Octreotide Bioindustria L.I.M.: detailed information

Package leaflet: Information for the user

OCTREOTIDE Bioindustria L.I.M. 0.05 mg/1 ml injectable solution or

concentrate for solution for infusion
OCTREOTIDE Bioindustria L.I.M. 0.1 mg/1 ml injectable solution or
concentrate for solution for infusion
OCTREOTIDE Bioindustria L.I.M. 0.5 mg/1 ml injectable solution or
concentrate for solution for infusion
OCTREOTIDE Bioindustria L.I.M. 1 mg/5 ml injectable solution or
concentrate for solution for infusion
octreotide
Generic Medicine
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 give it to other people, even if their symptoms are the same as yours, as it may 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:

What OCTREOTIDE Bioindustria L.I.M. is and what it is used for
What you need to know before using OCTREOTIDE Bioindustria L.I.M.
How to use OCTREOTIDE Bioindustria L.I.M.
Possible side effects
How to store OCTREOTIDE Bioindustria L.I.M.
Contents of the pack and other information

1. What OCTREOTIDE Bioindustria L.I.M. is and what it is used for

OCTREOTIDE Bioindustria L.I.M. is a medicine whose active substance is octreotide, a compound similar to somatostatin. Somatostatin is naturally present in the human body, where it inhibits the release of certain hormones such as growth hormone. The advantages of OCTREOTIDE Bioindustria L.I.M. compared to somatostatin are that it is more potent and its action lasts longer. This medicine is indicated for:

relieving symptoms associated with certain gastrointestinal 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 causes a variety of symptoms, such as flushing, diarrhoea, hypotension, skin rashes and weight loss. Treatment with octreotide helps control these symptoms.
in acromegaly, a condition in which the body produces an excessive amount 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, particularly in the hands and feet. OCTREOTIDE Bioindustria L.I.M. significantly reduces the symptoms of acromegaly, including headache, excessive sweating, numbness in the hands and feet, fatigue and joint pain;
to prevent complications following pancreatic surgery. Treatment with octreotide helps reduce the likelihood of complications (e.g. abdominal abscess, pancreatitis) after surgery;
to stop bleeding and prevent re-bleeding from gastro-oesophageal variceal rupture in patients with cirrhosis (chronic liver disease). Treatment with OCTREOTIDE Bioindustria L.I.M. helps control bleeding and reduce the need for blood transfusions.
for the treatment of pituitary adenomas that produce excessive amounts of thyroid-stimulating hormone (TSH). Excess thyroid-stimulating hormone (TSH) leads to hyperthyroidism. OCTREOTIDE Bioindustria L.I.M. is used to treat patients with pituitary tumours producing 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 achieve its full effect.

2. What you need to know before using OCTREOTIDE Bioindustria L.I.M.

Do not take OCTREOTIDE Bioindustria L.I.M.:

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 or nurse before you are given OCTREOTIDE Bioindustria L.I.M.:
if you know you have gallstones, have had them in the past, or if complications such as fever, chills, abdominal pain, or yellowing of the skin or eyes occur; inform your doctor, as prolonged use of OCTREOTIDE Bioindustria L.I.M. may lead to gallstone formation. Your doctor may ask you to have periodic gallbladder checks;
if you know you have problems with blood sugar levels, either too high (diabetes) or too low (hypoglycemia). When OCTREOTIDE Bioindustria L.I.M. is used to treat gastro-oesophageal variceal bleeding, blood sugar levels must be monitored;
if you have previously experienced episodes of vitamin B12 deficiency, your doctor may ask you to monitor your vitamin B12 levels;
octreotide may reduce heart rate and, at very high doses, may cause an irregular heart rhythm. Your doctor may monitor your heart rate during treatment.

Tests and monitoring
If you are receiving long-term treatment with OCTREOTIDE Bioindustria L.I.M., your doctor may
ask you to have periodic checks of thyroid function.
Your doctor may want to monitor your pancreatic enzymatic function.
Your doctor will check liver function.
Children
Experience with the use of OCTREOTIDE Bioindustria L.I.M. in children is limited.
Other medicines and OCTREOTIDE Bioindustria L.I.M.
Inform 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 OCTREOTIDE
Bioindustria L.I.M.
However, it has been reported that OCTREOTIDE Bioindustria L.I.M. may interact with certain drugs,
such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine.
If you are taking medicines to control blood pressure (such as beta-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.
If you are about to receive lutetium (Lu) oxodotreotide, a radiopharmaceutical therapy, your doctor may
interrupt and/or modify your treatment with OCTREOTIDE Bioindustria L.I.M.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or nurse before using this medicine.
OCTREOTIDE Bioindustria L.I.M. may be used during pregnancy only if clearly necessary.
Women of childbearing potential should use adequate contraception during treatment.
Women must not breastfeed during treatment with OCTREOTIDE Bioindustria L.I.M.
It is not known whether OCTREOTIDE Bioindustria L.I.M. is excreted in human breast milk.
Driving and using machines
OCTREOTIDE Bioindustria L.I.M. does not affect or affects negligibly the ability to drive
vehicles or operate machinery. However, during treatment with OCTREOTIDE Bioindustria
L.I.M., certain side effects such as headache and fatigue may occur, which could impair
your ability to drive or use machinery safely.
OCTREOTIDE Bioindustria L.I.M. contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is practically "sodium-free".

