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JAKAFI XR ruxolitinib 22 mg Tablet, Extended Release, 30-count — NDC 50881-0022-08 package photo

JAKAFI XR ruxolitinib 22 mg Tablet, Extended Release, 30-count

by Incyte Corporation · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-022-08)
NDC 50881-0022-08
🏷️ FDA NDC (as labeled) 50881-022-08 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 13, 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

FDA NDC (as labeled) 50881-022-08
Product NDC 50881-022
11-digit billing NDC 50881002208
NCPDP billing unit EA — each (per item)
RxCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349,
UNII 82S8X8XX8H
UPC 0350881015601, 0350881055089, 0350881022081, 0350881010606 +6 more
Application # NDA217180
SPL Set ID f1c82580-87ae-11e0-bc84-0002a5d5c51b
Established class (EPC) Kinase Inhibitor; Janus Kinase Inhibitor
Mechanism of action Janus Kinase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance RUXOLITINIB
GCN Seq No 088914
GCN 59104
HICL code 038202
Ingredient (HICL) Ruxolitinib Phosphate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3L
Therapeutic class — specific (HIC3) Antineoplastic - Janus Kinase (Jak) Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name JAKAFI XR 22 MG TABLET
FDB brand name Jakafi Xr
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50881-022-08 — 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 → 50881-0022-08. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor, Janus Kinase Inhibitor
Drug family (ATC) Agents for dermatitis, excluding corticosteroids, Janus-associated kinase (JAK) inhibitors
How it works Janus Kinase Inhibitors
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.

🏭 Manufacturer & labeler

LabelerIncyte Corporation
Application holderINCYTE CORP
FDA applicationNDA217180 (NDA)
Labeler code50881
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio22 products on file
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.

🩺 Clinical

Label name JAKAFI XR 22 MG TABLET Ingredient Ruxolitinib Phosphate
📗 Our plain-language guide HelloPharmacist
  • Ruxolitinib targets overactive enzymes called JAK1 and JAK2 that are driving your condition — whether that's abnormal bone marrow cell growth in myelofibrosis or polycythemia vera,...
  • What exactly is ruxolitinib treating in my body?
  • Please don't stop suddenly without talking to your doctor first. If you stop ruxolitinib abruptly, your disease symptoms can come back quickly and sometimes more severely. If a sid...
  • Can I stop taking it if I feel better or if the side effects bother me?
📖 Read our full Ruxolitinib guide →
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.

💊 What it looks like

Color white / pink / yellow / gray
ShapeRound
ImprintI;55
Size9 mm
ScoringNot scored
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 L4RXU2VPD6
    Hypromellose 2208 is a cellulose-based thickening agent derived from plant fibers. In medicines, it acts as a binder to hold ingredients together, a film-coating to protect the tablet, and a viscosity modifier to control how the drug dissolves and releases in the body.
  • UNII 39J80LT57T
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.

7 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.

