Treoject

Package leaflet: Information for the patient

Treoject 50 micrograms/ml, injectable solution in pre-filled syringe, 100 micrograms/ml, injectable solution in pre-filled syringe, 500 micrograms/ml, injectable solution in pre-filled syringe

octreotide
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• 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 Treoject is and what it is used for
2. What you need to know before using Treoject
3. How to use Treoject
4. Possible side effects
5. How to store Treoject
6. Contents of the pack and other information

1. What Treoject is and what it is used for

Treoject is a synthetic analogue of somatostatin. Somatostatin is naturally present in the human body, where it inhibits the release of certain hormones such as growth hormone. The advantages of Treoject over somatostatin are that it is more potent and has a longer duration of action.
Treoject is used

• in the treatment of acromegaly, a condition in which the body produces excessive amounts of growth hormone. Normally, growth hormone regulates the growth of tissues, organs, and bones. When present in excessive amounts, it causes an increase in the size of bones and tissues, especially in the hands and feet. Treoject significantly reduces the symptoms of acromegaly, including headache, excessive sweating, numbness in the hands and feet, fatigue, and joint pain.

• to relieve symptoms associated with certain gastrointestinal tract tumours (e.g. carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions, there is excessive production of specific hormones and other related substances in the stomach, intestine, or pancreas. This overproduction disrupts the body's natural hormonal balance and leads to a variety of symptoms such as flushing, diarrhoea, hypotension, skin rashes, and weight loss.
  Treatment with Treoject helps control these symptoms.

• to prevent complications following pancreatic surgery. Treatment with Treoject helps reduce the likelihood of complications (e.g. abdominal abscess, inflammation of the pancreas) after surgery.

• to stop bleeding and prevent re-bleeding from gastro-oesophageal variceal rupture in patients with cirrhosis (chronic liver disease). Treatment with Treoject helps control bleeding and reduces the need for blood transfusions.

• to treat pituitary adenomas that produce excessive amounts of thyroid-stimulating hormone (TSH). Excess thyroid-stimulating hormone (TSH) leads to hyperthyroidism. Treoject is used to treat patients with pituitary tumours that produce too much thyroid-stimulating hormone (TSH):

• when other treatments (surgery or radiotherapy) are not indicated or have not been effective;

• after radiotherapy, to cover the period required for radiotherapy to reach its maximum effectiveness.

2. What you need to know before taking Treoject

Do not take Treoject

• if you are allergic to octreotide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Treoject:

• if you know you have gallstones, or have had them in the past; inform your doctor, as prolonged use of Treoject may lead to gallstone formation. Your doctor may ask you to have periodic gallbladder examinations.
• if you know you have blood sugar problems, either too high (diabetes) or too low (hypoglycemia). When Treoject is used to treat gastro-oesophageal variceal bleeding, blood sugar levels must be monitored.
• if you have previously experienced episodes of vitamin B deficiency, your doctor may ask you to periodically monitor your vitamin B levels.

Tests and monitoring
If you are receiving Treoject treatment for a prolonged period, your doctor may ask you to have periodic checks of thyroid function.
Your doctor will monitor liver function.
Children
Experience with the use of Treoject in children is limited.
Other medicines and Treoject
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In general, you can continue taking other medicines while being treated with Treoject. However, it has been reported that Treoject may interact with certain drugs, such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine.
If you are taking medicines to control blood pressure (such as β-blockers or calcium antagonists) or agents to control fluid and electrolyte balance, your doctor may decide to adjust the dosage.
If you are diabetic, your doctor may decide to adjust your insulin dosage.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Treoject may be used during pregnancy only if clearly necessary.
Women of childbearing potential must use adequate contraception during treatment.
Women must not breastfeed during treatment with Treoject. It is not known whether Treoject is excreted in human milk.
Driving and using machines
Treoject does not affect or affects negligibly the ability to drive or use machines. However, during treatment with Treoject, some side effects such as headache and fatigue may occur, which could reduce your ability to drive or use machines safely.
Treoject contains sodium
Treoject contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically “sodium-free”.

3. How to take Treoject

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Depending on the condition being treated, Treoject may be administered as:

• a subcutaneous injection (under the skin), or
• an intravenous infusion (into a vein).

