Why BESREMi® (ropeginterferon alfa-2b-njft)?

BESREMi targets PV at the source of the disease

Now is the time: wherever you are in your journey with polycythemia vera (PV), it's important that you understand your treatment options. Consider talking with your doctor about a treatment that targets PV at its source.

BESREMi is the only FDA-approved treatment indicated for adults with PV that targets the bone marrow, helping to control blood cell counts. That's what makes BESREMi different—it addresses the cause of PV.

BESREMi gets to the source of polycythemia vera by targeting the bone marrow

Red Blood Cell

White Blood Cell

Platelet

BESREMi is not chemotherapy

, it's an innovative immunotherapy
A treatment that uses certain parts of the body's immune system to fight disease.
. This immunotherapy is a long-acting that you take once every 2 weeks to treat PV. After maintaining stable blood levels for 1 year, you may be able to take BESREMi once every 4 weeks.

Ropeginterferon alfa-2b-njft (BESREMi) is a recommended treatment for certain patients with PV¹

The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. The alliance creates national guidelines for recommended cancer treatment, called the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).

The NCCN Guidelines® are:

Designed to support decision-making
A well-respected resource for doctors around the world
Based on the latest data and clinical evidence
Continuously updated and revised to reflect new information

These guidelines recommend ropeginterferon alfa-2b-njft (BESREMi) as a preferred first-line cytoreductive treatment option for certain patients with PV.¹

BESREMi was proven to help a broad range of people living with PV

One study looked at the efficacy

, dosing, and safety of BESREMi in adults diagnosed with PV.

People were included regardless of:

History of cardiovascular events
Incidents that can damage the heart and blood vessels, such as a heart attack or stroke.
Prior treatment with hydroxyurea
A type of chemotherapy that reduces the production of abnormal blood cells and lowers the risk of blood clots.
(HU), a type of chemotherapy

Of the people who used BESREMi in the clinical study:

All were 35 to 82 years of age
33% had been treated with HU
22% had a previous thrombotic event
Situations where blood clots form in a blood vessel or the heart, which can block blood flow.

BESREMi showed meaningful outcomes

Complete Hematologic Response

Comprehensive Disease Control

8 out of 10

achieved complete
hematologic response

Blood cell counts (red blood cells
A common type of blood cell that delivers oxygen to the rest of the body.
, white blood cells
A type of blood cell that helps the body fight infections and disease.
, and platelets
Small cell fragments that help form clots and stop bleeding.
) returned to a normal level
No phlebotomy
A procedure of drawing blood to reduce excess blood cells and decrease blood volume.
in the past 2 months

BESREMi displayed PV control over the long term

Complete hematologic response (CHR) was observed over a 7.5-year clinical trial.

Another study looked at the efficacy and safety of BESREMi in adults with PV over a period of 6 years.

People were included if they:

Completed an initial study and benefited from BESREMi
Had no history or less than 3 years of treatment with HU

Of the people who used BESREMi in the study:

All were between 49 and 66 years old
32% had been treated with HU
22% had experienced a previous thrombotic event

BESREMi contributed to years without any phlebotomies

Phlebotomy-free rates

After 3 years, 78.4 percent of participants did not require phlebotomies to maintain normal hematocrit levels

After 5 years, 83.1 percent of participants did not require phlebotomies to maintain normal hematocrit levels

After 6 years, 81.4 percent of participants did not require phlebotomies to maintain normal hematocrit levels

Percentage of participants in which no phlebotomies
were required to maintain normal hematocrit
The percentage of red blood cells in your blood.
levels^*

*Among those with available data for each treatment year.

Taking charge of my treatment: Susan's story

Research and education may help you feel informed and empowered when exploring PV treatments. Watch Susan share how shaping her treatment plan with her doctor helped her discover BESREMi, which she chose as she continued her PV journey.

How to get started with BESREMi

BESREMi Pen™ is a single-dose prefilled pen that you administer once every 2 weeks. Find out how the ready-to-use pen delivers simplified dosing.

Take the first step

Possible side effects proven to lessen over time

Since BESREMi is a biologic interferon, it triggers your immune system to start working, which may make you more likely to experience some side effects. In clinical trials for BESREMi, some of these lessened over time.

Find out more

Read this Important Safety Information carefully. It explains the serious risks of BESREMi and how to take it safely. Talk to your healthcare provider if you have any questions.

What is the most important information I should know about BESREMi^®?

BESREMi^® can cause serious side effects, including conditions that may cause death or may worsen certain serious diseases you may already have. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking BESREMi permanently. These symptoms may go away in some people after they stop taking BESREMi.

Mental health problems, including suicide

BESREMi may cause mood or behavior problems that can get worse during treatment or after your last dose, including:

Irritability (getting upset easily)
Restlessness and agitation
Confusion
Depression (feeling low, hopeless, or bad about yourself)
Unusually grand ideas
Acting aggressive or impulsively
Thoughts of hurting yourself or others, or thoughts of suicide

If you develop any of these symptoms, call your healthcare provider immediately.