💲 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 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 · Q2 2026 $293.48 $8,804.37 / 30 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Jakafi Xr 22 mgthis 50881-0022-08 Incyte 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2026
First FDA approval
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 1, 2026 RLD RS ⏳ ~7.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8829013 — method of use (U-3227)
US 8829013 — method of use (U-3228)
US 8829013 — method of use (U-3227)
US 8829013 — method of use (U-3228)
US 8829013 — method of use (U-3227)
US 8829013 — method of use (U-3228)
US 8829013 — method of use (U-3227)
US 8829013 — method of use (U-3228)
US 8829013 — method of use (U-3227)
US 8829013 — method of use (U-3228)
US 9814722 — method of use (U-3226)
US 9814722 — method of use (U-3230)
US 9814722 — method of use (U-3226)
US 9814722 — method of use (U-3230)
US 9814722 — method of use (U-3226)
US 9814722 — method of use (U-3230)
US 9814722 — method of use (U-3226)
US 9814722 — method of use (U-3230)
US 9814722 — method of use (U-3226)
US 9814722 — method of use (U-3230)
US 9206187 — method of use (U-3227)
US 9206187 — method of use (U-3228)
US 9206187 — method of use (U-3227)
US 9206187 — method of use (U-3228)
US 9206187 — method of use (U-3227)
US 9206187 — method of use (U-3228)
US 9206187 — method of use (U-3227)
US 9206187 — method of use (U-3228)
US 9206187 — method of use (U-3227)
US 9206187 — method of use (U-3228)
US 10016429 — method of use (U-3226)
US 10016429 — method of use (U-3230)
US 10016429 — method of use (U-3226)
US 10016429 — method of use (U-3230)
US 10016429 — method of use (U-3226)
US 10016429 — method of use (U-3230)
US 10016429 — method of use (U-3226)
US 10016429 — method of use (U-3230)
US 10016429 — method of use (U-3226)
US 10016429 — method of use (U-3230)
US 9079912 — method of use (U-3227)
US 9079912 — method of use (U-3228)
US 9079912 — method of use (U-3230)
US 9079912 — method of use (U-3226)
US 9079912 — method of use (U-3227)
US 9079912 — method of use (U-3228)
US 9079912 — method of use (U-3230)
US 9079912 — method of use (U-3226)
US 9079912 — method of use (U-3227)
US 9079912 — method of use (U-3228)
US 9079912 — method of use (U-3230)
US 9079912 — method of use (U-3226)
US 9079912 — method of use (U-3227)
US 9079912 — method of use (U-3228)
US 9079912 — method of use (U-3230)
US 9079912 — method of use (U-3226)
US 9079912 — method of use (U-3227)
US 9079912 — method of use (U-3228)
US 9079912 — method of use (U-3230)
US 9079912 — method of use (U-3226)
US 8822481 — method of use (U-3227)
US 8822481 — method of use (U-3228)
US 8822481 — method of use (U-3230)
US 8822481 — method of use (U-3226)
US 8822481 — method of use (U-3227)
US 8822481 — method of use (U-3228)
US 8822481 — method of use (U-3230)
US 8822481 — method of use (U-3226)
US 8822481 — method of use (U-3227)
US 8822481 — method of use (U-3228)
US 8822481 — method of use (U-3230)
US 8822481 — method of use (U-3226)
US 8822481 — method of use (U-3227)
US 8822481 — method of use (U-3228)
US 8822481 — method of use (U-3230)
US 8822481 — method of use (U-3226)
US 8822481 — method of use (U-3227)
US 8822481 — method of use (U-3228)
US 8822481 — method of use (U-3230)
US 8822481 — method of use (U-3226)
US 11337927 — method of use (U-3227)
US 11337927 — method of use (U-3228)
US 11337927 — method of use (U-3230)
US 11337927 — method of use (U-3226)
US 11337927 — method of use (U-3227)
US 11337927 — method of use (U-3228)
US 11337927 — method of use (U-3230)
US 11337927 — method of use (U-3226)
US 11337927 — method of use (U-3227)
US 11337927 — method of use (U-3228)
US 11337927 — method of use (U-3230)
US 11337927 — method of use (U-3226)
US 11337927 — method of use (U-3227)
US 11337927 — method of use (U-3228)
US 11337927 — method of use (U-3230)
US 11337927 — method of use (U-3226)
US 11337927 — method of use (U-3227)
US 11337927 — method of use (U-3228)
US 11337927 — method of use (U-3230)
US 11337927 — method of use (U-3226)
US 11576864 — method of use (U-3227)
US 11576864 — method of use (U-3228)
US 11576864 — method of use (U-3230)
US 11576864 — method of use (U-3226)
US 11576864 — method of use (U-3227)
US 11576864 — method of use (U-3228)
US 11576864 — method of use (U-3230)
US 11576864 — method of use (U-3226)
US 11576864 — method of use (U-3227)
US 11576864 — method of use (U-3228)
US 11576864 — method of use (U-3230)
US 11576864 — method of use (U-3226)
US 11576864 — method of use (U-3227)
US 11576864 — method of use (U-3228)
US 11576864 — method of use (U-3230)
US 11576864 — method of use (U-3226)
US 11576864 — method of use (U-3227)
US 11576864 — method of use (U-3228)
US 11576864 — method of use (U-3230)
US 11576864 — method of use (U-3226)
US 11896717 — method of use (U-3227)
US 11896717 — method of use (U-3228)
US 11896717 — method of use (U-3230)
US 11896717 — method of use (U-3226)
US 11896717 — method of use (U-3227)
US 11896717 — method of use (U-3228)
US 11896717 — method of use (U-3230)
US 11896717 — method of use (U-3226)
US 11896717 — method of use (U-3227)
US 11896717 — method of use (U-3228)
US 11896717 — method of use (U-3230)
US 11896717 — method of use (U-3226)
US 11896717 — method of use (U-3227)
US 11896717 — method of use (U-3228)
US 11896717 — method of use (U-3230)
US 11896717 — method of use (U-3226)
US 11896717 — method of use (U-3227)
US 11896717 — method of use (U-3228)
US 11896717 — method of use (U-3230)
US 11896717 — method of use (U-3226)
US 11744832 — method of use (U-3226)
US 11744832 — method of use (U-3230)
US 11744832 — method of use (U-3226)
US 11744832 — method of use (U-3230)
US 11744832 — method of use (U-3226)
US 11744832 — method of use (U-3230)
US 11744832 — method of use (U-3226)
US 11744832 — method of use (U-3230)
US 11744832 — method of use (U-3226)
US 11744832 — method of use (U-3230)
US 11576865 — method of use (U-3227)
