Oczyesa XR: Uses, Side Effects and Dosage

What OCZYESA XR is used for:

OCZYESA XR is used for maintenance treatment in adults with acromegaly. Acromegaly is a condition where the body produces too much growth hormone. It is used in patients who have tolerated and responded to medicines like somatostatin.

How OCZYESA XR works:

People with acromegaly usually have a non-cancerous tumor in the pituitary gland (a part of the brain that produces hormones). The tumor causes the body to produce too much growth hormones, which in turn increases the levels of another hormone called IGF-1. This leads symptoms such as: enlargement of bones and other organs, headache, excessive sweating, numbness in the hands and feet, tiredness and joint pain.

OCZYESA XR works by blocking the release of growth hormone. This can help relieve these symptoms.

The ingredients in OCZYESA XR are:

Medicinal ingredient: octreotide (as octreotide hydrochloride)

Non-medicinal ingredients: edetic acid; ethanol, anhydrous; ethanolamine; glycerol dioleate; propylene glycol; soybean phosphatidylcholine

OCZYESA XR comes in the following dosage form:

Extended-release solution: 20 mg/mL

Do not use OCZYESA XR if:

• you are allergic to octreotide or any of the other ingredients of OCZYESA XR or its container.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OCZYESA XR. Talk about any health conditions or problems you may have, including if you:

• have heart problems. OCZYESA XR can affect the rate and regularity of your heartbeat.
• have gallbladder problems. Using OCZYESA XR for a long time can cause gallstones to form.
• have diabetes. OCZYESA XR may affect your blood sugar. If you are being treated with insulin, your doses may need to be reduced during treatment with OCZYESA XR.
• have ever had lack of vitamin B12.
• have kidneys problems and require dialysis.
• have liver problems, such as liver cirrhosis (scarring of the liver).
• you are 65 years of age or older. You may be at a higher risk of serious side effects.

Other warnings you should know about:

• Female patients

  Birth control and pregnancy

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your healthcare professional before taking OCZYESA XR. There are specific risks you should discuss with your healthcare professional.
  • If you are pregnant, avoid the use of OCZYESA XR. It is not known if OCZYESA XR may harm your unborn baby.
  • You should use effective birth control during treatment to avoid getting pregnant. Ask your healthcare professional for advice on the birth control methods that may be right for you.

Breastfeeding

• Do NOT breastfeed during treatment with OCZYESA XR It is not known if OCZYESA XR passes through breast milk.
• Talk to your healthcare professional about the best way to feed your baby during your treatment with OCZYESA XR.
• Check ups and testing

• You will have regular visits with your healthcare professional before and during treatment to monitor your health. They will:

  • Do blood tests to check growth hormone levels
  • Check your liver function during treatment
  • Check your thyroid function if you are treated with OCZYESA XR over a long period of time.
  • Check for heart problems through ECG (electrocardiogram) tests
  • Monitor for growth of tumors of the pituitary gland. This can cause serious complications, such as visual problems.
• Changes in blood sugar levels
• OCZYESA XR may affect your blood sugar. This may cause hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).
• When OCZYESA XR is used for a long time, your blood sugar levels may remain elevated.
• If you have diabetes, your healthcare professional may recommend regular monitoring your blood sugar levels. They may also change your dose of your diabetes drugs (such as insulin) during treatment with OCZYESA XR.
• Nutrition

• OCZYESA XR may:

  • affect your ability to absorb dietary fat.
  • lower vitamin B12 levels. Your healthcare professional will monitor your vitamin B12 levels periodically during treatment with OCZYESA XR.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with OCZYESA XR:

• medicines called beta blockers (for example atenolol and metoprolol) and calcium channel blockers (for example amlodipine and verapamil) that are used to treat high blood pressure or heart diseases
• medicines that control your fluid and electrolyte balance
• insulin or other medicines to treat diabetes
• quinidine: a medicine to treat irregular heart rhythm
• terfenadine: a medicine to treat allergic conditions
• cyclosporine: a medicine to suppress transplant rejection, treat severe skin diseases, and severe eye and joint inflammation.
• bromocriptine: a medicine used to treat variety of conditions such as menstrual problems, Parkinson’s Disease
• cimetidine: a medicine used to reduce the amount of acid in your stomach

How to take OCZYESA XR:

• Before you use the pen for the first time, your healthcare professional will show you how to use it. Take OCZYESA XR exactly as your healthcare professional tells you.
• OCZYESA XR must be injected under your skin (subcutaneous injection) only.
• OCZYESA XR should be injected in the belly, thigh or buttock. The injection site should be rotated within or between injection areas.
• Follow the instructions for use detailed in this leaflet.

