Ipstyl

Package leaflet: Information for the patient

Ipstyl 60 mg injectable solution, 90 mg injectable solution, 120 mg injectable solution

lanreotide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ipstyl 60 mg, 90 mg, 120 mg is and what it is used for
2. What you need to know before using Ipstyl 60 mg, 90 mg, 120 mg
3. How to use Ipstyl 60 mg, 90 mg, 120 mg
4. Possible side effects
5. How to store Ipstyl 60 mg, 90 mg, 120 mg
6. Contents of the pack and other information

1. What Ipstyl 60 mg, 90 mg, 120 mg is and what it is used for

The name of the medicine is Ipstyl. Ipstyl injectable solution is a prolonged-release formulation of lanreotide.
Lanreotide, the active substance, belongs to a group of medicines called “growth-inhibiting hormones”.
It is similar to another substance (a hormone) called “somatostatin”.
Lanreotide reduces the levels of certain hormones in the body, such as growth hormone (GH) and insulin-like growth factor type I (IGF-I), and inhibits the release of certain hormones in the gastrointestinal tract and intestinal secretions. In addition, it has an effect on certain types of advanced tumours (called neuroendocrine tumours) of the intestine and pancreas, by blocking or delaying their growth.
Ipstyl is used for:

• Treatment of acromegaly (a condition in which the body produces too much growth hormone) and in patients whose secretion of growth hormone (GH) has not normalized following surgery or radiotherapy.
• Treatment of symptoms such as hot flushes and diarrhoea that sometimes occur in patients with neuroendocrine tumours (very rare tumours originating in glands or endocrine cells).
• Treatment and control of the growth of certain advanced-stage tumours of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. It is used when these tumours cannot be surgically removed.

2. What you should know before using Ipstyl 60 mg, 90 mg, 120 mg

Do not use Ipstyl

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

Warnings and precautions
Exercise particular caution when being treated with Ipstyl
Talk to your doctor, pharmacist, or nurse before using Ipstyl:

• if you have gallstones, as lanreotide may lead to the formation of gallstones in the gallbladder. You may therefore require periodic monitoring. Your doctor may decide to discontinue treatment with lanreotide if complications arise due to gallstones;
• if you have been diagnosed with diabetes or suffer from hypoglycemia (low blood sugar levels), as lanreotide may alter blood glucose levels. Your doctor may periodically check your blood glucose levels and, in case of diabetes, may adjust your anti-diabetic treatment during therapy with lanreotide;
• if you have thyroid function disorders (the thyroid is a gland located in the front of the neck), as lanreotide may slightly affect thyroid function;
  If you have cardiac disorders, as during treatment with lanreotide a slowing of the heartbeat (sinus bradycardia) may occur.

If you suffer from any of the conditions listed above, consult your doctor or pharmacist before
using Ipstyl.
Contact your doctor or pharmacist during treatment:

• if you have fatty stools, loose stools, abdominal bloating, or weight loss, as lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents
Lanreotide is not recommended in children and adolescents.

Other medicines and Ipstyl
Some medicines may affect other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Particular attention should be paid when administering lanreotide concomitantly with:

• cyclosporine (a drug that suppresses the immune response, used for example after organ transplantation or in autoimmune diseases);
• bromocriptine (a dopamine agonist used in the treatment of certain brain tumors, Parkinson’s disease, or to control abnormal increases in prolactin hormone);
• medicines that induce bradycardia (reduced heart rate), such as beta-blockers;
• medicines known to be metabolized by cytochrome P450 enzymes and CYP3A4 (e.g., quinidine, terfenadine);
• insulin or other antidiabetic medicines (drugs that lower blood sugar levels). Your doctor may consider adjusting the dosage of these medicines.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Lanreotide should only be administered if strictly necessary.

Driving and using machines
Although no effects on the ability to drive or operate machinery have been clearly established, dizziness has been reported with Ipstyl injectable solution. If you experience dizziness, you must not drive or operate machinery.

3. How to use Ipstyl

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose

Ipstyl injectable solution is available in a pre-filled syringe ready for use, containing 60 mg, 90 mg or 120 mg of lanreotide acetate.

Acromegaly
In patients newly diagnosed, treatment may be initiated with Ipstyl injectable solution in a pre-filled syringe administered every 28 days at the most appropriate dose determined based on the clinical condition. Subsequently, the dosage should be individualized according to the response achieved. If the desired response is not obtained, the dosage may be adjusted by increasing the dose or reducing the intervals between administrations.

Treatment of clinical symptoms of neuroendocrine tumours (such as hot flushes and diarrhoea)
Treatment may be initiated with Ipstyl injectable solution in a pre-filled syringe administered every 28 days at the most appropriate dose determined based on the clinical condition. Subsequently, the dosage should be individualized by adjusting the doses or the interval between administrations according to the degree of symptom reduction achieved, changes in plasma concentrations of tumour-derived markers, and treatment tolerability.

