60 mg, 90 mg, and 120 mg solution for injection in a pre-filled syringe
Lanreotide
What Somatuline Autogel is and what it is used for
What Somatuline Autogel is
The name of your medicine is Somatuline Autogel. It is a long-acting form of lanreotide.
Lanreotide, the active substance, belongs to a group of medicines called “growth hormone inhibitors”. They are similar to another substance ( hormone ) called “somatostatin”. Lanreotide lowers the levels of hormones in the body, such as growth hormone ( GH ) and insulin-like growth factors 1 ( IGF -1 ), and inhibits the release of certain hormones in the gastrointestinal tract and intestinal secretions.
In addition, it has an effect on certain advanced types of tumors (so-called neuroendocrine tumors ) in the intestine and the pancreas by stopping or delaying their growth.
What Somatuline Autogel is used for
- long-term treatment of acromegaly (a condition where your body produces too much growth hormone ) when the level of growth hormone remains abnormal after surgery and/or radiation therapy, or in patients for whom surgery and/or radiation therapy are not an option
- relief of symptoms such as flushing and diarrhea that sometimes occur in patients with neuroendocrine tumors (NET)
- treatment and control of the growth of certain advanced tumors in the intestine and pancreas, so-called gastroenteropancreatic neuroendocrine tumors or GEP-NET. Used when this type of tumor cannot be removed by surgery.
What you need to know before using Somatuline Autogel
Do not use Somatuline Autogel
- if you are allergic (hypersensitive) to lanreotide, somatostatin or medicines from the same family (somatostatin analog), or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
Somatuline Autogel can cause changes in the blood glucose level. If you have diabetes, the need for insulin may change.
Tell your doctor if you:
- is diabetic
- have stones in the gallbladder ( gallstones ), as lanreotide can lead to gallstones in the gallbladder. In this case, your doctor may need to check you regularly. Your doctor may decide to stop treatment with lanreotide if complications associated with gallstones occur.
- have thyroid problems, as lanreotide may reduce your thyroid function slightly
- suffering from heart disease
- have ever had liver or kidney problems?
If any of the above applies to you, talk to your doctor or pharmacist before using Somatuline Autogel.
Children and young people
Somatuline Autogel is not recommended for children and adolescents.
Other medicines and Somatuline Autogel
Some medicines can affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Special care should be taken during simultaneous treatment with:
- ciclosporin (an immunosuppressive drug that reduces the immune response, taken after a transplant or in autoimmune disease)
- bromocriptine (dopamine agonist used in the treatment of certain types of tumors in the brain and in Parkinson’s disease or to prevent lactation after childbirth)
- bradycardia-inducing drugs (drugs that slow the heart rate, such as beta-blockers)
Dose adjustment of these drugs co-administered with lanreotide may be considered by your doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Lanreotide should only be given to you if necessary.
Driving ability and use of machinery
Dizziness, fatigue, and weakness have been reported during treatment with Somatuline Autogel. Your ability to drive and use machines may be affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Somatuline Autogel
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Recommended dose:
Treatment of acromegaly
The recommended dose is one injection every 28 days. Your doctor can adjust the dose using one of the three available strengths of Somatuline Autogel (60, 90, or 120 mg).
If your treatment is under good control, your doctor may recommend a change in the frequency of your injections with Somatuline Autogel 120 mg to an injection every 42 or 56 days.
Your doctor will also decide how long the treatment period should be.
Symptom relief (such as flushing and diarrhea) associated with neuroendocrine tumors
The recommended dose is one injection every 28 days. Your doctor can adjust the dose using one of the three available strengths of Somatuline Autogel (60, 90, or 120 mg).
If your treatment is under good control, your doctor may recommend a change in the frequency of your injections with Somatuline Autogel 120 mg, to an injection every 42 or 56 days.
Your doctor will also decide how long the treatment period should be.
Treatment of advanced tumors in the intestine and pancreas, so-called gastroenteropancreatic neuroendocrine tumors or GEP-NET. Used when this type of tumor cannot be removed by surgery.