3. How to use OCTREOTIDE Bioindustria L.I.M.

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, OCTREOTIDE Bioindustria L.I.M. 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 the maintenance dose.
Your doctor or nurse will explain how to inject OCTREOTIDE Bioindustria L.I.M. under the skin; however, 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 different site for each subcutaneous injection to avoid irritating any specific area.
Patients who are to perform subcutaneous injections themselves 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 may bring it to room temperature by holding it in your hands, but do not heat it.
A few people may experience pain at the subcutaneous 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 the OCTREOTIDE Bioindustria L.I.M. vial, check for the presence of particles or changes in color. Do not use if anything unusual is observed.
To avoid contamination, the stopper of multidose vials should not be punctured more than 10 times.

If you use more OCTREOTIDE Bioindustria L.I.M. than you should
Symptoms of overdose may include: irregular heartbeat, low blood pressure, cardiac arrest, reduced oxygen supply to the brain, severe upper abdominal pain, yellowing of the skin and eyes, nausea, loss of appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, abdominal swelling, malaise, high blood lactate levels, and irregular heart rhythm.
If you think you are experiencing symptoms of an overdose, inform your doctor immediately.

If you forget to take OCTREOTIDE Bioindustria L.I.M.
Take the missed dose as soon as you remember, then continue your treatment as usual. Skipping a dose is unlikely to cause serious consequences, but you may experience a temporary return of symptoms until treatment resumes normally.
Do not inject a double dose of OCTREOTIDE Bioindustria L.I.M. to make up for a forgotten dose.

If you stop using OCTREOTIDE Bioindustria L.I.M.
If treatment with OCTREOTIDE Bioindustria L.I.M. is stopped, symptoms may return.
Therefore, do not discontinue treatment with OCTREOTIDE Bioindustria L.I.M. 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. Inform 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;
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, low urine output, dark urine, flushed and dry skin;
Fast heartbeat.

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 feeling of malaise, itching, pale-coloured urine;
Irregular heartbeat;
Low platelet count in the blood; this may lead to increased bleeding or bruising. Inform your doctor immediately if you notice any of the above side effects.

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 as treatment continues.
Very common (may affect more than 1 in 10 users):

Diarrhoea;
Abdominal pain;
Nausea;
Constipation;
Flatulence;
Headache;
Local injection site pain.

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

Stomach discomfort after meals (dyspepsia);
Vomiting;
Feeling of stomach fullness;
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 experience pain at the subcutaneous 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.
If you are taking OCTREOTIDE Bioindustria L.I.M. 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 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 the website: 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 OCTREOTIDE Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
For long-term storage, both vials and cartridges must be stored at a temperature between 2°C and 8°C.
Store in the original packaging to protect from light.
During daily use, store below 25°C for a period of 2 weeks.
Cartridge: do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What OCTREOTIDE Bioindustria L.I.M. 0.05 mg/1ml injectable solution or concentrate for
infusion solution contains

The active substance is octreotide. One 1 ml vial contains octreotide acetate equivalent to 0.05 mg of octreotide.
The other components are: lactic acid, mannitol, sodium hydrogen carbonate, water for injections.

What OCTREOTIDE Bioindustria L.I.M. 0.1 mg/1ml injectable solution or concentrate for
infusion solution contains

The active substance is octreotide. One 1 ml vial contains octreotide acetate equivalent to 0.1 mg of octreotide.
The other components are: lactic acid, mannitol, sodium hydrogen carbonate, water for injections.

What OCTREOTIDE Bioindustria L.I.M. 0.5 mg/1ml injectable solution or concentrate for
infusion solution contains

The active substance is octreotide. One 1 ml vial contains octreotide acetate equivalent to 0.5 mg of octreotide.
The other components are: lactic acid, mannitol, sodium hydrogen carbonate, water for injections.

What OCTREOTIDE Bioindustria L.I.M. 1 mg/5ml injectable solution or concentrate for
infusion solution contains

The active substance is octreotide. One 5 ml vial contains octreotide acetate equivalent to 1 mg of octreotide.
The other components are: lactic acid, phenol, mannitol, sodium hydrogen carbonate, water for injections.

