Revcovi (Elapegademase) is a PEGylated recombinant adenosine deaminase (rADA) enzyme that is used to treat severe combined immunodeficiency (due to the deficiency of adenosine deaminase enzyme) in children and adults.

Revcovi (Elapegademase) Uses:

• Adenosine deaminase severe combined immune deficiency:
  • It is indicated in the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Elapegademase Adult dose:

Revcovi (Elapegademase) Dose in the treatment of Adenosine deaminase severe combined immune deficiency: IM:

Elapegademase is a medication used to treat a serious condition called Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID). This condition affects the immune system, making it very weak and unable to fight infections.

Here's how the dose of elapegademase is typically given:

For patients who haven't received this treatment before:

• The starting dose is 0.2 milligrams per kilogram of body weight, given into the muscle (intramuscular injection).
• This dose is given twice a week for at least 12 to 24 weeks.
• After the immune system starts to recover, the dose may be adjusted to keep certain laboratory values in check and to maintain the improvement in the immune system.

For patients switching from another medication called pegademase bovine:

• If the previous dose of pegademase bovine was not known or was less than 30 units per kilogram, the starting dose of elapegademase is at least 0.2 milligrams per kilogram once a week.
• If the previous dose of pegademase bovine was higher than 30 units per kilogram, the dose of elapegademase is calculated using a formula provided by the doctor.
• The doctor may increase the dose gradually if needed, based on the patient's response to treatment.

It's important to follow the doctor's instructions carefully and to monitor the patient's progress closely during treatment.

Elapegademase Dose in children:

Elapegademase Dose in the treatment of Adenosine deaminase severe combined immune deficiency (ADA-SCID):

Elapegademase is used to treat a serious condition called Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID). Here's how the dose is typically given:

For patients who haven't been treated with a similar medication before:

• The starting dose is 0.4 milligrams per kilogram of body weight per week.
• This dose is divided into two equal parts and given twice a week (0.2 milligrams per kilogram per dose).
• Treatment continues for at least 12 to 24 weeks until the immune system starts to recover.
• After the immune system improves, the dose may be adjusted to maintain specific levels in the blood and to keep the immune system working well.

For patients switching from another medication called pegademase bovine:

• If the previous dose of pegademase bovine is not known or was less than 30 units per kilogram, the starting dose of elapegademase is 0.2 milligrams per kilogram per week, given once a week.
• If the previous dose of pegademase bovine was higher than 30 units per kilogram, the dose of elapegademase is calculated using a formula provided by the doctor.
• The doctor may increase the dose gradually if needed, based on the patient's response to treatment.

It's important to follow the doctor's instructions carefully and to monitor the patient's progress closely during treatment.

Revcovi (Elapegademase) Pregnancy Category: N

• Studies on how elapegademase affects reproduction in animals have not been done.
• If someone needs to use elapegademase while pregnant, it's important to closely monitor the situation.

Use of Elapegademase during lactation

• It's uncertain whether elapegademase is found in breast milk.
• The decision to breastfeed while undergoing therapy with elapegademase should be carefully considered.
• Factors to think about include the potential risk of the infant being exposed to the medication through breast milk, the benefits of breastfeeding for the infant, and the benefits of the treatment for the mother.

Dose in Kidney disease:

• The manufacturer's labeling for elapegademase does not include any specific dosage adjustments for individuals with renal impairment.
• This suggests that the usual dosage recommendations apply regardless of kidney function.

Dose in Liver disease:

• The manufacturer's labeling for elapegademase does not include any specific dosage adjustments for individuals with hepatic (liver) impairment.
• This suggests that the usual dosage recommendations apply regardless of liver function.

Side effects of Revcovi (Elapegademase):

• Central Nervous System:
  • Abnormal Gait
  • Fatigue
  • Migraine
  • Seizures
• Dermatologic:
  • Facial Swelling
  • Fungal Skin Infection
  • Skin Rash
• Gastrointestinal:
  • Dental Caries
  • Diarrhea
  • Gastrointestinal Infection
  • Hematochezia
  • Nausea
  • Oral Candidiasis
  • Tooth Loss (Extraction)
  • Upper Abdominal Pain
  • Vomiting
• Hematologic & Oncologic:
  • Lymphadenopathy
  • Neutropenia
  • Pulmonary Hemorrhage
• Infection:
  • Abscess (Groin)
  • Infection (Stoma)
  • Influenza
  • Tooth Abscess
• Local:
  • Discomfort At Injection Site
• Neuromuscular & Skeletal:
  • Arthralgia
  • Asthenia
• Ophthalmic:
  • Conjunctivitis
• Otic:
  • Ear Residue
  • Debris
  • Or Precipitate; Ear Sign Or Symptom (Canal Irritation); Otitis Externa
• Renal:
  • Nephrolithiasis
• Respiratory:
  • Cough
  • ENT Infection (Ear Lobe)
  • Epistaxis
  • Hemoptysis
  • Nasal Mucosa Swelling
  • Oropharyngeal Pain
  • Pneumonitis
  • Productive Cough
  • Pulmonary Infection
  • Respiratory Failure
  • Upper Respiratory Tract Infection (CMV)
• Miscellaneous:
  • Laceration