Usual dose:

The recommended dose of OCZYESA XR is 20 mg once every 4 weeks.

Overdose:

Missed dose:

• If you missed a dose of OCZYESA XR, take it as soon as you remember. In exceptional circumstances, you can take OCZYESA XR up to 1 week before or 1 week after the scheduled 4-week dose.
• If it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule.
• Do NOT take two doses at the same time to make up for a dose you missed.

Possible side effects from using OCZYESA XR:

These are not all the possible side effects you may have when taking OCZYESA XR. If you experience any side effects not listed here, tell your healthcare professional.

• reactions at injection site including pruritus, swelling, mass, bleeding and pain

• fatigue/weakness

  • chest discomfort and pain
  • dizziness
  • stomach pain and pain in upper part of stomach
• diarrhea, fatty stools, loose stools
• nausea, vomiting
• abdominal bloating, flatulence
• indigestion
• inflammation of stomach lining
• constipation
• weight gain or loss
• joint pain, joint swelling
• headache/migraine
• depression

• excessive sweating and night sweats

  • hair loss
  • dehydration
  • vertigo (sense of spinning dizziness)
  • furuncle (pus-filled bump under skin)
  • abnormal uterine bleeding, postmenopausal bleeding
  • breast mass
  • altered mental status
  • sleeping difficulties
  • bruise

Treatment with OCZYESA XR may cause abnormal blood test results. This may include changes in thyroid function tests, liver function tests, changes of amylase, changes in blood fats, vitamin D and vitamin B12, minerals (calcium, sodium, magnesium), and hemoglobin in blood.

Your healthcare professional will tell you if your blood test results or electrocardiogram are abnormal and if you need treatment to correct these side effects.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

• Store at room temperature (15°C to 30°C). Do NOT refrigerate. OCZYESA XR should be protected from oxygen and light and be stored in the original package.
• Keep out of reach and sight of children.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements

If you want more information about OCZYESA XR:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling +1 (888) 668-2713

Imported and distributed by:

Progress Therapeutics Inc.

14-320 Harry Walker Pkwy., North

Newmarket, ON

L3Y 7B4

Date of Authorization: 2026-10-08

OCZYESA is a registered trademark of Camurus AB.

INSTRUCTIONS FOR USE

^PrOCZYESA^® XR

octreotide extended-release injectable solution

For subcutaneous use

Single use pre-filled pen, (20 mg/mL)

This Instructions for Use contains information on how to inject OCZYESA XR.

Read this Instructions for Use all the way through before using the OCZYESA XR pre-filled pen. Keep this Instructions for Use as you may need to read them again.

Do not inject yourself or someone else until you have been shown how to use the OCZYESA XR pre-filled pen. Your healthcare professional can show you or your caregiver how to prepare and inject a dose of OCZYESA XR before you try to do it for the first time. Call your healthcare professional if you have any questions.

The parts of the OCZYESA XR pre-filled pen before and after use

Before use:

After use:

Note: Packaging contains a small white cylinder, included for storage purposes only. Do not remove!

Important Information You Need to Know Before Injecting OCZYESA XR

• For single use only (do not reuse the OCZYESA XR pre-filled pen).

• For subcutaneous injection only (inject directly into fatty layer under the skin).

  Inspection window

  Needle guard

  Protective cap

  Plunger rod

  Protective cap (removed)

  white cylinder

• Do NOT inject intravascular (into the blood), intradermal (into the skin layer) or intramuscular (into the muscle).
• Do NOT use the OCZYESA XR pre-filled pen after the expiration date shown on the cardboard box, pouch or on the pen label.
• Do NOT use if the OCZYESA XR pre-filled pen appears damaged.
• Do NOT use if the packaging (cardboard box and pouch) or the seal is damaged.
• Do NOT remove the protective cap until you are ready to inject.

Storing the OCZYESA XR pre-filled pen

• Store the OCZYESA XR pre-filled pen at room temperature in the original packaging (cardboard box and unopened pouch) until ready to use.
• Do NOT refrigerate the OCZYESA XR pre-filled pen.
• Keep OCZYESA XR and all medicines out of the reach of children.

