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PROLEUKIN aldesleukin 1.1 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 73776-0022-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PROLEUKIN aldesleukin 1.1 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 73776-022-01 (Billing 73776-0022-01)

by Iovance Biotherapeutics, Inc · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of PROLEUKIN aldesleukin 1.1 mg/mL Injection, Powder, Lyophilized, For Solution from Iovance Biotherapeutics, Inc, marketed since May 1992 and currently FDA-listed. It is this product's only package size.

NDC 73776-0022-01
🏷️ FDA NDC (as labeled) 73776-022-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73776-022-01
Product NDC 73776-022
11-digit billing NDC 73776002201
NCPDP billing unit EA — each (per item)
RxCUI 105648, 307816
UNII M89N0Q7EQR
Application # BLA103293
SPL Set ID f3c516ad-d405-4fbe-af6a-962080dbfa7d
Established class (EPC) Lymphocyte Growth Factor
Physiologic effect Increased Lymphocyte Activation; Increased Lymphocyte Cell Production
Chemical class Interleukin-2
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1992-05-05
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ALDESLEUKIN
Biologic (Purple Book) 351(a)

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

GCN Seq No 016805
GCN 49031
HICL code 006402
Ingredient (HICL) Aldesleukin
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2G
Therapeutic class — specific (HIC3) Immunomodulators
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name PROLEUKIN 22 MILLION UNIT VIAL
FDB brand name Proleukin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016805
  • GCN: 49031
  • HICL (First Databank): 006402
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 105648
Why two NDCs? The FDA registers this code as 73776-022-01 — 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 → 73776-0022-01. 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 Lymphocyte Growth Factor class.

Pharmacologic class Lymphocyte Growth Factor
Drug family (ATC) Interleukins
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 PROLEUKIN 22 MILLION UNIT VIAL Ingredient Aldesleukin
📖 What it is MedlinePlus · NLM

Aldesleukin is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the kidney) that has spread to other parts of your body. Aldesleukin is also used to treat melanoma (a type of skin cancer) that has spread to other parts of your body. Aldesleukin is in a class of drugs known as cytokines. It is a man-made version of a naturally occurring protein that stimulates the body to produce other chemicals which increase the body's ability to fight cancer.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Proleukin is the brand name for aldesleukin, a man-made version of a natural immune protein called interleukin-2. It's approved to treat two types of advanced cancer: metastatic ki...
  • What exactly is Proleukin, and why has my doctor prescribed it for me?
  • You will need to be in the hospital for every dose — there's no at-home version of this treatment. Proleukin is given as a short IV drip (about 15 minutes) every 8 hours in cycles....
  • Will I be able to take this at home, or do I have to stay in the hospital?
📖 Read our full Aldesleukin guide →
1
Nutrient depletion considerations

Aldesleukin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aldesleukin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
73776-0022-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2024-07-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proleukin 1.1 mg/mLthis 73776-0022-01 Iovance 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

🏛️
1992
First FDA approval
May 1992
📍
2026
Currently FDA-listed
34 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Proleukinaldesleukin
🔒 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.
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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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.

5 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

LabelerIovance Biotherapeutics, Inc
FDA applicationBLA103293 (BLA)
Labeler code73776
First marketedMay 1992
Product typeHuman Prescription Drug
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.
🚨 Boxed Warning 🎯 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer Proleukin in a hospital setting with an intensive care facility.

Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.1) ] . Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] .

Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat pre-existing bacterial infections prior to initiation of Proleukin therapy and withhold Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.3) ] . WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITY, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning.

Capillary Leak Syndrome (CLS) including life-threatening or fatal reactions, has occurred in patients treated with Proleukin. Administer Proleukin in a hospital setting with an intensive care unit. Withhold or discontinue Proleukin as recommended.

( 2.4 , 4 , 5.1 ) Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended. ( 2.4 , 5.2 ) Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin.

Treat preexisting bacterial infections prior to initiating Proleukin and withhold Proleukin as recommended. ( 2.4 , 5.3 )

🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 )

1.1Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC).

1.2Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer Proleukin in an inpatient hospital setting with an intensive care facility. Evaluate cardiovascular, pulmonary, neurologic and renal function before beginning Proleukin. ( 2.1 ) See Full Prescribing Information for Premedication and Supportive medications.