If you are a patient with cirrhosis (chronic liver disease), your doctor may need to adjust your maintenance dose.
Your doctor or nurse will explain how to inject Treoject under the skin, but intravenous infusion must always be performed by a healthcare professional.

• Subcutaneous injection

The most suitable sites for subcutaneous injection are the arms, thighs, and abdomen.
Choose a new injection site for each subcutaneous injection to avoid irritating any particular area. Patients who wish to self-inject must receive clear instructions from their doctor or nurse.
If you store the medicine in the refrigerator, it is recommended to bring it to room temperature before use. This reduces the risk of injection site pain.
You can bring it to room temperature by holding it in your hands, but do not heat it.
A few people may experience pain at the injection site. This pain usually lasts only a short time. If this occurs, it can be relieved by gently massaging the injection site for a few seconds afterwards.
Before using Treoject, check for the presence of particles or changes in colour.
Do not use if anything unusual is observed.

• If you take more Treoject than you should

No life-threatening reactions have been reported following overdose with Treoject.
Symptoms of overdose include: irregular heartbeat, low blood pressure, cardiac arrest, reduced oxygen supply to the brain, severe pain in the upper stomach, yellowing of the skin and eyes, nausea, loss of appetite, diarrhoea, weakness, fatigue, lack of energy, weight loss, abdominal swelling, malaise, and high levels of lactic acid in the blood.
If you think you have symptoms of an overdose, inform your doctor immediately.

• If you forget to take Treoject

Take the missed dose as soon as you remember, then continue your treatment as usual.
If you miss a dose, there will be no serious consequences, but you may experience a temporary return of symptoms until treatment is resumed.
Do not inject a double dose of Treoject to make up for a forgotten dose.

• If you stop using Treoject

If you stop treatment with Treoject, symptoms may return. Therefore, do not stop treatment with Treoject unless instructed by your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious. Contact your doctor immediately if you experience any of the following:
Very common (may affect more than 1 in 10 users):

• Gallstones, which may cause sudden back pain.
• High blood sugar levels.

Common (may affect up to 1 in 10 users):

• Decreased thyroid activity (hypothyroidism), with changes in heart rate, appetite, or weight, fatigue, feeling cold, or swelling in the front of the neck.
• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right part of the abdomen, fever, nausea, yellowing of the skin and eyes (jaundice).
• Low blood sugar.
• Impaired glucose tolerance.
• Slow heart rate.

Uncommon (may affect up to 1 in 100 users):

• Thirst, reduced urination, dark urine, flushed and dry skin.
• Fast heart rate.

Other serious side effects

• Hypersensitivity reactions (allergy), including skin rash. A type of allergic reaction (anaphylaxis) that may cause difficulty swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure leading to dizziness or loss of consciousness.
• Inflammation of the pancreas (pancreatitis); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhoea.
• Inflammation of the liver (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching, pale-coloured urine.
• Irregular heartbeat.
• Low platelet count in the blood; this may lead to increased bleeding or bruising.

Contact your doctor immediately if you notice any of the side effects listed above.
Other side effects:
Inform your doctor, pharmacist, or nurse if you notice any of the following side effects. These are usually mild in intensity and tend to disappear with continued treatment.
Very common (may affect more than 1 in 10 users):

• Diarrhoea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence.
• Headache.
• Injection site reaction (local pain at the injection site).

Common (may affect up to 1 in 10 users):

• Stomach discomfort after meals (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Soft stools.
• Pale stools.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.

If you experience any of these side effects, inform your doctor, nurse, or pharmacist.
A small number of people may experience pain at the site of subcutaneous injection. This pain usually lasts only a short time. If this occurs, it can be relieved by gently massaging the injection site for a few seconds.
If you are taking Treoject for subcutaneous injection, avoid injecting close to mealtimes, as this may help reduce the risk of gastrointestinal side effects. It is therefore recommended to administer the injection between meals or at bedtime.
Reporting of side effects
If you experience any side effects, 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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Treoject

