SOMATULINE AUTOGEL (Lanreotide)

What is this medication?

Somatuline Autogel is a prolonged release formulation of lanreotide. Lanreotide is an octapeptide, an analogue of a naturally occurring hormone, somatostatin. Lanreotide lowers the levels of hormones in the body such as GH (growth hormone) and IGF-1 (insulin-like growth factor-1).

Somatuline Autogel is used for the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who do not respond to therapy with drugs called dopamine agonists.

Somatuline Autogel is used for the treatment of symptoms associated with carcinoid syndrome, such as flushing and diarrhoea.

Somatuline Autogel is used for the treatment and control of the growth of some advanced tumours of the intestine and pancreas that cannot be removed by surgery (called gastroenteropancreatic neuroendocrine tumours or GEP-NETs).

Somatuline Autogel is not recommended for use in children.

How should I use this medication?

Somatuline Autogel is intended for deep injection under the skin. It is for single use only. It should be injected as described in the instructions in this leaflet.

For the treatment of acromegaly or the symptoms of carcinoid syndrome, the recommended starting dose is 60 mg to 120 mg injected every 28 days. Depending on your response to the product, your doctor may vary the dose or the injection frequency. Your doctor will also decide on the length of your treatment.

For the treatment of advanced tumours of the intestine and pancreas that cannot be removed by surgery (gastroenteropancreatic neuroendocrine tumours - GEP-NETs), the recommended dose is 120mg every 28 days. Your doctor will decide how long you should be treated with Somatuline Autogel for tumour control.

If you are controlled on Somatuline Autogel, your doctor may suggest that the injection can be given by yourself or your carer. Your doctor or nurse will give you or your carer the appropriate training and confirm that you are both motivated and capable of doing this. Your doctor will continue to supervise the long-term management of your condition.

If the injection is being administered by a healthcare professional or your carer, the injection will usually be given as a deep subcutaneous injection in the upper, outer external quadrant of the buttock.

If you are giving the injection to yourself, the deep subcutaneous injection should be given in the upper, outer thigh.

The injection site should be alternated between right and left sides.

What if I miss a dose?

As soon as you realise that you have missed an injection, contact your doctor who will then advise when your next injection is to be given.

How should I store this medication?

Store Somatuline Autogel at 2°C-8°C in a refrigerator in its original package. Do not freeze. Keep it out of the reach and sight of children.

The syringe can be temporarily stored outside of the refrigerator up to a maximum of 24 hours (make sure the temperature stays below 40°C). Return the syringe to the refrigerator as soon as possible for continued storage and use.

Talk to your doctor or pharmacist if you have any questions on the storage of Somatuline Autogel.

DO NOT USE AFTER THE EXPIRY DATE SHOWN ON THE LABELS AND BOX.

DO NOT USE IF THE LAMINATED POUCH IS DAMAGED OR OPENED.

What are the possible side effects of using this medication?

The following side effects have been reported as common or very common in patients receiving Somatuline Autogel injections:

• bowel problems including diarrhea or loose stools, abdominal pain, passing wind or constipation
• feeling sick, vomiting, heartburn, abdominal bloating or discomfort
• possible occurrence of gallbladder stones (cholelithiasis) with long-term treatment. You may have symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, itchy skin.
• changes in blood sugar levels (low and high), diabetes
• slowing of the heart rate
• tiredness
• headache, dizziness
• hair loss or no hair growth
• moderate and short-lived pain at the injection site, sometimes with redness, swelling (nodule), itching tenderness or abscess
• changes in some liver or pancreas test results
• weight loss
• lack of energy
• feeling generally weak
• decrease in appetite
• pain that affects muscles, ligaments, tendons and bones
• excess fat in the stools
• biliary dilatation (enlargement of the bile ducts between your liver and gall bladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice and fever.

If you are diabetic, your doctor may check your blood sugar levels and possibly alter your anti-diabetic treatment while you are receiving Somatuline Autogel.

If you have heart problems, your doctor may check your heart rate and possibly alter your treatment while you are taking Somatuline Autogel.

Due to the possibility of gallbladder problems with this type of medicine, your doctor may want to conduct a gallbladder scan when you start receiving Somatuline Autogel and again at regular intervals thereafter.

Tell your doctor immediately if you notice any of the following side effects:

• feeling more thirsty or tired than usual and having a dry mouth. These may be signs that you have high blood sugar levels or are developing diabetes.
• feeling hungry, shaky, sweating more than usual or feeling confused. These may be signs of low blood sugar levels.

The frequency of the following side effects cannot be estimated from the available data:

• sudden, severe abdominal pain that may spread to the shoulder or back,
• tenderness of the abdomen,
• feeling nauseous,
• vomiting and having a fever, or
• having dark urine,
• clay-coloured stools or yellowing of the skin and eyes (jaundice).

These may be signs of gallstone complications.

Tell your doctor immediately if you notice that:

• your face becomes flushed or swollen or you develop spots or a rash
• your chest feels tight, you become short of breath or wheezy
• you feel faint, possibly as a result of a drop in blood pressure

These might be the result of an allergic reaction. The frequency of these side effects is not known; it cannot be estimated from the available data.

If any side effect is troublesome or causes any concern, you should tell your doctor or pharmacist.

What other drugs will affect Somatuline Autogel?

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription at your pharmacy, supermarket or health food shop.

Some medicines and Somatuline Autogel may interfere with each other. Somatuline Autogel may reduce the intestinal absorption of other drugs administered at the same time (e.g. cyclosporin A) or increase the bioavailability of bromocriptine. The dose of other drugs which reduce the heart rate (e.g. beta-blockers) may need to be reduced if Somatuline Autogel is administered.

Somatuline Autogel may interfere with the breakdown of some drugs by the liver enzymes (e.g. quinidine or terfenadine).

Your doctor or pharmacist have more information on medicines to be careful with or avoid while taking this medicine.