( 2.3 ) Recommended dosage: 600,000 IU/kg (0.037 mg/kg) every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 9 days of rest, repeat the schedule for a maximum of another 14 doses (total of 28 doses per course, as tolerated). ( 2.2 ) Evaluate patients approximately 4 weeks after completion of a course of therapy and again immediately prior to the start of the next course.

( 2.2 ) Dose modification for toxicity should be accomplished by withholding or interrupting a dose. ( 2.4 ) Follow reconstitution and dilution procedures. ( 2.5 )

2.1Recommended Evaluation and Testing Before Initiating Proleukin Conduct baseline hematologic, chemistry, renal and hepatic function tests. Additionally, evaluate cardiac ejection fraction, coronary artery disease as appropriate, pulmonary function with PFTs, and evaluate for renal, hepatic, and CNS impairment prior to initiating treatment with Proleukin [see Contraindications (4) , Warnings and Precautions (5.1 , 5.2) ]. Verify pregnancy status of females of reproductive potential prior to initiating Proleukin [see Warnings and Precautions (5.6) , Use in Specific Populations (8.1 , 8.3) ].

2.2Recommended Dosage Administer Proleukin in an inpatient hospital setting. An intensive care facility with specialists skilled in cardiopulmonary or intensive care medicine must be available [see Warnings and Precautions (5.1) ] . The recommended dosage of Proleukin for metastatic renal cell carcinoma and metastatic melanoma is described in Table 1.

Administer Proleukin as an intravenous infusion after dilution [see Dosage and Administration (2.5) ] . Administer pre-infusion medications and supportive treatment, as appropriate, prior to and during each infusion [see Dosage and Administration (2.3) ]. Discontinue Proleukin for unacceptable toxicity [see Dosage and Administration (2.4) ].

Table 1: Recommended Dosage of Proleukin Each course of therapy consists of the following: Cycle 1 Days 1-5 600,000 IU/kg (0.037 mg/kg) every 8 hours; maximum of 14 doses A maximum of 28 doses (2 cycles) per treatment course Rest period Days 6-14 Cycle 2 Days 15-19 600,000 IU/kg (0.037 mg/kg) every 8 hours; maximum of 14 doses Evaluate patients for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course. Additional courses of treatment may be administered to patients if there is a treatment response following the last course, and the patient did not experience any adverse reactions in previous course(s) that led to permanent discontinuation [see Dosage and Administration (2.4) ].

Separate each treatment course by a rest period of at least 7 weeks from the date of hospital discharge.

2.3Premedication and Supportive Medications Premedicate patients with an antipyretic immediately prior to beginning Proleukin. Continue antipyretics during treatment as needed for fever [see Warnings and Precautions (5.1 , 5.10) ]. Administer prophylactic antibiotics per institutional guidelines prior to beginning Proleukin and throughout the treatment course for patients with indwelling central catheters [see Warnings and Precautions (5.3) ].

Administer prophylactic medication for gastrointestinal irritation and bleeding during each Proleukin treatment course [see Adverse Reactions (6.1) ]. Additional medications may be needed if patients experience hypotension, dyspnea, rigors, nausea, diarrhea, pruritis, or dermatitis [see Warnings and Precautions (5.1 , 5.8 , 5.9) ].

2.4Dosage Modifications for Adverse Reactions No dose reduction for Proleukin is recommended for adverse reactions. In general, withhold or interrupt a dose or… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 22 million International Units (1.3 mg) of aldesleukin available as a white to off-white, lyophilized powder in a single-dose vial for reconstitution. When reconstituted, each mL contains 18 million International Units (1.1 mg) aldesleukin. For Injection: 22 million International Units (1.3 mg) lyophilized powder in a single-dose vial. ( 3 )

⛔ Contraindications 125 words ▾

4 CONTRAINDICATIONS Severe Hypersensitivity Reactions Proleukin is contraindicated in patients with a known history of severe hypersensitivity to aldesleukin or any component of the Proleukin formulation [see Adverse Reactions (6.2) ]. Organ Allografts Proleukin is contraindicated in patients with organ allografts [see Warnings and Precautions (5.5) ] . Significant Organ Impairment Proleukin is contraindicated in patients with significant cardiac (including those with an abnormal cardiac ejection fraction, impaired wall motion, or significant coronary artery disease), pulmonary (including those with an FEV1 ≤ 2 liters or < 75% predicted for height and age), renal, hepatic, or CNS impairment [see Warnings and Precautions (5.1 , 5.2 , 5.4) ] .

