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This email is sponsored by Incyte.

You are cordially invited to attend:

Two Distinct Pathways, One Shared Goal: A Nonoverlapping, Sequential Approach to Target Inflammation and Fibrosis in cGVHD

Presented By:

Michael Bishop, MD

University of Chicago
Chicago, IL

Date and Time:
Thursday, October 23, 2025

6:30 PM - 8:30 PM
Eastern Standard Time

Location

Sexy Steak

1942 Grand River Ave
Detroit, MI 48226

The program will begin at 6:30 PM. Please plan to arrive 15 minutes early.
Due to a change in Policy, Incyte will no longer provide or pay for alcohol at Speaker Programs.
Appropriate attendees include licensed HCPs with a direct role in patient care.

Registration

Online https://sphase.info/inc12595

You may also register by contacting your Incyte representative Joann Fawaz at (302) 438-9314 or [email protected] with the following information: name, title/degree, state(s) and state license number(s), affiliation, address, phone, and email.

Prior to registering, please review the program title to ensure you have not attended this program before.

Please see Important Safety Information for Jakafi and Niktimvo below and
Full Prescribing Information for each.

Please note this program is intended for US healthcare professionals who practice
in a specialty relevant to the program's FDA-approved indication or disease state.
This program is sponsored by lncyte and is not eligible for CE credits.

This is an educational event intended only for appropriate healthcare professionals.
Spouses, guests, and other individuals who are not the intended audience of this
educational program are not permitted to attend. Healthcare professionals who
are subject to federal, state, or local laws or government ethics restrictions may
not attend this event. Incyte will report the cost of any meals provided at this
event as required by federal, state, or local laws.

Incyte and its representatives will process your personal information that you
provide when you register in order to attend an educational event presented by
Incyte. You can learn more about Incyte's privacy practices at the following site:
https://www.incyte.com/privacy-policy. Please contact [email protected] if
you have any questions or concerns.

INDICATIONS AND USAGE

Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host
disease (aGVHD) in adult and pediatric patients 12 years and older.

Jakafi 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.

Niktimvo^™ (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-
blocking antibody indicated for the treatment of chronic graft-versus-host disease
(cGVHD) after failure of at least two prior lines of systemic therapy in adult and
pediatric patients weighing at least 40 kg.

JAKAFI Important Safety Information

Warnings and Precautions
Thrombocytopenia, Anemia and Neutropenia

•

Jakafi® (ruxolitinib) can cause dose-related effects of thrombocytopenia, anemia
and neutropenia. Perform a pre-treatment complete blood count (CBC) and
monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as
clinically indicated.

•

Manage thrombocytopenia by reducing the dose or temporarily interrupting
Jakafi. Platelet transfusions may be necessary.

•

Patients developing anemia may require blood transfusions and/or dose
modifications of Jakafi

•

Severe neutropenia (ANC <0.5 x 10⁹/L) was generally reversible by withholding
Jakafi until recovery

Risk of Infection
Tuberculosis

•

Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay
starting Jakafi until active serious infections have resolved. Observe patients
receiving Jakafi for signs and symptoms of infection and manage promptly.

•

Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for
signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi,
evaluate patients for TB risk factors and test those at higher risk for latent
infection. Consult a physician with expertise in the treatment of TB before
starting Jakafi in patients with evidence of active or latent TB. Continuation of
Jakafi during treatment of active TB 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 and evaluate.

Herpes Zoster and Herpes Simplex

•

Herpes zoster infection, reactivation and/or dissemination has been reported in
patients receiving Jakafi. Advise patients about early signs and symptoms of
herpes zoster and to seek treatment. Monitor patients for the development of
herpes simplex infections. If a patient develops evidence of dissemination of
herpes simplex, consider interrupting treatment with Jakafi.

Hepatitis B

•

Increases in hepatitis B viral load with or without associated elevations in alanine
aminotransferase and aspartate aminotransferase have been reported in
patients with chronic hepatitis B virus (HBV) infections.

Symptom Exacerbation Following Interruption or Discontinuation of Treatment

•

When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may
return within one week. After discontinuation, some patients with myelofibrosis
have experienced fever, respiratory distress, hypotension, DIC, or multi-organ
failure. If any of these occur after discontinuation or while tapering Jakafi,
evaluate and treat any intercurrent illness and consider restarting or increasing
the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without
consulting their physician. When discontinuing or interrupting Jakafi for reasons
other than thrombocytopenia or neutropenia, consider gradual tapering rather
than abrupt discontinuation.

