Nemolizumab-ilto
Generic Name: nemolizumab-ilto
Brand Names:
Nemluvio
11 DESCRIPTION Nemolizumab-ilto, an interleukin-31 receptor alpha (IL-31RA) antagonist, is a humanized monoclonal modified immunoglobulin G (IgG) antibody with a molecular weight of approximately 144 kDa. Nemolizumab-ilto is produced by recombinant DNA technology in Chinese Hamster Ovary cells. NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder in a dualchamber, single-dose, prefilled pen for subcutaneous use.
Overview
11 DESCRIPTION Nemolizumab-ilto, an interleukin-31 receptor alpha (IL-31RA) antagonist, is a humanized monoclonal modified immunoglobulin G (IgG) antibody with a molecular weight of approximately 144 kDa. Nemolizumab-ilto is produced by recombinant DNA technology in Chinese Hamster Ovary cells. NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder in a dualchamber, single-dose, prefilled pen for subcutaneous use.
Uses
1 INDICATIONS AND USAGE NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. ( 1.2 ) 1.1 Prurigo Nodularis NEMLUVIO is indicated for the treatment of adults with prurigo nodularis.
Dosage
2 DOSAGE AND ADMINISTRATION Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. ( 2.1 ) Prurigo Nodularis: Adult Patients Weighing Less Than 90kg: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. ( 2.2 ) Adult Patients Weighing 90kg or More: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. ( 2.2 ) Atopic Dermatitis: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater details elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions (5.1) ] Most common adverse reactions are: Prurigo Nodularis (incidence ≥1%): headache, dermatitis atopic, eczema, and eczema nummular. ( 6.1 ) Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. ( 5.1 ) Vaccinations: Avoid use of live vaccines during treatment with NEMLUVIO. ( 5.2 ) 5.1 Hypersensitivity Hypersensitivity reactions, such as facial angioedema, have been reported with use of NEMLUVIO. NEMLUVIO is contraindicated in patients with a known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO [ see Contraindications (4) , Adverse Reactions (6.1) ]. 4 CONTRAINDICATIONS NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [ see Warnings and Precautions (5.1) ]. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder available in a single-dose, dual-chamber, prefilled pen containing 30 mg of nemolizumab-ilto in one chamber and the diluent, water for injection, in the other chamber.
Frequently Asked Questions
What is Nemolizumab-ilto used for?▼
1 INDICATIONS AND USAGE NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. ( 1.2 ) 1.1 Prurigo Nodularis NEMLUVIO is indicated for the treatment of adults with prurigo nodularis.
What are the side effects of Nemolizumab-ilto?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater details elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions (5.1) ] Most common adverse reactions are: Prurigo Nodularis (incidence ≥1%): headache, dermatitis atopic, eczema, and eczema nummular. ( 6.1 ) Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Nemolizumab-ilto during pregnancy?▼
8.1 Pregnancy Risk Summary Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data).
What are the important warnings for Nemolizumab-ilto?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. ( 5.1 ) Vaccinations: Avoid use of live vaccines during treatment with NEMLUVIO. ( 5.2 ) 5.1 Hypersensitivity Hypersensitivity reactions, such as facial angioedema, have been reported with use of NEMLUVIO. NEMLUVIO is contraindicated in patients with a known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO [ see Contraindications (4) , Adverse Reactions (6.1) ]. 4 CONTRAINDICATIONS NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [ see Warnings and Precautions (5.1) ]. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. ( 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.