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SYNAREL is a brand name for Nafarelin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The hormonal management of endometriosis, including pain relief and reduction of endometriotic lesions. Use in controlled ovarian stimulation programmes prior to in-vitro fertilisation, under the supervision of an infertility specialist.
Verbatim from this product's MHRA label. Tap a section to expand.
Adult:
Synarel is for administration by the intranasal route only. Experience with the treatment of endometriosis has been limited to women 18 years of age and older.
Endometriosis:
In the use of Synarel in endometriosis, the aim is to induce chronic pituitary desensitisation, which gives a menopause-like state maintained over many months. The recommended daily dose of Synarel is 200 mcg taken twice daily as one spray (200 mcg of nafarelin) to one nostril in the morning and one spray into the other nostril in the evening (400 mcg/day).
Treatment should be started between days 2 and 4 of the menstrual cycle. The recommended duration of therapy is six months; only one 6-month course is advised. In clinical studies the majority of women have only received up to six-months treatment with Synarel.
Controlled ovarian stimulation prior to in vitro fertilisation:
In the use of Synarel associated with controlled ovarian stimulation prior to in vitro fertilisation, the long protocol should be employed, whereby Synarel is continued through a period of transient gonadotrophin stimulation lasting 10-15 days (the 'flare effect') through to pituitary desensitisation (down-regulation).
Down-regulation may be defined as serum oestradiol ≤50pg/ml and serum progesterone ≤1ng/ml, and the majority of patients down-regulate within 4 weeks. The recommended daily dose of Synarel is 400 mcg taken twice daily as one spray to each nostril in the morning, and one spray to each nostril in the evening (800 mcg/day).
g. hMG, is commenced, and the Synarel dosage maintained until the administration of hCG at follicular maturity (usually a further 8-12 days). If patients do not down-regulate within 12 weeks of starting Synarel, it is recommended that Synarel therapy be discontinued and the cycle cancelled.
Treatment may begin in either the early follicular phase (day 2) or the mid-luteal phase (usually day 21). Bottles contain either 30 or 60 doses and should not be used for a greater number of doses. The 60 dose-unit bottle is sufficient for 30 days' treatment at 400mcg (2 sprays) per day, and 15 days treatment at 800mcg (4 sprays) per day.
Initial treatment with nafarelin acetate may cause transient exacerbation of endometriosis and chronic treatment may induce a menopausal state. The following undesirable effects have been observed and reported during treatment of 282 adult patients with nafarelin acetate with the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Not known: Cannot be estimated from the available data.
Adult population MedDRA System Organ Class Frequency Undesirable Effects Immune system disorders Common Drug hypersensitivity (Chest pain, Dyspnoea, Pruritus, Rash, Urticaria) Endocrine disorders Common Oestrogen deficiency Very common Weight increasedMetabolism and nutrition disorders Common Weight decreased Very common Affect lability, Libido decreased Psychiatric disorders Common Depression, Insomnia, Libido increased Very common HeadacheNervous system disorders Common Paraesthesia Very common Hot flushVascular disorders Common Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Very common Rhinitis Very common Acne, Seborrhoea Common Hirsutism Skin and subcutaneous tissue disorders Uncommon Alopecia Very common MyalgiaMusculoskeletal and connective tissue disorders Uncommon Arthralgia Very common Breast atrophy, Vulvovaginal dryness Common Artificial menopause, Uterine haemorrhage Uncommon Breast enlargement, Ovarian cyst Reproductive system and breast disorders Not known Ovarian hyperstimulation syndrome General disorders and administration site conditions Very common Oedema Investigations Common Bone density decreased In addition to the above mentioned undesirable affects, migraine, blurred vision, palpitations, shortness of breath, increased levels of SGOT/SGPT and serum alkaline phosphatase have been reported but the frequencies are not known.
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.
When regularly used at the recommended dose, nafarelin inhibits ovulation. Patients should be advised to use non-hormonal, barrier methods of contraception. In the event of missed doses there may be breakthrough ovulation and a potential for conception.
If a patient becomes pregnant during treatment, administration of the drug must be discontinued and the patient must be informed of a potential risk to fetal development and/or miscarriage. As there is a risk of miscarriage in the patient population, a causal association with nafarelin acetate is uncertain.
NB Synarel treatment will be stopped at least 3 days before fertilised embryos are placed in the uterine cavity. As with other drugs in this class ovarian cysts have been reported to occur in the first two months of therapy with Synarel.
Many, but not all, of these events occurred in patients with polycystic ovarian disease. These cystic enlargements may resolve spontaneously, generally by about four to six weeks of therapy, but in some cases may require discontinuation of drug and/or surgical intervention.
After a course of therapy, if further treatment of endometriosis and fibroids with nafarelin acetate is contemplated, it is recommended that bone density be assessed before retreatment begins to ensure that values are within normal limits.
In adults, after six months of nafarelin acetate treatment there was very little, if any, decrease in the mineral content of the distal radius and second metacarpal. 3%, respectively. Substantial recovery of bone occurred during the post-treatment period.
9% at the end of treatment. 4% below pretreatment levels. Controlled ovarian stimulation prior to in vitro fertilisation; As with other GnRH agonists, there have been reports of ovarian hyperstimulation syndrome (OHSS), associated with the use of nafarelin in combination with gonadotropin.
