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Revcovi (elapegademase-lvlr) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat children and adults with adenosine deaminase severe combined immune deficiency (ADA-SCID). ADA-SCID is a rare immune system disease.
Revcovi is a type of medication called enzyme replacement therapy. It provides an outside source of adenosine deaminase (ADA), an enzyme that helps the body break down certain substances.
In ADA-SCID, toxic substances called deoxyadenosine nucleotides (dAXP) can build up and harm immune cells. Revcovi is linked with lower levels of these toxic substances and higher numbers of lymphocytes, which are white blood cells that help fight infection.
Doctors prescribe Revcovi when a child or adult has ADA-SCID. It is a rare inherited disease that is often fatal and can make it hard for the body to fight infections.
Revcovi is given only as an intramuscular injection. This means it is injected into a muscle.
Revcovi dosing depends on whether a person has used Adagen before. Adagen is another ADA enzyme replacement treatment used for ADA-SCID, though it is now discontinued in the United States.
For people who have not used Adagen before:
For people switching from Adagen to Revcovi:
Long-term dosing:
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Revcovi for ADA-SCID in children and adults, 10 people were treated overall. The most common side effects reported were:
Revcovi can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Chiesi USA, the manufacturer of Revcovi, offers the Chiesi Total Care program. Eligible individuals with commercial insurance may pay as little as $0 for their prescription. If you have government insurance or no insurance, the program website provides information about other support options.
The Chiesi Total Care program also provides support through a Patient Service Coordinator, including assistance with medication delivery and injection support. It offers guidance on administration, storage, and disposal, along with access to pharmacists, reimbursement specialists, and nursing support.
To learn more, visit the Chiesi Total Care website or call 866-272-7078.
Before and during treatment with Revcovi, your doctor will check blood tests. These may include trough plasma ADA activity and trough dAXP levels. These tests help the doctor decide if the dose is working.
Tell your doctor if you have any allergies to Revcovi or any ingredients in Revcovi.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Before starting Revcovi, tell your doctor if you have thrombocytopenia. Thrombocytopenia means low platelets, which can make it harder for blood to clot.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Revcovi, talk with your doctor about the risks and benefits.
These answers are fact-checked by our editorial staff.
How effective is Revcovi for ADA-SCID?
In a U.S. study, six people with ADA-SCID were treated with Revcovi. Five of the six people reached the 21-week treatment endpoint. Three of the six people stayed on Revcovi for more than 135 weeks.
Those three people maintained metabolic detoxification for at least two years. This means their toxic dAXP levels stayed within the target range, except for one test result in one person.
In a second study in Japan, four people with ADA-SCID were treated with Revcovi. All four people reached and maintained the same detoxification target during 21 weeks of treatment.
In three of the four people in the Japan study, lymphocyte counts increased from screening to day 15 and were stable or increasing during the maintenance period. Lymphocytes are white blood cells that help the body fight infections.
How long does Revcovi take to work for ADA-SCID?
Immune function generally improves after two to six months of Revcovi treatment. It may continue to improve over a longer time.
A person’s overall health may improve slowly. The drug label says this improvement should be seen by the end of the first year of treatment.
In one study, steady ADA activity levels were reached after seven weekly doses of Revcovi. ADA activity is a lab measure that helps doctors see how the treatment is working.
What tests or monitoring are needed with Revcovi for ADA-SCID?
Doctors monitor Revcovi treatment with blood tests. These tests may include:
Blood samples for ADA activity and dAXP are collected before the first Revcovi dose of the week.
For people who have not used Adagen before, ADA activity is checked every two weeks during the first eight to 12 weeks of treatment. Adagen is another ADA enzyme replacement treatment used for ADA-SCID.
For people who previously received Adagen, ADA activity is checked every four weeks during the first eight to 12 weeks. After that, ADA activity is checked every three to six months.
Two months after starting Revcovi, dAXP levels should stay below the target level. These levels should be checked at least twice a year.
Lymphocyte counts are also checked regularly. The timing depends on whether the person has used Adagen before.
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