Hypersensitivity to aldesleukin. ( 4 ) Organ allografts. ( 4 ) Significant organ impairment.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Renal Toxicity: Monitor renal function at baseline and throughout treatment. Withhold Proleukin or permanently discontinue, based on severity. ( 2.4 , 5.4 ) Immune-mediated Adverse Reactions: Exacerbation of pre-existing autoimmune disease or initial presentation of autoimmune and inflammatory disorders can occur in any system or tissue.

Proleukin may increase the risk of allograft rejection in transplant patients. Monitor patients and treat as indicated. ( 5.5 ) Severe Hypersensitivity Reaction: Permanently discontinue Proleukin for severe hypersensitivity reactions.

( 4 , 5.9 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 )

5.1Capillary Leak Syndrome Severe and life-threatening capillary leak syndrome (CLS) characterized by hypotension, dyspnea, edema, and hypoalbuminemia can occur with Proleukin, and can result in end organ toxicity including cardiac, respiratory, renal, hepatic toxicity, or death. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, or hepatic impairment. Avoid concomitant use of Proleukin with other products known to cause hypotension including antihypertensive drugs, those that cause renal toxicity, or hepatotoxicity.

CLS may begin immediately after Proleukin treatment is initiated. Monitor for signs and symptoms of CLS including assessments of vital signs, weight, fluid intake, albumin levels and urine output. Withhold or discontinue Proleukin for failure to maintain organ perfusion as demonstrated by altered mental status, reduced urine output, oxygen saturation <90%, a fall in the systolic blood pressure below 90 mm Hg, or onset of cardiac arrhythmias.

Initiate standard management for CLS, which may include intensive care [see Dosage and Administration (2.4) , Use in Specific Populations (8.1) ] .

5.2Neurologic Toxicity Proleukin can cause neurologic toxicities including mental status changes, speech difficulties, cortical blindness, limb or gait ataxia, hallucinations, agitation, obtundation, demyelinating polyneuropathy, and coma. Alterations in mental status may progress for several days before recovery begins. Permanent neurologic deficits have occurred.

Radiological findings included multiple and, less commonly, single cortical lesions on MRI and evidence of demyelination. One case of possible cerebral vasculitis has been reported. Monitor patients for signs and symptoms of neurological toxicity during Proleukin treatment.

Withhold Proleukin in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma. Permanently discontinue Proleukin for coma or toxic psychosis lasting >48 hours or for repetitive or difficult to control seizures [see Dosage and Administration (2.4) ]. Evaluate and treat CNS metastases prior to initiation of Proleukin.

If possible, avoid concomitant use of Proleukin with other product(s) with a known potential to cause neurotoxicity, and avoid Proleukin in patients with seizure disorders or abnormal intracranial imaging [see Contraindications (4) , Adverse Reactions (6.1 , 6.2) ] . Concomitant use of Proleukin with other products that cause neurotoxicity may result in a greater risk of severe neurotoxicity.

5.3Serious Infections Including Sepsis Proleukin can cause impaired neutrophil function (reduced chemotaxis) and an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Treat pre-existing bacterial infections prior to initiating Proleukin. Consider antibiotic prophylaxis in patients with indwelling central lines.

Monitor patients for the development of signs and symptoms of infection during treatment and withhold Proleukin based on severity [see Dosage and Administration (2.4) ].

5.4Renal Toxicity Serious renal toxicity, including oliguria and renal failure can occur with Proleukin [see Adverse Reactions (6.1 ,… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Capillary Leak Syndrome [see Warnings and Precautions (5.1) ]. Neurotoxicity [see Warnings and Precautions (5.2) ]. Serious Infections Including Sepsis [see Warnings and Precautions (5.3) ].

Renal Toxicity [see Warnings and Precautions (5.4) ]. Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.5) ]. Serious Manifestations of Eosinophilia [see Warnings and Precautions (5.7) ].

