What is Revcovi, and how does it work?

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

What are the side effects of Revcovi?

Common side effects of Revcovi include:

What is the dosage for Revcovi?

Recommended Dosage

Patients Transitioning From Adagen To Revcovi
  • If a patient's weekly Adagen dose is unknown, or a patient's weekly Adagen dose is at or lower than 30 U/kg, the recommended minimum starting dose of Revcovi is 0.2 mg/kg, intramuscularly, once a week.
  • If a patient's weekly Adagen dose is above 30 U/kg, an equivalent weekly Revcovi dose (mg/kg) should be calculated using the following conversion formula:
  • Revcovi dose in mg/kg = Adagen dose in U/kg/150
  • Subsequent doses may be increased by increments of 0.033 mg/kg weekly if trough ADA activity is under 30 mmol/hr/L, trough deoxyadenosine nucleotides (dAXP) are above 0.02 mmol/L, and/or the immune reconstitution is inadequate based on the clinical assessment of the patient.
  • The total weekly dose may be divided into multiple intramuscular (IM) administrations during a week.
Adagen-Naive Patients
  • The starting weekly dose of Revcovi is 0.4 mg/kg based on ideal body weight or actual weight whichever is greater, divided into two doses (0.2 mg/kg twice a week), intramuscularly, for a minimum of 12 to 24 weeks until immune reconstitution is achieved.
  • After that, the dose may be gradually adjusted down to maintain trough ADA activity over 30 mmol/hr/L, trough dAXP level under 0.02 mmol/L, and/or to maintain adequate immune reconstitution based on clinical assessment of the patient.
  • The optimal long-term dose and schedule of administration should be established by the treating physician for each patient individually and may be adjusted based on the laboratory values for trough ADA activity, trough dAXP level, and/or on the treating physician's medical assessment of the patient's clinical status.

What drugs interact with Revcovi?

  • The drug interaction potential of Revcovi is not known.

Is Revcovi safe to use while pregnant or breastfeeding?

  • Adequate and well-controlled studies with Revcovi have not been conducted in pregnant women to inform a drug-associated risk.
  • It is not known whether Revcovi can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
  • Human or animal lactation studies have not been conducted to assess the presence of Revcovi in breast milk, the effects on the breastfed infant, or the effects on milk production for the mother.

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Medically Reviewed on 11/9/2020
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All sections courtesy of the U.S. Food and Drug Administration