Contraindications to Revcovi (Elapegademase):

• According to the manufacturer's labeling, there are no contraindications listed for elapegademase.
• This means that there are no specific situations or conditions where the use of elapegademase is strictly prohibited based on the available information.

Warnings and precautions

Formation of antibodies:

• Elapegademase treatment may lead to the development of antibodies in some patients.
• If a patient experiences a persistent decrease in their pre-injection levels of plasma adenosine deaminase (ADA) to less than 15 mmol/hour/L, and other potential causes are ruled out (such as noncompliance), the possibility of antibody formation should be considered.
• In such cases, a specific test for antibody ADA should be conducted.
• Depending on the results and the patient's clinical condition, dosage adjustments may be necessary for those who develop antibodies.

Immune deficiency:

• Patients with immune deficiency are more susceptible to infections.
• It's important to maintain appropriate precautions to minimize the risk of infections until there is an improvement in immune function.
• This might include measures such as practicing good hand hygiene, avoiding contact with sick individuals.

Thrombocytopenia:

• Elapegademase should be used with caution in patients who have thrombocytopenia (low platelet count), as there is a risk of bleeding at the injection site.
• It is advisable to avoid using elapegademase in patients with severe thrombocytopenia.
• Thrombocytopenia can increase the risk of bleeding complications, so it's essential to assess the patient's platelet count and overall bleeding risk before administering elapegademase.
• Close monitoring and appropriate management are necessary to ensure the safety of treatment in patients with thrombocytopenia.

Elapegademase: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

Trough Plasma Adenosine Deaminase (ADA) Activity and Deoxyadenosine Nucleotides (dAXP) Levels

• Regular monitoring of trough plasma ADA activity and dAXP levels is important.
• More frequent monitoring may be necessary if therapy is interrupted or clearance increases.
• Blood samples for analysis should be collected before the first administration for the week.

Plasma ADA Activity (Trough Preinjection)

• Pegademase Bovine Naive Patients: Every 2 weeks
• Patients Transitioning from Pegademase Bovine: Every 4 weeks for the first 8 to 12 weeks of therapy, then every 3 to 6 months.
• Perform testing for antibodies to elapegademase if there is a persistent decrease in levels below 15 mmol/hour/L.
• Monitor immune function and clinical response closely. Take precautions to minimize infection if a persistent decrease in ADA activity occurs.

Erythrocyte dAXP Levels (Trough Preinjection)

• Monitor after 2 months, then at least twice yearly.

Lymphocyte Counts (Total and Subset)

• Pegademase Bovine Naive Patients: Every 4 to 8 weeks for up to 1 year, then every 3 to 6 months.
• All Other Patients: Every 3 to 6 months.

Regular monitoring helps ensure the effectiveness and safety of elapegademase therapy. Adjustments may be necessary based on test results and clinical response.

How to administer Revcovi (Elapegademase)?

• Route: Administer intramuscularly (IM). Do not administer intravenously (IV) or subcutaneously (SubQ).
• Preparation: Do not dilute or mix with other medications before administration.
• Immediate Administration: Administer immediately after syringe preparation with an appropriate needle (size and gauge) for IM administration for the patient.
• Injection Site: Avoid administration near an artery or nerve to minimize the risk of complications.
• Site Rotation: Periodically alternate injection sites to prevent irritation or discomfort at the injection site.

Mechanism of action of Revcovi (Elapegademase):

• Adenosine deaminase is an enzyme in the body that plays a crucial role in breaking down adenosine and deoxyadenosine.
• When someone lacks this enzyme due to a genetic condition, it leads to severe immunodeficiency disease, which can be life-threatening.
• Elapegademase is a treatment that provides the body with the adenosine deaminase enzyme it needs.
• By doing so, it helps reduce the levels of harmful adenosine and deoxyadenosine in the body and boosts the production of lymphocytes, which are important for a healthy immune system.

Time to peak:

• The time it takes for elapegademase to reach its peak concentration in the bloodstream is between 27.2 to 72 hours after administration.
• This means that it may take up to 72 hours for the medication to reach its highest level in the blood after it has been given.

International Brands of Elapegademase:

• Revcovi

Elapegademase Brand Names in Pakistan:

No Brands Available in Pakistan.