Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Buserelin acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Buserelin Injection. It contains a medicine called buserelin. This belongs to a group of medicines called gonadotropin releasing hormone analogues. This is a synthetic version of a hormone that occurs naturally in the body. It works by lowering the production of sex hormones. It can be used to treat infertility. It works by stopping the natural production of hormones that control ovulation. Synthetic hormones are then used to artificially stimulate ovulation. Your doctor should give you more information about how your treatment works.
e Buserelin Injection Do not use Buserelin Injection:
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Buserelin Injection. Warnings and precautions Talk to your doctor before using Buserelin Injection. Especially take care with Buserelin Injection and check with your doctor or pharmacist before using this medicine:
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This is because Buserelin Injection may be harmful to the developing baby. Women must have a pregnancy test to make sure they are not pregnant before being given this medicine. Buserelin Injection will be stopped before you are given the hormones used to stimulate ovulation. if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers' milk. if you get pregnant during treatment, stop having this medicine and tell your doctor immediately.
Driving and using machines You may feel dizzy, drowsy or have blurred eyesight while having this medicine. If this happens, do not drive or use any tools or machines. Anti-doping information The use of the medicinal product may lead to positive results in doping tests. In addition, misuse as a doping agent may endanger health. Buserelin Injection contains benzyl alcohol This medicine contains 2 – 5 mg benzyl alcohol in each dosage unit (depending on the applied dose) which is equivalent to 10 mg/ml solution. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast‐feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis"). Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis"). Buserelin Injection contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodiumfree'.
Buserelin Injection Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Posology Your doctor will start treatment on day 1 or day 21 of your menstrual cycle. The recommended daily dose is 200 to 500 micrograms given as a single daily injection or 500 micrograms twice a day.
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You will be given daily injections until blood tests show that levels of sex hormones are lowered. This usually takes one to three weeks. You will then be given other hormones as well as Buserelin Injection. Your doctor will tell you how long you are to continue having these medicines. Method of administration Buserelin Injection is normally given by a doctor or nurse. This is because it needs to be given as an injection underneath the skin (subcutaneous injection). The doctor or nurse will usually give you the first injections. You may then be trained how to give the injections to yourself. Your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained how to do so. If you are not sure what to do, talk to your doctor or nurse immediately. If you use more Buserelin Injection than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine. If you give yourself more Buserelin Injection than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Using too much Buserelin Injection may make you feel weak, nervous, dizzy and sick. You may also have a headache, hot flushes, stomach pain, swelling of the legs and breast pain. You may also have pain, bleeding or hardening of the skin at the site of injection. If you forget to use Buserelin Injection Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse. If you are injecting this medicine yourself and you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop using Buserelin Injection Keep using Buserelin Injection until your doctor tells you to stop. If you stop, your infertility treatment may be affected. Blood tests Using Buserelin Injection may affect the results of some blood tests. In particular, Buserelin Injection can change the level of liver enzymes and fats in the blood (lipids) shown up in blood tests. If you are going to have a blood test, it is important to tell your doctor you are having Buserelin Injection If you have any further questions on the use of this product, ask your doctor or pharmacist. 4
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Buserelin Injection and see a doctor or go to a hospital straight away:
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Feeling nervous, dizzy, tired or drowsy. Headache (which may be like a migraine) and disturbed sleep. Problems with memory and concentration. Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin. This can feel like 'pins and needles' (usually in the arms and legs) and is called paraesthesia. Dry eyes (possibly leading to eye irritation in people who wear contact lenses), blurred eyesight, feeling of pressure behind the eyes. Hearing problems such as ringing in the ears (tinnitus). Very fast, uneven or forceful heartbeat (palpitations). Facial swelling (puffiness) due to water retention which may also cause swollen arms or legs. Feeling or being sick, stomach ache, pain in the lower abdomen, diarrhoea or constipation. Dry skin or acne. Hair grows more than normal (including body and facial hair). Hair loss (including body or facial hair). Splitting of nails. Vaginal discharge, changes in breast size, breast tenderness or milk production. Changes in the level of liver enzymes, fats (lipids) and a substance called 'bilirubin' in the blood shown up in blood tests. Worsening of your condition if you have uterine fibroids. Frequency not known: changes in ECG (QT prolongation).
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Buserelin Injection 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 and label. The expiry date refers to the last day of that month. Once opened use within 15 days. Do not store above 25 °C. Do not freeze. Keep the vials in the outer carton in order to protect from light. Discoloured or cloudy solution should not be used. Each vial contains enough solution for ten doses. After finishing a course of treatment the vial should be disposed of and a new vial started for the next treatment. Do not throw away any medicines via wastewater or household waste. If you are using this medicine at home you will be given a container (a sharps bin) to use for disposal. Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist for disposal. These measures will help to protect the environment.
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What Buserelin Injection contains
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Buserelin 1 mg/ml solution for injection comes as injection containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Buserelin 1 mg/ml solution for injection is buserelin acetate.
