Frequently Asked
 Question

BESREMi® (ropeginterferon alfa-2b-njft) is a prescription injection approved by the FDA to treat adults with polycythemia vera (PV). This rare blood cancer causes the bone marrow to produce an excessive number of red blood cells. BESREMi works by targeting the source of the disease, the overactive bone marrow, and helping it produce normal levels of blood cells. It is a long-acting type of medicine called interferon (a protein that helps regulate blood cell production), helping lower blood counts and reduce the risk of blood clots and other complications.

BESREMi is indicated for adults with polycythemia vera, with or without an enlarged spleen. It should only be prescribed by a healthcare provider experienced in treating PV. BESREMi is not approved for use in children and may not be suitable for patients with certain medical conditions, such as severe depression, significant heart disease, active autoimmune disorders, or liver problems. Your doctor will determine if BESREMi is appropriate based on your health history and current blood counts.

BESREMi has been shown in clinical trials to normalize blood counts, reduce or eliminate the need for phlebotomy, and lower the risk of blood clots. Many patients have their blood cell, white cell, and platelet levels return to normal (called a complete hematologic response). Because BESREMi acts directly on the bone marrow, it offers a disease-modifying approach that can help manage the underlying cause of PV.

Common side effects include flu-like symptoms, such as fatigue, fever, chills, or muscle aches, which are more likely to occur during the first few injections. Some people may notice mild itching, dry skin, or headaches. More serious but less common side effects can include mood changes (such as depression), heart rhythm issues, liver or kidney problems, or autoimmune reactions. Contact your healthcare provider immediately if you experience new or worsening symptoms, such as chest pain, shortness of breath, or yellowing of the skin or eyes.

Store BESREMi in the refrigerator between 36°F and 46°F (2°C – 8°C) in its original carton to protect it from light. Do not freeze or shake it. BESREMi is a single-use medication; discard any leftover medicine and safely dispose of syringes in a sharps container as directed by your pharmacist or healthcare provider.

Some patients begin BESREMi after using other treatments such as hydroxyurea, while others start with it as first-line therapy. The combination or transition between treatments should only be managed by your doctor. Always tell your healthcare provider about all medications, vitamins, and supplements you take to avoid potential interactions.

Your doctor will order routine blood tests to check your hematocrit, white blood cell count, and platelet count to ensure the medicine is controlling your PV safely. Liver and kidney function tests may also be done periodically. Since interferon can affect mood or vision, your provider may screen for depression or recommend eye exams when needed.

You should not take BESREMi if you are allergic to interferons or any ingredient in the product, have severe depression or suicidal thoughts, active autoimmune disease, or serious heart or liver conditions. BESREMi may harm an unborn baby, so it should not be used during pregnancy, and effective birth control is required during and after treatment. Breastfeeding is also not recommended while taking BESREMi.

Yes, BESREMi may interact with other medicines, including some antivirals or drugs that affect the heart, liver, or immune system. These interactions can alter how your medications work or increase the risk of side effects. Always inform your doctor and pharmacist about all medicines, including over-the-counter drugs and supplements, that you are taking.

BESREMi can harm an unborn baby. Women must use effective contraception during treatment and for a period after the last dose as directed by their healthcare provider. Breastfeeding is not recommended because the safety of BESREMi in breast milk is unknown. If you’re planning a pregnancy, talk with your doctor before starting or stopping treatment.

The duration of treatment varies from patient to patient. Many continue long-term therapy to maintain stable blood counts and prevent PV-related complications. After about 1 year of stable control, your provider may extend the injection interval to every 4 weeks. Your doctor will tailor your treatment plan to your response and lab results.

The cost of BESREMi can vary depending on your insurance coverage and the pharmacy you use. Most commercial plans and Medicare include BESREMi on their formularies. The manufacturer also offers patient assistance and copay programs to help reduce out-of-pocket costs. Visit www.besremi.com or ask your healthcare team for more information about the BESREMi Patient Support Program.

If you have concerns about your treatment or experience side effects, please contact your healthcare provider immediately. Never stop or adjust your dose without consulting your healthcare provider. You can also review the FDA-approved prescribing information at accessdata.fda.gov or visit www.besremi.com for patient resources and support.

BESREMi is not chemotherapy. It is a type of immunotherapy known as an interferon. It works by modifying the body’s immune response and regulating the production of blood cells in the bone marrow. Unlike chemotherapy, it doesn’t directly kill cells, but instead helps normalize the process of blood cell production.

Most patients begin to see improvements in blood counts within a few months, but a complete response may take up to a year. Because BESREMi gradually rebalances blood cell production, patience and regular follow-up testing are essential.

Before starting BESREMi, your doctor will likely check your complete blood count (CBC), liver and kidney function, and thyroid levels. During treatment, these tests are repeated regularly to ensure the medication is safe and effective. Your doctor may also monitor mood, heart function, and eye health, depending on your medical history.

It’s best to limit or avoid alcohol, since both alcohol and interferons can affect the liver. Talk with your healthcare provider about what’s safe for you, especially if you already have liver issues or elevated liver enzymes.

Mood changes such as sadness, irritability, or loss of interest can sometimes occur with interferon treatments. If you or a loved one notices these symptoms, contact your doctor immediately. Do not stop treatment without consulting your provider; they can offer support or adjust your medication safely.

Yes, but you must keep it refrigerated between 36°F and 46°F (2°C – 8°C). Use a travel cooler with ice packs to maintain the temperature and avoid freezing the medicine. Always carry it in your hand luggage when flying, and bring a copy of your prescription or a doctor’s letter for airport security if needed.

Yes, after proper training, a caregiver or family member can administer your injection. Your healthcare provider or nurse will instruct you on how to inject safely and properly dispose of used syringes.

If you stop BESREMi suddenly, your blood counts may rise again, increasing your risk of blood clots. Do not stop taking this medication unless instructed to do so by your doctor. If you need to discontinue for medical reasons, your provider will guide you on how to do so safely and may transition you to another therapy.

Some patients may still require occasional phlebotomy early in treatment, but over time, many achieve stable hematocrit levels that no longer necessitate it. In studies, most patients on BESREMi eventually became phlebotomy-independent.

No, currently, there is no generic or biosimilar equivalent of BESREMi approved by the FDA. Ropeginterferon alfa-2b-njft is a unique formulation with extended dosing intervals, distinguishing it from older interferons, such as peginterferon alfa-2a or alfa-2b.

Clinical studies suggest that long-term treatment with interferons such as BESREMi may lower JAK2 V617F levels, the genetic driver mutation in most PV cases. This reduction may indicate potential disease-modifying activity, although not all patients experience the same effect.

While there is currently no cure for polycythemia vera, BESREMi can help control the disease, normalize blood counts, reduce symptoms, and potentially slow its progression. With consistent use and medical supervision, many patients maintain stable control for years.