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.
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 administration1
- 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 matter1
- 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 minutes1
- Revcovi is to be administered using polypropylene syringes. Draw the solution from the vial with a 25-gauge needle or larger1
- Change the needle to a size and gauge appropriate for the patient's intramuscular administration1
- Revcovi should be administered immediately after syringe preparation1
- Any remaining medication in the vial must be discarded immediately1
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.
- Revcovi. Prescribing information. Chiesi USA, Inc.; 2021.