Omlyclo® injection

Omlyclo® injection

This product is manufactured by Celltrion Healthcare Canada Ltd using the ingredient omalizumab.

This product is taken via subcutaneous injection.

Why is it prescribed?

Omalizumab is used to decrease the incidence of asthma flare-ups and improve control of asthma symptoms in adults and children over 6 years of age with moderate to severe persistent asthma not well-controlled with inhaled corticosteroids.

  • Omlyclo® is injected just under the skin.
  • Based on your dose, you may need more than one injection (up to four) per dose; these should be given in different areas of the body, but at least 2.5 cm from other injection sites.
  • If taking for asthma, you will probably need to continue taking your current asthma medications during Xolair® treatment but after 16 weeks you may be able to reduce or stop your current asthma medications. Your doctor will discuss this with you. You should not reduce the dose of other asthma medications without first discussing this with your doctor, even if you are feeling better.
  • You will receive Omlyclo® on a regular schedule. Continue receiving Omlyclo® injections even when you are feeling well.
  • Omlyclo® is supplied as a solution in a pre-filled syringe, and as a solution in a pre-filled pen. You or someone else can administer Omlyclo® after the first three doses, which should be given by or under the supervision of your healthcare provider.
    • How to use the pre-filled syringe
      • Remove Omlyclo® from refrigerator and allow it to reach room temperature (about 20-30 minutes).
      • When you are ready to use the syringe, wash your hands thoroughly with soap and water.
      • Clean the injection site with an alcohol swab.
      • Hold the pre-filled syringe by the syringe body in one hand. Gently pull the Cap straight off with the other hand. Do not hold the plunger rod while removing the Cap. You may see a few drops of liquid at the tip of the needle. This is normal.
      • Dispose the cap in a sharps disposal container.
      • Gently pinch a fold of skin at the injection site with one hand. Note: Pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). With a quick and “dart-like” motion, insert the needle completely into the fold of skin at a 45 to 90-degree angle. Do not touch the plunger rod while inserting the needle into the skin.
      • After the needle is inserted, release the pinch. Slowly push the plunger rod all the way down until the full dose of medicine gets injected, and the syringe is empty. Do not change the position of the pre-filled syringe after the injection has started. If the plunger rod is not fully pressed, the needle guard will not extend to cover the needle when it is removed.
      • After the pre-filled syringe is empty, slowly lift your thumb from the plunger rod until the needle is completely covered by the needle guard. Some bleeding may occur. Dispose they syringe in a sharps disposal. 
    • How to use the pre-filled pen
      • Take the carton containing the pen out of the refrigerator and leave it unopened so that it reaches room temperature (30 to 45 minutes). Each carton contains one pen. If you need more than one pen for your dose, remove all the cartons from the refrigerator at the same time.
      • When you are ready to use the syringe, wash your hands thoroughly with soap and water.
      • Clean the injection site with an alcohol swab.
      • Hold the pre-filled pen firmly with 1 hand and pull the cap straight off with the other hand. Do not twist the cap. Throw away the cap.
      • Hold the pre-filled pen comfortably with the needle cover directly against the skin and position it so you can see the viewing window. Without pinching or stretching the skin, place the pre-filled pen against the skin at a 90-degree angle.
      • Press straight down and hold the pre-filled pen firmly against the skin. The 1st click indicates that the injection has started. Hold the pre-filled pen tightly in place. Do not change the angle of the injection or remove the pre-filled pen until the injection is completed.
      • Keep holding the pre-filled pen against the skin. The yellow indicator will move within the viewing window.
      • Listen for the 2nd click. This indicates that the injection is almost complete. After you hear the 2nd “click”, continue to hold the pre-filled pen firmly against the skin and count slowly to 5 to make sure you inject the full dose. Hold the pre-filled pen in position until the yellow indicator has stopped moving and completely fills the viewing window to make sure the injection is complete.
      • After the yellow indicator has stopped moving and has completely filled the viewing window, lift the pre-filled pen straight up from the skin. The needle cover will automatically extend and lock over the needle. If the yellow indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist.
      • Put the used pen in a sharps disposal container immediately after use.
  • Notify your doctor immediately if you experience symptoms of an allergy (e.g. rash, itching, and swelling of the tongue and throat).
  • Store Omlyclo® in the refrigerator (2 to 8°C).

Alternatives

Other products that have the same ingredient as Omlyclo® injection are •Xolair® injection •

See other products used in the treatment of •asthma •

The usual recommended dose is between 75 mg to 600 mg subcutaneously (injected under the skin) every 2 or 4 weeks.  Doses (mg) and dosing frequency are determined by condition being treated, serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).


Omalizumab blocks a substance called immunoglobulin E (IgE) which is produced by your body. If you have allergic asthma, your body makes more IgE when you breathe in an allergen that triggers your asthma. Omalizumab helps stop the allergic-inflammatory process in allergic asthma.


Along with its needed effects, omalizumab may cause some unwanted or undesirable effects. Often, people using omalizumab never experience any unwanted effects. The severity and duration of these effects are dependant on many factors including duration of therapy, dose, and individual response. Possible unwanted effects include:

  • injection-site reactions (bruising, redness, warmth, burning, stinging, or other discomfort around the injection site)
  • viral and respiratory tract infections
  • sinus infections
  • headache
  • sore throat

Less common:

  • pain
  • dizziness
  • hair loss

Rare but serious side effects - seek medical help if you experience:

  • Sudden severe allergic reaction (sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heartbeat, dizziness and light headedness, shortness of breath, wheezing or trouble breathing)
  • bleeding or bruising more easily than normal
  • Pain, numbness or tingling in the arms and legs, lumps or raised patches in the skin, weakness and fatigue, loss of appetite and weight loss 
  • Joint pain, stiffness, rash, fever, swollen/enlarged lymph nodes 

 

 

 

 

 


Omalizumab is not a rescue medication and should not be used to treat sudden asthma attacks.
It is not a substitute for the medicines you are already taking.
Adding omalizumab to treatment with inhaled steroids (e.g. fluticasone) has been shown to reduce the number of asthma attacks. It has not been proven to work in other allergic conditions.
Oral or inhaled corticosteroids (e.g. prednisone, fluticasone) should not be abruptly stopped upon starting omalizumab therapy.
Use is not recommended in the following situations:

  • allergy to omalizumab or any component of the formulation

Caution is recommended in the following situations:

  • diabetes
  • glucose-galactose malabsorption syndrome

Use in pregnancy and breastfeeding: At this time there is limited information on use in pregnant and breastfeeding women. Consult your doctor or pharmacist before using.