Medicines with the same active substance, strength and form include: Suprecur Injection / Buserelin 1 mg/ml solution for injection, Suprefact 1 mg/ml Injection solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Buserelin 1 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.
Posology
The total daily dose is usually in the range 200 – 500 microgram (μg).
Treatment should start in the early follicular phase (day 1) or, provided the existence of an early pregnancy has been excluded, in the mid-luteal phase (day 21). It should continue at least until down regulation is achieved e.g. serum oestradiol < 180 pmol/l and serum progesterone < 3 nmol/l. This will usually take about 1 - 3 weeks.
Doses may have to be adjusted for individuals. Occasionally, patients may require up to 500 μg twice daily in order to achieve down-regulation.
When down-regulation is achieved, stimulation with gonadotropin is commenced while the dosage of buserelin is maintained. At the appropriate stage of follicular development, gonadotropin and buserelin are stopped and hCG is given to induce ovulation.
Treatment monitoring, oocyte transfer and fertilisation techniques are performed according to the normal practice of the individual clinic.
Luteal support with hCG or progesterone should be given as appropriate.
Method of administration
The daily dosage is given as a single injection by the subcutaneous route.
Hypersensitivity to the active substance, LHRH or to any of the excipients listed in section 6.1.
Buserelin should not be used in cases of undiagnosed vaginal bleeding.
It must not be used during pregnancy or lactation (see section 4.6 Pregnancy and lactation).
Buserelin Injection is for subcutaneous administration ONLY.
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as buserelin. Patients should be informed accordingly and treated as appropriate if symptoms occur.
Patients known to suffer from depression should be carefully monitored and treated if necessary during treatment with Buserelin Injection (risk of recurrence or worsening of depression).
In patients with hypertension, blood pressure must be monitored regularly (risk of deterioration of blood pressure levels).
QT Prolongation
Androgen deprivation therapy may prolong the QT interval.
In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Buserelin Injection.
The use of LHRH-agonists may be associated with decreased bone density and may lead to osteoporosis and an increased risk of bone fracture (see section 4.8). Particular caution is necessary in patients with additional risk factors for osteoporosis (e.g. chronic alcohol abuse, smokers, long-term therapy with anticonvulsants or corticosteroids or a family history of osteoporosis). It is recommended to periodically monitor bone mineral density (BMD) and use preventative measures during therapy to prevent osteopenia/osteoporosis.
In some patients treated with GnRH-agonists, change in glucose tolerance is observed (see section 4.8). In diabetic patients, blood glucose levels must be checked regularly (risk of deterioration of metabolic control).
Before treatment is started, it is recommended that a pregnancy test be performed.
In in-vitro fertilization, induction of ovulation must be performed under close medical supervision. Therefore, treatment with Buserelin Injection should be initiated only under the supervision of a specialist with experience of the indication.
Whenever the treatment is self-administered, it is strongly recommended that initial doses should be administered under close medical supervision due to the possibility of hypersensitivity reactions. Patients should cease injections and seek medical attention should any adverse event occur which may represent an allergic reaction.
Induction of ovulation should be carried out under close medical supervision. Risks specific to IVF/ET and related assisted reproduction procedures such as increase in miscarriages, ectopic and multiple pregnancies are unaltered under adjunctive use of buserelin. However, follicle recruitment may be increased especially in patients with polycystic ovarian disorder (PCOD).
Combined use of buserelin with gonadotropins may bear a higher risk of ovarian hyperstimulation syndrome (OHSS) than the use of gonadotropins alone.
In patients with polycystic ovarian syndrome, caution is recommended, because there is an increased tendency towards ovarian hyperstimulation syndrome (OHSS) when combined with gondatropins.
Possible clinical signs of ovarian hyperstimulation syndrome (OHSS) include: abdominal pain, feeling of abdominal tension, increased abdominal girth, occurrence of ovarian cysts, nausea, vomiting, as well as massive enlargement of the ovaries, dyspnoea, diarrhoea, oliguria, haemoconcentration, hypercoagulability. Pedicle torsion or rupture of the ovary may lead to an acute abdomen. Severe thromboembolic events may also occur. Fatal outcome is possible.
The stimulation cycle should be monitored carefully to identify patients at risk of developing OHSS. hCG should be withheld if necessary.
Ovarian cysts have been observed in the initial phase of buserelin treatment. No impact on the stimulation cycle has been reported so far.
Anti-doping information
The use of the medicinal product may lead to positive results in doping tests. In addition, misuse as a doping agent may endanger health.
Warnings on excipients
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
This medicine contains 2 - 5 mg benzyl alcohol in each dosage unit (depending on the applied dose) which is equivalent to 10 mg/ml solution.
Benzyl alcohol may cause allergic reactions.
Take care with pregnant or breast‑feeding women. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
High volume should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
During treatment with Buserelin Injection, the effect of antidiabetic agents may be attenuated.
In concomitant treatment with sexual hormones ("add back"), the dosage is to be selected so as to ensure that the overall therapeutic effect is not affected.
