Buserelin nasal 150 microgram
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Aqueous nasal spray containing 150 micrograms buserelin per actuation
Drugs List
Therapeutic Indications
Uses
Pituitary desensitisation in preparation for ovulation induction regimes
Treatment of endometriosis
Dosage
Adults
Endometriosis
Total recommended daily dose is 900 micrograms, given as a single 150 microgram dose spray in each nostril 3 times a day, starting on days 1 or 2 of menstruation. Intervals between doses should be as evenly spaced as possible.
The total duration of therapy should not exceed 6 months and should not be repeated.
A repeated course of treatment must only be administered after a careful review of the risk/benefit ratio by the attending physician since the possibility of additive effects on bone mass (reduction in bone mass) cannot be excluded.
Pituitary desensitisation before induction of ovulation by gonadotrophins
Total recommended daily dose is 600 micrograms, given as a single 150 microgram dose spray in one nostril 4 times a day. Intervals between doses should be as evenly spaced as possible throughout the waking hours.
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).
Treatment should continue until down-regulation is achieved (serum estradiol less than 50 nanograms/litre and serum progesterone less than 1 microgram/litre). This will usually take between 2 and 3 weeks.
Dosage should be adjusted according to individual response, and occasionally may need to be increased up to 1,200 micrograms (one spray in each nostril 4 times a day) to achieve these levels.
Once down-regulation has been achieved, stimulation with gonadotrophin is commenced whilst the dose of buserelin is maintained.
When the appropriate stage of follicular development is reached, the gonadotrophin and buserelin are both stopped, and chorionic gonadotrophin is then given to induce ovulation.
Additional Dosage Information
Absorption takes place through the nasal mucous membranes, and is reliable even if the patient has a cold or rhinitis. In these cases the nose should be cleared prior to administering the dose. If nasal decongestants are being used, they must be used at least 30 minutes after using buserelin.
Contraindications
Children under 18 years
Postmenopausal females
Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Family history of long QT syndrome
Depression
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Hypertension
Metabolic bone disease
Polycystic ovarian syndrome
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Contains benzalkonium chloride
Do not use other nasal preparations until 30 minutes after treatment
Exclude pregnancy prior to initiation of treatment
Consider monitoring ECG in patients at risk of QT prolongation
Monitor blood pressure in hypertensive patients
Monitor bone status in long term therapy
Monitor closely patient with depression
Monitor serum electrolytes
Monitor stimulation cycle
Advise patient to report any new or worsening depression/suicidal ideation
Ovarian cysts can develop in the initial treatment phase
Ovarian hyperstimulation syndrome can occur
Pregnancy confirmed: Discontinue this medication
Endometriosis: 6 months maximum duration of treatment. Do not repeat course
Endometriosis: There is a risk of ovulation if treatment is interrupted
Female: If contraception appropriate, non-hormonal methods required
Changes in menstrual bleeding patterns should be expected
In patients being treated for endometriosis a menstruation-like bleed often occurs during the first few weeks of treatment. In some patients receiving continuous treatment courses, breakthrough bleeding may occur. The recovery of pituitary-gonadal function usually occurs within 8 weeks of discontinuing treatment.
The combined use of buserelin and gonadotrophins may bear a higher risk of ovarian hyperstimulation syndrome (OHSS) than with gonadotrophins alone. Monitor the stimulation cycle carefully to identify patients at risk of developing OHSS, the addition of hCG should be withheld if necessary.
Symptoms of OHSS include abdominal pain, abdominal tension, increased abdominal girth, ovarian cysts, nausea, vomiting, ovarian enlargement, dyspnoea, diarrhoea, oliguria, haemoconcentration and hypercoagulability. An acute abdomen may occur as a result of pedicle tension or rupture of the ovary. Severe OHSS may result in thromboembolic events, with the possibility of fatal outcomes.
Pregnancy and Lactation
Pregnancy
Buserelin is contraindicated in pregnancy.
Pregnancy should be excluded before starting treatment.
Discontinue treatment immediately if pregnancy occurs.
Animal reproductive studies have shown foetal toxicity in rats at very high doses.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Buserelin is contraindicated in breastfeeding.
Manufacturer advises that use should be avoided. Small amounts are secreted in breast milk although no adverse effects on the infant have been observed.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Acne
Allergic asthma with dyspnoea
Alopecia
Anaphylactic shock
Anxiety
Blood lipid changes
Blurred vision
Breakthrough bleeding
Breast tenderness
Changes in breast size
Changes in libido
Changes in scalp or body hair
Concentration disturbances
Constipation
Contact lenses may irritate
Decrease in bone mineral density
Decreased glucose tolerance
Decreased glycaemic control in diabetes
Depression
Deterioration in blood pressure in hypertensive patients
Diarrhoea
Disturbances of appetite
Dizziness
Drowsiness
Dry skin
Dryness of eyes
Dyspareunia
Elevation of liver enzymes
Emotional lability
Facial oedema
Fatigue
Feeling of pressure behind the eyes
Headache
Hearing disturbances
Hirsutism
Hoarseness
Hot flushes
Hypersensitivity reactions
Increase in serum alkaline phosphatase (reversible)
Increased sweating
Increased thirst
Irritation of nasal mucosa
Itching
Lactation
Leucopenia
Leucorrhoea
Lower abdominal pain
Memory disturbances
Migraine
Musculoskeletal pain
Nausea
Neoplasms
Nervousness
Nose bleeds
Oedema of the extremities (arms and legs)
Osteoporosis
Ovarian cysts
Ovarian hyperstimulation syndrome (OHSS)
Palpitations
Paraesthesia
Pituitary adenomas
Prolongation of QT interval
Rash
Serum bilirubin increased
Shoulder pain
Skin reddening
Sleep disturbances
Smelling disturbances
Splitting nails
Stomach pain
Taste disturbances
Thrombocytopenia
Tinnitus
Tiredness
Urticaria
Vaginal discharge
Vaginal dryness
Vertebral and long bone fractures
Visual disturbances
Vomiting
Weight changes
Withdrawal vaginal bleeding during early treatment phase
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2016
Reference Sources
Joint Formulary Committee. British National Formulary. 71st ed. London: BMJ Group and Pharmaceutical Press; 2016.
Summary of Product Characteristics: Suprecur 150 mcg Nasal Spray Solution. SANOFI. Revised February 2015.
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