Lanreotide ADVANZ PHARMA 120 mg solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The product is known by the name above but will be referred to as Lanreotide Solution for Injection throughout the rest of this leaflet.

1. What Lanreotide Solution for Injection is and what it is used for
2. What you need to know before you use Lanreotide Solution for Injection
3. How to use Lanreotide Solution for Injection
4. Possible side effects
5. How to store Lanreotide Solution for Injection
6. Contents of the pack and other information

• The treatment of acromegaly (a condition where your body produces too much growth hormone)
• The relief of symptoms such as flushing and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NETs)
• The treatment and control of the growth of some advanced tumours of the intestine and pancreas called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. It is used when these tumours cannot be removed by surgery.

• if you are allergicto lanreotide, somatostatin or drugs from the same family (analogues of somatostatin) or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before using Lanreotide Solution for Injection:

• If you are diabetic, as Lanreotide Solution for Injection 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 Lanreotide Solution for Injection
• If you have gallstones, as Lanreotide Solution for Injection may lead to gallstone formation in the gallbladder. In this case, you may need to be monitored periodically. Your doctor may decide to stop treatment with lanreotide if complications arising from gallstones occur
• If you have any thyroid problems, as Lanreotide Solution for Injection may slightly decrease your thyroid function
• If you have cardiac disorders, as sinus bradycardia (slower heart beat) may occur under Lanreotide Solution for Injection treatment. Special care should be taken when initiating treatment with Lanreotide Solution for Injection in patients with bradycardia.

If any of the above applies to you, talk to your doctor or pharmacist before using Lanreotide Solution for Injection.

Lanreotide Solution for Injection is not recommended in children and adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Special care should be taken in case of co-administration with:

• Ciclosporin (a drug reducing immune reactions e.g. after transplantation or in cases 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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If so, Lanreotide Solution for Injection should be given to you only if clearly needed.

Lanreotide Solution for Injection is unlikely to affect your ability to drive or use machines, however possible side effects such as dizziness may occur with Lanreotide Solution for Injection. If you are affected be careful when driving or using machinery.

Treatment of acromegaly

The recommended dose is one injection every 28 days. Your doctor may adapt the dose of your injection using one of the three available strengths of Lanreotide Solution for Injection (60, 90 or 120mg).

If you are well controlled on your treatment, your doctor can recommend a change in the frequency of your Lanreotide120 mg injections to one injection every 42 or 56 days. Any change in dose will depend on your symptoms and how you respond to the medicine.

Your doctor will also decide how long you should be treated for.

The recommended dose is one injection every 28 days. Your doctor may adapt the dose of your injection using one of the three available strengths of Lanreotide Solution for Injection (60, 90 or 120 mg).

If you are well-controlled on your treatment, your doctor can recommend a change in the frequency of your Lanreotide120 mg injections to one injection every 42 or 56 days.

Your doctor will also decide how long you should be treated for.

The recommended dose is 120 mg every 28 days. Your doctor will decide how long you should be treated with Lanreotide Solution for Injection for tumour control.

Lanreotide Solution for Injection should be administered by deep subcutaneous injection.

The injection should be given by a healthcare professional (HCP) or a caregiver (family member or friend) or yourself after appropriate training from an HCP.

The decision regarding self-administration or administration by another trained person should be taken by your doctor. If you have any doubt on how to administer this injection at any time please contact your doctor or HCP for advice or further training.

If the injection is being given by a healthcare professional or someone else who has been trained (family member or friend), the injection will be given in the upper, outer external quadrant of the buttock (see Instruction for use, B5).

If you are injecting yourself after appropriate training, the injection should be given in the upper outer thigh (see Instruction for use, B5).

Attention: Please read all the instructions carefully before starting the injection. The injection is a deep subcutaneous injection that requires a specific technique different to normal subcutaneous injections.

The following instructions explain how to inject Lanreotide Solution for Injection

Please read all instructions carefully before starting the injection.

The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a colour varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.

B1. Remove Lanreotide Solution for Injection from the refrigerator 30 minutes prior to injecting. Injection of cold medication may be painful. Keep the laminated pouch sealed until just before the injection.
B2. Before opening the pouch, check that it is intact and that the medication has not expired. The expiry date is printed on the outer carton and the pouch - Do not use if the medication has expired or if the pouch is damaged.
B3. Wash hands with soap and dry hands thoroughly before starting.
B4. Make sure there is a clean surface for preparation.
B5. Choose injection site - the sites are shown below.
B6. Make sure to clean the injection site.
B7. Tear open the pouch and take out the pre-filled syringe.

If you are injecting someone else: Inject into the upper outer area of the buttock.

If you are injecting yourself: Inject into the upper outer part of your thigh.

Alternate the injection site between the right and left side each time you have an injection of Lanreotide Solution for Injection .

C1: Remove the cap from the syringe

• With one hand, hold the syringe barrel steady (not the plunger).
• With the other hand, remove the cap by twisting it.

C2: Open the needle pack

• Hold the needle pack and pull the lid off.
• Caution: Do not touch the open end of the needle pack. This needs to stay clean.

C3: Put the end of the syringe into open end of the needle pack

• Hold the needle pack with one hand.
• With the other, hold the syringe barrel steady (not the plunger) and twist until the syringe and needle are fully locked together.
• They are fully locked when you cannot turn it any further.

