Revcovi elapegademase-lvlr 1.6 mg/mL Injection, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other immunostimulants class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
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UNII 593YOG76RN
A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $8,948.55 | $8,948.55 / 1 vial |
| Medicare drug plans payPart D · Q2 2026 | $9,363.13 | $9,363.13 / 1 vial |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Revcovi 1.6 mg/mLthis 10122-0502-01 | Chiesi | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 5, 2030 |
Is there a biosimilar for REVCOVI 2.4 MG/1.5 ML VIAL?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 10122-0502-01 You're viewing this | 1 VIAL in 1 CARTON (10122-502-01) / 1.5 mL in 1 VIAL | 2018-10-05 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE REVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. REVCOVI is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Patients transitioning from Adagen to REVCOVI : The starting dose of REVCOVI is 0.2 mg/kg weekly, intramuscularly. See Full Prescribing Information (FPI) for conversion formula from Adagen to REVCOVI. ( 2.1 ) Adagen-naïve patients : The starting dose of REVCOVI is 0.4 mg/kg weekly based on ideal body weight or actual weight whichever is greater, divided into two doses (0.2 mg/kg twice a week), intramuscularly.
( 2.1 ) For complete information, maintenance dosing and therapeutic monitoring, see FPI. ( 2.1 , 2.3 ) REVCOVI is for intramuscular injection only. See FPI for administration instructions.
( 2.2 )
2.1Recommended Dosage Patients transitioning from Adagen to REVCOVI If a patient's weekly Adagen dose is unknown, or a patient's weekly Adagen dose is at or lower than 30 U/kg, the recommended minimum starting dose of REVCOVI is 0.2 mg/kg, intramuscularly, once a week. If a patient's weekly Adagen dose is above 30 U/kg, an equivalent weekly REVCOVI dose (mg/kg) should be calculated using the following conversion formula: REVCOVI dose in mg/kg = Adagen dose in U/kg 150 Subsequent doses may be increased by increments of 0.033 mg/kg weekly if trough ADA activity is under 30 mmol/hr/L, trough deoxyadenosine nucleotides (dAXP) are above 0.02 mmol/L, and/or the immune reconstitution is inadequate based on the clinical assessment of the patient.
The total weekly dose may be divided into multiple intramuscular (IM) administrations during a week. Adagen-naïve patients The starting weekly dose of REVCOVI is 0.4 mg/kg based on ideal body weight or actual weight whichever is greater, divided into two doses (0.2 mg/kg twice a week), intramuscularly, for a minimum of 12 to 24 weeks until immune reconstitution is achieved. After that, the dose may be gradually adjusted down to maintain trough ADA activity over 30 mmol/hr/L, trough dAXP level under 0.02 mmol/L, and/or to maintain adequate immune reconstitution based on clinical assessment of the patient.
The optimal long-term dose and schedule of administration should be established by the treating physician for each patient individually and may be adjusted based on the laboratory values for trough ADA activity, trough dAXP level, and/or on the treating physician's medical assessment of the patient's clinical status .
2.2Administration Instructions 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.
2.3Therapeutic Monitoring Schedule The treatment of ADA-SCID with REVCOVI should be monitored by measuring trough plasma ADA activity, trough 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. Collect blood samples for the analysis of trough plasma ADA activity and trough dAXP level prior to the firs…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 2.4 mg/1.5 mL (1.6 mg/mL) clear and colorless solution of elapegademase-lvlr in a single-dose vial. Injection: 2.4 mg/1.5 mL (1.6 mg/mL) in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 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. ( 5.1 ) Delay in Improvement of Immune Function: Protect immune deficient patients from infections until improvement in immune function. ( 5.2 )
5.1Injection Site Bleeding in Patients with Thrombocytopenia Since REVCOVI is administered by IM injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.
5.2Delay in Improvement of Immune Function Maintain precautions to protect immune deficient patients from infections until improvement in immune function has been achieved. The timing and degree of improvement in immune function may vary from patient to patient.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions reported were cough (50%) and vomiting (33%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. REVCOVI was administered intramuscularly in two prospective, open-label, single-arm, multi‑center studies to evaluate efficacy, safety, tolerability, and pharmacokinetics in patients with ADA-SCID: Study 1 was performed in the US and Study 2 was performed in Japan [see Clinical Studies ( 14 )] .
Overall, 10 patients were treated and adverse reactions reported are summarized below. Study 1 Study 1 is a one-way crossover study, conducted in the US, to evaluate the safety, efficacy, and pharmacokinetics of REVCOVI in patients with ADA‑SCID who were receiving therapy with Adagen. Six patients, 8 to 37 years of age enrolled in the study.
