Revcovi (elapegademase-lvlr)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*The treatment of ADA-SCID with elapegademase-lvlr should be monitored by measuring trough plasma adenosine deaminase (ADA) activity, trough deoxyadenosine nucleotide (dAXP) levels, and/or total lymphocyte counts. Monitoring should be more frequent if therapy was interrupted or if an enhanced rate of clearance of plasma ADA activity develops. See full prescribing information for specific instructions on therapeutic drug monitoring of elapegademase-lvlr, including target trough ADA activity and dAXP levels and recommended monitoring schedules.

*Collect blood samples for the analysis of trough plasma ADA activity and trough dAXP level prior to the first administration of elapegademase-lvlr for the week.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

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

Rare or Very Rare

• Hemolytic anemia
• Malignant lymphoma
• Thrombocytopenic disorder
• Thrombocytosis
• Urticaria

More Frequent

• Cough
• Vomiting

Rare or Very Rare

• Acute abdominal pain
• Arthralgia
• Headache disorder
• Injection site sequelae

No enhanced messaging available.

The safety and efficacy of elapegademase-lvlr have been established in pediatric patients.

Risk Summary: Adequate and well-controlled studies with elapegademase-lvlr have not been conducted in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with elapegademase-lvlr. It is not known whether elapegademase-lvlr can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Human Data: No pregnancy was reported for any patients receiving elapegademase-lvlr. There are two reports of confirmed cases of successful pregnancy and delivery in ADA-SCID patients treated with Adagen (pegademase bovine; the same class of enzyme replacement therapy used in the treatment of ADA-SCID). No teratogenic effects of Adagen were reported. For patients treated with elapegademase-lvlr, more frequent monitoring of the health status for both the mother during pregnancy and the development of the offspring is recommended.

Risk Summary: Human or animal lactation studies have not been conducted to assess the presence of elapegademase-lvlr in breast milk, the effects on the breastfed infant, or the effects on milk production for the mother. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for elapegademase-lvlr and any potential adverse effects on the breastfed infant from elapegademase-lvlr or from the underlying maternal condition.

Elapegademase-lvlr was not studied in patients 65 years and older.