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Litfulo ritlecitinib 50 mg Capsule, 28-count — NDC 63539-334-28 (Billing 63539-0334-28)

by U.S. Pharmaceuticals · 28 CAPSULE in 1 BOTTLE

This is a package of 28 capsules of Litfulo ritlecitinib 50 mg Capsule from U.S. Pharmaceuticals, marketed since Jul 2023 and currently FDA-listed. It is this product's only package size.

NDC 63539-0334-28
🏷️ FDA NDC (as labeled) 63539-334-28 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) 63539-334-28
Product NDC 63539-334
11-digit billing NDC 63539033428
RxCUI 2641601, 2641607
UNII EAG4T1459K
Application # NDA215830
SPL Set ID 1882f799-61b0-4813-965a-4910c4ae419c
Established class (EPC) Kinase Inhibitor
Mechanism of action Cytochrome P450 1A2 Inhibitors; Cytochrome P450 3A Inhibitors; Janus Kinase 3 Inhibitors; Tyrosine Kinase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-06
Route ORAL
Dosage form CAPSULE
Substance RITLECITINIB TOSYLATE
Quick answers
  • RxCUI (RxNorm): 2641601
Why two NDCs? The FDA registers this code as 63539-334-28 — 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 → 63539-0334-28. 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 Janus-associated kinase (JAK) inhibitors class.

Drug family (ATC) Janus-associated kinase (JAK) 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.

Clinical

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

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo 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 $154.35 $4,321.84 / 28 capsules
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
63539-0334-28 You're viewing this Main listing 28 CAPSULE in 1 BOTTLE Sample 2023-07-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Litfulo 50 mg 00069-0334-28 Pfizer 28 capsules — — FDA listed —
Litfulo 50 mgthis 63539-0334-28 U.S. 28 capsules — — 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

🏛️
2023
First FDA approval
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2041
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 Oct 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 23, 2023 RLD RS ⏳ ~15 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 12077533 — method of use (U-3994)
US 12116368 — drug substance
US 9617258 — drug substance
Exclusivity NCE
2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (3)
PatentTypeUse codeExpires
US 12077533 ↗ Method of use U-3994 Dec 3, 2034
US 12116368 ↗ Drug substance — Oct 17, 2041
US 9617258 ↗ Drug substance — Dec 3, 2034
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jun 23, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2041 — 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.

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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

8 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

LabelerU.S. Pharmaceuticals
Application holderPFIZER INC
FDA applicationNDA215830 (NDA)
Labeler code63539
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio23 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.

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 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. • Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active tuberculosis.

Test for latent TB before and during therapy; start treating latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ).

Monitor all patients for signs and symptoms of infection during and after treatment with LITFULO. ( 5.1 ) • Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.

LITFULO is not approved for use in RA patients. ( 5.2 ) • Malignancies were reported in patients treated with LITFULO ( 5.3 ). Higher rate of lymphomas and lung cancers with another JAK inhibitor vs.

TNF blockers in RA patients. • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ). • Thrombosis has occurred in patients treated with LITFULO.

Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 ) • Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB).

Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use.

Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) • Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.

LITFULO is not approved for use in RA patients. ( 5.2 ) • Malignancies have occurred in patients treated with LITFULO [see Warnings and Precautions (5.3) ] . Higher rate of lymphomas and lung cancers with another JAK inhibitor vs.

TNF blockers in RA patients. ( 5.3 ) • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients.

( 5.4 ) • Thrombosis has occurred in patients treated with LITFULO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.

( 5.5 )

🎯 Indications and Usage 94 words ▾

1 INDICATIONS AND USAGE LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

( 1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. ( 2.1 ) • Recommended dosage is 50 mg orally once daily. ( 2.2 ) • For dosage interruption for certain adverse reactions, see Full Prescribing Information. ( 2.4 )

2.1Recommended Evaluations and Immunizations Prior to Treatment Initiation Perform the following evaluations prior to LITFULO initiation: • Tuberculosis (TB) infection evaluation: LITFULO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of LITFULO [see Warnings and Precautions (5.1) ] . • Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C [see Warnings and Precautions (5.1) ] . • Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm 3 or a platelet count <100,000/mm 3 [see Warnings and Precautions (5.8) ] . • Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.9) ] .

2.2Recommended Dosage The recommended dosage of LITFULO is 50 mg orally once daily with or without food [see Clinical Pharmacology (12.3) ] . Swallow capsules whole. Do not crush, split, or chew LITFULO capsules. If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

2.3Patients with Severe Hepatic Impairment LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

2.4Treatment Interruption or Discontinuation If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair. Hematologic Abnormalities Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1. Table 1.