The recommended dose is 120 mg every 28 days.
Your doctor will decide how long you should be treated with Somatuline Autogel for tumor control.
Mode of administration
Somatuline Autogel should be given as a deep subcutaneous injection.
The injection can be given by either a healthcare professional or caregiver (family member or friend) or by yourself, after appropriate training from a healthcare professional.
If the same dose of Somatuline Autogel is given, you or a trained person, after appropriate training, can inject the medicine yourself. It is the healthcare staff who decide whether you or a trained person should administer the product. For instructions on how to inject the medicine yourself or a trained person, read the instructions for use below. If you have any doubts about how to administer this injection, contact your doctor or healthcare professional for advice or further training.
Instructions for use
NOTE! READ THE ENTIRE INSTRUCTIONS CAREFULLY BEFORE STARTING INJECTION ONE.
Injection one is a deep subcutaneous injection that requires a specific technique that differs from normal subcutaneous injections.
The following instructions describe how Somatuline Autogel should be injected.
Somatuline Autogel is supplied ready to use in a pre-filled syringe equipped with an automatic needle guard. The needle will retract automatically after completing the full injection, to prevent needlestick injuries.
- Take Somatuline Autogel out of the refrigerator 30 minutes before it is to be given. Injection of cold medicine can be painful. Do not open the laminated protective bag until immediately before the injection.
- Note: Check that the laminated protective bag is unbroken before opening and that the expiry date has not passed.
Do not use the pre-filled syringe:- If you drop or damage the pre-filled syringe or if the pre-filled syringe or protective bag appears damaged in any way.
- If the product has expired. The expiry date is printed on the outer carton and the protective bag. If any of the above apply, contact your doctor or pharmacist
- Wash your hands with soap.
- Tear open the protective bag along the dotted line and remove the pre-filled syringe. The content of the pre-filled syringe is a semi-solid phase that has a gel-like appearance with viscous properties and a color that varies from white to pale yellow. The supersaturated solution may also contain microbubbles that may be cleared during the injection. These differences are normal and do not affect the quality of the product
The product should be given immediately after opening the laminated protective bag. - Choose injection site:
a) If a healthcare professional or someone else, such as a trained family member or friend, is giving the injection: inject it into the upper outer quadrant of the buttock or the upper outer thigh. b) If you inject yourself: inject into the upper outer part of the thigh.
Alternate the injection site between the right and left sides each time you receive Somatuline Autogel. Avoid areas with liver spots, scar tissue, reddened skin, or skin that feels uneven. - Wash the injection site.
- Before injection, remove the prefilled syringe from its container. Discard the container.
- Remove the needle sleeve by pulling it off and discarding it.
- Flatten the injection area using the thumb and forefinger of the hand not holding the pre-filled syringe to stretch the skin. Do not pinch the skin. Use a strong and straight arrow-like motion to quickly insert the needle perpendicular to the skin (90-degree angle), all the way into the skin. The entire needle must go in completely. You should not see any of the needles when it is fully inserted.
Do not aspirate (do not retract) - Release the injection site that has been flattened with your hand. Press the piston with steady and very firm pressure. The medicine is thicker and slower to push than you might expect. Normally about 20 seconds are needed. Inject the full dose and push one last time to make sure you can’t push it down any further.
Note: Maintain thumb pressure on the plunger to prevent premature activation of the automatic needle guard. - Maintain pressure on the plunger while withdrawing the needle from the injection site.
- Release the pressure on the piston. The needle will automatically retract into the needle guard and lock into place.
- Gently press the injection site with a dry cotton ball or sterile compress to prevent bleeding. Do not rub or massage the injection site after injection.
- Dispose of the used syringe according to the instructions of the healthcare professional. DO NOT dispose of the syringe in household waste.
If you have used too much Somatuline Autogel
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Somatuline Autogel
Contact the healthcare system as soon as you discover that you have missed an injection. They will advise you when to take your next injection. Do not self-inject an extra injection to make up for a missed injection without talking to your healthcare provider.