Severe Hypersensitivity Reactions [see Warnings and Precautions (5.9) ]. Infusion-Related Reactions [see Warnings and Precautions (5.10) ] . Most common (≥ 30%) adverse reactions including laboratory abnormalities are hypotension, hyperbilirubinemia, dyspnea, rash, diarrhea, oliguria, chills, vomiting, thrombocytopenia, nausea, confusional state and increased creatinine.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Iovance Biotherapeutics Manufacturing LLC. at 1 844-845-IOVA 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. The safety of Proleukin was evaluated in a series of single and multicenter, controlled studies enrolling a total of 525 patients with metastatic renal cell carcinoma (mRCC studies) or metastatic melanoma (metastatic melanoma studies) [see Clinical Studies (14.1 , 14.2) ] .

In patients who received Proleukin in these studies, fatal adverse reactions occurred in 4% (11/255) of the patients with metastatic RCC, and 2% (6/270) of the patients with metastatic melanoma. In these studies, >90% of patients had doses withheld for adverse reactions [see Dosage and Administration (2.4) ]. The most common (≥30%) adverse reactions were hypotension, hyperbilirubinemia, dyspnea, rash, diarrhea, oliguria, chills, vomiting, thrombocytopenia, nausea, confusional state, and increased creatinine.

Table 4 summarizes adverse reactions that occurred in these studies. Table 4: Adverse Reactions (≥10% all grades or ≥1% Grade 4) in Patients with Metastatic Renal Cell Carcinoma or Metastatic Melanoma (n=525) receiving Proleukin Adverse Reaction Proleukin N = 525 All Grades (%) Grade 4 (%) General disorders Chills 52 0 Pyrexia 29 1 Edema peripheral 28 0 Malaise 27 0 Asthenia 23 0 Edema 15 0 Pain 12 0 Cardiac disorders Hypotension 71 3 Blood pressure fluctuation Not documented 1 Tachycardia 23 0 Dilated veins 13 0 Supraventricular tachycardia 12 1 Ventricular tachycardia <10 1 Cardiovascular disorder Cardiovascular disorder: Electrocardiogram abnormal, cardiac failure congestive.

11 0 Myocardial infarction <10 1 Arrhythmia 10 0 Cardiac arrest <10 1 Gastrointestinal disorders Diarrhea 67 2 Vomiting 50 0 Nausea 35 0 Stomatitis 22 <1 Decreased appetite 20 0 Abdominal pain 11 0 Abdominal distention 10 0 Blood and lymphatic system disorders Thrombocytopenia 37 1 Anemia 29 0 Leukopenia 16 0 Disseminated intravascular coagulation <10 1 Infections Infections 13 1 Sepsis <10 1 Hepatobiliary disorders Hyperbilirubinemia 40 2 Aspartate aminotransferase increased 23 1 Metabolic and nutritional disorders Weight increased 16 0 Acidosis 12 1 Hypomagnesemia 12 0 Hypocalcemia 11 <1 Blood alkaline phosphatase increased 10 0 Nervous system disorders Confusional state 34 1 Stupor <10 1 Coma <10 2 Psychotic disorder <10 1 Somnolence 22 0 Anxiety 12 0 Dizziness 11 0 Respiratory, thoracic, and mediastinal disorders Dyspnea 43 1 Lung disorder Lung disorder: Pulmonary congestion, rales, rhonchi.

24 0 Respiratory disorder Respiratory disorder: Acute respiratory distress syndrome, lung infiltration, lung disorder, respiratory failure, endotracheal intubation. 11 3 Apnea <10 1 Cough 11 0 Rhinitis 10 0 Skin and subcutaneous tissue disorders Rash 42 0 Pruritis 24… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 172 words ▾

7 DRUG INTERACTIONS Drug interaction studies with Proleukin have not been conducted. The drug interaction information described below have been observed post-marketing. See Full Prescribing Information for important drug interactions. ( 7 )

7.1Effect of Other Drugs on Proleukin Glucocorticoids Avoid concomitant use of glucocorticoids. Coadministration with glucocorticoids may reduce aldesleukin antitumor effectiveness.

