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Revcovi elapegademase-lvlr 1.6 mg/mL Injection, 1 vial — NDC 10122-0502-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Revcovi elapegademase-lvlr 1.6 mg/mL Injection, 1 vial — NDC 10122-502-01 (Billing 10122-0502-01)

by Chiesi USA, Inc. · 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL

This is a package of 1 vial of Revcovi elapegademase-lvlr 1.6 mg/mL Injection from Chiesi USA, Inc., marketed since Oct 2018 and currently FDA-listed. It is this product's only package size.

NDC 10122-0502-01
🏷️ FDA NDC (as labeled) 10122-502-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 10122-502-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
10122 labeler · 502 product · 01 package
Package marketed since
Oct 5, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 1012250201 7
Medicaid fills, this package
175 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class III · Aug 19, 2026 — Failed Stability Specifications: Out of specification stability result for the protein concentration profile. (Chiesi USA, Inc.) · FDA recall D-0838-2026
Lots / codes: Lot#: 1221973, Exp 3/24/2027 · reported Sep 9, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10122-502-01
Product NDC 10122-502
11-digit billing NDC 10122050201
NCPDP billing unit ML — per mL (volume)
RxCUI 2059223, 2059228
UNII 9R3D3Y0UHS
Application # BLA761092
SPL Set ID 8c073f84-cdd0-40e4-b3a9-172687267f28
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-10-05
Route INTRAMUSCULAR
Dosage form INJECTION
Substance ELAPEGADEMASE
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 30902030202020
GPI class Revcovi
GCN Seq No 079092
GCN 45525
HICL code 045340
Ingredient (HICL) Elapegademase-Lvlr
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z1
Therapeutic class — intermediate (HIC2) Positive Effects On Wide-Spread Tissue
HIC3 code Z1K
Therapeutic class — specific (HIC3) Metabolic Dx Enzyme Replacemt,Sev.comb.immune Def.
AHFS code 44:00.00.00
AHFS class Enzymes
FDB label name REVCOVI 2.4 MG/1.5 ML VIAL
FDB brand name Revcovi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079092
  • GCN: 45525
  • GPI-14 (Medi-Span): 30902030202020
  • HICL (First Databank): 045340
  • AHFS class code: 44:00.00.00
  • RxCUI (RxNorm): 2059223
Why two NDCs? The FDA registers this code as 10122-502-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 10122-0502-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other immunostimulants class.

Drug family (ATC) Other immunostimulants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name REVCOVI 2.4 MG/1.5 ML VIAL Ingredient Elapegademase-Lvlr

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $9,021.65 $9,021.65 / 1 vial
Medicare drug plans payPart D · Q2 2026 $9,363.13 $9,363.13 / 1 vial
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
10122-0502-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL 2018-10-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Revcovi 1.6 mg/mLthis 10122-0502-01 Chiesi 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2018
First FDA approval
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2030. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 5, 2018 ⏳ ~4 yr to latest listed protection

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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Revcovielapegademase-lvlr
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2018 2020 2022 2024 2026 2028 2030
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 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.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateOct 5, 2030
Common questions
Is there a biosimilar for REVCOVI 2.4 MG/1.5 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.
  • 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.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChiesi USA, Inc.
FDA applicationBLA761092 (BLA)
Labeler code10122
First marketedOct 2018
Product typeHuman Prescription Drug
Portfolio25 products on file

More NDCs from Chiesi USA, Inc. labeler code 10122

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 34 words ▾

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 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions 124 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 12 words ▾

7 DRUG INTERACTIONS The drug interaction potential of REVCOVI is not known.

👥 Use in Specific Populations ~1 min read ▾

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 168 words ▾

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 21 words ▾

8.4Pediatric Use The safety and efficacy of REVCOVI have been established in pediatric patients [see Clinical Studies ( 14 )].

🧓 Geriatric Use 13 words ▾

8.5Geriatric Use REVCOVI was not studied in patients 65 years and older.

🆘 Overdosage 75 words ▾

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 ~2 min read ▾

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 134 words ▾

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 94 words ▾

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 113 words ▾

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 44 words ▾

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

🧬 Pharmacokinetics ~1 min read ▾

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.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics The effect of REVCOVI on the QT interval is not known.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Study 1 Study 1, conducted in the US (NCT 01420627), is an ongoing Phase 3, open-label, multicenter, single-arm, one-way crossover study of REVCOVI. The purpose of this clinical study is to evaluate the safety, efficacy, and PK of REVCOVI in 6 patients with ADA-SCID, 4 males and 2 females, who are receiving therapy with Adagen. The study treatment consists of three phases: Adagen Lead-in Phase (minimum of 3 weeks), the REVCOVI Treatment Phase (weeks 1 through 21), and followed by the REVCOVI Maintenance Phase.

Six patients treated in the study were 8 to 37 years of age at the start of the study. The starting weekly dose of REVCOVI was calculated based on the last Adagen dose received in the study. Weekly REVCOVI doses ranged from 0.188 mg/kg to 0.292 mg/kg [see Dosage and Administration ( 2.1 )].