Laboratory Monitoring Guidance Laboratory Measure Recommendation ALC = absolute lymphocyte count. Platelet Count Treatment should be discontinued if platelet count is <50,000/mm 3 Lymphocytes Treatment should be interrupted if ALC is <500/mm 3 and may be restarted once ALC return above this value. ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and thereafter according to routine patient management [see Warnings and Precautions (5.8) ] .

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 50 mg of ritlecitinib, size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black. Capsules: 50 mg of ritlecitinib ( 3 )

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6) ] . LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity : Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. ( 5.6 ) • Hypoglycemia in Patients with Diabetes : Consider increased monitoring of blood glucose; advise diabetic patients to notify their healthcare provider if they develop signs and symptoms of hypoglycemia. ( 5.7 ) • Laboratory Abnormalities : Perform ALC and platelet counts prior to LITFULO initiation.

Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. ( 5.8 ) • Vaccinations : Avoid use of live vaccines during or shortly prior to LITFULO treatment. ( 5.9 )

5.1Serious Infections Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis [see Adverse Reactions (6.1) ] . Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO.

Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of serious infection or an opportunistic infection • who have resided or traveled in areas of endemic TB or mycoses, or • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LITFULO.

Interrupt LITFULO if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with LITFULO should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored. LITFULO may be resumed once the infection is controlled.

Tuberculosis Screen patients for tuberculosis (TB) before starting therapy. LITFULO should not be given to patients with active TB. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB.

In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk and consider screening patients at high risk for TB during treatment with LITFULO. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical trials [see Adverse Reactions (6.1) ] . If a patient develops herpes zoster, consider interrupting treatment until the episode resolves.

Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with LITFULO. Patients with evidence of HIV infection or hepatitis B or C infection were excluded from clinical trials.

5.2Mortality In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO.

5.3Malignancy and Lymphoproliferative Disorders Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials of LITFULO [see Adverse Reactions (6.1) ] . In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers.

A higher rate of lung cancers was… [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: • Serious Infections [see Warnings and Precautions (5.1) ] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] • Thromboembolic Events [see Warnings and Precautions (5.5) ] • Hypersensitivity [see Warnings and Precautions (5.6) ] • Laboratory Abnormalities [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 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 LITFULO was evaluated in three randomized, placebo-controlled clinical trials and one long-term trial in subjects with alopecia areata, including alopecia totalis and alopecia universalis, who were 12 years of age and older.

A total of 1628 subjects were treated with LITFULO representing 2085 subject-years of exposure. There were 1011 subjects with at least 1 year of exposure to LITFULO. In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 subjects were exposed to LITFULO with 130 receiving 50 mg once daily for up to 24 weeks.

The median age of subjects was 33 years, 105 (11.9%) subjects were 12 to <18 years old and 22 (2.5%) subjects were 65 years of age or older. The majority of subjects were White (70.7%) and female (63.6%). Adverse reactions occurring at ≥1% in the treated groups and at a higher rate than placebo are presented in Table 2.

A total of 2 (1.5%) subjects treated with LITFULO 50 mg were discontinued from the trials due to adverse reactions. Table 2. Adverse Reactions in Clinical Trials of LITFULO for the Treatment of Alopecia Areata Reported in ≥1% of subjects and at a higher rate than placebo for up to 24 weeks.

LITFULO 50 mg N=130 n (%) Placebo N=213 n (%) Headache Headache includes headache and migraine. 14 (10.8) 18 (8.5) Diarrhea Diarrhea includes diarrhea and frequent bowel movements. 13 (10.0) 8 (3.8) Acne Acne includes acne and acne pustular.

8 (6.2) 10 (4.7) Rash Rash includes rash and dermatitis allergic. 7 (5.4) 2 (0.9) Urticaria 6 (4.6) 3 (1.4) Folliculitis 4 (3.1) 4 (1.9) Pyrexia 4 (3.1) 0 Dermatitis atopic 3 (2.3) 1 (0.5) Dizziness 3 (2.3) 3 (1.4) Blood creatine phosphokinase increased 2 (1.5) 0 Herpes zoster 2 (1.5) 0 Red blood cell count decreased 2 (1.5) 0 Stomatitis 2 (1.5) 0 Specific Adverse Reactions Exposure adjusted incidence rates were adjusted by clinical trial size for all adverse reactions reported in this section. Overall Infections In the placebo-controlled trials, for up to 24 weeks, overall infections were reported in 66 subjects (80.35 per 100 subject-years) treated with placebo and 43 subjects (74.53 per 100 subject-years) treated with LITFULO 50 mg.