7.2Effect of Proleukin on Other Drugs Radiographic Iodinated Contrast Media Monitor for delayed adverse reactions in patients receiving iodinated contrast media following Proleukin. Administration of radiographic iodinated contrast media following administration of interleukin-2 resulted in acute, atypical adverse reactions that resemble the immediate side effects caused by Proleukin in some patients [see Warnings and Precautions (5.8) ] . Effect on Cytochrome P-450 Substrates For certain CYP substrates, minimal changes in the concentration may lead to serious adverse reactions.

Monitor for toxicity or drug concentration changes of such CYP substrates when co-administered with Proleukin. Aldesleukin causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings in an animal study and its mechanism of action, Proleukin may cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. Data on the use of Proleukin in pregnant women are limited and insufficient to assess the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes; however, development of capillary leak syndrome during pregnancy can lead to adverse fetal outcomes (see Clinical Considerations ) .

Intravenous administration of aldesleukin to pregnant rats during the period of organogenesis resulted in embryo lethality at doses 27 times and maternal toxicities at doses 2.1 times the human exposure at the recommended clinical dose (see Data ) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15–20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Capillary leak syndrome in women who are exposed to Proleukin during pregnancy may result in maternal hypotension and decreased placental perfusion. Severe or prolonged maternal hypotension and decreased placental perfusion can lead to intrauterine growth restriction, perinatal asphyxia, or fetal/neonatal demise. Monitor fetal and neonatal status in pregnant women who develop capillary leak syndrome associated with Proleukin.

Data Animal Data Aldesleukin has been shown to have embryolethal effects in rats when given in doses at 27 to 36 times the human dose (scaled by body weight). Significant maternal toxicities were observed in pregnant rats administered aldesleukin by IV injection at doses 2.1 to 36 times higher than the human dose during critical period of organogenesis.

8.2Lactation Risk Summary There are no data on the presence of aldesleukin in either human or animal milk, the effects on the breastfed child, or the effects on milk production. Maternal cytokines are known to be present in human breast milk. Because of the potential for serious adverse reactions from Proleukin in a breastfed child, such as impaired immune function, advise women not to breastfeed during treatment.

8.3Females and Males of Reproductive Potential Based on animal data and mechanism of action, Proleukin may cause embryo-fetal harm [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating Proleukin [see Use in Specific Populations (8.1) ]. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with Proleukin.

8.4Pediatric Use The safety and effectiveness of Proleukin have not been established in pediatric patients.

8.5Geriatric Use Clinical studies of Proleukin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings in an animal study and its mechanism of action, Proleukin may cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. Data on the use of Proleukin in pregnant women are limited and insufficient to assess the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes; however, development of capillary leak syndrome during pregnancy can lead to adverse fetal outcomes (see Clinical Considerations ) .

Intravenous administration of aldesleukin to pregnant rats during the period of organogenesis resulted in embryo lethality at doses 27 times and maternal toxicities at doses 2.1 times the human exposure at the recommended clinical dose (see Data ) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15–20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Capillary leak syndrome in women who are exposed to Proleukin during pregnancy may result in maternal hypotension and decreased placental perfusion. Severe or prolonged maternal hypotension and decreased placental perfusion can lead to intrauterine growth restriction, perinatal asphyxia, or fetal/neonatal demise. Monitor fetal and neonatal status in pregnant women who develop capillary leak syndrome associated with Proleukin.

Data Animal Data Aldesleukin has been shown to have embryolethal effects in rats when given in doses at 27 to 36 times the human dose (scaled by body weight). Significant maternal toxicities were observed in pregnant rats administered aldesleukin by IV injection at doses 2.1 to 36 times higher than the human dose during critical period of organogenesis.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of Proleukin have not been established in pediatric patients.

🧓 Geriatric Use 30 words ▾

8.5Geriatric Use Clinical studies of Proleukin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🆘 Overdosage 35 words ▾

10 OVERDOSAGE Exceeding the recommended dose of Proleukin has been associated with a more rapid onset of severe or life-threatening toxicities. Treat toxicities supportively; life-threatening toxicities may be ameliorated by the intravenous administration of dexamethasone.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Aldesleukin is an interleukin-2 lymphocyte growth factor. The antitumor activity of aldesleukin has not been fully characterized. In vitro studies performed on human cell lines show enhancement of lymphocyte mitogenesis and cytotoxicity, induction of killer cell activity [lymphokine-activated killer (LAK) and natural killer (NK) cells] and interferon gamma production, and proliferation of human interleukin-2-dependent cell lines.