US 11576865 — method of use (U-3228)
US 11576865 — method of use (U-3230)
US 11576865 — method of use (U-3226)
US 11576865 — method of use (U-3227)
US 11576865 — method of use (U-3228)
US 11576865 — method of use (U-3230)
US 11576865 — method of use (U-3226)
US 11576865 — method of use (U-3227)
US 11576865 — method of use (U-3228)
US 11576865 — method of use (U-3230)
US 11576865 — method of use (U-3226)
US 11576865 — method of use (U-3227)
US 11576865 — method of use (U-3228)
US 11576865 — method of use (U-3230)
US 11576865 — method of use (U-3226)
US 11576865 — method of use (U-3227)
US 11576865 — method of use (U-3228)
US 11576865 — method of use (U-3230)
US 11576865 — method of use (U-3226)
US 7598257 — drug substance (U-3227)
US 7598257 — drug substance (U-3228)
US 7598257 — drug substance (U-3227)
US 7598257 — drug substance (U-3228)
US 7598257 — drug substance (U-3227)
US 7598257 — drug substance (U-3228)
US 7598257 — drug substance (U-3227)
US 7598257 — drug substance (U-3228)
US 7598257 — drug substance (U-3227)
US 7598257 — drug substance (U-3228)
US 8415362 — drug substance
US 8530485 — drug product
US 10874616 — drug product
US 8415362 — drug substance
US 10874616 — drug product
US 8722693 — drug substance
US 11213528 — drug product
US 8722693 — drug substance
US 8722693 — drug substance
US 8722693 — drug substance
US 11213528 — drug product
US 10874616 — drug product
US 10874616 — drug product
US 10874616 — drug product
US 8530485 — drug product
US 11213528 — drug product
US 11213528 — drug product
US 8415362 — drug substance
US 8530485 — drug product
US 8530485 — drug product
US 8415362 — drug substance
US 11213528 — drug product
US 8722693 — drug substance
US 8415362 — drug substance
US 8530485 — drug product
US 8829013*PED — drug product
US 8829013*PED — drug product
US 8829013*PED — drug product
US 8829013*PED — drug product
US 8829013*PED — drug product
US 10016429*PED — drug product
US 10016429*PED — drug product
US 10016429*PED — drug product
US 10016429*PED — drug product
US 10016429*PED — drug product
US 10874616*PED — drug product
US 10874616*PED — drug product
US 10874616*PED — drug product
US 10874616*PED — drug product
US 10874616*PED — drug product
US 8822481*PED — drug product
US 8822481*PED — drug product
US 8822481*PED — drug product
US 8822481*PED — drug product
US 8822481*PED — drug product
US 11213528*PED — drug product
US 11213528*PED — drug product
US 11213528*PED — drug product
US 11213528*PED — drug product
US 11213528*PED — drug product
US 11337927*PED — drug product
US 11337927*PED — drug product
US 11337927*PED — drug product
US 11337927*PED — drug product
US 11337927*PED — drug product
US 11576864*PED — drug product
US 11576864*PED — drug product
US 11576864*PED — drug product
US 11576864*PED — drug product
US 11576864*PED — drug product
US 8722693*PED — drug product
US 8722693*PED — drug product
US 8722693*PED — drug product
US 8722693*PED — drug product
US 8722693*PED — drug product
US 11896717*PED — drug product
US 11896717*PED — drug product
US 11896717*PED — drug product
US 11896717*PED — drug product
US 11896717*PED — drug product
US 11576865*PED — drug product
US 11576865*PED — drug product
US 11576865*PED — drug product
US 11576865*PED — drug product
US 11576865*PED — drug product
US 8415362*PED — drug product
US 8415362*PED — drug product
US 8415362*PED — drug product
US 8415362*PED — drug product
US 8415362*PED — drug product
US 7598257*PED — drug product
US 7598257*PED — drug product
US 7598257*PED — drug product
US 7598257*PED — drug product
US 7598257*PED — drug product
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (265)
PatentTypeUse codeExpires
US 8829013 ↗ Method of use U-3227 Jun 12, 2028
US 8829013 ↗ Method of use U-3228 Jun 12, 2028
US 8829013 ↗ Method of use U-3227 Jun 12, 2028
US 8829013 ↗ Method of use U-3228 Jun 12, 2028
US 8829013 ↗ Method of use U-3227 Jun 12, 2028
US 8829013 ↗ Method of use U-3228 Jun 12, 2028
US 8829013 ↗ Method of use U-3227 Jun 12, 2028
US 8829013 ↗ Method of use U-3228 Jun 12, 2028
US 8829013 ↗ Method of use U-3227 Jun 12, 2028
US 8829013 ↗ Method of use U-3228 Jun 12, 2028
US 9814722 ↗ Method of use U-3226 Dec 12, 2026
US 9814722 ↗ Method of use U-3230 Dec 12, 2026
US 9814722 ↗ Method of use U-3226 Dec 12, 2026
US 9814722 ↗ Method of use U-3230 Dec 12, 2026
US 9814722 ↗ Method of use U-3226 Dec 12, 2026
US 9814722 ↗ Method of use U-3230 Dec 12, 2026
US 9814722 ↗ Method of use U-3226 Dec 12, 2026
US 9814722 ↗ Method of use U-3230 Dec 12, 2026
US 9814722 ↗ Method of use U-3226 Dec 12, 2026
US 9814722 ↗ Method of use U-3230 Dec 12, 2026
US 9206187 ↗ Method of use U-3227 Dec 12, 2026
US 9206187 ↗ Method of use U-3228 Dec 12, 2026
US 9206187 ↗ Method of use U-3227 Dec 12, 2026
US 9206187 ↗ Method of use U-3228 Dec 12, 2026
US 9206187 ↗ Method of use U-3227 Dec 12, 2026
US 9206187 ↗ Method of use U-3228 Dec 12, 2026
US 9206187 ↗ Method of use U-3227 Dec 12, 2026
US 9206187 ↗ Method of use U-3228 Dec 12, 2026
US 9206187 ↗ Method of use U-3227 Dec 12, 2026
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FDA exclusivity
CodeWhat it grantsExpires
ODE*Orphan Drug Exclusivity (7-year)Sep 22, 2028
ODE*Orphan Drug Exclusivity (7-year)Sep 22, 2028
ODE*Orphan Drug Exclusivity (7-year)Sep 22, 2028
ODE*Orphan Drug Exclusivity (7-year)Sep 22, 2028
ODE*Orphan Drug Exclusivity (7-year)Sep 22, 2028
PEDPediatric Exclusivity (+6 months)Mar 22, 2029
PEDPediatric Exclusivity (+6 months)Mar 22, 2029
PEDPediatric Exclusivity (+6 months)Mar 22, 2029
PEDPediatric Exclusivity (+6 months)Mar 22, 2029
PEDPediatric Exclusivity (+6 months)Mar 22, 2029
Common questions
Is there a generic version of JAKAFI XR 22 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for JAKAFI XR 22 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2034 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50881-0022-08 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-022-08) 2026-05-01 Active