If you stop using Somatuline Autogel
A break in more than one dose or premature termination of treatment with Somatuline Autogel may affect the success of the treatment. Talk to your doctor before stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects:
- feel more thirsty or tired than usual, and have a dry mouth. This could be a sign that you have high blood sugar levels or are developing diabetes
- hungry, shaky, sweating more than usual, or feeling confused. These can be signs of low blood sugar.
The frequency of these side effects is common and may occur in up to 1 in 10 people.
Contact a doctor/health care immediately if you notice that:
- you get a red face, swelling or spots, and rashes
- you feel pressure on your chest, you become short of breath or wheezing
- you feel weak, possibly as a result of a drop in blood pressure.
These may be the result of an allergic reaction. The frequency of this side effect is not known; it cannot be calculated from the available data.
Tell your doctor or pharmacist if you notice any of the following side effects.
The most common expected side effects are gastrointestinal problems, problems with the gallbladder, and reactions at the injection site. The side effects that can occur with Somatuline Autogel are listed below according to their frequency.
Very common (affects more than 1 in 10 people)
- diarrhea, loose stools, stomach pain
- gallstones and other gallbladder problems. 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
Common (affects 1 in 10 people)
- weight loss
- lack of energy
- slow heartbeat
- a strong feeling of fatigue
- decreased appetite
- feeling generally weak
- excess fat in the stool
- feeling dizzy, headache
- hair loss or reduced hair growth
- pain affecting muscles, ligaments, tendons, and bones
- reactions at the injection site such as pain, calluses, or itching
- abnormal liver and pancreas test results and changes in blood sugar levels
- nausea, vomiting, constipation
- gas, bloating or general discomfort, indigestion
- biliary dilatation (enlargement of the bile ducts between the liver and the gallbladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice, and fever
- bleeding in the skin
Uncommon (may affect up to 1 in 100 people)
- hot flashes
- sleep difficulties
- change in stool color
- change in the levels of sodium and alkaline phosphatase shown in the blood tests
Frequency not known (cannot be estimated from available data)
- Sudden, severe pain in the lower abdomen – this may be a sign of inflammation of the pancreas ( pancreatitis )
- Redness, pain, warmth, and swelling at the injection site, which may feel fluid-filled when pressed, fever – this may be a sign of an abscess ( abscess )
- Sudden severe pain in the upper right or middle part of the abdomen, which may spread to the shoulder or back, tenderness, nausea, vomiting and high fever – these may be signs of inflammation of the gallbladder (cholecystitis).
- Pain in the upper right part of the stomach (abdomen), fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, and fatigue – these may be signs of inflammation of the bile duct (cholangitis).
Because lanreotide can change your blood sugar levels, your doctor may want to check your blood sugar, especially at the beginning of treatment.
Just as gallbladder problems can occur with this type of medicine, your doctor may want to monitor your gallbladder from the time you start taking Somatuline Autogel until some time afterward.
Tell your doctor or pharmacist if you notice any of the side effects above.
How to store Somatuline Autogel
Store in a refrigerator (2°C – 8°C) in the outer carton. Light sensitive.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and label after “EXP.”. The expiration date is the last day of the specified month.
Medicines that have been stored in an unopened laminated protective bag at a temperature that did not exceed 40°C for a maximum of 24 hours can be put back into the refrigerator for storage and used at a later time. This may be repeated a maximum of three times.
Each syringe is in an individual package.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
– The active substance is lanreotide 60 mg (in approx. 0.2 ml solution), 90 mg (in approx. 0.3 ml solution) and 120 mg (in approx. 0.4 ml solution) per prefilled syringe as lanreotide acetate.
-Other ingredients are water for injections, acetic acid, and concentrated (for pH adjustment).
Appearance and package sizes of the medicine
Somatuline Autogel is a viscous liquid for injection in a pre-filled syringe, ready to use and equipped with an automatic needle guard. It is a white to slightly yellow semi-solid preparation.
Each pack contains a pre-filled syringe with an injection needle, packed in a laminated bag and a cardboard box.
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