Loading…
BUSERELIN is a brand name for Buserelin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.
Verbatim from this product's MHRA label. Tap a section to expand.
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).
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.
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.
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.
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. 5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Buserelin Injection. 8). 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. 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.
1. Buserelin should not be used in cases of undiagnosed vaginal bleeding. 6 Pregnancy and lactation).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
g. blurred vision), feeling of pressure behind the eyes. Ear and labyrinth disorders – Rare cases of tinnitus, hearing disorders found. Cardiac disorders – Frequent palpitations. 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. 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. 4). For preparation of ovulation induction, however, no negative effect on the course of stimulation has been reported so far. 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. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 breastfeeding 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).