Source: FDA, National Drug Code (US) Revision Year: 2021
Tildrakizumab-asmn is a humanized IgG1/k antibody that specifically binds to the p19 subunit of interleukin-23 (IL-23).
Tildrakizumab-asmn is produced in a recombinant Chinese hamster ovary (CHO) cell line and has an approximate molecular mass of 147 kilodaltons.
ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied in a single-dose prefilled syringe with a glass barrel and 29-gauge fixed, 1/2-inch needle.
The syringe is fitted with a passive needle guard and a needle cover.
Each 1 mL single-dose prefilled syringe contains 100 mg of tildrakizumab-asmn formulated in: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and Water for Injection, USP with a pH of 5.7-6.3.
| Dosage Forms and Strengths |
|---|
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Injection: 100 mg/mL solution in a single-dose prefilled syringe. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. |
| How Supplied |
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ILUMYA (tildrakizumab-asmn) Injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied as one single-dose prefilled syringe per carton that delivers 1 mL of a 100 mg/mL solution. NDC 47335-177-95 Each prefilled syringe is equipped with a passive needle guard and a needle cover. Manufactured in Germany for: Sun Pharma Global FZE, Sharjah, U.A.E. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 |
| Drug | Countries | |
|---|---|---|
| ILUMYA | Australia, Israel, Japan, United States |
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