Description of the appearance of OCTREOTIDE Bioindustria L.I.M. and contents of the pack

OCTREOTIDE Bioindustria L.I.M. 0.05 mg/1ml, 0.1 mg/1ml and 0.5 mg/ml: 10 vials of 1 ml.
OCTREOTIDE Bioindustria L.I.M. 1 mg/5ml: 1 vial of 5 ml.

Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
via De Ambrosiis 2, 15067 Novi Ligure (AL) - Italy

The following information is intended exclusively for physicians or healthcare professionals

Dosage and Administration
Gastro-entero-pancreatic endocrine tumors
Begin with a dose of 0.05 mg once or twice daily by subcutaneous route.
Depending on the clinical response, effect on tumor hormone levels (in carcinoid tumors, urinary 5-hydroxyindoleacetic acid concentrations), and tolerability, the dosage may be gradually increased to 0.1–0.2 mg three times daily. In exceptional cases, higher doses may be required. Maintenance doses should be individually adjusted for each patient.
In carcinoid tumors, treatment should be discontinued if no benefit is observed within one week of initiating therapy with OCTREOTIDE Bioindustria L.I.M. at the maximum tolerated dose.

Pancreatic function
Exocrine pancreatic insufficiency (EPI) has been observed in some patients receiving octreotide for the treatment of gastroenteropancreatic neuroendocrine tumors. Symptoms of EPI may include steatorrhea, loose stools, abdominal bloating, and weight loss. In patients presenting with these symptoms, screening and appropriate treatment for EPI should be considered according to clinical guidelines.

Acromegaly
Initially 0.05–0.1 mg every 8–12 hours by subcutaneous route. Dose adjustments should be based on monthly monitoring of plasma GH and IGF-1 levels (reference values: GH < 2.5 ng/mL; IGF-1 within normal range), clinical symptoms, and tolerability. In most patients, the optimal daily dose is 0.3 mg. The maximum daily dose of 1.5 mg must not be exceeded. In patients on stable OCTREOTIDE Bioindustria L.I.M. dosage, GH and IGF-1 levels should be monitored every 6 months.
If, within 3 months of treatment with OCTREOTIDE Bioindustria L.I.M., there is no significant reduction in GH levels and no improvement in clinical symptoms, therapy should be discontinued.

Complications following pancreatic surgery
0.1 mg three times daily by subcutaneous route for 7 consecutive days, starting on the day of surgery at least one hour before laparotomy.

Gastro-oesophageal variceal bleeding
The recommended dosage is 25 micrograms/hour administered as a continuous intravenous infusion for 5 days.
Blood glucose levels must be monitored during treatment.

Treatment of TSH-secreting pituitary adenomas
The generally most effective dosage is 0.1 mg three times daily by subcutaneous route.
Dosage may be adjusted based on TSH and thyroid hormone responses. At least 5 days of treatment are required to evaluate efficacy.

Use in elderly patients
There is no evidence of reduced tolerability or need for dosage adjustment in elderly patients treated with OCTREOTIDE Bioindustria L.I.M.

Use in children
Experience with octreotide use in children is limited.

Use in patients with impaired hepatic function
In patients with hepatic cirrhosis, the drug's half-life may be prolonged, necessitating adjustment of the maintenance dosage.

Use in patients with impaired renal function
Impaired renal function does not affect total exposure (calculated as Area Under the Concentration-time Curve or AUC) to subcutaneously administered octreotide; therefore, no dose adjustment of octreotide is required.

Incompatibilities
Octreotide acetate is not stable in total parenteral nutrition (TPN) solutions.

Special precautions for disposal and handling
Subcutaneous administration: Medical or nursing staff must adequately instruct patients who wish to self-administer subcutaneous injections. For better local tolerability, it is recommended to administer the solution at room temperature and avoid repeated injections in close proximity within limited areas. Vials should be opened immediately before administration, and any unused portion must be discarded. From a microbiological standpoint, the product should be used immediately. In the case of vials, if used for multiple withdrawals, the conditions of use are the responsibility of the user, who must take all necessary precautions to prevent contamination.

Intravenous infusion administration: Visually inspect the medicinal product before administration for changes in color or presence of particles. Do not use if anything unusual is observed. For intravenous infusion, dilute the product prior to administration.
OCTREOTIDE Bioindustria L.I.M. (octreotide acetate) is physically and chemically stable for 24 hours in physiological saline solution.
From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, the times and conditions of use are the responsibility of the user.
The contents of a 0.5 mg vial must be dissolved in 60 mL of physiological saline, and the resulting solution should be administered using an infusion pump. This procedure must be repeated as frequently as necessary for the prescribed duration of treatment.

For further information, consult the Summary of Product Characteristics.

Octreotide Bioindustria L.I.M.