HELPFUL RESOURCES and links for patients taking OMLYCLO®
Information and support for your treatment journey with OMLYCLO is just a phone call away.
Celltrion CONNECT® is here for you every step of the way. For questions and support, call:
Monday – Friday between 8 AM – 8 PM ET.
You are not alone on your treatment journey. The organizations below help raise awareness and provide support for patients.
Food Allergy Research & Education (FARE) works on behalf of more than 33 million people in the U.S. with the disease of food allergy, which can cause life-threatening allergic reactions. Our mission is to improve the quality of life and health of those with food allergy through transformative research, education, and advocacy. They are the nation's leading food allergy nonprofit and the largest provider of charitable funds to food allergy research.
Kids With Food Allergies (KFA) is a division of the Asthma and Allergy Foundation of America (AAFA), the nation’s oldest and leading asthma and allergy not-for-profit organization. We are dedicated to saving lives and reducing the burden of food allergies through support, advocacy, education, and research. Our free online KFA community gives you access to our support forums and other resources to help you manage food allergies, such as recipes, food recalls, webinars, advocacy and research opportunities, and more.
Allergy & Asthma Network (AAN) is a trusted national nonprofit helping people living with asthma, allergies, and related conditions feel informed, supported, and connected. They advance patient education, advocacy, and outreach to improve health outcomes and quality of life.
Asthma and Allergy Foundation of America (AAFA), a not-for-profit organization founded in 1953, is the leading patient organization for people with asthma and allergies, and the oldest asthma and allergy patient group in the world. As a mission-driven nonprofit, they work to save lives and improve the quality of life for people affected by asthma and allergic diseases through support, advocacy, education, and research.
Food Allergy & Anaphylaxis Connection Team (FAACT) is a national nonprofit organization dedicated to improving the lives of individuals and families affected by food allergies and anaphylaxis. Through education, advocacy, awareness, and support, FAACT empowers patients, caregivers, and healthcare professionals with trusted resources to help manage food allergies and promote safer, healthier communities.
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.