Somatuline LA (Lanreotide)
Somatuline LA 30mg
powder and solvent for prolonged release suspension for injection
Active substance: Lanreotide
1. WHAT SOMATULINE LA IS AND WHAT IT IS USED FOR
Somatuline LA 30 mg is a long acting formulation of lanreotide. Lanreotide – the active substance – belongs to the group of antigrowth hormones. It is similar to the naturally occurring hormone called somatostatin. Lanreotide lowers the levels of hormones in the body such as GH (growth hormone) and IGF-1 (insulin-like growth factor-1) and inhibits the release of some gastro-intestinal hormones and intestinal secretions. Somatuline LA 30 mg is indicated for
• the long-term treatment of acromegaly (a condition where too much growth hormone is produced).
• the treatment of symptoms that occur with certain endocrine tumours of the gastrointestinal tract.
• the treatment of primary thyrotropic adenomas (pituitary tumour associated with hyperthyroidism),
2. BEFORE YOU USE SOMATULINE LA
Do not use Somatuline LA 30 mg
• if you are allergic (hypersensitive) to lanreotide or drugs from the same family (analogues of somatostatin) or any of the other ingredients of Somatuline LA 30 mg.
• Take special care with Somatuline LA 30 nig.
• if you are diabetic as lanreotide may affect your blood sugar levels. Your doctor may check your blood sugar levels and possibly alter your anti-diabetic treatment while you are receiving Somatuline LA 30 mg
• if you have gallstones, as lanreotide may lead to gallstone formation. Therefore you may need to be monitored periodically.
• if you have any thyroid problems, as lanreotide may slightly decrease your thyroid function.
• if you have cardiac disorders, as sinus bradycardia (slower heart beat) may occur under lanreotide treatment. Special care should be taken when initiating treatment with lanreotide in patients with bradycardia.
• if you have an endocrine tumour of the gastrointestinal tract, your doctor should not prescribe you lanreotide before excluding the presence of an obstructive intestinal tumour.
If any of the above applies to you, then you should speak to your doctor.
Taking or using other medicines
Some medicines have effects on the action of other medicines. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Special care should be taken in case of co-administration with
• ciclosporin (a drug reducing immune reaction e.g. after transplantation or in case of autoimmune disease),
• bromocriptine (dopamine agonist used in the treatment of certain types of tumours of the brain and Parkinson’s disease or to prevent lactation following childbirth),
• bradycardia-inducing drugs (drugs slowing the heart beat, e.g. beta blockers).
Dose adjustments of such concomitant medications may be considered by your doctor.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Please tell your doctor immediately if you are pregnant, or if you think you might be pregnant, or if you are breast-feeding. If so, lanreotide should be administered to you only if clearly needed.
- Use in children
Somatuline LA 30 mg is not recommended in children.
- Driving and using machines
Somatuline LA 30 mg is unlikely to affect your ability to drive or use machines, however possible side effects such as dizziness may occur with Somatuline LA 30 mg. If you are affected, be careful when driving or using machinery.
3. HOW TO USE SOMATULINE LA
Somatuline LA 30 mg should be administered by healthcare professionals. Your doctor or nurse will prepare and give the injections.
- The usual dose
The recommended starting dose is one injection every 14 days. Your doctor may change the length of time between your injections. This will depend on your symptoms and how you respond to the medicine. Your doctor will decide on how long you should be treated for.
- Method of administration
Somatuline LA 30 mg is administrated intramuscularly into the buttock. The injection is performed by healthcare professionals only.
- If you receive more Somatuline LA 30 mg than you should
If you are given too much Somatuline LA 30 mg, you may experience additional or more severe side effects. Please tell your doctor if you think it is the case.
- If you forget to use Somatuline LA 30 mg
As soon as you realise that you have missed an injection, contact your healthcare professional, who will give you advice about the timing of your next injection. Do NOT administer yourself extra injections to make up for a forgotten injection.
In long-term treatment with Somatuline LA 30 mg one forgotten dosage will not dramatically affect the success of your therapy.
- If you stop using Somatuline LA 30 mg
An interruption or early termination of the lanreotide treatment can affect the success of the treatment. Please askyour doctor before you stop the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Somatuline LA 30 mg can cause side effects, although not everybody gets them.
