Lanreotide Zentiva 120 mg solution for injection in a Pre-filled syringe – patient leaflet, side effects, dosage

1. What Lanreotide is and what it is used for

What Lanreotide is and how it works

The name of your medicine is Lanreotide Zentiva 60 mg, 90 mg or 120 mg, solution for injection in a pre-filled syringe, called Lanreotide in this leaflet. It is a long acting formulation of Lanreotide.

Lanreotide, the active substance, belongs to a group of medicines called “antigrowth hormones”. It is similar to another substance (a hormone) called “somatostatin”.

Lanreotide lowers the levels of hormones in the body such as growth hormone (GH), and insulin-like growth factor 1 (IGF-1) and inhibits the release of some hormones in the gastrointestinal tract and intestinal secretions. Additionally, it has an effect on some advanced type of tumours (called neuroendocrine tumours) of the intestine and pancreas by stopping or delaying their growth.

What Lanreotide is used for:

• the long term treatment of acromegaly (a condition where your body produces too much growth hormone).
• the relief of symptoms associated with acromegaly – such as feeling tired, headaches, sweating, joint pain and numb hands and feet.
• 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.

2. What you need to know before you use Lanreotide

Do not use Lanreotide

• if you are allergic (hypersensitive) to lanreotide, somatostatin or drugs from the same family (analogues of somatostatin) 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:

• 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 lanreotide.
• if you have gallstones, as lanreotide 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 may slightly decrease your thyroid function.
• if you have cardiac disorders, as sinus bradycardia (slower heart beat) may occur with lanreotide treatment. Special care should be taken when initiating treatment with lanreotide in patients with bradycardia (heart rhythm disorder). If any of the above applies to you, talk to your doctor or pharmacist before using Lanreotide.

Talk to your doctor or pharmacist during the treatment:

• If you have fatty stools, loose stools, abdominal bloating or weight loss, as lanreotide may affect pancreatic enzymes

  secretion involved in food digestion.

  Children and adolescents

  Lanreotide is not recommended in children and adolescents. Other medicines and Lanreotide

  Some medicines have an effect on the action 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 in case of co-administration with:

  • ciclosporin (a drug reducing immune reaction taken 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),
  • anti-diabetic treatment (drug reducing high blood glucose levels),
  • bradycardia inducing drugs (drugs slowing the heart beat, such as beta blockers).

Dose adjustments of such concomitant medications may be considered by your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lanreotide should be administered to you only if clearly needed. Driving and using machines

Lanreotide is unlikely to affect your ability to drive or use machines, however possible side effects such as dizziness may occur with Lanreotide. If you are affected you should not drive or use machines.

3. How to use Lanreotide

Always use Lanreotide exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Recommended dose

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 (60, 90 or 120 mg). If you are well controlled on a somatostatin analogue or Lanreotide 60 mg or 90 mg, your doctor can recommend a change to Lanreotide 120 mg at a frequency of one injection every 42 or 56 days. Your doctor will also decide how long you should be treated for.

Relief of symptoms (such as flushing and diarrhoea) associated with neuroendocrine tumours

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 (60, 90 or 120 mg). If you are well controlled on your treatment, your doctor can recommend a change in the frequency of your Lanreotide 120 mg injections to one injection every 42 or 56 days. Your doctor will also decide how long you should be treated for. Treatment of advanced tumours of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. Used when these tumours 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 Lanreotide for tumour control.

Method of administration

Lanreotide 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 a HCP.

The decision of 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 or the upper outer thigh (see figures 5a & 5b below). If you are injecting yourself after appropriate training, the injection should be given in the upper outer thigh (see figure 5b below).

Instructions for Use

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. Lanreotide is supplied in a ready to use pre-filled syringe fitted with an automatic safety system. The needle will retract automatically following the full administration of the product to prevent needle stick injury.

1. 1.

   Remove Lanreotide from the refrigerator 30 minutes

   prior to administration. Injection of cold medication may be painful. Keep laminated pouch sealed until just prior to injection.

2. 2.

   Attention Before opening the pouch, check that it is intact

   and that the medication has not expired.

   Do not use the pre-filled syringe:

   • If you drop or damage the pre-filled syringe or if the pre-

     filled syringe or pouch appear damaged in any way.

   • If the product has expired; the expiry date is printed on

     the outer carton and the pouch.

If any of the above apply you should contact your doctor or pharmacist.

1. 3. Wash hands with soap.
2. 4.

   Tear-open the pouch along the dotted line and take out the

   pre-filled syringe. The content of the pre-filled 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.

After opening the protective laminated pouch, the product should be administered immediately.

1. 5.

   Select an injection site:

   5a. If a healthcare professional (HCP) or someone else like

   a trained family member or friend is doing the injection: use the superior external (upper, outer) quadrant of the buttock or the upper outer thigh for injection. 5b. If you are injecting yourself: use the upper outer part of

   your thigh.

