Patients may pay as little as$0 for each dose of OMLYCLO
All patients enrolled in the Celltrion CONNECT® Patient Support Program are automatically screened for financial assistance. If eligible, they will be enrolled in the Celltrion CARES Co-pay Program. Program is subject to annual maximum limits and certain limitations. Please see full Terms and Conditions.
If your doctor administers OMLYCLO in the office, the Celltrion CARES Co-pay program can also help with injection costs. Eligible patients with commercial insurance may pay as little as $0 per injection out-of-pocket cost. The program covers up to $1,500 per calendar year benefit period. The final amount owed may be as little as $0, but may vary depending on the health insurance plan.
Program is subject to annual maximum limits and certain limitations. Please see full Terms and Conditions
Enroll in Celltrion CARESPatients who are uninsured may be eligible to receive OMLYCLO at no cost. Patient eligibility criteria, including household income limits, and program Terms and Conditions apply. Celltrion CONNECT can help evaluate patients’ eligibility for assistance.
A Nurse Connector™ is a registered healthcare professional* who can help patients along their OMLYCLO treatment journey
A Nurse Connector supports your patients by providing:
Patients who are enrolled in the Celltrion CONNECT Patient Support Program will be offered Nurse Connector support automatically.
*While Nurse Connectors are registered healthcare professionals, they cannot offer medical advice. Patients who have an urgent or specific question related to their healthcare will be directed to contact their healthcare provider.
Direct your patients to this video, which explains how to self-administer OMLYCLO using the prefilled syringe. Please instruct patients to read the Instructions for Use prior to injecting at home.
Safely dispose of OMLYCLO prefilled syringes with a sharps container. This program is intended to support patients prescribed OMLYCLO.
If the patient resides in California: Visit www.sharpstakebackcalifornia.org to order a sharps container
If the patient resides 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.
WARNING: ANAPHYLAXIS
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis.
Contraindications: severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO.
Anaphylaxis. Life-threatening anaphylaxis has occurred after omalizumab products, with signs/symptoms including bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue; it can occur as early as the first dose, beyond 1 year after starting, and has been reported up to 4 days after administration. Initiate OMLYCLO in a healthcare setting equipped to manage anaphylaxis and observe patients for an appropriate period after dosing; educate patients on signs/symptoms and the need for immediate medical care. Risk is increased in patients with a history of anaphylaxis to foods, medications, or other causes. After therapy is safely established, self-administration OMLYCLO prefilled syringe may be appropriate for selected patients/caregivers based on risk mitigation (including: no prior history of anaphylaxis, at least 3 supervised doses without hypersensitivity, ability to recognize and appropriately treat anaphylaxis, and ability to perform SC injections correctly). Discontinue OMLYCLO in patients who experience a severe hypersensitivity reaction.
Malignancy. Malignant neoplasms have been observed in clinical studies; the impact of longer exposure and use in patients at higher baseline risk is not known, and limitations of longer-term observational data preclude definitively ruling out a malignancy risk with omalizumab products.
Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to relieve acute asthma exacerbations; do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Advise patients to seek medical care if asthma remains uncontrolled or worsens after starting OMLYCLO.
Corticosteroid Reduction. Do not abruptly discontinue systemic or inhaled corticosteroids when starting OMLYCLO for asthma or CRSwNP; taper gradually under physician supervision. In CSU patients, use of omalizumab products in combination with corticosteroids has not been evaluated.
Eosinophilic Conditions. Rarely, patients with asthma on omalizumab products have developed serious systemic eosinophilia, sometimes with vasculitis consistent with Churg-Strauss syndrome, often in the setting of oral corticosteroid reduction. Be alert for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy; a causal association has not been established.
Fever, Arthralgia, and Rash. In post-approval use, a serum sickness–like constellation (arthritis/arthralgia, rash, fever, lymphadenopathy) has occurred 1 to 5 days after injections and may recur with additional doses; stop OMLYCLO if this constellation develops.
Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection during OMLYCLO therapy; available data are insufficient to define the duration of monitoring needed after stopping treatment. A clinical trial in a high-risk setting observed more infections with omalizumab than placebo; response to appropriate anti-geohelminth treatment was not different between groups.
Laboratory Tests. Total serum IgE increases after dosing and may remain elevated for up to 1 year after discontinuation due to drug:IgE complexes; do not use total IgE levels obtained less than 1 year after discontinuation to reassess dosing regimen for asthma, CRSwNP, or IgE-mediated food allergy because these levels may not reflect steady-state free IgE levels.
Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.
Most Common Adverse Reactions
Please see the full Prescribing Information for complete details. To report suspected adverse reactions, contact CELLTRION USA INC. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com