Across clinical trials, including the long-term trial, overall infections were reported in 645 subjects (50.71 per 100 subject-years) treated with LITFULO 50 mg or higher. Serious Infections In the placebo-controlled trials, for up to 24 weeks, 3 subjects reported serious infections across all ritlecitinib doses studied. Across clinical trials, including the long-term trial, serious infections were reported in 12 subjects (0.66 per 100 subject-years) treated with LITFULO 50 mg or higher.

The most common serious infections were related to appendicitis, COVID-19 infection (including pneumonia), and sepsis. Herpes Zoster In the placebo-controlled trials, for up to 24 weeks, herpes zoster… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Certain CYP3A substrates : Additional monitoring and dose adjustment of CYP3A substrate should be considered. ( 7.1 ) • Certain CYP1A2 substrates : Additional monitoring and dose adjustment of CYP1A2 substrate should be considered. ( 7.1 ) • Certain CYP3A inducers: Coadministration with strong inducers of CYP3A is not recommended. ( 7.2 )

7.1Effects of LITFULO on Other Drugs Table 3 includes clinically significant drug interactions affecting other drugs. Table 3. Clinically Significant Interactions Affecting Other Drugs CYP3A Substrates Where Small Concentration Changes May Lead to Serious Adverse Reactions Clinical Impact Ritlecitinib is a CYP3A inhibitor.

Concomitant use of ritlecitinib increases AUC and C max of CYP3A substrates [see Clinical Pharmacology (12.3 )] , which may increase the risk of adverse reactions of these substrates. Intervention Consider additional monitoring and dosage adjustment in accordance with approved product labeling of CYP3A substrates where small concentration changes may lead to serious adverse reactions when used with LITFULO. CYP1A2 Substrates Where Small Concentration Changes May Lead to Serious Adverse Reactions Clinical Impact Ritlecitinib is a CYP1A2 inhibitor.

Concomitant use of ritlecitinib increases AUC and C max of CYP1A2 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions of these substrates. Intervention Consider additional monitoring and dosage adjustment in accordance with the approved product labeling of CYP1A2 substrates where small concentration changes may lead to serious adverse reactions when used concomitantly with LITFULO.

7.2Effects of Other Drugs on LITFULO Table 4 includes clinically significant drug interactions affecting LITFULO. Table 4. Clinically Significant Interactions Affecting LITFULO CYP3A Inducers Clinical Impact Concomitant use of strong CYP3A inducer (e.g., rifampin) may decrease AUC and C max of ritlecitinib [see Clinical Pharmacology (12.3) ] , which may result in loss of or reduced clinical response.

Intervention Coadministration with strong inducers of CYP3A is not recommended.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation : Breastfeeding not recommended. ( 8.2 ) • Severe Hepatic Impairment: Not recommended. ( 8.6 )

8.1Pregnancy Pregnancy Exposure Registry If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940. Risk Summary Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison, respectively (see Animal Data ) .

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The estimated background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively.

Data Animal Data In an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the MRHD based on AUC comparison). Maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the MRHD based on AUC comparison). There was no developmental toxicity at 75 mg/kg/day (16 times the MRHD based on AUC comparison).

In an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the MRHD based on AUC comparison). There was no developmental toxicity at doses up to 25 mg/kg/day (12 times the MRHD based on AUC comparison).

In a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the MRHD based on AUC comparison). At 175 mg/kg/day (41 times the MRHD based on AUC comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. Bred females in the F 1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day.

8.2Lactation Risk Summary There are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Ritlecitinib is present in the milk of lactating rats (see Data ) . When a drug is present in animal milk, it is likely that it will be present in human milk.

Because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with LITFULO and for approximately 14 hours after the last dose (approximately 6 elimination half-lives). Data After a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. The mean milk to plasma AUC ratio was 2.2.

8.4Pediatric Use The safety and effectiveness of LITFULO for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. A total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a piv… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940. Risk Summary Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison, respectively (see Animal Data ) .

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The estimated background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively.

Data Animal Data In an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the MRHD based on AUC comparison). Maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the MRHD based on AUC comparison). There was no developmental toxicity at 75 mg/kg/day (16 times the MRHD based on AUC comparison).

In an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the MRHD based on AUC comparison). There was no developmental toxicity at doses up to 25 mg/kg/day (12 times the MRHD based on AUC comparison).

In a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the MRHD based on AUC comparison). At 175 mg/kg/day (41 times the MRHD based on AUC comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. Bred females in the F 1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use The safety and effectiveness of LITFULO for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. A total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (Trial AA-I). Efficacy was consistent between the pediatric patients and adults [see Clinical Studies (14) ] .

The adverse reaction profile in the pediatric patients was similar to adults. The safety and efficacy of LITFULO have not been established in pediatric patients under 12 years of age.

