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THERAPEUTIC MONITORING HELPS ACHIEVE APPROPRIATE DOSING

RECOMMENDED STARTING DOSE

0.4 mg/kg/wk based on ideal body weight or actual body weight, whichever is higher

Divided into 2 weekly doses for a minimum of 12-24 weeks

Until immune reconstitution is achieved

Once immune reconstitution is achieved, dose may be gradually adjusted down to maintain trough ADA activity >30 mmol/hr/L, trough deoxyadenosine levels <0.02 mmol/L, and/or to maintain adequate immune reconstitution based on the clinical assessment of the patient.1

Improvement in the general clinical status of the patient may be gradual but should be apparent by the end of the first year of therapy.1

REVCOVI® MONITORING SCHEDULE

First 3 months of treatment: monitor patients
every 2 weeks
4-12 months of treatment: monitor patients
every 1-2 months
1 year+ of treatment: monitor patients
every 3-6 months
Target
ADA Activity Every
2 weeks
Every
3-6 months
Every
3-6 months
Trough plasma ADA activity ≥30 mmol/h/La
Erythrocyte dAXP At week 8 Every
6 months
Every
6 months
Trough dAXP levels <0.02 mmol/L
Total & Subset
Lymphocytes
At weeks
4, 8, and 12
Every
1-2 months
Every
3-6 months
General improvementb

a A decrease of ADA activity below 30 mmol/hr/L might suggest noncompliance or a development of antibodies (anti-drug, anti-PEG, and neutralizing antibodies). Test for antibodies to Revcovi if pre-injection trough plasma ADA activity falls below 15 mmol/hr/L consistently. If there is a decline in ADA activity levels, monitor immune function and clinical status more closely and take precautions to minimize the risk of infection.
b Immune function, including the ability to produce antibodies, generally improves after 2-6 months of therapy, and matures over a longer period. Improvement in the general clinical status of the patient may be gradual (as evidenced by improvement in various clinical parameters) but should be apparent by the end of the first year of therapy.

REVCOVI DOSING GUIDE

Download for more information about Revcovi dosing, administration, and monitoring.

DOWNLOAD

ADMINISTRATION

Revcovi is for IM injection only. Follow sterile IM administration technique guidelines appropriate to the patient's age and anatomy (i.e. choice of needle gauge and length, site of administration). Take precautions not to inject into or near an artery or nerve. Alternate the injection site periodically.1

PREPARATION OF INJECTION AND PROCEDURE INSTRUCTIONS

  • Revcovi should not be diluted nor mixed with any other drug prior to administration.1
  • Visually inspect Revcovi for particulate matter and discoloration prior to administration. Revcovi is a clear, colorless solution: discard if solution is discolored, cloudy or contains particulate matter.1
  • Do not freeze or shake. Revcovi should not be used if there are any indications that it may have been frozen. Once removed from refrigeration, allow Revcovi to equilibrate to room temperature for 30 minutes.1
  • Revcovi is to be administered using polypropylene syringes. Draw the solution from the vial with a 25- gauge needle or larger.1
  • Change the needle to a size and gauge appropriate for the patient's intramuscular administration.1
  • Revcovi should be administered immediately after syringe preparation.1
  • Any remaining medication in the vial must be discarded immediately.1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Injection site bleeding in patients with thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe.
  • Delay in improvement of immune function: Protect immune deficient patients from infections until improvement in immune function.

ADVERSE REACTIONS

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

In addition, the following post-marketing reports for the same class of enzyme replacement therapy used in the treatment of ADA-SCID may also be seen with Revcovi treatment:

  • Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia
  • Dermatological events: injection site erythema, urticaria
  • Lymphomas

IMPORTANT MONITORING INFORMATION

Treatment with Revcovi should be monitored by measuring trough plasma ADA activity and trough dAXP levels for maintenance of therapeutic targets. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely, and precautions should be taken to minimize the risk of infection.

INDICATION

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

Please see the Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Injection site bleeding in patients with thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe.
  • Delay in improvement of immune function: Protect immune deficient patients from infections until improvement in immune function.

ADVERSE REACTIONS

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

In addition, the following post-marketing reports for the same class of enzyme replacement therapy used in the treatment of ADA-SCID may also be seen with Revcovi treatment:

  • Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia
  • Dermatological events: injection site erythema, urticaria
  • Lymphomas

IMPORTANT MONITORING INFORMATION

Treatment with Revcovi should be monitored by measuring trough plasma ADA activity and trough dAXP levels for maintenance of therapeutic targets. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely, and precautions should be taken to minimize the risk of infection.

INDICATION

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

Please see the Full Prescribing Information.

Reference
  1. Revcovi. Prescribing information. Chiesi USA, Inc.; 2021.
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