🧭 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) — 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 FDA registers it as 50881-022-08, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50881-0022-08, written without dashes as 50881002208. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50881-0022-08, the first segment (50881) is the labeler code FDA assigned to Incyte Corporation; the middle segment (0022) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Incyte Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Incyte Corporation 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 Indications and Usage 205 words ▾

1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 )

1.1Myelofibrosis JAKAFI/JAKAFI XR is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults.

1.2Polycythemia Vera JAKAFI/JAKAFI XR is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.

1.3Acute Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.

1.4Chronic Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below. Myelofibrosis ( 2.2 ) The starting dose of JAKAFI/JAKAFI XR is based on patient’s baseline platelet count: • Greater than 200 × 10 9 /L: JAKAFI 20 mg given orally twice daily or JAKAFI XR 44 mg given orally once daily. • 100 x 10 9 /L to 200 x 10 9 /L: JAKAFI 15 mg given orally twice daily or JAKAFI XR 33 mg given orally once daily. • 50 x 10 9 /L to less than 100 x 10 9 /L: JAKAFI 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily.

Polycythemia Vera ( 2.3 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily. Acute Graft-Versus-Host Disease ( 2.4 ) The starting dose of JAKAFI is 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Chronic Graft-Versus-Host Disease ( 2.5 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily.

2.1Monitoring to Assess Safety Prior to JAKAFI/JAKAFI XR treatment: Perform a complete blood count (CBC) [see Warnings and Precautions ( 5.1 )] . Inquire about past infections, including tuberculosis, herpes simplex, herpes zoster, and hepatitis B [see Warnings and Precautions ( 5.2 )] . During treatment with JAKAFI/JAKAFI XR : Perform a CBC every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Warnings and Precautions ( 5.1 )] .

Assess lipid parameters approximately 8 to 12 weeks following initiation of JAKAFI/JAKAFI XR therapy [see Warnings and Precautions ( 5.5 )] .

2.2Recommended Dosage for Myelofibrosis The recommended starting dose of JAKAFI/JAKAFI XR is based on platelet count (Table 1). Doses may be titrated based on safety and efficacy. Table 1: JAKAFI/JAKAFI XR Starting Doses for Myelofibrosis Platelet Count JAKAFI Starting Dose JAKAFI XR Starting Dose Greater than 200 x 10 9 /L 20 mg orally twice daily 44 mg orally once daily 100 x 10 9 /L to 200 x 10 9 /L 15 mg orally twice daily 33 mg orally once daily 50 x 10 9 /L to less than 100 x 10 9 /L 5 mg orally twice daily 11 mg orally once daily Dose Modification Guidelines for Hematologic Toxicity for Patients With Myelofibrosis Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Dose Reductions JAKAFI dose reductions should be considered if the platelet counts decrease as outlined in Table 2 with the goal of avoiding dose interruptions for thrombocytopenia.

Table 2: Myelofibrosis: JAKAFI Dosing Recommendations for Thrombocytopenia for Patients Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Dose at Time of Platelet Decline Platelet Count 25 mg Twice Daily 20 mg Twice Daily 15 mg Twice Daily 10 mg Twice Daily 5 mg Twice Daily New Dose New Dose New Dose New Dose New Dose 100 to less than 125 x 10 9 /L 20 mg twice daily 15 mg twice daily No change No change No change 75 to less than 100 x 10 9 /L 10 mg twice daily 10 mg twice daily 10 mg twice daily No change No change 50 to less than 75 x 10 9 /L 5 mg twice daily 5 mg twice daily 5 mg twice daily 5 mg twice daily No change Less than 50 x 10 9 /L Hold Hold Hold Hold Hold JAKAFI XR dose reductions should be considered if the platelet counts decrease as outlined in Table 3, with the goal of avoiding dose interruptions for thrombocytopenia.

Table 3: Myelofibrosis: JAKAFI XR Dosing Recommendations for Thrombocytopenia for Patients Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Dose at Time of Platelet Decline Platelet Count 55 mg Once Daily 44 mg Once Daily 33 mg Once Daily 22 mg Once Daily 11 mg Once Daily New Dose New Dose New Dose New Dose New Dose 100 to less than 125 x 10 9 /L 44 mg once daily 33 mg once daily No change No change No change 75 to less than 100 x 10 9 /L 22 mg once daily 22 mg once daily 22 mg once daily No change No change 50 to less than 75 x 10 9 /L 11 mg once daily 11 mg once daily 11 mg once daily 11 mg once d…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS JAKAFI : 5 mg tablets - round and white with "INCY" on one side and "5" on the other. 10 mg tablets - round and white with "INCY" on one side and "10" on the other. 15 mg tablets - oval and white with "INCY" on one side and "15" on the other.

20 mg tablets - capsule-shaped and white with "INCY" on one side and "20" on the other. 25 mg tablets - oval and white with "INCY" on one side and "25" on the other. JAKAFI XR : 11 mg extended-release tablets - round and light pink with “I” on one side and “11” on the other.

22 mg extended-release tablets - round and light yellow with “I” on one side and “22” on the other. 33 mg extended-release tablets - round and pink with “I” on one side and “33” on the other. 44 mg extended-release tablets - round and grey with “I” on one side and “44” on the other.

55 mg extended-release tablets - round and yellow with “I” on one side and “55” on the other. JAKAFI tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. ( 3 ) JAKAFI XR extended-release tablets: 11 mg, 22 mg, 33 mg, 44 mg and 55 mg.

( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia, and Neutropenia: Manage by dose reduction or interruption, or transfusion. ( 5.1 ) Risk of Infection: Assess patients for signs and symptoms of infection and initiate appropriate treatment promptly. Serious infections should have resolved before starting therapy with JAKAFI/JAKAFI XR.

( 5.2 ) Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with JAKAFI/JAKAFI XR. ( 5.3 ) Risk of Non-Melanoma Skin Cancer: Perform periodic skin examinations. ( 5.4 ) Lipid Elevations: Assess lipid levels 8 to 12 weeks from start of therapy and treat as needed.

( 5.5 ) Major Adverse Cardiovascular Events (MACE): Monitor for development of MACE. ( 5.6 ) Thrombosis: Evaluate and treat symptoms of thrombosis promptly. ( 5.7 ) Secondary Malignancies: Monitor for development of secondary malignancies, particularly in patients who are current or past smokers.

( 5.8 )

5.1Thrombocytopenia, Anemia, and Neutropenia Treatment with JAKAFI/JAKAFI XR can cause thrombocytopenia, anemia, and neutropenia [ see Adverse Reactions ( 6.1 )] . Manage thrombocytopenia by reducing the dose or temporarily interrupting JAKAFI/JAKAFI XR. Platelet transfusions may be necessary [ see Dosage and Administration ( 2 ) ] .

Patients developing anemia may require blood transfusions and/or dose modifications of JAKAFI/JAKAFI XR. Severe neutropenia (ANC less than 0.5 × 10 9 /L) was generally reversible by withholding JAKAFI/JAKAFI XR until recovery. Perform a pre-treatment CBC and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [ see Dosage and Administration ( 2 )] .

5.2Risk of Infection Serious bacterial, mycobacterial, fungal, and viral infections have occurred [ see Adverse Reactions ( 6.1 )] . Delay starting therapy with JAKAFI/JAKAFI XR until active serious infections have resolved. Observe patients receiving JAKAFI/JAKAFI XR for signs and symptoms of infection and manage promptly.

Use active surveillance and prophylactic antibiotics according to clinical guidelines. Tuberculosis Tuberculosis infection has been reported in patients receiving JAKAFI. Observe patients receiving JAKAFI/JAKAFI XR for signs and symptoms of active tuberculosis and manage promptly.

Prior to initiating JAKAFI/JAKAFI XR, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting JAKAFI/JAKAFI XR.

The decision to continue JAKAFI/JAKAFI XR during treatment of active tuberculosis should be based on the overall risk-benefit determination. Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred with JAKAFI treatment. If PML is suspected, stop JAKAFI/JAKAFI XR and evaluate.

Herpes Zoster and Herpes Simplex Herpes zoster infection has been reported in patients receiving JAKAFI [see Adverse Reactions ( 6.1 )] . Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected. Herpes simplex virus reactivation and/or dissemination has been reported in patients receiving JAKAFI [see Adverse Reactions ( 6.2 )] .

Monitor patients for the development of herpes simplex infections. If a patient develops evidence of dissemination of herpes simplex, consider interrupting treatment with JAKAFI/JAKAFI XR; patients should be promptly treated and monitored according to clinical guidelines. Hepatitis B Hepatitis B viral load (HBV-DNA titer) increases, with or wit…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions ( 5.1 )] Risk of Infection [see Warnings and Precautions ( 5.2 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancer [see Warnings and Precautions ( 5.4 )] Lipid Elevations [ see Warnings and Precautions ( 5.5 )] Major Adverse Cardiovascular Events (MACE) [ see Warnings and Precautions ( 5.6 )] Thrombosis [ see Warnings and Precautions ( 5.7 )] Secondary Malignancies [ see Warnings and Precautions ( 5.8 )] In myelofibrosis and polycythemia vera, the most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia.

The most common nonhematologic adverse reactions (incidence ≥ 15%) are bruising, dizziness, headache, and diarrhea. ( 6.1 ) In acute graft-versus-host disease, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections (pathogen not specified) and edema.

( 6.1 ) In chronic graft-versus-host disease, the most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥ 20%) are infections (pathogen not specified) and viral infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 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 JAKAFI XR has been established from adequate and well-controlled studies of JAKAFI in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease [see Clinical Studies ( 14 )] .

Below is a display of the adverse reactions of JAKAFI in these adequate and well-controlled studies. Myelofibrosis The safety of JAKAFI was assessed in 617 patients in 6 clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with MF in 2 Phase 3 studies. In these 2 Phase 3 studies, patients had a median duration of exposure to JAKAFI of 9.5 months (range: 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months.

One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In patients starting treatment with 15 mg twice daily (pretreatment platelet counts of 100 to 200 × 10 9 /L) and 20 mg twice daily (pretreatment platelet counts greater than 200 × 10 9 /L), 65% and 25% of patients, respectively, required a dose reduction below the starting dose within the first 8 weeks of therapy. In a double-blind, randomized, placebo-controlled study of JAKAFI, among the 155 patients treated with JAKAFI, the most frequent adverse reactions were thrombocytopenia and anemia [see Table 14] .

Thrombocytopenia, anemia, and neutropenia are dose-related effects. The 3 most frequent nonhematologic adverse reactions were bruising, dizziness, and headache [see Table 13 ] . Discontinuation for adverse events, regardless of causality, was observed in 11% of patients treated with JAKAFI and 11% of patients treated with placebo.