Non-Melanoma Skin Cancer (NMSC)

•

NMSC including basal cell, squamous cell, and Merkel cell carcinoma have
occurred. Perform periodic skin examinations.

Lipid Elevations

•

Treatment with Jakafi has been associated with increases in total cholesterol,
low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters
8-12 weeks after initiating Jakafi.

Major Adverse Cardiovascular Events (MACE)

•

Another JAK-inhibitor has increased the risk of major adverse cardiovascular
events (MACE), including cardiovascular death, myocardial infarction, and stroke
(compared to those treated with TNF blockers) in patients with rheumatoid
arthritis, a condition for which Jakafi is not indicated. Consider the benefits and
risks for the individual patient prior to initiating or continuing therapy with Jakafi
particularly in patients who are current or past smokers and patients with other
cardiovascular risk factors. Patients should be informed about the symptoms of
serious cardiovascular events and the steps to take if they occur.

Thrombosis

•

Another JAK-inhibitor has increased the risk of thrombosis, including deep
venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis
(compared to those treated with TNF blockers) in patients with rheumatoid
arthritis, a condition for which Jakafi is not indicated. In patients with
myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical
trials, the rates of thromboembolic events were similar in Jakafi and control
treated patients. Patients with symptoms of thrombosis should be promptly
evaluated and treated appropriately.

Secondary Malignancies

•

Another JAK-inhibitor has increased the risk of lymphoma and other
malignancies excluding NMSC (compared to those treated with TNF blockers) in
patients with rheumatoid arthritis, a condition for which Jakafi is not indicated.
Patients who are current or past smokers are at additional increased risk.

Adverse Reactions

•

In myelofibrosis and polycythemia vera, the most common hematologic adverse
reactions (incidence >20%) were thrombocytopenia and anemia. The most
common nonhematologic adverse reactions (incidence ≥15%) are bruising,
dizziness, headache and diarrhea.

•

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%) were
infections (pathogen not specified) and edema.

•

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%) were infections
(pathogen not specified) and viral infections.

Drug Interactions

•

Avoid concomitant use with fluconazole doses greater than 200 mg. Dose
modifications may be required when administering Jakafi with fluconazole doses
of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or
hepatic impairment. Patients should be closely monitored and the dose titrated
based on safety and efficacy.

Pregnancy

•

Use of Jakafi during pregnancy is not recommended and should only be used if
the potential benefit justifies the potential risk to the fetus. Women taking Jakafi
should not breastfeed during treatment and for 2 weeks after the final dose.

NIKTIMVO Important Safety Information

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Niktimvo^™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related
reactions, including hypersensitivity reactions, occurred in 18% of patients who
received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in
1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have
previously experienced an infusion-related reaction to Niktimvo. Monitor patients
for signs and symptoms of infusion-related reactions, including fever, chills, rash,
flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or
permanently discontinue Niktimvo based on the severity of the reaction.

Embryo-Fetal Toxicity
Based on its mechanism of action, Niktimvo may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
the fetus. Advise females of reproductive potential to use effective contraception
during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 44% of patients who received Niktimvo
(N=79). Serious adverse reactions in > 2 patients included infection (pathogen
unspecified) (14%), viral infection (14%), and respiratory failure (5.1%). Permanent
discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients
and dose reduction due to adverse reaction occurred in 8% of patients. Dose
interruptions due to an adverse reaction occurred in 44% of patients. The adverse
reactions leading to dose interruption in > 2 patients were viral infection, infection
(pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥ 15%) adverse reactions, including laboratory abnormalities,
were increased aspartate aminotransferase (AST), infection (pathogen unspecified),
increased alanine aminotransferase (ALT), decreased phosphate, decreased
hemoglobin, viral infection, increased gamma glutamyl transferase (GGT),
musculoskeletal pain, increased lipase, fatigue, increased amylase, increased
calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase
(ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in < 10% of patients who received Niktimvo
included:

• Eye disorders: periorbital edema

• Skin and subcutaneous disorders: pruritus

• Vascular disorders: hypertension

Immunogenicity: Anti-Drug Antibody-Associated Adverse Reactions
Across treatment arms in patients with cGVHD who received Niktimvo in clinical
trials, among the patients who developed anti-drug antibodies (ADAs),
hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing
antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise
women not to breastfeed during treatment and for 30 days after the last dose of
Niktimvo.

Females and Males of Reproductive Potential
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating
Niktimvo.

Contraception
Females
Advise females of reproductive potential to use effective contraception during
treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION
Dosage Modifications for Adverse Reactions
Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the
start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months
thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information
for more recommendations.

Please see the Full Prescribing Information for each by clicking on the logos below.

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