Preparing to Inject OCZYESA XR

Step 1. Gather supplies

Find a clean, flat surface to place the following supplies on:

• OCZYESA XR pre-filled pen

• alcohol wipe (not included)

• cotton ball or gauze pad (not included)
• bandage (not included)

• a sharps disposal container (not included) (See Step 10)

  pre-filled pen

  alcohol wipes cotton ball/gauze pad

  bandage

  sharps disposal container

Step 2. Inspect the OCZYESA XR pre-filled pen

• Remove the pouch from the cardboard box. Open the pouch and remove the OCZYESA XR pre-filled pen.

• Check the label to be sure that you have the correct medicine.
• Check the expiration date shown on the cardboard box, the pouch or on the OCZYESA XR pre-filled pen label. Do NOT use the OCZYESA XR pre-filled pen if the expiration date has passed.
• Check that the liquid is yellowish to yellow and clear. You may see an air bubble. This is normal.
• Do NOT use the OCZYESA XR pre-filled pen if the liquid is cloudy or contains visible particles.

Step 3. Wash your hands

• Wash your hands well with soap and water. Dry your hands completely.

Step 4. Choose the injection site

Important: OCZYESA XR must be given by injection under the skin (subcutaneous injection) only.

Do NOT inject OCZYESA XR by any other route of administration.

• Choose an injection area (belly, thigh, or buttock). The injection site should be in an area with enough fatty (subcutaneous) tissue.
• Each injection area can have multiple injection sites.

• You may need help from someone who has been instructed in how to give your injection if you cannot reach certain injection areas.

  Liquid

  Medicine and dose

  Expiration date

• Do NOT inject into skin that is tender, damaged, bruised or scarred.
• Do NOT inject in a recently used injection site in the chosen injection area.
• Do NOT inject within 5 cm of the belly button.

Step 5. Clean the injection site

• Clean the injection site with an alcohol wipe.
• Let the injection site air dry before injecting.
• Do NOT touch the cleaned area again before the injection.

Step 6. Remove and throw away the protective cap

• Hold the OCZYESA XR pre-filled pen pointed up with one hand. With the other hand pull the protective cap straight off. It may take some force to remove. Do NOT wiggle or twist the cap.
• You may see a drop of liquid at the end of the needle. This is normal.
• Do NOT recap. Throw away the protective cap right away.
• Do NOT touch or press the needle guard. This could activate the OCZYESA XR pre-filled pen.

Injecting OCZYESA XR

Step 7. Prepare to start the injection

• Pinch and hold the skin at the injection site between your thumb and fingers. Hold the pinch until the injection is complete.
• With your other hand hold the OCZYESA XR pre-filled pen so that you can see the inspection window.
• Place the OCZYESA XR pre-filled pen straight (at a 90° angle) and flat against the pinched skin.

Step 8. Give the injection

Inject OCZYESA XR by following the steps in figures A, B and C.

• Push the OCZYESA XR pre-filled pen all the way down and hold the OCZYESA XR pre-filled pen against the skin. This will make the needle guard slide up into the OCZYESA XR pre-filled pen.
• You will hear a first click to let you know the injection has started (Figure A).

• The plunger rod will move down through the inspection window.
• Continue to hold the OCZYESA XR pre-filled pen down.
• When you hear the second click, continue to keep the OCZYESA XR pre-filled pen down for an additional 5 seconds (Figures B, C).
• Check that the plunger rod is completely seen in the inspection window.

Step 9. Remove the OCZYESA XR pre-filled pen

• Remove the OCZYESA XR pre-filled pen from the skin. The injection is now completed. Release the pinched skin.
• The needle remains hidden by the needle guard to protect against needle-stick injury.
• You may have a small amount of blood or liquid at the injection site. This is normal. Use a cotton ball or gauze pad on the area and apply a bandage if needed.

• Do NOT rub the injection site.

  A

  B

  C

Dispose of OCZYESA XR pre-filled pen

Step 10. Dispose of the OCZYESA XR pre-filled pen

• Throw away (dispose of) the used OCZYESA XR pre-filled pen in a sharps disposal container right after use.
• Do NOT throw away (dispose of) OCZYESA XR pre-filled pens in your household trash.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Manufactured by:

Camurus AB

Rydbergs torg 4, SE-224 84, Lund

Sweden

Imported and distributed by:

Progress Therapeutics Inc.

14-320 Harry Walker Pkwy., North

Newmarket, ON

L3Y 7B4

OCZYESA® is a registered trademark of Camurus AB

© Camurus AB

Approved: Month/Year