Patients' exposure to REVCOVI ranged from 2 weeks to 146 weeks. No deaths were reported and one patient discontinued treatment due to injection site pain associated with an earlier drug product formulation that was consequently modified. The most common adverse reactions were cough (3/6 patients) and vomiting (2/6 patients).
Other adverse reactions that were reported in one patient each were: abdominal pain upper, arthralgia, asthenia, cerumen impaction, conjunctivitis, convulsion, dental caries, diarrhea, ear canal irritation, ear lobe infection, epistaxis, fatigue, fungal skin infection, gait disturbance, gastrointestinal infection, groin abscess, hematochezia, haemophilus infection (pulmonary), hemoptysis, influenza, injection site discomfort, laceration, lymphadenopathy, migraine, nasal edema, nausea, nephrolithiasis, oral candidiasis, oropharyngeal pain, otitis externa, productive cough, rash, stoma site infection, swelling face, tooth abscess, tooth extraction and upper respiratory tract infection, regardless of investigator causality assessment.
Study 2 Study 2 is a single-arm clinical study that was conducted to assess the safety, efficacy and pharmacokinetics of REVCOVI in patients with ADA-SCID. Four patients 3.4 months to 25 years of age, all Asian, were enrolled in the study and received REVCOVI. Three patients received REVCOVI for 21 weeks and one patient received REVCOVI for 15 weeks.
One death due to CMV pneumonitis and respiratory failure was observed in an infant, who had also experienced pulmonary hemorrhage, respiratory failure and upper respiratory tract infection that represented serious adverse events. Neutropenia was a serious adverse reaction reported by one of the patients. There were 22 reported adverse events for four patients.
Most common adverse events were respiratory infections (2/4 patients).
6.2Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity results from Study 1 and Study 2 suggest that patients who previously received Adagen may present an immunologic response to REVCOVI. Therefore, monitoring for changes in ADA levels during REVCOVI treatment is recommended. [see Dosage and Administration ( 2.3 )] The observed incidence of antibodies (including neutralizing antibodies) is dependent on assay sensitivity and specificity, assay methodology, and concomitant medications.
Therefore, the comparison of the incidence of antibodies to REVCOVI with the incidence of antibodies to other products may be misleading.
6.3Postmarketing Experience with ADAGEN The following postmarketing adverse reactions were voluntarily reported for Adagen, the same class of enzyme replacement therapy used in the treatment of ADA-SCID, and may also be seen with REVCOVI treatment: Hematologic: hemolytic anemia, aut…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The drug interaction potential of REVCOVI is not known.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Adequate and well-controlled studies with REVCOVI have not been conducted in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with REVCOVI. It is not known whether REVCOVI 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. Data Human No pregnancy was reported for any patients receiving REVCOVI.
There are two reports of confirmed cases of successful pregnancy and delivery in ADA-SCID patients treated with Adagen (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 REVCOVI, more frequent monitoring of the health status for both the mother during pregnancy and the development of the offspring is recommended.
8.2Lactation Risk Summary Human or animal lactation studies have not been conducted to assess the presence of REVCOVI 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 REVCOVI and any potential adverse effects on the breastfed infant from REVCOVI or from the underlying maternal condition.
8.4Pediatric Use The safety and efficacy of REVCOVI have been established in pediatric patients [see Clinical Studies ( 14 )].
8.5Geriatric Use REVCOVI was not studied in patients 65 years and older.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Adequate and well-controlled studies with REVCOVI have not been conducted in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with REVCOVI. It is not known whether REVCOVI 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. Data Human No pregnancy was reported for any patients receiving REVCOVI.
There are two reports of confirmed cases of successful pregnancy and delivery in ADA-SCID patients treated with Adagen (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 REVCOVI, more frequent monitoring of the health status for both the mother during pregnancy and the development of the offspring is recommended.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of REVCOVI have been established in pediatric patients [see Clinical Studies ( 14 )].
🧓 Geriatric Use ▾
8.5Geriatric Use REVCOVI was not studied in patients 65 years and older.
🆘 Overdosage ▾
10 OVERDOSAGE There are no reports of administration of REVCOVI in excess of the prescribed doses. The highest weekly prescribed dose administered in the clinical studies was 0.4 mg/kg. In nonclinical studies, there was no evidence of toxicity related to study drug at doses up to 1.8-fold the clinical dose (based on mean human AUC normalized to the dose of REVCOVI administered per patient), except for a slight increase in activated partial thromboplastin time (APTT).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action SCID associated with a deficiency of ADA enzyme is a rare, inherited, and often fatal disease. ADA enzyme is involved in purine metabolism, catalyzing the irreversible hydrolytic deamination of adenosine or deoxyadenosine to inosine or deoxyinosine, respectively, as well as several naturally occurring methylated adenosine compounds. Maintaining a low level of 2'-deoxyadenosine and adenosine is crucial for proper number and function of immune cells as well as decreasing the frequency of opportunistic infections.