Table 15 presents the most common nonhematologic adverse reactions occurring in patients who received JAKAFI in the double-blind, placebo-controlled study during randomized treatment. Table 15: Myelofibrosis: Nonhematologic Adverse Reactions Occurring in Patients on JAKAFI in the Double-Blind, Placebo-Contro…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Fluconazole: Avoid concomitant use with fluconazole doses greater than 200 mg. Reduce JAKAFI/JAKAFI XR dosage with fluconazole doses less than or equal to 200 mg. ( 2.6 , 7 ) Strong CYP3A4 Inhibitors: Reduce, interrupt, or discontinue JAKAFI/JAKAFI XR doses as recommended except in patients with acute or chronic graft-versus-host-disease. ( 2.6 , 7 )

7.1Effect of Other Drugs on JAKAFI/JAKAFI XR Fluconazole Concomitant use of JAKAFI/JAKAFI XR with fluconazole increases ruxolitinib exposure [ see Clinical Pharmacology ( 12.3 )] , which may increase the risk of exposure-related adverse reactions. Avoid concomitant use of JAKAFI/JAKAFI XR with fluconazole doses of greater than 200 mg daily. Reduce the JAKAFI/JAKAFI XR dosage when used concomitantly with fluconazole doses of less than or equal to 200 mg [ see Dosage and Administration ( 2.6 )] .

Strong CYP3A4 Inhibitors Concomitant use of JAKAFI/JAKAFI XR with strong CYP3A4 inhibitors increases ruxolitinib exposure [ see Clinical Pharmacology ( 12.3 )] , which may increase the risk of exposure-related adverse reactions. Reduce the JAKAFI/JAKAFI XR dosage when used concomitantly with strong CYP3A4 inhibitors except in patients with aGVHD or cGVHD [ see Dosage and Administration ( 2.6 )] . Strong CYP3A4 Inducers Concomitant use of JAKAFI/JAKAFI XR with strong CYP3A4 inducers may decrease ruxolitinib exposure [ see Clinical Pharmacology ( 12.3 )] , which may reduce efficacy of JAKAFI/JAKAFI XR.

Monitor patients frequently and adjust the JAKAFI/JAKAFI XR dose based on safety and efficacy [ see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment: Reduce JAKAFI/JAKAFI XR starting dose or avoid treatment as recommended. ( 2.7 , 8.6 ) Hepatic Impairment: Reduce JAKAFI/JAKAFI XR starting dose or avoid treatment as recommended. ( 2.7 , 8.7 ) Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data) . There are no studies with the use of JAKAFI/JAKAFI XR in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown.

Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk in the U.S. general population of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30, or 60 mg/kg/day in rats and 10, 30, or 60 mg/kg/day in rabbits.

There were no treatment-related malformations. Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily.

In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% of the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day.

There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth, and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily).

8.2Lactation Risk Summary No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast-fed child, or the effects on milk production. Ruxolitinib and/or its metabolites were present in the milk of lactating rats (see Data) . Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for JAKAFI in human studies, discontinue breastfeeding during treatment with JAKAFI/JAKAFI XR and for 2 weeks after the final dose.

Data Animal Data Lactating rats were administered a single dose of [ 14 C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13-fold the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma.

8.4Pediatric Use Myelofibrosis The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of MF in pediatric patients have not been established. Polycythemia Vera The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of PV in pediatric patients have not been established. Acute Graft-Versus-Host Disease The safety and effectiveness of JAKAFI for treatment of steroid-refractory aGVHD has been established for treatment of pediatric patients 12 years and older.

Use of JAKAFI in pediatric patients with steroid-refractory aGVHD is supported by evidence from adequate and well-controlled trials of JAKAFI in adults [ see Clinical Studies ( 14.3 )] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of steroid-refractory aGVHD has not been established in pediatric patien…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data) . There are no studies with the use of JAKAFI/JAKAFI XR in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown.

Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk in the U.S. general population of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30, or 60 mg/kg/day in rats and 10, 30, or 60 mg/kg/day in rabbits.

There were no treatment-related malformations. Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily.

In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% of the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day.

There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth, and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily).

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Myelofibrosis The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of MF in pediatric patients have not been established. Polycythemia Vera The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of PV in pediatric patients have not been established. Acute Graft-Versus-Host Disease The safety and effectiveness of JAKAFI for treatment of steroid-refractory aGVHD has been established for treatment of pediatric patients 12 years and older.

Use of JAKAFI in pediatric patients with steroid-refractory aGVHD is supported by evidence from adequate and well-controlled trials of JAKAFI in adults [ see Clinical Studies ( 14.3 )] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of steroid-refractory aGVHD has not been established in pediatric patients younger than 12 years old. Chronic Graft-Versus-Host Disease The safety and effectiveness of JAKAFI for treatment of cGVHD after failure of one or two lines of systemic therapy has been established for treatment of pediatric patients 12 years and older.

Use of JAKAFI in pediatric patients with cGVHD after failure of one or two lines of systemic therapy is supported by evidence from adequate and well-controlled trials of JAKAFI in adults and adolescents [ see Clinical Studies ( 14.4 )] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of cGVHD has not been established in pediatric patients younger than 12 years old. Other Myeloproliferative Neoplasms, Leukemias, and Solid Tumors The safety and effectiveness of ruxolitinib were assessed but not established in a single-arm trial (NCT01164163) in patients with relapsed or refractory solid tumors, leukemias, or myeloproliferative neoplasms.