Administration of aldesleukin in animals and humans produces multiple immunological effects in a dose-dependent manner. These effects include activation of cellular immunity and the production of cytokines including tumor necrosis factor, IL-1, and interferon gamma. In vivo experiments in murine melanoma and sarcoma tumor models have shown inhibition of tumor growth.

12.2Pharmacodynamics Dose-dependent immunological effects including activation of cellular immunity with lymphocytosis, eosinophilia, and thrombocytopenia, and the production of cytokines including tumor necrosis factor, IL-1, and gamma interferon were observed following administration of aldesleukin in animals and humans. Aldesleukin exposure-response relationships and the time course of pharmacodynamic response are unknown.

12.3Pharmacokinetics Aldesleukin serum concentrations change proportionally with the Proleukin dosage. Distribution Aldesleukin is rapidly distributed (distribution half-life of 13 minutes) into the extravascular space following a Proleukin intravenous infusion. Elimination The serum elimination half-life aldesleukin is 85 minutes in patients with cancer following a 5-minute intravenous infusion of Proleukin.

The mean clearance rate of aldesleukin is 268 mL/min. Metabolism Aldesleukin is metabolized to amino acids in the proximal convoluted tubules of the kidney. Excretion Aldesleukin is primarily excreted in the kidney by both glomerular filtration and peritubular extraction.

In the kidney it is metabolized and excreted into urine with little or no aldesleukin present.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies. In clinical studies, using an enzyme-linked immunosorbent assay (ELISA), low titers of anti-aldesleukin antibodies were observed in 74% (57 of 77) of patients with metastatic renal cell carcinoma treated with an every 8-hour Proleukin regimen and in 66% (33 of 50) of patients with metastatic melanoma treated with a variety of intravenous regimens.

In a separate study in 13 patients, following the first cycle of therapy, the geometric mean aldesleukin exposure (AUC) on Day 15 compared to Day 1 increased by 68% in 11 patients who developed anti-aldesleukin antibodies while no change was observed in the 2 antibody-negative patients. Overall, neutralizing antibodies were detected in 1 patient. Based on these data, the clinical relevance of anti-aldesleukin antibodies could not be assessed.

🧬 Mechanism of Action 111 words ▾

12.1Mechanism of Action Aldesleukin is an interleukin-2 lymphocyte growth factor. The antitumor activity of aldesleukin has not been fully characterized. In vitro studies performed on human cell lines show enhancement of lymphocyte mitogenesis and cytotoxicity, induction of killer cell activity [lymphokine-activated killer (LAK) and natural killer (NK) cells] and interferon gamma production, and proliferation of human interleukin-2-dependent cell lines.

Administration of aldesleukin in animals and humans produces multiple immunological effects in a dose-dependent manner. These effects include activation of cellular immunity and the production of cytokines including tumor necrosis factor, IL-1, and interferon gamma. In vivo experiments in murine melanoma and sarcoma tumor models have shown inhibition of tumor growth.

📦 How Supplied / Storage and Handling 68 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Proleukin ® (aldesleukin) for injection is supplied in single-dose vials. Each vial contains 22 million International Units (1.3 mg) of Proleukin. NDC 73776-022-01 Individually boxed single-dose vial Store unopened vials refrigerated at 2° to 8°C (36° to 46°F) in the original carton to protect from light. Do not use beyond the expiration date printed on the vial. NOTE: This product contains no preservative.

📦 Storage and Handling 36 words ▾

Store unopened vials refrigerated at 2° to 8°C (36° to 46°F) in the original carton to protect from light. Do not use beyond the expiration date printed on the vial. NOTE: This product contains no preservative.

📋 Description 214 words ▾

11 DESCRIPTION Aldesleukin is a human interleukin-2 lymphocyte growth factor produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. It is a purified protein with a molecular weight of approximately 15,300 Da. This recombinant form differs from native interleukin-2 in the following ways: a) aldesleukin is not glycosylated; b) the molecule has no N-terminal alanine; c) the molecule has serine substituted for cysteine at amino acid position 125.