The most commonly expected side effects are gastrointestinal disorders, gall bladder problems and injection site reactions. The side effects that could occur with Somatuline LA30mg are listed according to their frequencies below.
Very common (more than 1 patient in 10):
a. diarrhoea, loose stools, abdominal pain
b. gallstones and gall bladder problems
Common (1 to 10 patients in 100):
c. fatigue
d. injection site reactions
e. nausea, vomiting, constipation, flatulence, abdominal distension, abdominal discomfort, dyspepsia (indigestion)
f. biliary dilatation (enlargement of the gall bladder)
g. sinus bradycardia (slower heart beat) h. dizziness, headache
i. alopecia, hypotrichosis (loss of hair or reduced development of body hair)
j. hypoglycaemia (low blood sugar level)
k. abnormal laboratory values (ALAT, ASAT, blood bilirubin, blood glucose, glycosylated haemoglobin)
l. decreased weight
Uncommon (1 to 10 patients in 1.000):
m. hot flushes
n. faeces discoloured
o. diabetes mellitus, hyperglycaemia (high blood sugar level)
p. asthenia (high blood sugar level)
q. insomnia (difficulty in sleeping)
r. abnormal laboratory values (blood alkaline phosphatase, blood sodium)
Occasional cases of inflammation of the pancreas (pancreatitis) have also been reported.
Since lanreotide may alter your blood sugar levels, your doctor may want to monitor your blood sugar levels especially at the initiation of the treatment.
Similarly, as gall bladder problems can occur with this type of medicine, your doctor may want to monitor your gall bladder when you start receiving Somatuline LA 30 mg and from time to time afterwards.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Somatuline LA 30mg
Keep out of the reach and sight of children.
Store in a refrigerator (2°C to 8°C) in the original package.
Do not use after the expiry date which is stated on the carton and labels after <exp>. The expiry date refers to the last day of that month.
Somatuline LA 30mg is for single use only. Your doctor or nurse will dissolve the powder into the solvent to obtain a suspension which should be used immediately after reconstitution. Any unused suspension should be discarded appropriately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Somatuline LA 30 mg contains The active substance is: lanreotide (30 mg)
The other ingredients are:
»Powder:
Lactide glycolide copolymer,
Lactic glycolic copolymer,
Mannitol,
Carmellose sodium,
Polysorbate 80.
»Solvent: Mannitol, Water for injections
What Somatuline LA 30 mg looks like and contents of the pack Somatuline LA 30 mg is provided as powder and solvent for prolonged release suspension for injection.
The powder is practically white and is supplied in a small glass vial (fitted with an elastomer stopper and crimped with an aluminium/plastic cap) together with an ampoule containing 2 mL of solvent and with a sterile set of injection made of 1 empty syringe and 2 needles. The alass vial is sliahtlv tinted.
After reconstitution the suspension has a milky aspect.
Pack size of 1 vial, 1 ampoule, 1 syringe and 2 needles. Pack size of 2 vials, 2 ampoules, 2 syringes and 4 needles. Pack size of 6 vials, 6 ampoules, 6 syringes and 12 needles.
Not all pack sizes may be marketed.
Somatuline LA 30 mg solution for injection
Lanreotide
Powder for suspension for intramuscular injection
INFORMATION FOR THE DOCTOR
1
Draw up the suspension vehicle (mannito solution 2 ml) Into the syringe with one of the pink needles.
2
Transfer the suspension vehicle into the Somatuline LA vial, by inserting the needle through the rubber stopper and slowly injecting the solution. DO NOT REMOVE THE SYRINGE.
3
GENTLY shake the contents of the vial from side to side, 20 to 30 times until a milky homogeneous suspension is obtained.
4
DO NOT INVERT THE VIAL. This is important to ensure that most of the suspension is drawn up into the syringe. Draw up as much of the suspension as possible. An extra amount is included to compensate for the small residue which will remain in the vial.
5
REMOVE THE NEEDLE, push the air from the syringe and then attach the other pink needle. The injection should be given INTRAMUSCULARLY, ideally in the gluteal muscles. Inject the contents of the syringe IMMEDIATELY AND RAPIDLY
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