Besremi (ropeginterferon alfa-2b or ropeginterferon alfa-2b-njft) is a newly-approved, injectable medication used to treat a rare type of blood cancer called polycythemia vera (PV). This medication is a recommended option for certain adults with PV, but it also has many potential risks and side effects.
Besremi (ropeginterferon alfa-2b) is a biologic medication. It affects how the cells in your bone marrow work. This is thought to help lower the production of red blood cells.
| Common Brands | Besremi |
|---|---|
| Drug Class | Biologic |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
How to use Besremi (ropeginterferon alfa-2b)
Besremi (ropeginterferon alfa-2b) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Besremi (ropeginterferon alfa-2b) has a black box warning for potentially causing serious or life-threatening mental health, hormone, heart, and blood cell problems. Your provider will monitor your symptoms and order certain lab tests regularly throughout treatment. If you have symptoms of these side effects, seek medical help right away or contact your provider so they can manage your treatment. Specific signs and symptoms for each of these problems include the following:
Besremi (ropeginterferon alfa-2b) can cause several side effects in many other parts of your body. Most are rare, but to lower your risk, your provider will check for symptoms and order lab tests regularly throughout treatment. If you're experiencing any severe side effects, contact your provider. Your provider will adjust your dose or stop your Besremi (ropeginterferon alfa-2b) treatment. Some examples of side effects that can happen throughout your body include the following.
Severe allergic reactions to Besremi (ropeginterferon alfa-2b) are possible, including life-threatening reactions like facial swelling, shock, and anaphylaxis (e.g., closing of the throat). If you notice difficulty breathing, a choking sensation, swelling around your eyes, swelling of the lips or tongue, dizziness, or nausea after using Besremi (ropeginterferon alfa-2b), get medical attention right away.
The starting dose depends on whether you've previously taken a different first-choice medication for PV called hydroxyurea (Hydrea).
Your provider will adjust your dose based on how well Besremi (ropeginterferon alfa-2b) is working for you and if you're having side effects. The maximum single dose is 500 mcg.
Once your blood cell counts become stable after at least 1 year of Besremi (ropeginterferon alfa-2b) treatment, your provider might change how often you receive this medication from every 2 weeks to once every month.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Besremi (ropeginterferon alfa-2b) will not be safe for you to take.
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Polycythemia vera (PV) is a rare blood cancer that affects the bone marrow and causes your body to make too many blood cells (e.g., red blood cells). This can cause your blood to thicken, which can put you at risk for life-threatening problems like blood clots, heart attack, and stroke. Each person with PV can experience different symptoms of PV. Some symptoms include itchiness; shortness of breath; numbness or tingling in the hands, feet, arms, or legs; bleeding or bruising more than usual; or painful joint swelling. Others include fatigue, weakness, dizziness, and blurry vision. Besremi helps treat PV by working in the bone marrow to decrease the production of blood cells.
Because Besremi can cause side effects that affect different parts of your body, your provider will order several tests to check your health before you start this medication and also regularly throughout treatment. Some tests you can expect include blood tests that check your liver, kidney, and pancreas health, as well as your thyroid hormone levels, cholesterol levels, and blood cell counts. Your provider might also perform physical exams to check your heart, lungs, and skin health. Additionally, you'll need to get routine dental and eye exams. Ask your provider if you have any questions about these tests or what they're used to check for.
Besremi is given through an injection under the skin into the fat tissue between your skin and muscle. It can be injected into your lower stomach or top of your thigh. If you're injecting into your stomach, make sure to inject at least 2 inches away from your belly button. Never inject it into your muscle or vein since this can lead to side effects. Make sure to use a different injection site each time to lower the risk of bruising and skin irritation.
In studies, 60% of people taking Besremi achieved complete hematological response (CHR), which means the levels of red blood cells, white blood cells, and platelets returned to normal; spleen size was normal; and there weren't blood clots, heart attacks, or strokes that happened. It took some people about 8 months of treatment to achieve complete hematological response, and it lasted for about 14 months for certain people. Overall, 80% of people taking Besremi saw their blood cell counts return to normal, which lasted about 21 months for some people.
There haven't been any human or animal studies looking at how Besremi affects pregnant females or their babies. However, based on how Besremi works, there's a chance it can cause harm to your baby. If you're female and able to become pregnant, your provider will order a pregnancy test before you start Besremi to confirm you're not pregnant. Then, use birth control during treatment with Besremi and for at least 2 months after your last dose. Additionally, it's not recommended to breastfeed during treatment and for 2 months after your last dose. Let your provider know if you're pregnant, thinking of becoming pregnant, or breastfeeding before starting Besremi or during treatment.
