Source: FDA, National Drug Code (US) Revision Year: 2026
Tividenofusp alfa-eknm is a fusion protein consisting of the hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme iduronate-2-sulfatase (IDS) fused to the N-terminus of an immunoglobulin G1 (IgG1) fragment, crystallizable (Fc). It is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. The approximate molecular weight of tividenofusp alfa-eknm is 110 kDa.
AVLAYAH (tividenofusp alfa-eknm) for injection is a sterile, preservative-free, white to off-white lyophilized powder with a cake-like appearance for intravenous infusion after reconstitution and dilution. Each single-dose vial contains 150 mg tividenofusp alfa-eknm, and the inactive ingredients dibasic sodium phosphate (5 mg), methionine (7.5 mg), monobasic sodium phosphate (7.7 mg), polysorbate 20 (3 mg), sodium chloride (14.6 mg), and sucrose (300 mg). The pH is 6.5 after reconstitution.
| Dosage Forms and Strengths |
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For injection: 150 mg of tividenofusp alfa-eknm as a white to off-white lyophilized powder with a cake-like appearance in a single-dose vial for reconstitution and further dilution. |
| How Supplied |
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AVLAYAH (tividenofusp alfa-eknm) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder with a cake-like appearance in a single-dose vial. Each vial contains 150 mg of tividenofusp alfa-eknm. AVLAYAH is available as one carton containing a 150 mg single-dose vial (NDC 84976-001-01). Manufactured by: Denali Therapeutics Inc., 161 Oyster Point Boulevard, South San Francisco, CA 94080, U.S. License Number: 2385 |
| Drug | Countries | |
|---|---|---|
| AVLAYAH | United States |
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