EBGLYSS 250 mg/2mL
lebrikizumab-lbkz · INJECTION, SOLUTION · Eli Lilly and Company
EBGLYSS is a injection, solution containing lebrikizumab-lbkz at 250 mg/2mL, taken subcutaneous. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- EBGLYSS
- Generic Name
- lebrikizumab-lbkz
- NDC Code (Product)
0002-7772- Manufacturer
- Eli Lilly and Company
- Strength
- 250 mg/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761306
- Drug Class
- Interleukin-13 Antagonist [EPC]
- Marketing Start
- 09/13/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids. EBGLYSS ® is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Prior to EBGLYSS treatment, complete all age-appropriate vaccinations according to current immunization guidelines. ( 2.1 ) The recommended dosage of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg (one injection) every 2 weeks until Week 16 or later, when adequate clinical response is achieved. The maintenance dose of EBGLYSS is 250 mg every 4 weeks or 250 mg every 8 weeks. ( 2.2 ) Administer by subcutaneous injection. ( 2.4 ) 2.1 Vaccination Prior to Administration of EBGLYSS Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions ( 5.4 )] . 2.2 Recommended Dosage The recommended subcutaneous dosage of EBGLYSS is an initial dose of 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later, when adequate clinical response is achieved. The maintenance dosage of EBGLYSS is 250 mg every four weeks or 250 mg every eight weeks [see Pharmacodynamics ( 12.2 ) and Clinical Studies ( 14.1 )] . 2.3 Concomitant Topical Therapies EBGLYSS can be used with or without topical corticosteroids (TCS). Topical calcineurin inh…
Contraindications
4 CONTRAINDICATIONS EBGLYSS is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of EBGLYSS [see Warnings and Precautions ( 5.1 )] . Prior serious hypersensitivity to lebrikizumab-lbkz or any excipients in EBGLYSS. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions ( 5.1 )] Conjunctivitis and Keratitis [see Warnings and Precautions ( 5.2 )] Most common (≥1%) adverse reactions are conjunctivitis, injection site reactions, and herpes zoster. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Atopic Dermatitis The safety of EBGLYSS was evaluated across 4 randomized, double-blind, placebo-controlled, multicenter trials in subjects with moderate-to-severe atopic dermatitis including 3 phase 3 trials (ADvocate 1, ADvocate 2, ADhere) and 1 phase 2 dose ranging trial (KGAF). In these 4 trials, mean age was 37 years; 50% of subjects were male; 62% were White, 13% were Black, and 20% were Asian. In term…
Frequently Asked Questions
What is EBGLYSS used for?
EBGLYSS contains lebrikizumab-lbkz. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is EBGLYSS a controlled substance?
EBGLYSS is not classified as a controlled substance by the DEA.
What is the generic name for EBGLYSS?
The generic name for EBGLYSS is lebrikizumab-lbkz. There are no other listed brand versions of lebrikizumab-lbkz.
What is the NDC code for EBGLYSS 250 mg/2mL?
The NDC (National Drug Code) for EBGLYSS 250 mg/2mL is 0002-7772, listed by Eli Lilly and Company.
Other EBGLYSS Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)