Source: FDA, National Drug Code (US) Revision Year: 2020
Elapegademase-lvlr is a recombinant adenosine deaminase (rADA) based on bovine amino acid sequence, conjugated to monomethoxypolyethylene glycol (mPEG). rADA is manufactured in E. coli and is covalently conjugated to mPEG with a succinimidyl carbamate linker to produce methoxypolyethylene glycol recombinant adenosine deaminase (SC-PEG rADA). The approximate molecular weight of elapegademase-lvlr (SC-PEG rADA) is 113 KDa.
REVCOVI (elapegademase-lvlr) injection is a sterile, preservative free, clear, colorless solution for intramuscular use supplied in single-dose vials. Each vial provides 1.5 mL of solution containing 2.4 mg elapegademase-lvlr (1.6 mg/mL), sodium chloride (12.75 mg), sodium phosphate dibasic heptahydrate (12.7 mg), sodium phosphate monobasic monohydrate (3.81 mg), and Water for Injection, USP. The pH is 6.9.
| Dosage Forms and Strengths |
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Injection: 2.4 mg/1.5 mL (1.6 mg/mL) clear and colorless solution of elapegademase-lvlr in a single-dose vial. |
| How Supplied |
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REVCOVI (elapegademase-lvlr) injection, 2.4 mg/1.5 mL (1.6 mg/mL), is a sterile, preservative free, clear, colorless solution for intramuscular use available as one single-dose vial per carton (NDC 57665-002-01). The vial stopper is not made with natural rubber latex. Single-dose vial; do not re-use the vial. Discard unused portions. |
| Drug | Countries | |
|---|---|---|
| REVCOVI | Japan, United States |
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