Proleukin exists as biologically active, non-covalently bound microaggregates with an average size of 27 recombinant interleukin-2 molecules; the aggregation state of aldesleukin may differ compared to native interleukin-2. The manufacturing process for aldesleukin involves fermentation in a defined medium containing tetracycline hydrochloride. The presence of tetracycline hydrochloride is not detectable in the final product.

Proleukin (aldesleukin) for injection is a sterile, preservative-free white to off-white, lyophilized powder, which has a cake-like appearance, supplied in single-dose vials for intravenous administration after reconstitution and dilution. When reconstituted with 1.2 mL Sterile Water for Injection, USP, each mL contains 18 million International Units (1.1 mg) aldesleukin, mannitol (50 mg), sodium dodecyl sulfate (0.19 mg), buffered with disodium hydrogen phosphate dihydrate (1.12 mg) and sodium dihydrogen phosphate dihydrate (0.19 mg) to a pH of 7.5 (range 7.2 to 7.8).

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Inform patients or caregivers of the following risks of Proleukin: Capillary Leak Syndrome Advise patients about the risk of capillary leak syndrome and to inform their healthcare provider immediately if they develop new or worsening symptoms of hypotension, dyspnea, or edema [see Warnings and Precautions (5.1) ]. Neurotoxicity Advise the patient to inform their healthcare provider immediately if they develop mental status changes, speech difficulties, blindness, ataxia, hallucinations, agitation, or experienced a seizure [see Warnings and Precautions (5.2) ].

Serious Infections Including Sepsis Advise patients to inform their healthcare provider immediately if they develop signs of infection or sepsis including fever, chills, weakness, dyspnea [see Warnings and Precautions (5.3) ]. Immune-mediated Adverse Reactions Advise patients that Proleukin can cause immune-mediated adverse reactions and can exacerbate pre-existing autoimmune disease. These immune-mediated adverse reactions can occur in any organ system or tissue.

Proleukin may also increase the risk of allograft rejection in transplant patients. Advise patients to contact their healthcare provider for any new or worsening signs or symptoms [see Warnings and Precautions (5.5) ] . Hypothyroidism, sometimes preceded by hyperthyroidism, has been reported following Proleukin treatment.

Evaluate thyroid function at baseline and periodically during treatment and initiate thyroid replacement therapy as clinically indicated. Hyperglycemia and/or diabetes mellitus has been reported during Proleukin therapy. Monitor patients for hyperglycemia and initiate treatment with insulin as clinically indicated.

Serious Manifestations of Eosinophilia Advise patients to inform their healthcare provider immediately if they develop serious symptoms of eosinophilia including new severe rash or dyspnea [see Warnings and Precautions (5.7) ]. Delayed Adverse Reactions to Iodinated Contrast Media Advise patients to inform their health care provider that they received Proleukin prior to undergoing imaging that requires iodinated contrast material [see Warnings and Precautions (5.8) ]. Embryo-Fetal Toxicity Advise females of reproductive potential to use effective contraception during treatment with Proleukin [see Warnings and Precautions (5.6) , Use in Specific Populations (8.1 , 8.3) ] .

Proleukin may cause fetal harm. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) , Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise females not to breastfeed during treatment with Proleukin [see Use in Specific Populations (8.2) ] .

Hypersensitivity Advise patients to inform their healthcare provider if they develop signs and symptoms of hypersensitivity reactions [see Warnings and Precautions (5.9) ].

🧬 Pharmacokinetics 105 words ▾

12.3Pharmacokinetics Aldesleukin serum concentrations change proportionally with the Proleukin dosage. Distribution Aldesleukin is rapidly distributed (distribution half-life of 13 minutes) into the extravascular space following a Proleukin intravenous infusion. Elimination The serum elimination half-life aldesleukin is 85 minutes in patients with cancer following a 5-minute intravenous infusion of Proleukin.

The mean clearance rate of aldesleukin is 268 mL/min. Metabolism Aldesleukin is metabolized to amino acids in the proximal convoluted tubules of the kidney. Excretion Aldesleukin is primarily excreted in the kidney by both glomerular filtration and peritubular extraction.

In the kidney it is metabolized and excreted into urine with little or no aldesleukin present.

