Lebrikizumab-lbkz
Generic Name: lebrikizumab-lbkz
Brand Names:
Ebglyss
11 DESCRIPTION Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa.
Overview
11 DESCRIPTION Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa.
Uses
1 INDICATIONS AND USAGE EBGLYSS is indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis 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 adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis 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
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 is EBGLYSS 250 mg every 4 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 )] .
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions including angioedema and urticaria, have occurred after administration of EBGLYSS. Discontinue EBGLYSS in the event of a serious hypersensitivity reaction. ( 5.1 ) Conjunctivitis and Keratitis: Report new onset or worsening eye symptoms to a healthcare provider. ( 5.2 ) Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to anti-helminth treatment, discontinue treatment with EBGLYSS until the infection resolves. ( 5.3 ) Vaccinations: Avoid use of live vaccines during treatment with EBGLYSS. 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 )
Pregnancy
8.1 Pregnancy Risk Summary Available data on lebrikizumab-lbkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations) .
Storage
Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). If necessary, EBGLYSS can be stored at room temperature up to 30°C (86°F) for up to 7 days in the original carton. Dispose of EBGLYSS that has been left at room temperature for longer than 7 days. Store in the original carton to protect from light until use. Do not freeze. Do not use EBGLYSS if it has been frozen. Do not shake.
Frequently Asked Questions
What is Lebrikizumab-lbkz used for?▼
1 INDICATIONS AND USAGE EBGLYSS is indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis 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 adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis 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 )
What are the side effects of Lebrikizumab-lbkz?▼
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.
Can I take Lebrikizumab-lbkz during pregnancy?▼
8.1 Pregnancy Risk Summary Available data on lebrikizumab-lbkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations) .
What are the important warnings for Lebrikizumab-lbkz?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions including angioedema and urticaria, have occurred after administration of EBGLYSS. Discontinue EBGLYSS in the event of a serious hypersensitivity reaction. ( 5.1 ) Conjunctivitis and Keratitis: Report new onset or worsening eye symptoms to a healthcare provider. ( 5.2 ) Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to anti-helminth treatment, discontinue treatment with EBGLYSS until the infection resolves. ( 5.3 ) Vaccinations: Avoid use of live vaccines during treatment with EBGLYSS. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.