Elevated adenosine levels, as occurring in ADA deficiency, contribute to apoptosis and a block in the differentiation of thymocytes, causing severe T‑lymphopenia. Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number [see Clinical Studies ( 14 )].
12.2Pharmacodynamics The effect of REVCOVI on the QT interval is not known.
12.3Pharmacokinetics The pharmacokinetics (PK) of REVCOVI were evaluated based on steady state plasma ADA activity in six patients with ADA-SCID (five adults and one pediatric) from two studies (Study 1 and Study 2) who received weekly IM injections at doses ranging from 4.99 to 19.6 mg [see Clinical Studies ( 14 )] . The PK results are summarized in Table 1. Table 1 Individual Estimates of Steady State Plasma Pharmacokinetic Parameters of REVCOVI Following Weekly IM Administration in ADA-SCID Patients Study Patient's Age (yrs), Sex, Race Weekly Dose (mg) [mg/kg] T max (hr) DN AUC 0-168hr (hr*mmol/hr/L)/ (mg/kg) b DN C max (mmol/hr/L)/ (mg/kg) b C trough (mmol/hr/L) c a PK data calculated over the dosing interval after weekly IM administration of REVCOVI at a stable REVCOVI dose for at least five consecutive weeks b Dose-normalized (DN) AUC 0-168hr and C max estimates based on mg/kg/week dose of REVCOVI c Non-dose normalized steady state C trough ADA activity in plasma at Day 7 prior to administration of next weekly dose Study 1 a 19, Male, Hispanic/Latino 10.0 [0.188] 47.7 32710 237 29.0 21, Male, Hispanic/Latino 10.2 [0.224] 71.9 31343 219 37.7 37, Male, Black/African American 19.6 [0.2] 48.2 42400 292 46.2 30, Female, White/Caucasian 10.0 [0.209] 72.0 24564 166
23.5Study 2 a 25, Male, Asian 10.0 [0.167] 48.0 37605 251 33.5 16, Female, Asian 4.99 [0.233] 27.2 19013 150
20.2In Study 1, steady state ADA activity levels were reached following seven consecutive once weekly IM doses of REVCOVI. In addition, dAXP activity levels in all patients at the majority of all sampling timepoints in Study 1 were less than 0.02 mmol/L.
🧬 Mechanism of Action ▾
12.1Mechanism of Action SCID associated with a deficiency of ADA enzyme is a rare, inherited, and often fatal disease. ADA enzyme is involved in purine metabolism, catalyzing the irreversible hydrolytic deamination of adenosine or deoxyadenosine to inosine or deoxyinosine, respectively, as well as several naturally occurring methylated adenosine compounds. Maintaining a low level of 2'-deoxyadenosine and adenosine is crucial for proper number and function of immune cells as well as decreasing the frequency of opportunistic infections.
Elevated adenosine levels, as occurring in ADA deficiency, contribute to apoptosis and a block in the differentiation of thymocytes, causing severe T‑lymphopenia. Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number [see Clinical Studies ( 14 )].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING REVCOVI (elapegademase-lvlr) injection, 2.4 mg/1.5 mL (1.6 mg/mL), is a sterile, preservative free, clear, colorless solution for intramuscular use available as one single-dose vial per carton (NDC 10122-502-01). The vial stopper is not made with natural rubber latex. Single-dose vial; do not re-use the vial.
Discard unused portions. Store REVCOVI in the refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
REVCOVI should not be used if there are any indications that it may have been frozen.
📋 Description ▾
11 DESCRIPTION Elapegademase-lvlr is a recombinant adenosine deaminase (rADA) based on bovine amino acid sequence, conjugated to monomethoxypolyethylene glycol (mPEG). rADA is manufactured in E. coli and is covalently conjugated to mPEG with a succinimidyl carbamate linker to produce methoxypolyethylene glycol recombinant adenosine deaminase (SC-PEG rADA). The approximate molecular weight of elapegademase-lvlr (SC-PEG rADA) is 113 KDa. REVCOVI (elapegademase-lvlr) injection is a sterile, preservative free, clear, colorless solution for intramuscular use supplied in single-dose vials.
Each vial provides 1.5 mL of solution containing 2.4 mg elapegademase-lvlr (1.6 mg/mL), sodium chloride (12.75 mg), sodium phosphate dibasic heptahydrate (12.7 mg), sodium phosphate monobasic monohydrate (3.81 mg), and Water for Injection, USP. The pH is 6.9.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Importance of Compliance Counsel patients and caregivers that continuous therapy and adherence to the recommended drug schedule is important for the success of the treatment. Manufactured by: Chiesi USA, Inc. Cary, NC 27518, USA, U.S. License No. 2150 CTRV-001-0526-01-W Chiesi