Okteva

Leaflet accompanying the packaging: patient information

Okteva, 10 mg, powder and solvent for prolonged-release suspension for injection

with prolonged release

Okteva, 20 mg, powder and solvent for prolonged-release suspension for injection

Okteva, 30 mg, powder and solvent for prolonged-release suspension for injection

octreotide

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Okteva and what is it used for
• 2. Important information before using Okteva
• 3. How to use Okteva
• 4. Possible side effects
• 5. How to store Okteva
• 6. Contents of the packaging and other information

1. What is Okteva and what is it used for

Okteva is a synthetic derivative of somatostatin, a substance found in the human body, which inhibits the action of certain hormones, such as growth hormone. Okteva acts stronger than somatostatin and its action lasts longer.

Okteva is used

• in the treatment of acromegaly, a disease in which the body produces too much growth hormone. In healthy individuals, growth hormone affects the growth of tissues, organs, and bones. Too much growth hormone causes an increase in the size of bones and tissues, especially hands and feet. Okteva significantly alleviates the symptoms of acromegaly, including headache, excessive sweating, numbness of hands and feet, fatigue, and joint pain. In most cases, excessive production of growth hormone is due to the enlargement of the pituitary gland (pituitary adenoma); treatment with Okteva may reduce the size of the adenoma.

Okteva is used in the treatment of patients with acromegaly:

• in whom other types of treatment for acromegaly (surgical treatment or radiotherapy) are not indicated or are ineffective;
• after radiotherapy, during the transitional period, before the full effect of radiotherapy occurs;
• to alleviate symptoms associated with excessive production of certain specific hormones and other similar substances by the stomach, intestines, and pancreas; Excessive production of hormones and other similar natural substances can be caused by certain rare diseases of the stomach, intestines, or pancreas. This disrupts the body's natural hormonal balance and is the cause of many symptoms, such as facial flushing, diarrhea, low blood pressure, rash, and weight loss. The use of Okteva helps to alleviate these symptoms:
• in the treatment of neuroendocrine tumors located in the intestine (e.g., in the appendix, small intestine, or colon); Neuroendocrine tumors are rare tumors located in different parts of the body. Okteva is also used to inhibit the growth of this type of tumor, if they are located in the intestine (e.g., in the appendix, small intestine, or colon);
• in the treatment of pituitary tumors that secrete too much thyroid-stimulating hormone (TSH); Too much TSH leads to hyperthyroidism. Okteva is used in patients with pituitary tumors that secrete too much TSH:
• when other types of treatment (surgical treatment or radiotherapy) are not suitable or are ineffective;
• after radiotherapy, during the transitional period, before radiotherapy reaches its full effectiveness.

2. Important information before using Okteva

You should follow all the doctor's recommendations. They may differ from the information contained in this leaflet.
You should read the following information before using Okteva.

When not to use Okteva:

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

Warnings and precautions

Before starting treatment with Okteva, you should discuss with your doctor:

• if the patient knows they have or have had gallstones in the past; or if any complications occur, such as fever, chills, abdominal pain, or yellowing of the skin or eyes; you should tell your doctor, as long-term use of Okteva may cause gallstones. The doctor may order periodic gallbladder checks;
• if the patient has diabetes, as Okteva may affect blood sugar levels. If the patient has diabetes, their blood sugar levels should be regularly monitored;
• if the patient has had a decreased level of vitamin B12 in the past, the doctor may order periodic checks of vitamin B12 levels.

Examinations and check-ups

If the patient is being treated with Okteva for a long time, the doctor may order periodic checks of thyroid function.
The doctor will monitor the patient's liver function.
The doctor may order a check of pancreatic enzyme activity.

Children

There is limited experience with the use of Okteva in children.

Okteva and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During treatment with Okteva, you can usually continue taking other medicines.
However, it has been reported that Okteva affects the action of certain medicines, such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine.
If you are taking a medicine to lower your blood pressure (e.g., a beta-blocker or calcium antagonist) or a medicine to maintain water and electrolyte balance, your doctor may adjust the dosage.
In patients with diabetes, it may be necessary to adjust the insulin dose with the doctor.
If you are going to receive lutetium (Lu) oxodotreotide therapy, a radiopharmaceutical treatment, your doctor may interrupt and/or adjust Okteva treatment for a short period.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Okteva may be used during pregnancy only if necessary.
Women of childbearing age should use effective methods of contraception during treatment.
You should not breastfeed while using Okteva. It is not known whether Okteva passes into breast milk.

