FDA Approves Treatment for Polycythemia Vera

On November 12, 2021, the U.S. Food and Drug Administration (FDA) approved Besremi® (ropeginterferon alfa-2b-njft) injection. Besremi is approved for use by adults with polycythemia vera (PV). Besremi is not approved for use in children.^1,2

PV is a type of blood cancer that causes too many red blood cells. These extra cells thicken the blood. This causes slower blood flow. It also causes a higher chance of blood clots. PV affects about 6,200 people in the United States every year.¹

The approval makes Besremi:¹

• The first drug for PV that people can take regardless of past treatment(s)
• The first interferon therapy approved for PV

Besremi is an important development for people with PV because it can manage symptoms and complications. It can also treat cancer early, helping long-term health.³

What are the ingredients in Besremi?

The active ingredient in Besremi is called ropeginterferon alfa-2b-njft.^1-3

How does Besremi work?

Besremi interferon therapy for PV works on the immune system to slow down red blood cell production.¹

The usual treatment for PV includes:¹

• Phlebotomies (procedures that remove extra red blood cells)
• Drugs to lower the number of blood cells, including Besremi

Evidence for Besremi

Besremi was studied for 7.5 years in a multicenter, single-arm phase 3 trial. The study was called the Proud/Continuation-PV clinical trial. It looked at the safety and effectiveness of Besremi.^1,3

In the trial, 51 adults with PV took Besremi for about 5 years. To determine effectiveness, the trial looked at how many people had a complete response. This means that the red blood cell volume was less than 45 percent without recent phlebotomy. A complete response also included normal spleen size, normal counts of white cells and platelets, and no blood clots. Results show that 61 percent of people in the study had a complete response.^1,3

What are the possible side effects of Besremi?

The most common side effects of Besremi include:^1,2

• Cold or flu symptoms
• Pain in the muscles, joints, or bones
• Tiredness
• Itching
• Low white blood cells
• Low platelets
• High levels of liver enzymes

Besremi can also cause urinary tract infection, depression, and transient ischemic attacks (mini-strokes).²

These are not all the possible side effects of Besremi. Talk to your doctor about what to expect when taking Besremi. You should also call your doctor if you have any changes that concern you when taking Besremi.

Things to know about Besremi

Besremi can worsen certain diseases or conditions and cause life-threatening complications or death. Besremi can cause mood and behavior changes. Stop taking Besremi and tell your doctor right away if you have changes in your mood such as depression or aggression or thoughts of self-harm.²

Besremi can cause or worsen autoimmune problems. These may include diabetes or thyroid problems. Besremi can cause problems with the skin, eyes, liver, kidneys, teeth, and/or gums. Besremi can also cause heart or heart rhythm problems. Besremi can cause dizziness, drowsiness, and hallucinations. Do not drive until you know how Besremi affects you.²

Besremi can harm an unborn baby. If you can become pregnant, you should use birth control during treatment and for some time after the last dose of Besremi. You should also not breastfeed during treatment with Besremi and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Besremi.²

You should not take Besremi if you:²

• Are allergic to the drug
• Have or have had a severe psychiatric disorder
• Have had a transplant and have a weakened immune system
• Have or have had an autoimmune disease
• Have liver disease

Before beginning treatment with Besremi, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

For more information, read the full prescribing information of Besremi.