Store in the refrigerator (2°C - 8°C).
During daily use, the product may be stored at temperatures below 30°C for a period of 30 days.
Do not freeze. Keep in the original packaging to protect the medicine from light.
After dilution in 0.9% sodium chloride, when stored in glass bottles: the chemical and physical stability of the product has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the product should be used immediately.
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 label after "Exp". The expiry date refers to the last day of that month.
Do not use this medicine if you notice any particles or anything unusual.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Other information

What Treoject contains
Each pre-filled syringe with 1 ml of injectable solution contains 50 micrograms of
octreotide as octreotide acetate.
Each pre-filled syringe with 1 ml of injectable solution contains 100 micrograms
of octreotide as octreotide acetate.
Each pre-filled syringe with 1 ml of injectable solution contains 500 micrograms
of octreotide as octreotide acetate.
The active substance is octreotide as octreotide acetate.
The excipients are: (S)-lactic acid, sodium chloride, sodium hydroxide and water for
injectable preparations.

Description of the appearance of Treoject and contents of the pack
The medicine is available in pre-filled syringes containing 1 ml of a clear, colourless injectable solution.
Packs of 5, 6 or 10 pre-filled syringes in white, opaque PVC thermoformed blisters sealed with an aluminium foil.
Multiple packs of 20 (2 x 10) and 30 (3 x 10) pre-filled syringes in white, opaque PVC thermoformed blisters sealed with an aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Lifepharma S.p.A.
Via dei Lavoratori 54
20092 Cinisello Balsamo (MI)
Italy
Tel. + 39 02 64433019
Fax. + 39 02 66047755
e-mail: [email protected]

Manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milano.
Tel. + 39 02 64431
Fax. + 39 02 644346
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area with the following names:
Italy: Treoject 50 - 100 – 500 - microgrammes/ml solution for injection in pre-filled syringe
Belgium: Siroctid 50 -100 - 500 microgram/ml oplossing voor injectie in een voorgevulde spuit
Netherlands: Siroctid 50 - 100 - 500 microgram/ml oplossing voor injectie, in voorgevulde spuit

The following information is intended exclusively for physicians or healthcare professionals:
The following is an extract from the SmPC and should be used for correct administration of Treoject.

• For parenteral use only: subcutaneous (SC) or intravenous (IV).

Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep pre-filled syringes in the blister and outer packaging to protect from light.

Usage:
To reduce injection site discomfort, allow the solution to reach room temperature before administration. Avoid repeated injections at short intervals into the same injection site.
Before administration, the solution should be inspected visually for any discoloration or presence of particles.
Do not use unless the solution is clear and free from visible solid particles.

• Intravenous infusion (for healthcare professionals)

When Treoject is to be administered by intravenous infusion, the contents of a 500 microgram pre-filled syringe must be diluted in 60 mL of physiological saline and the resulting solution administered using an infusion pump. This procedure must be repeated as frequently as required for the prescribed duration of treatment.

Disposal:
Any unused solution or material (or material that has been in contact) with Treoject injectable solution must be disposed of in accordance with local regulations for injectable waste.

Dosage of Treoject to be used
The dose of Treoject depends on the condition being treated.

• Acromegaly Treatment is usually initiated at 0.05–0.1 mg every 8 or 12 hours by subcutaneous route. The dose may subsequently be adjusted based on therapeutic effects and symptom control (such as fatigue, sweating and headache). In most patients, the optimal daily dose is 0.1 mg three times daily. A maximum daily dose of 1.5 mg should not be exceeded.

• Gastrointestinal tract tumours Treatment is usually initiated at a dose of 0.05 mg once or twice daily by subcutaneous injection. Based on response and tolerability, the dose may be gradually increased to 0.1–0.2 mg three times daily. In carcinoid tumours, treatment should be discontinued if no benefit is observed after 1 week of treatment at the maximum tolerated dose.

• Complications following pancreatic surgery The usual dosage is 0.1 mg three times daily by subcutaneous route for 1 week, starting at least 1 hour before surgery.

• Gastro-oesophageal variceal bleeding The recommended dosage is 25 micrograms/hour by continuous intravenous infusion for 5 days. During treatment, blood glucose levels must be monitored.

• Treatment of TSH-secreting pituitary adenomas The generally most effective dosage is 100 micrograms three times daily by subcutaneous injection. The dose may be adjusted according to TSH and thyroid hormone responses. At least 5 days of treatment are required to assess efficacy.