🧓 Geriatric Use 89 words ▾

8.5Geriatric Use No dose adjustment is required for patients ≥65 years of age. A total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. Clinical trials of LITFULO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.

🆘 Overdosage 114 words ▾

10 OVERDOSAGE LITFULO was administered in clinical trials up to a single oral dose of 800 mg. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetics (PK) data up to and including a single oral dose of 800 mg in healthy adult volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 48 hours.

There is no specific antidote for overdose with LITFULO. Treatment should be symptomatic and supportive, and monitor patients for signs and symptoms of adverse reactions [see Clinical Trials Experience (6.1) ] . In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action LITFULO is a kinase inhibitor. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site. In cellular settings, ritlecitinib inhibits cytokine induced STAT phosphorylation mediated by JAK3-dependent receptors.

Additionally, ritlecitinib inhibits signaling of immune receptors dependent on TEC kinase family members. The relevance of inhibition of specific JAK or TEC family enzymes to therapeutic effectiveness is not currently known.

12.2Pharmacodynamics Lymphocyte Subsets A dose-dependent early decrease in absolute lymphocyte levels, T lymphocytes (CD3) and T lymphocyte subsets (CD4 and CD8) was associated with LITFULO treatment in patients with alopecia areata. In addition, there was a dose-dependent early decrease in NK cells (CD16/56) which remained stable at the lower level up to Week 48. For the 50 mg QD dose, there was an initial decrease in median lymphocyte levels which remained consistent up to Week 48.

There was no change observed in B lymphocytes (CD19) in any treatment group. Cardiac Electrophysiology At 12 times the mean maximum exposure of the 50 mg once daily dose in patients with alopecia areata, there was no clinically relevant effect on the QTc interval.

12.3Pharmacokinetics Ritlecitinib AUC 0-tau and C max increase in an approximately dose-proportional manner up to 200 mg. Steady state was reached approximately by Day 4. Absorption The ritlecitinib absolute oral bioavailability is approximately 64%.

Ritlecitinib peak plasma concentrations were reached within 1 hour following an oral dose. Effect of Food Food does not have a clinically significant impact on the systemic exposures of ritlecitinib. The coadministration of a 100 mg ritlecitinib capsule with a high-fat meal reduced the ritlecitinib C max by ~32% and AUC inf was increased by 11%.

In clinical trials, ritlecitinib was administered without regard to meals [see Dosage and Administration (2.2) ] . Distribution Approximately 14% of circulating ritlecitinib is bound to plasma proteins. Elimination The ritlecitinib mean terminal half-life ranges from 1.3 to 2.3 hours.

Metabolism The metabolism of ritlecitinib is mediated by multiple pathways with no single route contributing to more than 25% of the total metabolism. These pathways include: • Glutathione S-transferase (GST): cytosolic GST A1/3, M1/3/5, P1, S1, T2, Z1 and microsomal GST 1/2/3 • CYP enzymes (CYP3A, CYP2C8, CYP1A2, and CYP2C9) Excretion Approximately 66% of radiolabeled ritlecitinib dose is excreted in the urine and 20% in the feces. Approximately 4% of the ritlecitinib dose is excreted unchanged drug in urine.

Specific Populations No clinically relevant differences in the pharmacokinetics of ritlecitinib were observed based on age (12-73 years), body weight, gender, GST genotype, and race. Patients with Renal Impairment The AUC 24 observed in patients with severe renal impairment (eGFR <30 mL/min) was 55.2% higher compared with the AUC 24 in matched participants with normal renal functions. These differences are not considered clinically significant.

Ritlecitinib has not been studied in patients with mild (eGFR 60 to <90 mL/min) or moderate (eGFR 30 to <60 mL/min) renal impairment, as a clinically relevant increase in ritlecitinib exposure is not expected in these patients. The eGFR and classification of renal function status of patients was done using the Modification of Diet in Renal Disease (MDRD) formula. Ritlecitinib has not been studied in patients with ESRD or in renal transplant recipients.

Patients with Hepatic Impairment Patients with moderate (Child Pugh B) hepatic impairment had an 18.5% increase in ritlecitinib AUC 24 compared to patients with normal hepatic function. Ritlecitinib has not been studied in patients with mild (Child Pugh A) hepatic impairment, as a clinically relevant increase in… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 79 words ▾

12.1Mechanism of Action LITFULO is a kinase inhibitor. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site. In cellular settings, ritlecitinib inhibits cytokine induced STAT phosphorylation mediated by JAK3-dependent receptors.

Additionally, ritlecitinib inhibits signaling of immune receptors dependent on TEC kinase family members. The relevance of inhibition of specific JAK or TEC family enzymes to therapeutic effectiveness is not currently known.