   Injection by HCP

   or a trained person

   5a 5b

   Self-injection or injection by HCP or

   OK OK OK OK

   Alternate the injection site between the right and left side each time you receive an injection of Lanreotide. Avoid areas with moles, scar tissue, reddened skin, or skin that feels bumpy.

   1. 6. Clean the injection site.
   2. 7.

      Before injecting, remove the pre-filled syringe from its tray.

      Discard the tray.

   3. 8. Remove the needle cap by pulling off and discard it.
   4. 9.

      Flatten injection area using the thumb and index finger of

      the hand not holding the pre-filled syringe to stretch the skin. Do not pinch the skin. Use a strong, straight dart-like motion to quickly insert the needle perpendicular to the skin (90-degree angle), all the way into the skin. It is very important that you insert the needle completely. You should not see any needle once it is fully inserted.

      Do not aspirate (do not draw back)

   5. 10.

      Release injection site that has been flattened by your

      hand. Push plunger with steady very firm pressure. The medication is thicker and harder to push than you might expect.

      Typically 20 seconds are needed. Inject the full dose and give a final push to make sure you cannot depress it any further.

Note: maintain pressure on the plunger with your thumb to avoid activation of the automatic safety system.

1. 11. Without releasing the pressure on the plunger, withdraw the needle from the injection site.
2. 12. Then release pressure on the plunger. The needle will automatically retract into the needle guard where it will be locked permanently.
3. 13. 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.
4. 14. Dispose of the used syringe as instructed by your doctor or healthcare provider. Do not dispose of the device in your general household rubbish.

If you use more Lanreotide than you should

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

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

If you forget to use Lanreotide

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.

If you stop using Lanreotide

An interruption of more than one dose or early termination of the Lanreotide treatment can affect the success of the treatment. Please talk to your doctor before you stop the treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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 this side effect is not known; it cannot be estimated from the available data.

Other side effects

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

Needle cap

Tray Before use

After use (needle guard)

Syringe body

The most commonly expected side effects are gastrointestinal disorders, gallbladder problems and injection site reactions. The side effects that could occur with Lanreotide 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, 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)
• redness, pain, warmth and swelling at the injection site that may feel fluid-filled when pressed, fever – this may be a sign of abscess
• sudden, severe pain in the upper right or centre abdomen that may spread to the shoulder or back, tenderness of the abdomen, nausea, vomiting and high fever – this may be a sign of inflammation of the gallbladder (cholecystitis)
• 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)
• Decrease in pancreatic enzymes. As lanreotide may affect the release of pancreatic enzymes involved in food digestion, you may have symptoms such as fatty stools, loose stools, abdominal bloating or weight loss.

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.

5. How to store Lanreotide

Keep this medicine out of the sight and re

ach

of children. Do not use this medicine after the expiry d

ate

which is printed on the carton and labels after <exp>. The

exp

iry date refers to the last day of that month.

Store Lanreotide between 2°C to 8°C in a

refr

igerator in its original package in order to protect from li

ght

. Once removed from the refrigerator, produ

ct

left in its sealed pouch may be returned to the refrigerator

(the

number of temperature excursions must not excee

d t

hree times) for continued storage and later use, provided

it h

as been stored for no longer than a total of 72 hours at below

30

°C. Each syringe is packed individually. Do not throw away any medicines via was

tew

ater or household waste. Ask your pharmacist how to throw

aw

ay medicines no longer required. These measures will h

elp

to protect the environment.

6. Contents of the pack and other infor

ma

tion

What Lanreotide contains

The active substance is:

lanreotide 60mg, 90mg or 120mg

The other ingredients are:

water for injection

glacial acetic acid (for pH adjustment).

What Lanreotide looks like and contents of the pack

Lanreotide Zentiva 60 mg, 90 mg and 120 mg, solution for injection is a viscous solution for injection in a pre-filled syringe ready to use, fitted with an automatic safety system. It is a white to pale yellow semi solid formulation. Each pre-filled syringe is packed in a laminated pouch and a cardboard box.

Box of one pouch containing one 0.5 mL syringe with an automatic safety system and one needle (1.2 mm x 20 mm). Box of three pouches, each one containing one 0.5 mL pre-filled syringe and one needle (1.2 mm x 20 mm).

1 x 60 mg, 3 x 60 mg

1 x 90 mg, 3 x 90 mg

1 x 120 mg, 3 x 120 mg

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Zentiva Pharma UK Limited,

12 New Fetter Lane,

London,

EC4A 1JP,

United Kingdom.

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132JH, Hoofddorp,

The Netherlands.

Or

Terapia S.A.,

124 Fabricii Street,

400632 Cluj-Napoca,

Romania.

This leaflet was last revised in January 2025.

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