🧬 Pharmacodynamics 50 words ▾

12.2Pharmacodynamics Dose-dependent immunological effects including activation of cellular immunity with lymphocytosis, eosinophilia, and thrombocytopenia, and the production of cytokines including tumor necrosis factor, IL-1, and gamma interferon were observed following administration of aldesleukin in animals and humans. Aldesleukin exposure-response relationships and the time course of pharmacodynamic response are unknown.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Metastatic Renal Cell Cancer The efficacy of Proleukin was evaluated in two hundred fifty-five patients with metastatic renal cell carcinoma (mRCC) in 7 clinical studies conducted at 21 institutions (mRCC studies). Eligible patients had an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and normal organ function as determined by cardiac stress test, pulmonary function tests, and creatinine ≤1.5 mg/dL. Studies excluded patients with brain metastases, active infections, organ allografts, and diseases requiring steroid treatment.

Not all patients in these studies received the recommended Proleukin dosing regimen. The major efficacy outcome measure was objective response rate (ORR) determined by investigator assessment per ECOG response criteria for solid tumors (1982). Efficacy results are summarized in Table 5.

Table 5: Proleukin Efficacy Results in mRCC Studies Proleukin (n=255) Objective Response Rate ORR (95% CI), % 15% (11, 20) Complete Response (CR), % 7% Partial Response (PR), % 8% Duration of response (months) Number of Patients Who Responded n= 37 Median (months) 54 Range (months) 3, 131 Denotes ongoing responses

14.2Metastatic Melanoma The efficacy of Proleukin was evaluated in two hundred seventy patients with metastatic melanoma in 8 clinical studies conducted at 22 institutions (metastatic melanoma studies). Eligible patients had an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and normal organ function as determined by cardiac stress test, pulmonary function tests, and creatinine ≤1.5 mg/dL. Studies excluded patients with brain metastases, active infections, organ allografts, and diseases requiring steroid treatment.

Not all patients in these studies received the recommended Proleukin dosing regimen. Patients with metastatic melanoma received a median of 18 of the 28 scheduled doses of Proleukin during the first course of therapy. The major efficacy outcome measure was objective response rate (ORR) determined by investigator assessment per ECOG response criteria for solid tumors (1982).

Efficacy results are summarized in Table 6. Table 6: Proleukin Efficacy Results in Metastatic Melanoma Studies Proleukin (n=270) Objective Response Rate ORR (95% CI) 16% (12, 21) Complete Response (CR), % 6% Partial Response (PR), % 10% Duration of response (months) Number of Patients Who Responded n= 43 Median (months) (95% CI) 9 Range (months) 1, 122 Denotes ongoing responses

🧪 Nonclinical Toxicology 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic and genotoxic potential of aldesleukin have not been evaluated. Animal fertility studies have not been conducted with aldesleukin.

13.2Animal Toxicology and/or Pharmacology Repeated doses of aldesleukin administered to animals intravenously resulted in dose-dependent extramedullary hematopoiesis and lymphoid hyperplasia.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 26 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic and genotoxic potential of aldesleukin have not been evaluated. Animal fertility studies have not been conducted with aldesleukin.

📄 Package Label / Principal Display Panel 44 words ▾

PRINCIPAL DISPLAY PANEL - 1.3 mg Vial Carton NDC 73776-022-01 Proleukin ® (aldesleukin) for injection 22 million International Units/Vial (1.3 mg/vial) Single-Dose Vial Discard Unused Portion For Intravenous Infusion After Dilution Refrigerate Rx only IOVANCE BIOTHERAPEUTICS PRINCIPAL DISPLAY PANEL - 1.3 mg Vial Carton

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

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 PROLEUKIN (this brand).

Top reported reactions

Pyrexia148
Hypotension111
Thrombocytopenia83
Diarrhoea82
Vomiting71
Nausea69
Fatigue66

Age at onset

Neonate1
Infant1
Child13
Adult24
Elderly13

Reporter sex

0 reports

Serious outcomes

Hospitalization601
Death206
Life-threatening136
Disabling33
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 130 41
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Iovance Biotherapeutics, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Iovance Biotherapeutics, 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.
← 73776-0001-12 · Iovance 73796-0110-15 · Prostock →
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.