This video explains how to self-administer OMLYCLO using the autoinjector pen. Please be sure to read the Instructions for Use prior to self-injecting at home.
INJECTION SUPPORT and resources for patients taking OMLYCLO®
A Nurse Connector™ is a registered healthcare professional* who can help you along your OMLYCLO treatment journey
Support you can expect from a Nurse Connector includes*:
- Supplemental injection training to help you get started and become comfortable self-injecting OMLYCLO
- OMLYCLO education on storage and handling, dosing schedule, and injection site rotation
- Ongoing support for as long as you need to be confident in your use of OMLYCLO
*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.
OMLYCLO injection resources
It’s normal to have questions about injections or taking OMLYCLO. You can utilize these helpful injection resources to help you on your treatment journey.
- OMLYCLO Prefilled Syringe Injection Video
OMLYCLO Prefilled Syringe Instructions for Use (IFU)Download the IFU and read carefully prior to injecting OMLCYLO with the prefilled syringe at home. A Nurse Connector can also provide additional injection training and guidance.
How to obtain a sharps container
Safely dispose of OMLYCLO prefilled syringes with a sharps container. This program is intended to support patients prescribed OMLYCLO.
If you reside in California: Visit www.sharpstakebackcalifornia.org to order a sharps container
If you reside in the continental United States (excluding Hawaii, Alaska, and Puerto Rico): Call (855) 216-7657 to order a sharps container
For more information on safe sharps disposal, visit safeneedledisposal.org.
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.