Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
Hypersensitivity to lanreotide or related peptides or any of the excipients.
Somatuline LA may reduce gallbladder motility and lead to gallstone formation. Therefore, patients may need to be monitored periodically.
There have been post-marketing reports of gallstones resulting in complications, including cholecystitis, cholangitis, and pancreatitis, requiring cholecystectomy in patients taking Somatuline LA. If complications of cholelithiasis are suspected, discontinue Somatuline LA and treat appropriately.
Pharmacological studies in animals and humans show that Somatuline LA, like somatostatin and its analogues, inhibits secretion of insulin and glucagon. Hence, patients treated with Somatuline LA may experience hypoglycaemia or hyperglycaemia. Blood glucose levels should be monitored when Somatuline LA treatment is initiated, or when the dose is altered and any antidiabetic treatment should be adjusted accordingly.
Slight decrease in thyroid function has been seen during treatment with lanreotide in acromegalic patients, though clinical hypothyroidism is rare. Thyroid function tests are recommended where clinically indicated.
In patients without underlying cardiac problems Somatuline LA may lead to a decrease of heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to Somatuline LA treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with lanreotide in patients with bradycardia (see section 4.5).
The pharmacological gastrointestinal effects of lanreotide may reduce the intestinal absorption of co-administered drugs including ciclosporin.
Concomitant administration of ciclosporin with lanreotide may decrease the relative bioavailability of ciclosporin and therefore may necessitate the adjustment of ciclosporin dose to maintain therapeutic levels.
Interactions with highly plasma bound drugs are unlikely in view of the moderate binding of lanreotide to serum proteins.
Limited published data indicate that concomitant administration of somatostatin analogues and bromocriptine may increase the availability of bromocriptine.
Concomitant administration of bradycardia-inducing drugs (e.g. beta blockers) may have an additive effect on the slight reduction of heart rate associated with Somatuline LA. Dose adjustments of such concomitant medications may be necessary.
The limited published data available indicate that somatostatin analogues may decrease the metabolic clearance of compounds known to be metabolised by Cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that Somatuline may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g. quinidine, terfenadine) should therefore be used with caution.
Studies in animals showed no evidence of teratogenic effects following treatment with Somatuline LA.
Data on a limited number of exposed pregnancies indicate no adverse effects of Somatuline on pregnancy or on the health of the foetus/new born child. To date, no other relevant epidemiological data are available.
Somatuline LA should be administered to pregnant women only if clearly needed.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when Somatuline is administered during lactation.
Reduced fertility was observed in female rats due to the inhibition of GH secretion at doses in excess of those achieved in humans at therapeutic doses.
While no effect on the ability to drive and use machines has been established, dizziness has been reported with Somatuline LA. If a patient is affected, he/she should not drive or operate machinery.
Undesirable effects reported by patients suffering from acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs) treated with lanreotide in clinical trials are listed under the corresponding body organ systems according to the following classification:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
The most commonly expected adverse drug reactions following treatment with lanreotide are gastrointestinal disorders (most commonly reported are diarrhoea and abdominal pain, usually mild or moderate and transient), cholelithiasis (often asymptomatic) and injection site reactions (pain, nodules and induration).
The profile of undesirable effects is similar for all indications.
Post-marketing safety experience (frequency not known): Injection site abscess
Common: Hypoglycaemia, decreased appetite**, hyperglycaemia, diabetes mellitus
Uncommon: Insomnia*
Common: Dizziness, headache, lethargy**
Common: Sinus bradycardia*
Uncommon: Hot flush*
Very common: Diarrhoea, loose stools*, abdominal pain
Common: Nausea, vomiting, constipation, flatulence, abdominal distension, abdominal discomfort*, dyspepsia, steatorrhoea**
Uncommon: Faeces discoloured*
Post-marketing safety experience (frequency not known): Pancreatitis
Very common: Cholelithiasis
Common: Biliary dilatation*
Post-marketing safety experience (frequency not known): Cholecystitis, Cholangitis
Common: Muskuloskeletal pain**, myalgia**
Common: Alopecia, hypotrichosis*
Common: Asthenia, fatigue, injection site reactions (pain, mass, induration, nodule, pruritus)
Common: ALAT increased*, ASAT abnormal*, ALAT abnormal*, blood bilirubin increased*, blood glucose increased*, glycosylated haemoglobin increased*, weight decreased, pancreatic enzymes decreased**
Uncommon: ASAT increased*, blood alkaline phosphatase increased*, blood bilirubin abnormal*, blood sodium decreased*
Post-marketing safety experience (frequency not known): Allergic reactions (including angioedema, anaphylaxis, hypersensitivity)
* based on a pool of studies conducted in acromegalic patients
** based on a pool of studies conducted in patients with GEP-NETs
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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