Important: Tight the syringe firmly to avoid drug leakage.

C4: Remove the needle from the pack

• Hold the syringe barrel (not the plunger).
• Pull the needle straight out from the needle pack without twisting or turning to make sure that the syringe is well connected to the safety needle.

Caution: The needle is partially exposed from this step onwards.

• NEVER TOUCH OR TRY TO OPEN THE GREEN NEEDLE SHIELD
• GREEN NEEDLE SHIELD is NOT a removable cap or cover for the needle.
• GREEN NEEDLE SHIELD will automatically activate during the needle insertion.
• GREEN NEEDLE SHIELD will automatically cover and lock around the needle once the injection is complete.
• GREEN NEEDLE SHIELD is a self-operating safety lock mechanism.

D1: Position the syringe

• To check which site you should use, refer to section B.
• Stretch the skin around the injection site flat and tight using your thumb and index finger.
• Hold the lower part of the syringe barrel (not the plunger) with your other hand.
• Position the syringe at a 90-degree angle to the skin.

D2: Insert the needle

• Without folding or pressing on the skin at the injection site, push the needle firmly against the skin.
• The Green needle shield will retract, and the safety mechanism will activate.
• Keep going until only the collar of the Green needle shield is visible.
• Do not push the plunger in this step. Hold the syringe in this position for the next step.

D3: Push the top of the plunger

• Move your hand from the skin to the plunger.
• Push the plunger slowly until the top touches the syringe barrel (it is easier to depress the plunger with your dominant hand).
• This should take around 20 seconds.

E1: Remove from the skin

• Lift the syringe straight up and away from your body.
• The Green needle shield will cover the needle.

E2: Apply gentle pressure

• Apply gentle pressure to the injection site with a dry cotton ball or sterile gauze to prevent any bleeding.
• Do not rub or massage the injection site after administration.

E3: Throw away

• Dispose of the used syringe and needle according to your local laws and regulations or how your doctor has shown you.
• The needles are not reusable.
• Do not dispose of the syringe or needle in your general household rubbish.

If you have injected more Lanreotide Solution for Injection than you should, please tell your doctor.

If you have injected or if you are given too much Lanreotide Solution for Injection you may experience additional or more severe side effects (see section 4 “Possible Side Effects”).

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 self-inject extra injections to make up for a forgotten injection, without discussing with your healthcare professional.

An interruption of more than one dose or early termination of the Lanreotide Solution for Injection treatment can affect the success of the treatment. Please talk to your doctor before you stop the treatment.

• 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 these side effects is common, it may affect up to 1 in 10 people.

• 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.

Tell your doctor or pharmacist if you notice any of the following side effects.

The most commonly expected side effects are gastrointestinal disorders, gallbladder problems and injection site reactions. The side effects that could occur with Lanreotide Solution for Injection are listed according to their frequencies below.

Very common: may affect more than 1 in 10 people:

• Diarrhoea, loose stools, abdominal 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: may affect up to 1 in 10 people:

• Weight loss
• Lack of energy
• Slow heart beat
• Feeling very tired
• Decrease in appetite
• Feeling generally weak
• Excess fat in the stools
• Feeling dizzy, having a headache
• Loss of hair or less development of body hair
• Pain that affects muscles, ligaments, tendons and bones
• Reactions where the injection is given such as pain, hard skin or itching
• Abnormal liver and pancreas test results and changes in blood sugar levels
• Nausea, vomiting, constipation, passing wind, stomach bloating or discomfort, indigestion
• Biliary dilatation (enlargement of the bile ducts between your liver and gallbladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice and fever

Uncommon: may affect up to 1 in 100 people:

• Hot flushes
• Difficulty sleeping
• A change in the colour of the stools
• Changes to sodium and alkaline phosphatase levels, shown in blood tests

Not known: frequency cannot be estimated from the available data:

• Sudden, severe pain in your lower stomach. This may be a sign of an inflamed pancreas (pancreatitis).
• Abscess at the site of injection which may feel fluid-filled when pressed (redness, pain, warmth and swelling which may be associated with fever)
• Inflammation of the gallbladder (cholecystitis) - you may have symptoms such as severe and sudden pain in the upper right or centre abdomen, the pain may spread to the shoulder or back, tenderness of the abdomen, nausea, vomiting and high fever
• Pain in the upper right part of your belly (abdomen), fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-coloured stools, dark urine, tiredness – these may be signs of inflammation of the bile duct (cholangitis).

Since Lanreotide Solution for Injection 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 gallbladder problems can occur with this type of medicine, your doctor may want to monitor your gallbladder when you start receiving Lanreotide Solution for Injection, and from time to time afterwards.

Tell your doctor or pharmacist if you notice any of the side effects above.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is lanreotide (60 mg, 90 mg or 120 mg)
• The other ingredients are water for injection and glacial acetic acid (for pH adjustment)

Lanreotide Solution for Injection is a viscous solution for injection in a 0.5 mL semi-transparent plastic syringe accompanied with a single use needle-safe device. It is a white to pale yellow semi-solid formulation.

Each pre-filled syringe is packed in an aluminium pouch and in a carton box.

Box of 0.5 mL syringe with one co-packaged safety needle (1.2 mm x 20 mm).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

ADVANZ PHARMA Limited is part of the ADVANZ PHARMA Group