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Buserelin Injection with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Pregnancy must be excluded before starting buserelin and the medication should be stopped on the day of administration of hCG.
Buserelin passes into breast milk in small amounts. Although negative effects on the infant have not been observed, it is recommended that breast-feeding be avoided during treatment with Buserelin Injection in order to prevent the infant from ingesting small quantities of buserelin with breast milk.
Certain adverse effects (e.g. dizziness) may impair the ability to concentrate and react, and therefore constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
After administration of the injection, pain or local reaction at the injection site is possible. Hypersensitivity reactions may also occur. These may become manifest for example as reddening of the skin, itching, skin rashes (including urticaria) and allergic asthma with dyspnoea as well as, in isolated cases, anaphylactic/anaphylactoid shock.
Treatment with buserelin inhibits oestrogen production. As evidence of the biological response to hormone deprivation, patients may experience menopausal-like symptoms and withdrawal bleeding, which are directly related to the pharmacological action of the drug. Symptoms such as hot flushes, increased sweating, dry vagina, dyspareunia and loss of libido generally occur some weeks after starting treatment and may be severe in some patients. Withdrawal bleeding may occur during the first few weeks of treatment. Breakthrough bleeding may occur during continuing treatment. After several months' treatment, a decrease in bone mass may occur.
Changes in bone density: a decrease in bone mineral, the magnitude of which relates to the duration of therapy, occurs during treatment with buserelin alone. The evidence available indicates that six months treatment is associated with a decrease in bone mineral density of the spine of 3.5 %. These changes are similar to those seen with other agonists. Increased levels of serum alkaline phosphatase may occur.
Other adverse effects may include:
Neoplasms benign and malignant – Very rare cases of pituitary adenomas were reported during treatment with LH-RH agonists, including buserelin.
Blood disorders – Very rare cases of thrombocytopenia or leukopenia.
Metabolism and nutrition disorders – Frequent increase or decrease in weight Occasional changes in appetite and increased thirst. Rarely increase or decrease in blood lipid levels. Very rarely, reduction in glucose tolerance which may lead to the worsening of metabolic control in diabetics.
Psychiatric disorders – Frequent nervousness, emotional instability. Occasional anxiety, depression or worsening of existing depression.
Mood changes, depression, frequency:
Long term use: Common
Short term use: uncommon
Nervous system disorders – Dizziness, headache (in women in rare cases migraine-like), sleep disturbances, tiredness, drowsiness. Occasional paraesthesia (especially in the arms and legs), disturbances of memory and concentration.
Eye disorders – Occasional dry eyes (possibly leading to eye irritations in people who wear contact lenses), impaired vision (e.g. blurred vision), feeling of pressure behind the eyes.
Ear and labyrinth disorders – Rare cases of tinnitus, hearing disorders found.
Cardiac disorders – Frequent palpitations.
Frequency unknown: QT prolongation (see sections 4.4 and 4.5)
Vascular disorders – Occasional oedema (of face and extremities) and hot flushes. Very rare cases of a deterioration of blood pressure levels in patients with hypertension.
Gastrointestinal disorders – Frequent lower abdominal pain, stomach ache, nausea, vomiting, diarrhoea, constipation.
Hepato-biliary disorders – Occasional increase in serum liver enzyme levels (e.g. transaminases), increase in serum bilirubin.
Skin and subcutaneous tissue disorders – Frequent dry skin, acne, increase or decrease in scalp hair (alopecia, hirsutism). Occasional increase or decrease in body hair, splitting nails.
Musculoskeletal and bone disorders – Frequent musculoskeletal discomfort and pain (including shoulder pain/stiffness). The use of LHRH-agonists may be associated with decreased bone density and may lead to osteoporosis and an increased risk of bone fracture. The risk of skeletal fracture increases with the duration of therapy.
Reproductive system and breast disorders – Frequent Vaginal discharge, increase or decrease in breast size, breast tenderness. Occasional lactation.
In the initial phase of treatment with buserelin, ovarian cysts may develop (see also section 4.4). For preparation of ovulation induction, however, no negative effect on the course of stimulation has been reported so far.
In-vitro fertilization/embryo transfer programmes and similar assisted reproduction procedures carry inherent risks, e.g. increased occurrence of ectopic pregnancies, miscarriages or multiple pregnancies; this also applies where buserelin is used as adjunctive therapy. The fact that follicle recruitment may be increased under buserelin treatment (especially in the case of polycystic ovaries) may, however, in some patients also represent a desirable effect.
Combined use of buserelin with gonadotropins may bear a higher risk of ovarian hyperstimulation syndrome (OHSS) than the use of gonadotropins alone (see section 4.4).
Degeneration of uterine fibroids in women with uterine fibroids.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedemas of the lower extremities, and mastodynia as well as to local reactions at the injection site such as pain, haemorrhage and induration (see section 4.8). Treatment should be symptomatic.
Ask anything about Buserelin 1 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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