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

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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. Package contents 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. Excessive amounts of growth hormone cause 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 acromegaly treatment (surgical or radiotherapy) are contraindicated or ineffective;
• after radiotherapy, during the transition 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); Excessive amounts of thyroid-stimulating hormone (TSH) lead to hyperthyroidism. Okteva is used in patients with pituitary tumors that secrete too much thyroid-stimulating hormone (TSH):
• when other types of treatment (surgical or radiotherapy) are inappropriate or ineffective;
• after radiotherapy, during the transition period, before radiotherapy achieves its full effectiveness.

2. Important information before using Okteva

Follow the doctor's instructions carefully. They may differ from the information contained in this leaflet.
Read the following information before using Okteva.

When not to use Okteva:

Warnings and precautions

Before starting treatment with Okteva, discuss the following with your doctor:

Tests and check-ups

If the patient is being treated with Okteva for a long time, the doctor may order periodic thyroid function tests.
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

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Okteva may only be used during pregnancy if absolutely necessary.
Women of childbearing age should use effective contraception during treatment.
Do not breastfeed while using Okteva. It is not known whether Okteva passes into breast milk.

Driving and using machines

Okteva has no or negligible influence on the ability to drive and use machines. However, certain side effects that may occur during Okteva treatment, 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 only be administered 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

No life-threatening reactions have been reported after Okteva overdose.
Symptoms of overdose include: hot flashes, frequent urination, fatigue, depression, anxiety, and lack of concentration.
If an overdose is suspected and the patient experiences the above symptoms, they should inform their doctor immediately.

Missing a dose of Okteva

If an injection is missed, 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, do not stop using Okteva without consulting a doctor.
If you have any further doubts about using this medicine, consult a doctor, nurse, or pharmacist.

4. Possible side effects

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

Some side effects may be serious. Inform 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
• Gallbladder inflammation; 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

• Allergic reactions (hypersensitivity), including skin rash
• A type of allergic reaction (anaphylaxis), which can cause difficulty swallowing or breathing, swelling, and tingling, with possible low blood pressure, dizziness, or loss of consciousness.
• Pancreatitis; symptoms may include sudden abdominal pain, 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 excessive bleeding or bruising.

If the patient notices any of the above symptoms, they should inform their doctor immediately.

Other side effects:

If the patient notices any of the following side effects, they should inform their doctor, pharmacist, or nurse. These side 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 full in the stomach
• Fatty stools
• Loose stools
• Discoloration of stools
• Dizziness
• Lack of appetite
• Changes in liver function tests
• Hair loss
• Shortness of breath
• Weakness

If any side effects occur, inform your doctor, nurse, or pharmacist.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
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

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Store in a 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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).
• Other ingredients are: in the powder (vial): copolymer of D,L-lactic acid 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 seal 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 seal 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, 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 for healthcare professionals only:

What dose of Okteva to use

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 administration. Then, the dose should be adjusted based on growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels and clinical symptoms.
For patients who, after 3 months, have not fully controlled clinical symptoms and biochemical parameters (GH; IGF-1), the dose of Okteva may be increased to 30 mg every 4 weeks. If, after another 3 months, GH, IGF-1, and/or other symptoms are still not adequately controlled while receiving a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks.
For patients who have a GH level consistently below 1 microgram/l and normalized IGF-1 levels, and whose fastest-relapsing symptoms of acromegaly have regressed after 3 months of treatment with a dose of 20 mg, Okteva may be administered at a dose of 10 mg every 4 weeks. However, especially in this group of patients, close monitoring of treatment efficacy by measuring GH and IGF-1 levels and assessing clinical symptoms is recommended during treatment with this lower dose of Okteva.
For patients receiving a fixed dose of Okteva, GH and IGF-1 levels should be determined every 6 months.
Hormone-producing tumors of the stomach, intestines, and pancreas

• Treatment of patients with symptoms associated with hormone-producing 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 administration of Okteva.
For 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.
For 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 stomach, intestinal, and pancreatic tumors are exacerbated, it is recommended to administer additional subcutaneous octreotide at the dose used before Okteva was introduced. This may occur especially during the first 2 months of treatment, before therapeutic levels of octreotide are achieved.

• Treatment of patients with advanced neuroendocrine tumors originating from the midgut or with an unknown primary tumor, in whom a primary tumor 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 and continued for 3 months before possible dose adjustment. Then, the dose can be adjusted based on TSH and thyroid hormone secretion.

Instructions for preparation and administration of 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 injection
Follow the instructions below to properly reconstitute Okteva before administration by deep intramuscular injection into the buttock.
Three critical requirements must be met for proper reconstitution.

Failure to meet these requirements may result in improper administration.

• The injection kit must reach room temperature.Remove the injection kit from the refrigerator and let it sit at room temperature for at least 30 minutes before reconstitution, but no longer than 24 hours.
• After adding the solvent, let the vial sit for 5 minutes to ensure complete dissolution of the powder.
• After dissolution, 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 transfer all the solvent into the vial.

Step 4

IMPORTANT: It is crucial to let the vial sit for 5 minutes to

ensure complete dissolution of the powder.
NOTE: The plunger may move back up due to slight overpressure in the vial, which is normal.
At this stage, 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 to form a uniform suspension(a homogeneous milky suspension). If some powder does not dissolve,

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 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 bring any visible air bubbles to the top, and then expel them from the syringe. Proceed immediatelyto Step 8. Any delay may cause sediment to form.

Step 8

• Okteva must be administered

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 two 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: Record the injection site on the patient's card, changing it every month.
• Discard the syringe immediately (into an appropriate sharps disposal container).