetate).
- The other ingredients are polylactic acid.
What the medicine looks like and contents of the pack
Pre-filled polycarbonate plastic syringe with acrylonitrile-butadiene-styrene copolymer flask and needle, sealed in a polyethylene terephthalate/aluminum / PE composite film bag.
The packages contain:
- 1 pre-filled syringe with 1 implant
- 2 pre-filled syringes with 1 implant in each syringe
- 3 pre-filled syringes with 1 implant in each syringe
- 5 pre-filled syringes with 1 implant in each syringe .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
EVER Pharma Jena GmbH, Otto-Schott- Strasse 15, 07745 Jena, Germany
or
EBEWE Pharma Ges.mbH Nfg. KG, Mondseestrasse 11, 4866 Unterach, Austria
or
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria