Rx Item-REVCOVI- elapegademase-lvlr injection 2.4mg/1.5ml IM by Leadiant Bioscie

For: Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID). These highlights do not include all the information needed to use REVCOVI� safely and effectively. See full prescribing information for REVCOVI.

REVCOVI (elapegademase-lvlr) injection, for intramuscular use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

REVCOVI is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. (1)
DOSAGE AND ADMINISTRATION

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Patients transitioning from Adagen to REVCOVI: The starting dose of REVCOVI is 0.2 mg/kg weekly, intramuscularly. See Full Prescribing Information (FPI) for conversion formula from Adagen to REVCOVI. (2.1)

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Adagen-na�ve patients: The starting dose of REVCOVI is 0.4 mg/kg weekly based on ideal body weight, divided into two doses (0.2 mg/kg twice a week), intramuscularly. (2.1)
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For complete information, maintenance dosing and therapeutic monitoring, see FPI. (2.1, 2.3)
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REVCOVI is for intramuscular injection only. See FPI for administration instructions. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 2.4 mg/1.5 mL (1.6 mg/mL) in a single-dose vial. (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

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Injection Site Bleeding in Patients with Thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe. (5.1)
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Delay in Improvement of Immune Function: Protect immune deficient patients from infections until improvement in immune function. (5.2)

ADVERSE REACTIONS

The most common adverse reactions reported were cough (50%) and vomiting (33%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant at toll-free phone 1-888-393-4584 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2018 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.

Store REVCOVI in the refrigerator between 2�C to 8�C (36�F to 46�F) in the original carton to protect from light. Do not freeze or shake. REVCOVI should not be used if there are any indications that it may have been frozen.

Rx Item-REVCOVI- elapegademase-lvlr inje
RX57665-002-01

Rx Item-REVCOVI- elapegademase-lvlr inje
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