Pegademase bovine-naïve patients
Starting dose with Revcovi is 0.4 mg/kg/wk based on ideal body weight divided into two weekly doses for a minimum of 12-24 weeks until immune reconstitution is achieved. Some patients may take longer than 24 weeks to reach immune reconstitution
Once immune reconstitution is achieved, dose may be gradually adjusted down to maintain trough ADA activity >30 mmol/hr/L, trough dAXP levels <0.02 mmol/L, and/or to maintain adequate immune reconstitution based on the clinical assessment of the patient
Pre-injection Lab Monitoring Schedule1
Sample monitoring schedule below reflects most frequent monitoring interval and should be individualized for each patient.
A decrease of ADA activity below 30 mmol/hr/L might suggest non-compliance 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.
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 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.
Preparation of Injection and Procedure Instructions
- Revcovi should not be diluted nor mixed with any other drug prior to administration.
- 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.
- 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.
- Revcovi is to be administered using polypropylene syringes. Draw the solution from the vial with a 25- gauge needle or larger.
- Change the needle to a size and gauge appropriate for the patient’s intramuscular administration.
- Revcovi should be administered immediately after syringe preparation.
- Any remaining medication in the vial must be discarded immediately.
1. Revcovi™ (elapegademase-lvlr) injection prescribing information. Leadiant Biosciences Inc.; 2018.
Revcovi (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
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.
The most commonly reported adverse reactions were cough and vomiting.
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
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.
Please refer to Revcovi’s Full Prescribing Information.