📦 How Supplied / Storage and Handling 117 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING LITFULO capsules are packaged in child-resistant, white, high-density polyethylene (HDPE) bottles with polypropylene (PP) cap with a foil heat induction seal liner. The bottles contain 1g of desiccant in a high-density polyethylene (HDPE) canister. Do not eat the desiccant.

Dosage Form Strength Description Bottle Size (number of capsules) NDC Number Capsules 50 mg of ritlecitinib Size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black. 28 count bottle 0069-0334-28 Store LITFULO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Keep in original package.

📦 Storage and Handling 27 words ▾

Store LITFULO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original package.

📋 Description 135 words ▾

11 DESCRIPTION LITFULO (ritlecitinib) capsules are formulated with ritlecitinib tosylate, a kinase inhibitor. Ritlecitinib tosylate is a white to off white to pale pink solid which is freely soluble in water. The chemical name is 1-{(2 S ,5 R )-2-Methyl-5-[(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)amino]piperidin-1-yl}prop-2-en-1-one 4-methylbenzene-1-sulfonic acid.

The molecular formula for ritlecitinib tosylate is C 22 H 27 N 5 O 4 S. The molecular weight is 457.55 g/mol and its structural formula is: LITFULO is supplied for oral administration as a 50 mg immediate-release capsule. Each capsule contains 50 mg ritlecitinib (equivalent to 80.13 mg ritlecitinib tosylate) and the following inactive ingredients: crospovidone, glyceryl dibehenate, lactose monohydrate, microcrystalline cellulose, and hypromellose (HPMC) capsule shells.

The yellow/blue, opaque capsule shells contain Brilliant blue FCF – FD&C Blue, hypromellose, titanium dioxide, and yellow iron oxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Advise patients not to crush, split or chew LITFULO capsules [see Dosage and Administration (2.2) ]. Serious Infections Inform patients that they may develop infections when taking LITFULO which in some cases can be serious.

Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.1) ] . Advise patients that the risk of herpes zoster is increased in patients treated with LITFULO [see Warnings and Precautions (5.1) ]. Malignancies Inform patients that LITFULO may increase their risk of certain cancers, including skin cancers.

Periodic skin examinations are recommended while using LITFULO [see Warnings and Precautions (5.3) ]. Thromboembolic Events Advise patients that events of PE and retinal artery occlusion have been reported in clinical trials with LITFULO. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a thrombosis [see Warnings and Precautions (5.5) ].

Hypersensitivity Reactions Advise patients to discontinue LITFULO and seek immediate medical attention if they develop any signs and symptoms of serious allergic reaction [see Warnings and Precautions (5.6) ] . Hypoglycemia in Patients with Diabetes Consider advising patients with diabetes to increase monitoring of blood glucose, since hypoglycemia, including severe hypoglycemia, has been reported after starting JAK inhibitors. Advise diabetic patients to notify their healthcare provider(s) if they develop signs or symptoms of hypoglycemia [see Warnings and Precautions (5.7) ] .

Laboratory Abnormalities Inform patients that LITFULO may affect certain lab tests, and that blood tests are required before and during LITFULO treatment [see Dosage and Administration (2.1) and Warnings and Precautions (5.8) ]. Vaccinations Advise patients that vaccination with live vaccines is not recommended during LITFULO treatment and shortly prior to LITFULO treatment. Instruct patients to inform the healthcare practitioner that they are taking LITFULO prior to a potential vaccination [see Warnings and Precautions (5.9) ].

Pregnancy Advise pregnant females and females of reproductive potential to inform their healthcare providers if they are pregnant or intend to becomes pregnant during treatment with LITFULO. Instruct patients to report their pregnancy to Pfizer Inc. at 1-877-390-2940 [see Use in Specific Populations (8.1) ]. Lactation Advise women not to breastfeed during treatment with LITFULO and for 14 hours after the last dose [see Use in Specific Populations (8.2) ].

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 6/2026 Medication Guide LITFULO™ (lit-FUL-oh) (ritlecitinib) capsules, for oral use What is the most important information I should know about LITFULO?

LITFULO may cause serious side effects, including: 1. Serious infections LITFULO is a medicine that affects your immune system. LITFULO can lower the ability of your immune system to fight infections.

Some people have had serious infections while taking LITFULO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body and have been hospitalized. Some people taking similar medicines to LITFULO have died from these infections. • Your healthcare provider should test you for TB before starting treatment with LITFULO. • Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with LITFULO. You should not start taking LITFULO if you have any kind of infection unless your healthcare provider tells you it is okay.

