CELLTRION CONNECT® A patient support program that provides personalized support for patients prescribed OMLYCLO®

Work with your healthcare provider (HCP) to enroll  in the Celltrion CONNECT® Patient Support Program

Your HCP can enroll you through an easy online portal, or you and your HCP can download, complete, and sign the Enrollment Form when you are in the office. Your HCP will then fax the completed form.

If your HCP has already enrolled you online, you can complete the enrollment process here by signing the patient consent form. You must sign the form in order to complete the enrollment process.

Sign Patient Consent

A Celltrion CONNECT Case Coordinator can help you look at your choices for starting OMLYCLO with confidence

Your Celltrion CONNECT Case Coordinator can provide  personalized support* to help you get started with OMLYCLO, including:

Verify insurance coverage and assist with prior authorizations or appeals
Determine eligibility for financial assistance and connect you with resources

Learn About Financial Assistance*Working with a Case Coordinator is optional. You may opt out if you choose.

Nurse Connector™ Support^†

If your doctor decides that you or a caregiver may be able to  self-inject OMLYCLO at home, you should receive training on  the right way to prepare and inject OMLYCLO.

A Nurse Connector can provide self-injection training. Do not try to self-inject OMLYCLO until you have been shown the right way to give OMLYCLO injections. Use OMLYCLO exactly as prescribed by your doctor.

Discover Nurse Connector Support†While Nurse Connectors are registered healthcare professionals, they cannot offer medical advice. If you have an urgent or specific question related to your healthcare, please contact your healthcare provider.

Indications and Important Safety Information

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 a 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 OMLYCLO.

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 by calling Celltrion USA Inc. at 1-800-560-9414, FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

INDICATIONS

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 one 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.