A small loss of trabecula bone mineral content occurs during 6 months treatment with nafarelin. Although this is mostly reversible within 6 months of stopping treatment, there are no data on the effects of repeat courses on bone loss.
Retreatment with Synarel or use for longer than 6 months is, therefore, not recommended. (See Special warnings and precautions for use on 'Changes in bone density'). Synarel should not be administered to patients who: 1. are hypersensitive to GnRH, GnRH agonist analogues or any of the excipients in Synarel; 2.
have undiagnosed vaginal bleeding; 3. are pregnant or may become pregnant whilst taking Synarel (see 'use in pregnancy and lactation'); 4. are breast-feeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The 30 dose-unit bottle is sufficient for 15 days' treatment at 400mcg (2 sprays) per day, and 7 days' treatment at 800mcg (4 sprays) per day. Patients should therefore be advised that continued use after this time may result in delivery of an insufficient amount of nafarelin.
Important Tips about using Synarel • The pump should produce a fine mist, which can only happen by a quick and firm pumping action. It is normal to see some larger droplets of liquid within the fine mist. However, if Synarel comes out of the pump as a thin stream of liquid instead of a fine mist, Synarel may not work as well, and the patient should talk to a pharmacist.
• Be sure to clean the Spray Tip after priming (at the time of the first use). The spray tip should then be cleaned before and after every use. Failure to do this may result in a clogged tip that may cause the patient not to get the right amount of medicine that is prescribed for them.
Always replace the safety clip and the plastic dust cap on the nasal piece after use to help prevent the tip becoming clogged. • The pump is made to deliver only a set amount of medicine, no matter how hard you pump it. • Do not try to make the tiny hole in the spray tip larger.
If the hole is made larger the pump will deliver a wrong dose of Synarel.
Priming the Spray Pump:
Before the patient uses a bottle of Synarel for the first time, they have to prime the spray pump. This only needs to be done once, before they use the first dose. 1. Remove and save the safety clip and the plastic dust cap to uncover the nasal piece.
Hold the bottle with in an upright position away from you with two fingers on the 'shoulders' and your thumb on the bottom of the bottle. 2. Prime the pump by pressing the bottle upwards several times firmly and quickly until the air is expelled and a fine spray appears.
This usually requires about 5 - 7 presses. It is not necessary to prime the pump again during subsequent use. You will waste your medicine if you prime the pump every time you use it. 3.
Clean the Spray Tip after Priming:
Hold the bottle in a horizontal position and rinse the spray tip with warm water, while wiping the tip with your finger or a clean soft cloth for 15 seconds. Do not clean the spray tip with a pointed object. This could cause an improper dose of the spray to be delivered.
Do not remove the pump from the bottle, as this will release the priming pressure. Wipe the tip dry with a clean soft cloth or tissue. Using the Spray Pump 1. Gently blow the nose to clear the nostrils. 2. Remove the safety clip and the plastic cap to uncover the nasal piece.
Hold the bottle as shown previously. 3. Clean the tip of pump. Hold the bottle in a horizontal position and rinse the spray tip with warm water, while wiping the tip with your finger or a clean soft cloth for 15 seconds. Do not clean the spray tip with a pointed object.
This could cause an improper dose of the spray to be delivered. Do not remove the pump from the bottle, as this will release the priming pressure. Wipe the tip dry with a clean soft cloth or tissue. 4. Bend head forward slightly. Close one nostril and put the spray tip into the other, aiming towards the back and outer side of the nose.
5. Press the bottle firmly up between thumb and fingers once only whilst gently breathing in through the nostril. For patients using 4 sprays per day, Synarel should now be sprayed into the other nostril. 6. Remove the sprayer from the nostril.
Bend head backwards for a few seconds to let the spray spread over back of the nose. 7. Clean the tip of pump. Hold the bottle in a horizontal position and rinse the spray tip with warm water, while wiping the tip with your finger or a clean soft cloth for 15 seconds.
Do not clean the spray tip with […]
Patients being treated for controlled ovarian stimulation prior to in vitro fertilisation should be monitored carefully. 8). Transient ovarian cyst formation is a recognised complication of GnRH agonist use. These cysts tend to regress spontaneously over a number of weeks and are more common when GnRH agonists are commenced in the follicular phase of the cycle.
There are no clinical data available on the use of Synarel in ovulation induction regimens involving patients with polycystic ovarian syndrome. Caution is advised in this patient group as they are at greater risk of excessive follicular recruitment when undergoing ovulation induction regimes.
Administration of nafarelin in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within 8 weeks after treatment is discontinued. Diagnostic tests of pituitary-gonadal function conducted during the treatment and up to 8 weeks after discontinuation of nafarelin therapy may therefore be misleading.
Sneezing during or immediately after dosing may impair absorption of nafarelin acetate. If sneezing occurs upon administration, repeating the dose may be advisable. 5). Synarel contains the preservative benzalkonium chloride. Long-term use may cause oedema of the nasal mucosa.
If a persistent oedema in the nasal mucosa is suspected, a medicinal product for nasal use without preservative should be chosen, if possible. If such products for nasal use are not available, the use of other formulations of the medicinal product should be considered.
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as nafarelin acetate. Patients should be informed accordingly and treated as appropriate if symptoms occur.