Driving and using machines

Okteva has no effect or negligible effect on the ability to drive and use machines. However, certain side effects that may occur during treatment with Okteva, such as headache and fatigue, may reduce the patient's ability to drive and use machines safely.

Okteva contains sodium

Okteva contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".

3. How to use Okteva

Okteva should be administered exclusively by deep intramuscular injection into the buttock.
During long-term administration, injections should be performed alternately in the left and right buttock.

Using a higher dose of Okteva than recommended

After an overdose of Okteva, no life-threatening reactions have been reported.
Symptoms of overdose include: hot flashes, frequent urination, fatigue, depression, anxiety, and lack of concentration.
If you feel that an overdose has occurred and the patient is experiencing the above symptoms, you should tell your doctor immediately.

Missing a dose of Okteva

If an injection is not administered at the right time, it should be administered as soon as possible, and then treatment should be continued as before. Administering a dose a few days later is not harmful, but it may cause a temporary recurrence of disease symptoms until the planned treatment schedule is resumed.

Stopping treatment with Okteva

After stopping treatment with Okteva, disease symptoms may recur. Therefore, you should not stop using Okteva without consulting your doctor.
If you have any further doubts about using this medicine, you should consult your doctor, nurse, or pharmacist.

4. Possible side effects

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

Some side effects can be serious. You should tell your doctor immediately if you experience any of the following symptoms:

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

• Gallstones causing sudden back pain
• High blood sugar levels

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

• Hypothyroidism (underactive thyroid) affecting heart rate, appetite, or weight changes; fatigue, feeling cold, or swelling of the front of the neck
• Changes in thyroid function tests
• Cholecystitis; symptoms may include pain in the right upper abdomen, fever, nausea, yellowing of the skin and eyes (jaundice)
• Low blood sugar levels
• Impaired glucose tolerance
• Slow heart rate

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

• Thirst, low urine output, dark urine, dry, reddened skin
• Fast heart rate

Other serious side effects

• Hypersensitivity reactions (allergy), including skin rash
• A type of allergic reaction (anaphylaxis), which can cause difficulty swallowing or breathing, swelling, and tingling, with possible low blood pressure with dizziness or loss of consciousness.
• Pancreatitis; symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea
• Hepatitis; symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching, pale urine
• Irregular heartbeat
• Low platelet count; this can cause increased bleeding or bruising.

If you notice any of the above symptoms, you should tell your doctor immediately.

Other side effects:

If you notice any of the following side effects, you should tell your doctor, pharmacist, or nurse. These effects are usually mild and tend to disappear as treatment progresses.
Very common(may affect more than 1 in 10 people):

• Diarrhea
• Abdominal pain
• Nausea
• Constipation
• Bloating with gas
• Headache
• Pain at the injection site.

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

• Discomfort in the stomach after eating (indigestion)
• Vomiting
• Feeling of fullness in the stomach
• Fatty stools
• Loose stools
• Discoloration of stool
• Dizziness
• Loss of appetite
• Changes in liver function tests
• Hair loss
• Shortness of breath
• Weakness

If you experience any side effects, you should tell your doctor, nurse, or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Okteva

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light.
Store in the refrigerator (2°C – 8°C). Do not freeze.
On the day of injection, Okteva can be stored at a temperature below 25°C.
Do not store Okteva after reconstitution. The prepared suspension must be used immediately.
Do not use this medicine after the expiry date stated on the label and packaging after "EXP" and "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Do not use this medicine if you notice any foreign particles or a change in color.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Okteva contains

• The active substance of Okteva is octreotide. One vial contains 10 mg, 20 mg, or 30 mg of octreotide (as octreotide acetate).
• The other ingredients are: in the powder (vial): copolymer of D,L-lactic and glycolic acid (55:45) and mannitol (E 421), in the solvent (ampoule-syringe): sodium carmellose, mannitol (E 421), poloxamer 188, and water for injections.

