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Frequently Asked Questions

Here you can find answers to the most common questions about OMLYCLO

What is OMLYCLO?

OMLYCLO is the first and only biosimilar that can be used in place of Xolair® (omalizumab). Like Xolair, it is used to reduce inflammation from certain conditions, such as:

  • Moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids
  • Chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough
  • Food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic
  • Chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment

What is a biosimilar?

OMLYCLO is the first and only prescription biosimilar of Xolair® (omalizumab).

Biosimilar means that:

  • The biologic product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product
  • There are no clinically meaningful differences in how it works or in how safe it is compared to the reference product

A biosimilar is typically more affordable than the reference product.

As a biosimilar of Xolair, OMLYCLO is considered to be just as safe and effective as Xolair in treating all of the conditions it is prescribed for.

Since OMLYCLO is a biosimilar of Xolair, it can be used in its place. OMLYCLO has been approved to be interchangeable with Xolair by the FDA, which means OMLYCLO can be used in its place without disruption. The FDA reviewed switching from Xolair to OMLYCLO and found no added safety risk or loss of effectiveness. OMLYCLO is proven to work the same way as Xolair.

FDA, Food and Drug Administration.

How is OMLYCLO provided?

OMLYCLO can be given at home. OMLYCLO is available in single-dose*, prefilled syringe injections that offer you the flexibility and control of self-administration.

OMLYCLO can also be given as an injection under the skin by a healthcare provider in a healthcare setting. Your doctor will monitor you after treatment begins.

Most people receive OMLYCLO every 2 or 4 weeks.

*Some dosage strengths require multiple injections.

What are the benefits of treatment with OMLYCLO?

Just like Xolair® (omalizumab), OMLYCLO works by blocking an antibody called immunoglobulin E (IgE).

OMLYCLO works by attaching to IgE to calm an allergic response. When your body has an allergic reaction, your immune system is responding to an allergen. This response is caused by an overproduction of IgE. OMLYCLO helps prevent the allergic reaction by attaching to IgE and stopping your body's allergic response.

OMLYCLO was shown to be as safe and effective as Xolair in blocking an allergic response.

How safe and effective is OMLYCLO compared to Xolair® (omalizumab)?

Clinical study results showed that OMLYCLO and Xolair worked as effectively and had similar safety in chronic spontaneous urticaria (CSU). This helped support FDA approval of OMLYCLO for all of the same conditions that Xolair is approved to treat. As a biosimilar of Xolair, OMLYCLO can be expected to be just as safe and effective at treating all of the conditions it is being prescribed for.

In addition, omalizumab, the active ingredient in both OMLYCLO and Xolair, has been shown to help people with multiple food allergies tolerate more of the foods they are allergic to. In one study, omalizumab worked better than oral immunotherapy (OIT), and fewer people stopped treatment because of side effects. Because OMLYCLO contains omalizumab, the same benefits are expected with OMLYCLO.

What are the side effects of OMLYCLO?

OMLYCLO can cause serious side effects.

OMLYCLO can cause serious side effects, including a severe allergic reaction called anaphylaxis. It can happen after your first dose or after many doses, and right after an injection or even days later. Get emergency help right away if you have trouble breathing, chest tightness, dizziness, fainting, hives, swelling of the throat or tongue, or trouble swallowing. Because of this risk, treatment is started with your healthcare provider and patients are monitored after treatment begins.

Other serious side effects may include

  • cancer
  • inflammation of the blood vessels
  • fever, muscle aches, and rash
  • parasitic infection
  • heart and circulation problems

Common side effects can vary depending on what OMLYCLO is being used to treat. They may include

  • joint pain
  • dizziness
  • feeling tired
  • itching or skin rash
  • headache
  • injection-site reactions
  • cough or cold-like symptoms
  • nausea
  • fever, infections, swelling, and bone fractures

These are not all of the possible side effects of OMLYCLO.

You should also review "What is the most important information I should know about OMLYCLO?" in the Medication Guide and talk with your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Celltrion USA, Inc. at 1-800-560-9414.

FDA, Food and Drug Administration.

IMPORTANT SAFETY INFORMATION

OMLYCLO may cause serious side effects, including:

Severe allergic reactions (anaphylaxis) can happen when you receive OMLYCLO. The reaction can occur after the first dose, or after many doses. It may also occur right after an OMLYCLO injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving OMLYCLO and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Cancer. Cases of cancer were observed in some people who received omalizumab.

Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive OMLYCLO. Tell your healthcare provider right away if you have rash, chest pain, shortness of breath, a feeling of pins and needles, or numbness of your arms or legs.

Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving an OMLYCLO injection. If you have any of these symptoms, tell your healthcare provider.

Parasitic infection. Some people who are at a high risk for parasite (worm) infections get a parasite infection after receiving OMLYCLO. Your healthcare provider can test your stool to check if you have a parasite infection.

Heart and circulation problems. Some people who receive OMLYCLO have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision.

Before receiving OMLYCLO, tell your healthcare provider about all of your medical conditions, including if you:

  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if OMLYCLO may harm your unborn baby or if it passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use OMLYCLO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not receive and use OMLYCLO if you are allergic to omalizumab products or any of the ingredients in OMLYCLO.

The most common side effects of OMLYCLO:

In adults and children 12 years of age and older with asthma: joint pain, especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.

In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses; headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.

In adults with chronic rhinosinusitis with nasal polyps: headache, injection-site reactions, joint pain, upper abdominal pain, and dizziness.

In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat, or sinuses, cough, joint pain, and upper respiratory tract infection.

In people with food allergy: injection-site reactions and fever.

These are not all the possible side effects of OMLYCLO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the Medication Guide and talk with your healthcare provider.

INDICATIONS

What is OMLYCLO?
OMLYCLO® (omalizumab-igec) is an injectable prescription medicine used to treat:

  • moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if OMLYCLO is safe and effective in people with asthma under 6 years of age.
  • chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if OMLYCLO is safe and effective in people with CRSwNP under 18 years of age.
  • food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking OMLYCLO, you should continue to avoid all foods to which you are allergic. It is not known if OMLYCLO is safe and effective in people with food allergy under 1 year of age.
  • chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if OMLYCLO is safe and effective in people with CSU under 12 years of age.

OMLYCLO should not be used for the emergency treatment of any allergic reactions, including anaphylaxis, to treat other forms of hives, or sudden breathing problems.

IMPORTANT SAFETY INFORMATION

OMLYCLO may cause serious side effects, including:

Severe allergic reactions (anaphylaxis) can happen when you receive OMLYCLO. The reaction can occur after the first dose, or after many doses. It may also occur right after an OMLYCLO injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving OMLYCLO and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Cancer. Cases of cancer were observed in some people who received omalizumab.

Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive OMLYCLO. Tell your healthcare provider right away if you have rash, chest pain, shortness of breath, a feeling of pins and needles, or numbness of your arms or legs.

Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving an OMLYCLO injection. If you have any of these symptoms, tell your healthcare provider.

Parasitic infection. Some people who are at a high risk for parasite (worm) infections get a parasite infection after receiving OMLYCLO. Your healthcare provider can test your stool to check if you have a parasite infection.

Heart and circulation problems. Some people who receive OMLYCLO have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision.

Before receiving OMLYCLO, tell your healthcare provider about all of your medical conditions, including if you:

  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if OMLYCLO may harm your unborn baby or if it passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use OMLYCLO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not receive and use OMLYCLO if you are allergic to omalizumab products or any of the ingredients in OMLYCLO.

The most common side effects of OMLYCLO:

In adults and children 12 years of age and older with asthma: joint pain, especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.

In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses; headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.

In adults with chronic rhinosinusitis with nasal polyps: headache, injection-site reactions, joint pain, upper abdominal pain, and dizziness.

In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat, or sinuses, cough, joint pain, and upper respiratory tract infection.

In people with food allergy: injection-site reactions and fever.

These are not all the possible side effects of OMLYCLO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the Medication Guide and talk with your healthcare provider.

INDICATIONS

What is OMLYCLO?
OMLYCLO® (omalizumab-igec) is an injectable prescription medicine used to treat:

  • moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if OMLYCLO is safe and effective in people with asthma under 6 years of age.
  • chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if OMLYCLO is safe and effective in people with CRSwNP under 18 years of age.
  • food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking OMLYCLO, you should continue to avoid all foods to which you are allergic. It is not known if OMLYCLO is safe and effective in people with food allergy under 1 year of age.
  • chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if OMLYCLO is safe and effective in people with CSU under 12 years of age.

OMLYCLO should not be used for the emergency treatment of any allergic reactions, including anaphylaxis, to treat other forms of hives, or sudden breathing problems.