The patients included 18 children (age 2 to < 12 years) and 14 adolescents (age 12 to < 17 years). Overall, 19% of patients received more than 1 cycle. No new safety signals were observed in pediatric patients in this trial.

The safety and effectiveness of ruxolitinib in combination with chemotherapy for treatment of high-risk, de novo CRLF2 rearranged or JAK pathway–mutant Ph-like acute lymphoblastic leukemia (ALL) were assessed but not established in a single-arm trial (NCT02723994). The patients included 2 infants (age < 2 years), 42 children (age 2 to < 12 years) and 62 adolescents (age 12 to < 17 years). No new safety signals were observed in pediatric patients in this trial.

Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal Day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures (eg, bone mineral content, peripheral quantitative computed tomography, and x-ray analysis) occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal Day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day.

Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily.

🧓 Geriatric Use 111 words ▾

8.5Geriatric Use Of the total number of patients with MF in clinical studies with JAKAFI, 52% were 65 years and older, while 15% were 75 years and older. No overall differences in safety or effectiveness of JAKAFI were observed between these patients and younger patients. Clinical studies of JAKAFI in patients with aGVHD did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.

Of the total number of patients with cGVHD treated with JAKAFI in clinical trials, 11% were 65 years and older. No overall differences in safety or effectiveness of JAKAFI were observed between these patients and younger patients.

🆘 Overdosage 57 words ▾

10 OVERDOSAGE There is no known antidote for overdoses with JAKAFI/JAKAFI XR. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia, and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of JAKAFI/JAKAFI XR.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs), JAK1 and JAK2, which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation, and subsequent localization of STATs to the nucleus leading to modulation of gene expression. MF and PV are myeloproliferative neoplasms (MPNs) known to be associated with dysregulated JAK1 and JAK2 signaling.

In a mouse model of JAK2V617F-positive MPN, oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (eg, TNF-α, IL-6). JAK-STAT signaling pathways play a role in regulating the development, proliferation, and activation of several immune cell types important for GVHD pathogenesis. In a mouse model of aGVHD, oral administration of ruxolitinib was associated with decreased expression of inflammatory cytokines in colon homogenates and reduced immune-cell infiltration in the colon.

12.2Pharmacodynamics JAKAFI inhibits cytokine-induced STAT3 phosphorylation in whole blood from patients with MF and PV. STAT3 phosphorylation reached maximal inhibition 2 hours after JAKAFI dosing and returned to near baseline by 10 hours in patients with MF and PV. Cardiac Electrophysiology At a dose of 1.25 to 10 times the highest recommended starting dosage, JAKAFI does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics JAKAFI Mean ruxolitinib maximal plasma concentration (C max ) and AUC increased proportionally over a single dose range of 5 mg to 200 mg (4 times the approved highest recommended total daily dosage of 25 mg twice daily). Mean ruxolitinib C max ranged from 205 nM to 7100 nM and AUC ranged from 862 nM*hr to 30,700 nM*hr over a single dose range of 5 mg to 200 mg. Steady state is reached by Day 3 following repeat twice daily administration of JAKAFI.

JAKAFI XR Ruxolitinib C max and AUC increased in a dose proportional manner following single dose administration from the lowest to the highest strength of JAKAFI XR. Steady state is reached by Day 3 following repeat once daily administration of JAKAFI XR. Absorption JAKAFI Ruxolitinib achieves C max within 1 hour to 2 hours post-dose.

Oral absorption of ruxolitinib is estimated to be at least 95%. JAKAFI XR Ruxolitinib extended-release achieves C max within approximately 3 hours post-dose. Effect of Food JAKAFI and JAKAFI XR No clinically relevant changes in the pharmacokinetics of ruxolitinib were observed upon administration of JAKAFI with a high-fat, high-calorie meal (approximately 800 to 1000 calories of which 50% were derived from fat).

Distribution The mean ruxolitinib volume of distribution at steady-state is 72 L (coefficient of variation [CV] 29%) in patients with MF and 75 L (23%) in patients with PV. Protein binding of ruxolitinib is approximately 97%, mostly to albumin. Elimination JAKAFI The mean elimination half-life of ruxolitinib is approximately 3 hours and the mean elimination half-life of ruxolitinib and its metabolites is approximately 5.8 hours in healthy volunteers.

Ruxolitinib clearance (%CV) was

17.7 L/h in women and

22.1L/h in men with MF (39%). Ruxolitinib clearance (%CV) was

12.7L/h (42%) in patients with PV. Ruxolitinib clearance (%CV) was

11.8L/h (63%) in patients with aGVHD. Ruxolitinib clearance (%CV) was

9.7L/h (51%) in patients with cGVHD. JAKAFI XR The mean elimination half-life of ruxolitinib extended-release is approximately 5 hours in healthy volunteers. Metabolism Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9. Excretion Following a single oral dose of radiolabeled ruxolitinib, 74% of radioactivity was excreted in urine and 22% via feces. Unchanged drug accounted for less than…

🧬 Mechanism of Action 162 words ▾

12.1Mechanism of Action Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs), JAK1 and JAK2, which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation, and subsequent localization of STATs to the nucleus leading to modulation of gene expression. MF and PV are myeloproliferative neoplasms (MPNs) known to be associated with dysregulated JAK1 and JAK2 signaling.