New or worsening autoimmune problems

BESREMi may cause your immune system to attack healthy cells, leading to conditions such as thyroid disease, increased blood sugar (hyperglycemia), or type 1 diabetes. Call your healthcare provider if you experience:

Extreme tiredness
Frequent urination
Excessive thirst

Heart problems

BESREMi may cause heart problems, including:

Cardiomyopathy (heart muscle disease)
Heart attack
Irregular heartbeat (atrial fibrillation)
Decreased blood flow to the heart

You should not take BESREMi if you have:

Uncontrolled high blood pressure
Congestive heart failure
A serious abnormal heart rhythm
Narrowing of the arteries to your heart
Certain types of chest pain (angina)
A recent stroke or heart attack

Who should not take BESREMi?

Do not take BESREMi if you:

Have or had severe mental health problems, especially depression, suicidal thoughts, or attempted suicide
Have or had a serious or untreated autoimmune disease
Are allergic to interferon or any ingredient in BESREMi (symptoms may include itching, swelling, trouble breathing, dizziness, or chest pain)
Have certain types of liver disease
Have had a transplant and take immune-suppressing medication

Before using BESREMi, tell your healthcare provider about all of your medical conditions, including if you have any of the following:

Do not take BESREMi if you:

A mental illness
Type 1 diabetes
Heart or bleeding problems
Problems with your immune system
Hepatitis B or HIV infection
Kidney or liver problems
Are pregnant or planning to become pregnant

BESREMi may harm your unborn baby. Use effective birth control during treatment and for at least 8 weeks after your last dose
BESREMi may affect your menstrual cycle and could stop your periods
Do not breastfeed while taking BESREMi

What are the possible side effects of BESREMi? Serious side effects include:

Low blood cell counts: taking BESREMi can lead to infections, anemia, or bleeding problems. Call your healthcare provider right away if you develop weakness and tiredness, bruising easily, nose bleeds often, fever, chills, burning and painful urination, urinating often, or coughing up yellow or pink mucus (phlegm)
Serious allergic reactions: Get medical help right away if you get any of the following symptoms: skin rash or hives; itching; swelling of the face, eyes, lips, tongue, or throat; trouble breathing; chest pain; or feeling faint
Eye problems: BESREMi can cause severe eye problems with your retinas that can lead to vision loss or blindness. You should have an eye exam before and during treatment with BESREMi if you have diabetes or high blood pressure and also have retinal problems
Liver problems: BESREMi can cause increases in liver enzymes and liver damage. Your healthcare provider should do blood tests to monitor your liver enzymes and liver function before you start and during treatment with BESREMi
Kidney problems: Your healthcare provider will do blood tests to check your kidney function before starting and during treatment with BESREMi. Tell your healthcare provider right away if you develop any symptoms of a kidney problem, including: changes in the amount or color of your urine, swelling in your ankles, blood in your urine, or loss of appetite
Tooth and gum problems: BESREMi can cause tooth loss and/or dry mouth. It is important for you to brush your teeth well, two times each day and have regular dental examinations during treatment with BESREMi
Skin reactions: BESREMi may cause reaction such as rash, itching, and hair loss
Increased triglycerides: You may require blood tests to monitor levels

The most common side effects of BESREMi include:

Flu-like symptoms, including tiredness, weakness, fever, chills, muscle aches, and joint pain
Itching
Sore throat

These are not all of the possible side effects of BESREMi.

Call your doctor for medical advice about side effects. You may report side effects to PharmaEssentia at 1-800-999-2449 or FDA at 1-800-FDA-1088.

Please see full Prescribing Information including Boxed Warning and Medication Guide for BESREMi.

Read this Important Safety Information carefully. It explains the serious risks of BESREMi and how to take it safely.
Talk to your healthcare provider if you have any questions.MORE

What is the most important information I should know about BESREMi^®?

BESREMi can cause serious side effects, including conditions that may cause death or may worsen certain serious diseases you may already have. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking BESREMi permanently. These symptoms may go away in some people after they stop taking BESREMi.

Read this Important Safety Information carefully.
It explains the serious risks of BESREMi and how to take it safely. Talk to your healthcare provider if you have any questions.
MORE

What is the most important information I should know about BESREMi^®?

BESREMi^® may cause you to develop

Read this Important Safety Information carefully.
It explains the serious risks of BESREMi and how to take it safely. Talk to your healthcare provider if you have any questions.
MORE

What is the most important information I should know about BESREMi^®?

BESREMi can cause serious side effects that may cause death or may worsen certain serious

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BESREMi, the BESREMi logo, and PharmaEssentia are registered trademarks of PharmaEssentia Corporation, and BESREMi Pen, the BESREMi Pen logo, the PharmaEssentia logo, PharmaEssentia SOURCE, and the PharmaEssentia SOURCE logo are trademarks of PharmaEssentia Corporation.
US-BSRM-2400203 (v2.0) 06/2025

Why BESREMi?

Why BESREMi?

BESREMi targets PV at the source of the disease

Ropeginterferon alfa-2b-njft (BESREMi) is a recommended treatment for certain patients with PV¹