Treatment of advanced stage tumours of the intestine and pancreas, known as gastroenteropancreatic neuroendocrine tumours or GEP-NETs. To be used when these tumours cannot be surgically removed
The recommended dose is 120 mg every 28 days.
Your doctor will determine the duration of therapy with Ipstyl for tumour control.

Method of administration

Ipstyl must be administered via deep subcutaneous injection.
The injection should be given by a healthcare professional, or by a family member or friend, or by yourself after appropriate training by a doctor.
The decision regarding self-administration or administration by a trained person must be made by your doctor.
If you have any doubts about how to administer Ipstyl, please contact your doctor or healthcare professional at any time for advice or further instructions.

If the injection is administered by a healthcare professional or another person who has been adequately trained (relative or friend), it must be given in the upper outer quadrant of the buttock or in the upper outer part of the thigh (see below, Fig. 5a and 5b).
In case of self-administration, after appropriate training, the injection must be given in the upper outer part of the thigh (see below, Fig. 5b).

Instructions for use
WARNING: Read the instructions carefully before administering the injection.
Administration is performed via a deep subcutaneous injection, which requires a specific technique different from standard subcutaneous injections.
The following instructions explain how to administer Ipstyl.
Ipstyl is supplied in a pre-filled syringe ready for use, equipped with an automatic safety system. The needle retracts automatically after complete administration of the product to prevent needle-stick injuries.

1. Remove IPSTYL injectable solution from the refrigerator 30 minutes before administration. Injecting cold medication may be painful. Keep the sealed foil pouch until shortly before injection.

2. Caution: Before opening the pouch, check that it is intact and that the medicine has not expired.

Do not use the pre-filled syringe:

• If the pre-filled syringe has been dropped or damaged, or if the pre-filled syringe or pouch appears damaged in any way.
• If the product has expired; the expiry date is printed on the outer carton and on the pouch.

If any of the above conditions occur, contact your doctor or pharmacist.

3. Wash your hands with soap.
4. Open the pouch along the dotted line and remove the pre-filled syringe. The contents of the pre-filled syringe are a semi-solid solution with a gel-like appearance, viscous in consistency, and ranging in colour from white to pale yellow. The solution may also contain microbubbles, which may disappear during injection. These variations are normal and do not affect the quality of the product.

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

5. Choose an injection site:

5a: If the injection is administered by a healthcare professional, or by a trained family member or friend, inject into the upper outer quadrant of the buttock or into the upper outer part of the thigh.
or
5b: If self-administering, inject into the upper outer part of the thigh.

• Alternate the injection site between the right and left side. Avoid areas with moles, scars, redness, or irregular-looking skin.

6. Clean the injection site.
7. Before administering the injection, remove the pre-filled syringe from its container. Discard the container.

8. Remove the needle cap by pulling it off and dispose of it.

9. Stretch the injection area between the thumb and index finger of the hand not holding the pre-filled syringe to flatten the skin. Do not pinch the skin. Insert the needle quickly and perpendicularly (at a 90-degree angle) into the skin with a firm, straight motion, deeply into the subcutaneous tissue. It is very important that the needle is inserted completely. Once fully inserted, no part of the needle should be visible.

Do not aspirate (do not pull back).

10. Release the skin previously stretched at the injection site. Push the plunger with a firm, steady, and decisive pressure. The medication is thick and may be harder to push than expected. This usually takes about 20 seconds. Inject the full dose and give a final push to ensure that no further plunger movement is possible.

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

11. While maintaining pressure on the plunger, remove the needle from the injection site.

12. At this point, release the pressure on the plunger. The needle will automatically retract into its housing and remain permanently locked.

13. Apply light pressure to the injection site with dry cotton or a sterile gauze to prevent possible bleeding. Do not rub or massage the injection site after administration.
14. The syringe must be properly disposed of according to instructions from your doctor or other healthcare professional. Do not dispose of the device in household waste.

Use in children and adolescents
The use of Ipstyl is not recommended in children and adolescents due to lack of safety and efficacy data.

If you have impaired renal and/or hepatic function
No dose adjustment is necessary if you have impaired renal and/or hepatic function.
Elderly
No dose adjustment is necessary.
If you use more Ipstyl than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

If you forget to use Ipstyl
As soon as you realize you have missed an injection, contact your doctor, who will advise you on the next injection. DO NOT administer additional injections on your own to make up for the missed dose without first discussing it with your doctor.