You may be at a higher risk of developing shingles (herpes zoster). Before starting LITFULO, tell your healthcare provider if you: • are being treated for an infection. • have an infection that has not gone away or that keeps coming back. • have diabetes, chronic lung disease, HIV, or a weak immune system. • have TB or have been in close contact with someone with TB. • have had shingles (herpes zoster). • have had hepatitis B or hepatitis C. • live or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections.

These infections may happen or become more severe if you use LITFULO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. • think you have an infection or have symptoms of an infection such as: o fever, sweating, or chills o muscle aches o cough or shortness of breath o blood in your phlegm o weight loss o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinating more often than usual o feeling very tired After starting LITFULO, call your healthcare provider right away if you have any symptoms of an infection.

LITFULO can make you more likely to get infections or make any infections that you have worse. If you get a serious infection, your healthcare provider may stop treatment with LITFULO until your infection is controlled. 2.

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. LITFULO is a kinase inhibitor medicine. 3.

Cancer and immune system problems LITFULO may increase your risk of certain cancers by changing the way your immune system works. • Lymphoma and other cancers, including skin cancers, can happen in people taking LITFULO. • People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are current or past smoker. • Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment with LITFULO.

Tell your healthcare provider if you have ever had any type of cancer. 4. Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while using LITFULO, including: • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and come… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Ritlecitinib AUC 0-tau and C max increase in an approximately dose-proportional manner up to 200 mg. Steady state was reached approximately by Day 4. Absorption The ritlecitinib absolute oral bioavailability is approximately 64%.

Ritlecitinib peak plasma concentrations were reached within 1 hour following an oral dose. Effect of Food Food does not have a clinically significant impact on the systemic exposures of ritlecitinib. The coadministration of a 100 mg ritlecitinib capsule with a high-fat meal reduced the ritlecitinib C max by ~32% and AUC inf was increased by 11%.

In clinical trials, ritlecitinib was administered without regard to meals [see Dosage and Administration (2.2) ] . Distribution Approximately 14% of circulating ritlecitinib is bound to plasma proteins. Elimination The ritlecitinib mean terminal half-life ranges from 1.3 to 2.3 hours.

Metabolism The metabolism of ritlecitinib is mediated by multiple pathways with no single route contributing to more than 25% of the total metabolism. These pathways include: • Glutathione S-transferase (GST): cytosolic GST A1/3, M1/3/5, P1, S1, T2, Z1 and microsomal GST 1/2/3 • CYP enzymes (CYP3A, CYP2C8, CYP1A2, and CYP2C9) Excretion Approximately 66% of radiolabeled ritlecitinib dose is excreted in the urine and 20% in the feces. Approximately 4% of the ritlecitinib dose is excreted unchanged drug in urine.

Specific Populations No clinically relevant differences in the pharmacokinetics of ritlecitinib were observed based on age (12-73 years), body weight, gender, GST genotype, and race. Patients with Renal Impairment The AUC 24 observed in patients with severe renal impairment (eGFR <30 mL/min) was 55.2% higher compared with the AUC 24 in matched participants with normal renal functions. These differences are not considered clinically significant.

Ritlecitinib has not been studied in patients with mild (eGFR 60 to <90 mL/min) or moderate (eGFR 30 to <60 mL/min) renal impairment, as a clinically relevant increase in ritlecitinib exposure is not expected in these patients. The eGFR and classification of renal function status of patients was done using the Modification of Diet in Renal Disease (MDRD) formula. Ritlecitinib has not been studied in patients with ESRD or in renal transplant recipients.

Patients with Hepatic Impairment Patients with moderate (Child Pugh B) hepatic impairment had an 18.5% increase in ritlecitinib AUC 24 compared to patients with normal hepatic function. Ritlecitinib has not been studied in patients with mild (Child Pugh A) hepatic impairment, as a clinically relevant increase in ritlecitinib exposure is not expected in these patients. Ritlecitinib has not been studied in patients with severe (Child Pugh C) hepatic impairment and is not recommended for use in these patients [see Dosage and Administration (2.3) and Use In Specific Populations (8.6) ] .

Drug Interaction Studies Clinical Studies Effect of other drugs on ritlecitinib The effect of coadministered drugs on the pharmacokinetics of ritlecitinib is presented in Table 5. Table 5. Change in Pharmacokinetics of Ritlecitinib in the Presence of Coadministered Drugs Coadministered Drugs Regimen of Coadministered Drug Dose of Ritlecitinib Ratio Ratios for C max and AUC inf compare coadministration of ritlecitinib with the drug versus administration of ritlecitinib alone.