The efficacy endpoints assessed were as follows: Trough dAXP Level (metabolic detoxification was defined as a trough erythrocyte dAXP concentration equal to or below 0.02 mmol/L) Trough plasma ADA activity (adequate trough plasma ADA activity is defined as trough plasma ADA activity equal to or above 15 mmol/hr/L) Immune status (lymphocyte and B-, T-, and NK-lymphocyte subset counts as well as quantitative immunoglobulin [Ig] concentration [IgG, IgA, IgM]) A PK assessment was performed during Week 9 of the REVCOVI Treatment phase [see Clinical Pharmacology ( 12.3 )] .

Five of six patients reached the 21-week endpoint of the Treatment Phase, and three of six patients received treatment with REVCOVI (elapegademase-lvlr) for over 135 weeks. These patients (except for one value in a patient at Treatment Week 47) had erythrocyte dAXP concentration equal to or below 0.02 mmol/L. These patients had trough plasma ADA activity equal to or above 15 mmol/hr/L at 88/89 timepoints and maintained metabolic detoxification for at least 2 years under REVCOVI treatment.

Patients achieved trough plasma ADA activity above 30 mmol/hr/L by week 5, except for one patient who achieved this level at week 1. The mean trough plasma ADA activity for patients receiving REVCOVI at a normalized dose of 0.2 mg/kg/week were 34.3 ± 6.6 mmol/hr/L. The same patients had a mean trough plasma ADA activity of 14.2 ± 5.1 mmol/hr/L when treated with Adagen at a normalized dose of 30 U/kg/week during the Lead-in Phase of the study.

Lymphocyte and subset counts during REVCOVI treatment increased above levels observed during the Adagen Lead-in Phase (i.e., PK day 1 or before the start of REVCOVI treatment): maximum increases of approximately 3-fold at Weeks 60-73 for one patient, maximum increases of approximately 2- to 3-fold at Weeks 73-99 for one patient and approximately 1.5- to 3-fold for the third patient at several timepoints. For these three patients who completed the primary endpoint (21 weeks of treatment) and received REVCOVI for over 135 weeks, a positive trend between high trough plasma ADA activity and increased total lymphocyte counts was observed.

Observations for the other three patients in the study, indicate that these patients also achieved complete detoxification based on trough dAXP level and trough plasma ADA activity, and show stable or slightly increased lymphocyte counts during REVCOVI treatment relative to values recorded during the Adagen Lead-in Phase.

14.2Study 2 Study 2, conducted in Japan, is a single-arm clinical study that assessed the safety, efficacy and PK of REVCOVI in patients with ADA-SCID. The study includes two phases: 1) Evaluation, consisting of a Dose Adjustment Period (5 weeks) and a Dose Maintenance Period (16 weeks); and 2) Continuous Administration (Extension) Phase, to be continued until the end of the study. A total of four patients were enrolled in the study: two males (age 25 years and 3.4 months) and two females (age 16 years and 4.3 months).

Two patients, who were on Adagen treatment within 4 weeks before entering the study, received a first dose of REVCOVI that was calculated to be equivalent to t… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 33 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential and impairment of fertility have not been performed with REVCOVI.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 30 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential and impairment of fertility have not been performed with REVCOVI.

📄 Package Label / Principal Display Panel 29 words ▾

PRINCIPAL DISPLAY PANEL - 2.4 mg/1.5 mL Vial Carton NDC10122-502-01 Revcovi ® (elapegademase-lvlr) Injection 2.4 mg/1.5 mL (1.6 mg/mL) For Intramuscular Use Only SINGLE-DOSE VIAL Discard Unused Portion Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
175
Units reimbursed last 4 qtrs
4.1K
Gross reimbursed last 4 qtrs
$36.54M
Avg / prescription
$208,786.72
Avg / unit
$9,021.65
Latest quarter Q1 2026
49Rx
Fee-for-service vs managed care ⓘ
51% FFS 49% MCO
Fee-for-service · 90 Rx Managed care · 85 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 618 units · 10.8 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 468 units · 2.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,944 units · 5.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 1,020 units · 4.5 per 100k residents FL
Units reimbursed · per 100k residents
2.410.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Minnesota 10.8 /100k
2 California 5.0 /100k
3 Florida 4.5 /100k
4 New York 2.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Revcovi — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Revcovi. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.61M
Claims incl. refills
21
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$410,187.26
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Revcovi (this brand).

Top reported reactions

Nasopharyngitis37
Cough23
Covid-1922
Bone Marrow Transplant13
Sinusitis13
Pneumonia12
Weight Decreased12

Age at onset

Adult1

Reporter sex

295 reports
Male · 49%
Female · 51%

Serious outcomes

Hospitalization44
Death6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 64 4
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Chiesi USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chiesi USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 10122-0460-02 · Chiesi 10122-0510-01 · Chiesi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.