If you stop using Ipstyl
Missing more than one dose or prematurely discontinuing treatment with lanreotide may compromise the success of therapy. Do not stop treatment with Ipstyl on your own; follow your doctor’s instructions carefully. If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following side effects:

• Unusual thirst or tiredness, dry mouth – these may be signs that you have high blood sugar levels or are developing diabetes
• Feeling hungry, shaky, sweating abnormally, or feeling confused – these may be signs of low blood sugar levels.
  The frequency of these side effects is common and may affect up to 1 in 10 people.

Contact your doctor immediately if you notice:

• That your face becomes red or swollen, or you develop spots or skin rashes
• That your chest feels heavy and you become short of breath or start to wheeze
• A feeling of weakness, possibly due to a drop in blood pressure.

These may be symptoms of an allergic reaction.
The frequency of these side effects is not known: it cannot be estimated based on available data.

Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects.
The most common side effects expected with this medicine are: gastrointestinal disorders, gallstones, and injection site reactions. The side effects that may occur with lanreotide are listed below by frequency:

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

• Diarrhoea, faecal incontinence, abdominal pain
• Gallstones and other biliary problems. You may experience symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, skin itching

Common: may affect up to 1 in 10 people:

• Weight loss
• Loss of energy
• Slowing of the heartbeat
• Feeling very tired
• Decreased appetite
• Generalised weakness
• Excess fat in the stools
• Dizziness, headache
• Hair loss or reduced growth of body hair
• Pain affecting muscles, ligaments, tendons, and bones
• Reactions at the injection site such as pain, skin hardening, or itching
• Abnormal liver and pancreas function test results, changes in blood sugar levels
• Nausea, vomiting, constipation, flatulence, bloating or stomach discomfort, indigestion
• Bile duct dilation (enlargement of the bile ducts between the liver, gallbladder, and intestine). You may experience symptoms such as stomach pain, nausea, jaundice, and fever

Uncommon: may affect up to 1 in 100 people:

• Hot flushes
• Difficulty sleeping
• Change in stool colour
• Changes in blood levels of sodium and alkaline phosphatase

Frequency not known: frequency cannot be estimated based on available data:

• Severe and sudden 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, accompanied by fever – this may be a sign of an abscess
• Sudden and severe pain in the upper right or central abdomen, which may spread to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever – this may be a sign of inflammation of the gallbladder (cholecystitis)
• Pain in the upper right part of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-coloured stools, dark urine, fatigue – these may be signs of inflammation of the bile duct (cholangitis)
• Decrease in pancreatic enzymes. Since lanreotide can affect the release of pancreatic enzymes involved in food digestion, you may experience symptoms such as fatty stools, loose stools, abdominal bloating, or weight loss

Because lanreotide can alter blood sugar levels, your doctor may wish to monitor your blood sugar levels, especially at the beginning of treatment.
Similarly, since gallbladder problems may occur with this medicine, your doctor may want to check your gallbladder at the start of lanreotide therapy and periodically during treatment.
Following the instructions in this leaflet can reduce the risk of side effects.
Tell your doctor or pharmacist if you notice any of the adverse events described above.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ipstyl

Store in a refrigerator (2°C - 8°C).
Keep in the original packaging to protect the medicine from light. Once removed from the refrigerator, the medicine in the sealed pouch may be returned to the refrigerator (the number of temperature excursions must not exceed three) and stored for subsequent use, provided that it has been kept in total for no more than 72 hours below 40°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and pouch after the word "Exp". The expiry date refers to the last day of that month.
Each syringe is individually packaged.
Do not use this medicine if the packaging or pouch is damaged or open.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ipstyl contains

• The active substance is lanreotide. Each pre-filled syringe contains a supersaturated solution of lanreotide acetate equivalent to 0.246 mg of lanreotide base per mg of solution, ensuring the administration of 60 mg, 90 mg, or 120 mg of lanreotide, respectively.
• The other components are water for injections and glacial acetic acid (to adjust pH).

Description of the appearance of Ipstyl and contents of the pack
Ipstyl is a dense injectable solution available in a ready-to-use pre-filled syringe containing 60 mg, 90 mg, or 120 mg of lanreotide acetate.
The pre-filled syringe, equipped with an automatic safety system, contains a solution for subcutaneous use.
Each pre-filled syringe is packaged in a laminated pouch and a cardboard box.
The pack contains one 0.5 ml syringe with automatic safety system with attached needle (1.20 mm x 20 mm).

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
IPSEN S.p.A.
Via Vittor Pisani n. 22
20124 Milan, Italy

Manufacturer
Ipsen Pharma Biotech S.A.S,
Parc d'Activités du Plateau de Signes
Chemin Départemental n. 402
83870 Signes (France)

Detailed and updated information on this medicinal product is available by scanning the QR code on the outer packaging with a smartphone. The same information is also available at the following URL: http://qr-ipsen.it/t2vb12y/