(90% Confidence Interval) C max AUC inf Strong CYP3A inhibitor: Itraconazole Drug interaction with CYP3A inhibitor is not clinically significant. 200 mg once daily × 5 days 30 mg 1.03 (0.83, 1.27) 1.15 (1.05, 1.27) Strong CYP enzyme inducer: Rifampin 600 mg once daily × 8 days 50 mg 0.75 (0.63, 0.89) 0.56 (0.52, 0.60) Effect of ritlecitinib on other drugs The effect of ritlecitinib on the pharmacokinetics of coadministered drugs is presented in Table 6. Table 6.

Change in Pharmacokinetics of Coadministered Drugs in the Presence of Ritlecitinib Coadministered Drugs Dose Regimen of Ritlecitinib Ratio Ratios for C ma… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 121 words ▾

12.2Pharmacodynamics Lymphocyte Subsets A dose-dependent early decrease in absolute lymphocyte levels, T lymphocytes (CD3) and T lymphocyte subsets (CD4 and CD8) was associated with LITFULO treatment in patients with alopecia areata. In addition, there was a dose-dependent early decrease in NK cells (CD16/56) which remained stable at the lower level up to Week 48. For the 50 mg QD dose, there was an initial decrease in median lymphocyte levels which remained consistent up to Week 48.

There was no change observed in B lymphocytes (CD19) in any treatment group. Cardiac Electrophysiology At 12 times the mean maximum exposure of the 50 mg once daily dose in patients with alopecia areata, there was no clinically relevant effect on the QTc interval.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy and safety of LITFULO were evaluated in one randomized, double-blind, placebo-controlled trial (Trial AA-I) in subjects 12 years of age and older with alopecia areata with ≥50% scalp hair loss, including alopecia totalis (AT) and alopecia universalis (AU). Trial AA-I evaluated a total of 718 subjects who were randomized to one of the following treatment regimens for 48 weeks: 1) 200 mg once daily for 4 weeks followed by 50 mg once daily for 44 weeks; 2) 200 mg once daily for 4 weeks followed by 30 mg once daily for 44 weeks; 3) 50 mg once daily for 48 weeks; 4) 30 mg once daily for 48 weeks; 5) 10 mg once daily for 48 weeks; 6) placebo for 24 weeks followed by 200 mg once daily for 4 weeks and 50 mg once daily for 20 weeks; or 7) placebo for 24 weeks followed by 50 mg once daily for 24 weeks.

The recommended dose of LITFULO is 50 mg once daily and the results for this dose are discussed below. Across all treatment groups 62% of subjects were female, 68% were White, 26% were Asian, and 4% were Black or African American. The majority of subjects (85%) were adults (≥18 years of age) with a mean age of 33.7 years.

A total of 105 (15%) subjects 12 to <18 years of age and 20 (3%) subjects 65 years of age and older were enrolled. The mean baseline Severity of Alopecia Tool (SALT) score ranged from 88.3 to 93.0 across treatment groups; among subjects without AT/AU at baseline, the mean SALT score ranged from 78.3 to 87.0. The majority of subjects had abnormal eyebrows (83%) and eyelashes (75%) at baseline across treatment groups.

The median duration since alopecia areata diagnosis was 6.9 years and the median duration of the current alopecia areata episode was 2.5 years. Randomization was stratified by AT/AU status with 46% of subjects classified as AT/AU based upon a baseline SALT score of 100. Clinical Response Assessment of scalp hair loss was based on the SALT score.

At Week 24, a greater proportion of subjects had a SALT ≤20 response (20% or less of scalp hair loss) and SALT ≤10 response (10% or less of scalp hair loss) with LITFULO compared to placebo (Table 7). The percentage of subjects achieving SALT ≤20 response by visit is shown in Figure 1. Table 7.

Proportion of Subjects with Response on the SALT Scale at Week 24 LITFULO 50 mg QD (N=130) % Responders Placebo (N=131) % Responders Difference from Placebo (95% CI) Abbreviations: CI = confidence interval; N = total number of subjects; QD = once daily; SALT = Severity of Alopecia Tool. SALT ≤20 response SALT ≤20 responders were subjects with scalp hair loss of ≤20%. SALT scores range from 0 to 100 with 0 = no scalp hair loss and 100 = total scalp hair loss.

23.01.6 21.4 (13.4, 29.5) SALT ≤10 response SALT ≤10 responders were subjects with scalp hair loss of ≤10%. 13.4 1.5 11.9 (5.4, 18.3) Figure 1. SALT ≤20 Response through Week 24 Abbreviations: QD = once daily; SALT = Severity of Alopecia Tool.

Figure 1

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat carcinogenicity study, ritlecitinib increased the incidence of combined benign and malignant thymomas in female rats, and thyroid follicular adenomas and combined follicular adenomas and carcinomas in male rats at 100 mg/kg/day (29 times the MRHD based on AUC comparison). No ritlecitinib-related tumors were noted at doses up to 30 mg/kg/day (6.3 times the MRHD based on AUC comparison). No ritlecitinib-related tumors were noted in a 6-month Tg.rasH2 mouse carcinogenicity study at doses up to 300 mg/kg/day.