In a mouse model of JAK2V617F-positive MPN, oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (eg, TNF-α, IL-6). JAK-STAT signaling pathways play a role in regulating the development, proliferation, and activation of several immune cell types important for GVHD pathogenesis. In a mouse model of aGVHD, oral administration of ruxolitinib was associated with decreased expression of inflammatory cytokines in colon homogenates and reduced immune-cell infiltration in the colon.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING JAKAFI (ruxolitinib) tablets are available as follows: JAKAFI Trade Presentations NDC Number Strength Description Tablets per Bottle 50881-005-60 5 mg Round tablet with “INCY” on one side and “5” on the other 60 50881-010-60 10 mg Round tablet with “INCY” on one side and “10” on the other 60 50881-015-60 15 mg Oval tablet with “INCY” on one side and “15” on the other 60 50881-020-60 20 mg Capsule-shaped tablet with “INCY” on one side and “20” on the other 60 50881-025-60 25 mg Oval tablet with “INCY” on one side and “25” on the other 60 JAKAFI XR (ruxolitinib) extended-release tablets are available as follows: JAKAFI XR Trade Presentations NDC Number Strength Description Tablets per Bottle 50881-011-08 11 mg Round light pink tablet with “I” on one side and “11” on the other 30 50881-022-08 22 mg Round light yellow tablet with “I” on one side and “22” on the other 30 50881-033-08 33 mg Round pink tablet with “I” on one side and “33” on the other 30 50881-044-08 44 mg Round grey tablet with “I” on one side and “44” on the other 30 50881-055-08 55 mg Round yellow tablet with “I” on one side and “55” on the other 30 Store JAKAFI/JAKAFI XR at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container. Protect from light.

📋 Description 219 words ▾

11 DESCRIPTION Ruxolitinib phosphate is a kinase inhibitor with the chemical name ( R )-3-(4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-1 H -pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36. Ruxolitinib phosphate has the following structural formula: Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8. JAKAFI (ruxolitinib) tablets are for oral administration.

Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of ruxolitinib free base, equivalent to 6.6 mg, 13.2 mg, 19.8 mg, 26.4 mg, or 33 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. JAKAFI XR (ruxolitinib) extended-release tablets are for oral administration. Each tablet contains 11 mg, 22 mg, 33 mg, 44 mg, or 55 mg of ruxolitinib free base equivalent to 14.5 mg, 29 mg, 43.6 mg, 58.1 mg, or 72.6 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate.

In addition, the film coating contains the following inactive ingredients: colorants (black iron oxide, red iron oxide, and yellow iron oxide), copovidone, hypromellose, polydextrose, polyethylene glycol, titanium dioxide, and triglycerides. Ruxolitinib phosphate structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Thrombocytopenia, Anemia, and Neutropenia Inform patients that JAKAFI/JAKAFI XR is associated with thrombocytopenia, anemia and neutropenia, and of the need to monitor CBC before and during treatment. Advise patients to observe for and report bleeding [see Warnings and Precautions ( 5.1 )] .

Infections Inform patients of the signs and symptoms of infection and to report any such signs and symptoms promptly. Inform patients regarding the early signs and symptoms of herpes zoster and of PML, and advise patients to seek the advice of a clinician if such symptoms are observed [see Warnings and Precautions ( 5.2 )] . Symptom Exacerbation Following Interruption or Discontinuation of Treatment Inform patients that after discontinuation of treatment, signs and symptoms from myeloproliferative neoplasms may flare.

Instruct patients not to interrupt or discontinue JAKAFI/JAKAFI XR therapy without consulting their healthcare provider [see Warnings and Precautions ( 5.3 )] . Non-Melanoma Skin Cancer Inform patients that JAKAFI/JAKAFI XR may increase their risk of certain NMSCs. Advise patients to inform their healthcare provider if they have ever had any type of skin cancer or if they observe any new or changing skin lesions [see Warnings and Precautions ( 5.4 )] .

Lipid Elevations Inform patients that JAKAFI/JAKAFI XR may increase blood cholesterol, and of the need to monitor blood cholesterol levels [see Warnings and Precautions ( 5.5 )] . Major Adverse Cardiovascular Events Advise patients that events of MACE including myocardial infarction, stroke, and cardiovascular death, have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated. Advise patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions ( 5.6 )] .

Thrombosis Advise patients that events of DVT and PE have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated. Advise patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions ( 5.7 )] . Secondary Malignancies Advise patients, especially current or past smokers and patients with a known secondary malignancy (other than a successfully treated NMSC), that lymphoma and other malignancies (excluding NMSC) have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated [see Warnings and Precautions ( 5.8 )] .

Drug-Drug Interactions Advise patients to inform their healthcare providers of all medications they are taking, including over-the-counter medications, herbal products and dietary supplements [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . Dialysis Inform patients on dialysis that their dose should not be taken before dialysis but only following dialysis [see Dosage and Administration ( 2.7 )] . Lactation Inform women not to breastfeed during treatment with JAKAFI/JAKAFI XR and for 2 weeks after the final dose [see Use in Specific Populations ( 8.2 )] .

Compliance Advise patients to continue taking JAKAFI/JAKAFI XR every day for as long as their physician tells them and that this is a long-term treatment. Patients should not change dose or stop taking JAKAFI/JAKAFI XR without first consulting their physician. Patients should be aware that after discontinuation of treatment, signs and symptoms from myeloproliferative neoplasms are expected to return.

Manufactured for: Incyte Corporation 1801 Augustine Cut-off Wilmington, DE 19803 JAKAFI is a registered trademark of Incyte. JAKAFI XR is a trademar…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50881-0020-60 · Incyte 50881-0023-11 · Incyte →
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.