What Okteva looks like and contents of the pack

Okteva 10 mg
Each single pack contains: 1 glass vial containing 10 mg of octreotide, closed with a rubber stopper and an aluminum seal with a dark blue flip-off cap, 1 glass ampoule-syringe containing 2 ml of solvent, 1 safety needle for injections, and 1 vial connector or,
3 glass vials containing 10 mg of octreotide, 3 glass ampoule-syringes containing 2 ml of solvent, 3 safety needles for injections, and 3 vial connectors.
Okteva 20 mg
Each single pack contains: 1 glass vial containing 20 mg of octreotide, closed with a rubber stopper and an aluminum cap with an orange flip-off cap, 1 glass ampoule-syringe containing 2 ml of solvent, 1 safety needle for injections, and 1 vial connector or,
3 glass vials containing 20 mg of octreotide, 3 glass ampoule-syringes containing 2 ml of solvent, 3 safety needles for injections, and 3 vial connectors.
Okteva 30 mg
Each single pack contains: 1 glass vial containing 30 mg of octreotide, closed with a rubber stopper and an aluminum cap with a dark red flip-off cap, 1 glass ampoule-syringe containing 2 ml of solvent, 1 safety needle for injections, and 1 vial connector or,
3 glass vials containing 30 mg of octreotide, 3 glass ampoule-syringes containing 2 ml of solvent, 3 safety needles for injections, and 3 vial connectors.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer

PLIVA HRVATSKA d.o.o. (PLIVA CROATIA Ltd.)
Prilaz baruna Filipovića 25
Zagreb 10000
Croatia
Merckle GmbH,
Ludwig-Merckle-Str. 3
Blaubeuren
89143
Germany
Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

To obtain more detailed information about the medicine and its names in other EU member states, you should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:February 2024.
Information intended exclusively for healthcare professionals:

What dose of Okteva should be used

Acromegaly
It is recommended to start treatment with Okteva at a dose of 20 mg every 4 weeks for 3 months. Patients receiving subcutaneous octreotide may start treatment with Okteva the next day after the last subcutaneous octreotide injection. Then, the dose should be adjusted based on the level of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) in the blood, as well as clinical symptoms.
Patients who, after 3 months, have not fully controlled clinical symptoms and biochemical parameters (GH; IGF-1) may have their dose increased to 30 mg every 4 weeks. If, after another 3 months, GH, IGF-1, and/or other symptoms are still not properly controlled while taking a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks.
Patients who have a GH level consistently below 1 microgram/l, and whose IGF-1 blood level has normalized, and whose fastest-relapsing objective and subjective symptoms of acromegaly have regressed after 3 months of treatment with a dose of 20 mg, may be given Okteva at a dose of 10 mg every 4 weeks. However, especially in this group of patients, it is recommended to closely monitor the effectiveness of treatment by measuring GH and IGF-1 levels in the blood and assessing clinical objective and subjective symptoms during treatment with this lower dose of Okteva.
Patients receiving a fixed dose of Okteva should have their GH and IGF-1 levels checked every 6 months.
Hormonally active tumors of the stomach, intestines, and pancreas

• Treatment of patients with symptoms associated with hormonally active neuroendocrine tumors of the stomach, intestines, and pancreas

It is recommended to start treatment with Okteva at a dose of 20 mg every 4 weeks.
Patients receiving subcutaneous octreotide should continue this treatment at the previously effective dose for 2 weeks after the first injection of Okteva.
In patients who, after 3 months of treatment, have experienced satisfactory alleviation of symptoms and improvement in biological markers, the dose of Okteva may be reduced to 10 mg every 4 weeks.
In patients who, after 3 months of treatment, have experienced only partial alleviation of symptoms, the dose of Okteva may be increased to 30 mg every 4 weeks.
On days when, despite treatment with Okteva, symptoms associated with tumors of the stomach, intestines, and pancreas are severe, it is recommended to administer an additional subcutaneous injection of octreotide at the dose used before Okteva was introduced. This may occur especially during the first 2 months of treatment, before the therapeutic level of octreotide is reached.

• Treatment of patients with advanced neuroendocrine tumors originating from the midgut or with an unknown primary tumor site, in whom a primary tumor site not originating from the midgut has been ruled out

The recommended dose of Okteva is 30 mg, administered every 4 weeks. Treatment with Okteva to inhibit tumor growth should be continued in the absence of tumor progression.