Ritlecitinib was not mutagenic in the in vitro bacterial reverse mutation assay (Ames assay). Ritlecitinib was positive in an in vitro micronucleus assay in TK6 cells. However, mechanistic studies determined that ritlecitinib is aneugenic and does not present a clinically relevant genotoxic concern.

Additionally, in an in vivo rat bone marrow micronucleus assay, ritlecitinib was not aneugenic or clastogenic at doses up to 400 mg/kg/day. Ritlecitinib had no effects on female rat fertility at doses up to 200 mg/kg/day (55 times the MRHD based on AUC comparison). Effects on male rat fertility were noted (higher preimplantation loss resulting in lower number of implantation sites and corresponding lower litter size in naïve females mated with ritlecitinib-dosed males) at 200 mg/kg/day (55 times the MRHD based on AUC comparison).

No effects on male fertility were noted at doses up to 60 mg/kg/day (14 times the MRHD based on AUC comparison). No effects on spermatogenesis (sperm counts, production rate, motility, or morphology) were noted at any dose.

13.2Animal Toxicology and Pharmacology In two 9-month oral repeat dose toxicity studies in dogs, dose-related reversible axonal dystrophy was noted in the brainstem, spinal cord, sciatic nerve, nerve branches of the vagus nerve, and myenteric/submucosal plexuses of the GI tract at doses ≥20 mg/kg/day (14 times the MRHD based on AUC comparison). At 40 mg/kg/day (33 times the MRHD based on AUC comparison), ritlecitinib-related axonal dystrophy caused adverse reversible hearing loss and waveform deficits in brainstem auditory evoked potential (BAEP) testing.

BAEP deficits were first noted during Month 7 of dosing and persisted through the end of dosing. No auditory threshold deficits were noted at 6 months after the end of dosing. No BAEP deficits were noted at doses ≤20 mg/kg/day.

Additional mechanistic studies provided preliminary evidence that ritlecitinib-related hearing loss was not directly caused by JAK3 or TEC family kinase inhibition, but did not identify the underlying mechanism of axonal dystrophy in dogs.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat carcinogenicity study, ritlecitinib increased the incidence of combined benign and malignant thymomas in female rats, and thyroid follicular adenomas and combined follicular adenomas and carcinomas in male rats at 100 mg/kg/day (29 times the MRHD based on AUC comparison). No ritlecitinib-related tumors were noted at doses up to 30 mg/kg/day (6.3 times the MRHD based on AUC comparison). No ritlecitinib-related tumors were noted in a 6-month Tg.rasH2 mouse carcinogenicity study at doses up to 300 mg/kg/day.

Ritlecitinib was not mutagenic in the in vitro bacterial reverse mutation assay (Ames assay). Ritlecitinib was positive in an in vitro micronucleus assay in TK6 cells. However, mechanistic studies determined that ritlecitinib is aneugenic and does not present a clinically relevant genotoxic concern.

Additionally, in an in vivo rat bone marrow micronucleus assay, ritlecitinib was not aneugenic or clastogenic at doses up to 400 mg/kg/day. Ritlecitinib had no effects on female rat fertility at doses up to 200 mg/kg/day (55 times the MRHD based on AUC comparison). Effects on male rat fertility were noted (higher preimplantation loss resulting in lower number of implantation sites and corresponding lower litter size in naïve females mated with ritlecitinib-dosed males) at 200 mg/kg/day (55 times the MRHD based on AUC comparison).

No effects on male fertility were noted at doses up to 60 mg/kg/day (14 times the MRHD based on AUC comparison). No effects on spermatogenesis (sperm counts, production rate, motility, or morphology) were noted at any dose.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.7 ) 6/2026

📄 Package Label / Principal Display Panel 56 words ▾

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label Sample PROFESSIONAL SAMPLE – NOT FOR SALE ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 63539-334-28 Pfizer Litfulo™ (ritlecitinib) capsules 50 mg* Do not crush, split, or chew the capsules Do not eat the desiccant. 28 Capsules Rx only PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label Sample

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

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

Medicare Part D (outpatient prescription) spending for Litfulo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Litfulo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.74M
Claims incl. refills
921
Beneficiaries
413
Spend / beneficiary
$11,474.08
Spend / claim
$5,145.27
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 — Not published for this NDC No photo available yet for this listing.
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 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 U.S. Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
U.S. Pharmaceuticals 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.
← 63539-0295-30 · U.S. 63539-0336-14 · U.S. →
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.