• Treatment of TSH-secreting pituitary tumors

Treatment with Okteva should be started at a dose of 20 mg every 4 weeks, continued for 3 months before possible dose adjustment. Then, the dose can be adjusted based on TSH and thyroid hormone secretion.

Instructions for preparing and administering Okteva by deep intramuscular injection

FOR DEEP INTRAMUSCULAR INJECTION ONLY

Kit:

aOne vial containing Okteva powder
bOne ampoule-syringe containing solvent for reconstitution
cOne vial connector for reconstitution
dOne safety needle for injections
You should follow the instructions below to properly reconstitute Okteva before administering a deep intramuscular injection into the buttock.
For proper reconstitution of Okteva, 3 requirements are critical.

Failure to meet these requirements may result in improper administration of the medicine.

• The injection kit must reach room temperature.You should remove the injection kit from the refrigerator and leave it at room temperature for at least 30 minutes before reconstitution, but no longer than 24 hours.
• After adding the solvent, you should leave the vial for 5 minutes to ensure complete dissolution of the powder.
• After dissolution, you should shake the vial moderatelyin a horizontal plane for at least 30 seconds to form a uniform suspension.The Okteva suspension must be prepared immediatelybefore administration.

Okteva can only be administered by trained medical personnel.

Step 1

• Remove the Okteva injection kit from the refrigerator where it was stored.

IMPORTANT: It is crucial to start the reconstitution process only when the injection kit has reached room temperature.

Leave the kit at room temperature for at least 30 minutes before reconstitution, but no longer than 24 hours.

NOTE:The injection kit can be returned to the refrigerator if necessary.

Step 2

• Remove the plastic cap from the vial and wipe the rubber stopper with an alcohol swab.
• Remove the foil covering the vial connector packaging, take out the vial connector, holding it between the white Luer connector and the collar. DO NOT TOUCH the connector ends at any point.
• Place the vial on a flat surface. Put the vial connector on the vial and push it down until it clicks into place.
• Wipe the vial connector end with an alcohol swab.

Step 3

• Remove the cap from the ampoule-syringe containing the solvent and screw the syringe onto the vial connector.
• Slowly push the plunger all the way down to ensure the entire solvent is in the vial.

Step 4

IMPORTANT: It is crucial to leave the vial

for 5 minutesto ensure the powder is completely dissolvedin the solvent.
NOTE: The plunger may be pushed back up due to slight overpressure in the vial, which is normal. At this stage, you should

prepare the patient for injection.

Step 5

• After the powder has dissolved, check that the plunger is pushed all the way down to the bottom of the syringe.

IMPORTANT:Holding the plunger pushed all the way down, gentlyshake the vial horizontallyfor at least30 seconds, untilall the powder has formed a uniform suspension(a homogeneous milky suspension). If some powder does not dissolve,repeat the gentle shaking for another 30 seconds.

Step 6

• Invert the syringe with the vial and slowly pull back the plunger to draw the entire contents of the vial into the syringe.
• Unscrew the syringe from the vial connector.

Step 7

• Prepare the injection site by wiping it with an alcohol swab.
• Screw the safety needle for injections onto the syringe.
• If immediate administration is not possible, gently shake the syringe again to obtain a uniform milky suspension just before administration.
• Remove the protective needle cap with a straight upward motion.
• Gently tap the syringe with your fingers to move any visible air bubbles up, then immediately proceed to Step 8. Any delay may cause sediment to form.

Step 8

• Okteva must be administered

exclusively by deep intramuscular injection into the buttock, NEVER intravenously.

• Insert the entire needle into the left or right buttock at a 90° angle to the skin surface.
• Slowly pull back the plunger to ensure the needle is not in a blood vessel (change the needle position if it is in a blood vessel).
• Slowly, with steady pressure, push the plunger until the syringe is empty. Remove the needle from the injection site and activate the needle protective cap (following the instructions in Step 9).

Step 9

• Activate the needle protective cap using one of the following 2 methods:
• press the folding part of the cap against a hard surface (Figure A)
• or press the folding part of the cap with your finger (Figure B).
• Proper activation will be confirmed by a loud click.
• NOTE: You should record the injection site on the patient's card, changing it every month.
• The syringe should be disposed of immediately (in a suitable sharps container).