Besremi
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.
What is Besremi (ropeginterferon alfa-2b)?
What is Besremi (ropeginterferon alfa-2b) used for?
- Polycythemia vera in adults
How Besremi (ropeginterferon alfa-2b) works
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.
Drug facts
Side effects of Besremi (ropeginterferon alfa-2b)
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.
Common Side Effects
- Flu-like symptoms (59%)
- Joint pain (47%)
- Feeling tired (47%)
- Itching (45%)
- Nose and throat inflammation (43%)
- Muscle or bone pain (41%)
- Headache (39%)
- Diarrhea (33%)
- Sweating (29%)
- Nausea (28%)
- Upper respiratory tract infection (e.g., common cold; 27%)
- Injection site reactions (26%)
Less Common Side Effects
- Dizziness
- Muscle spasms
- Stomach pain
- Low appetite
- Hair loss
- Swelling
- Rash
- Urinary tract infection
- Low blood cell counts
- High blood pressure
Besremi (ropeginterferon alfa-2b) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: hives, rash, blisters, skin reddening, swelling of the lips or tongue, difficulty breathing
- Other serious, life-threatening problems: see Risks and Warnings
The following Besremi (ropeginterferon alfa-2b) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Eye pain, change in vision, vision loss
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
- Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
- Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
- Tooth decay—change in tooth color, bad breath, sensitive gums or teeth
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Dry mouth
- Fatigue
- Hair loss
- Joint pain
- Muscle pain
- Sweating
Pros and cons of Besremi (ropeginterferon alfa-2b)
Pros
- Works well to correct blood cell counts in people with PV
- Injected every 2 to 4 weeks
- Available as a prefilled syringe for easier use
- Can use long term (clinical studies lasted 7.5 years)
- Can use at home, if approved by your provider
Cons
- Brand name only, which can be expensive
- Has a lot of risks and side effects so you have to be carefully monitored during treatment
- Might be hard for some people to administer as instructed
- Unknown if safe or works well in children under 18 years old
Pharmacist tips for Besremi (ropeginterferon alfa-2b)
- Besremi (ropeginterferon alfa-2b) can cause serious side effects and problems in many of your body's organs. Your provider will monitor your health regularly throughout treatment to help lower your risk for these problems.
- Make sure to have good oral hygiene (regularly brushing your teeth and flossing) and receive check-ups from your dentist regularly. Additionally, make sure to see your optometrist for regular eye check-ups as well. This will help monitor and prevent mouth- and eye-related side effects.
- Besremi (ropeginterferon alfa-2b) can make you sleepy and dizzy. Make sure to avoid doing anything that requires you to be alert or have full attention, like driving or operating heavy machinery, until you know how this medication affects you.
- Tell your provider about all of the medications you're taking or planning to take, especially any opioids, benzodiazepines, or sleep medications. Taking these medications with Besremi (ropeginterferon alfa-2b) can raise your risk for serious brain and mental health side effects, such as sleepiness, dizziness, depression, and suicide. Don't start any new medications without talking to your provider or pharmacist first.
How to use Besremi (ropeginterferon alfa-2b)
- Make sure you know how to give yourself Besremi (ropeginterferon alfa-2b) to avoid accidentally hurting yourself or wasting the medication. Carefully read the instructions for use. Contact your provider or pharmacist if you have any questions on how to use this medication.
- If you're traveling on an airplane with Besremi (ropeginterferon alfa-2b), it's recommended to fill out a letter of medical necessity for travel and keep it with you.
- Store Besremi (ropeginterferon alfa-2b) in the refrigerator (but don't freeze it). Keep the syringes in the original carton away from light.
- When it's time for your dose, take a Besremi (ropeginterferon alfa-2b) prefilled syringe out of the refrigerator, and allow it to reach room temperature. This will take about 15 to 30 minutes. Don't try to warm up the medication any other way (e.g., microwave, under hot water) because you might damage it.
- Each Besremi (ropeginterferon alfa-2b) syringe provides a single dose of medication. Throw away the syringe after each use, even if there's still some remaining inside. This is because the syringes don't contain any preservatives to keep germs and bacteria out of the medication once you open it.
- After giving yourself the medication, throw away the used syringe and needle in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle). This lowers the risk of needle-stick injuries. Don't throw them away in your trash can. Learn more about how to throw away your sharps on the FDA's website.
Common questions about Besremi (ropeginterferon alfa-2b)
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 (ropeginterferon alfa-2b) helps treat PV by working in the bone marrow to decrease the production of blood cells.
Because Besremi (ropeginterferon alfa-2b) 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 (ropeginterferon alfa-2b) 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 (ropeginterferon alfa-2b) 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 (ropeginterferon alfa-2b) 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 (ropeginterferon alfa-2b) affects pregnant females or their babies. However, based on how Besremi (ropeginterferon alfa-2b) 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 (ropeginterferon alfa-2b) to confirm you're not pregnant. Then, use birth control during treatment with Besremi (ropeginterferon alfa-2b) 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 (ropeginterferon alfa-2b) or during treatment.
How to save using GoodRx
Risks and warnings for 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.
Risk of serious or life-threatening mental health, hormone, heart, and blood cell problems
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:
- Mental health problems: depression, suicidal thoughts or behavior, aggressive behavior, bipolar disorder, or confusion.
- Thyroid or blood sugar problems: hyperthyroidism or hypothyroidism (too much or too little thyroid hormones in the body), other thyroid problems, high blood sugar, or diabetes. Symptoms include changes in eating habits, changes in ability to tolerate cold or heat, and changes in weight.
- Heart problems: problems affecting your heart muscle's ability to pump blood (cardiomyopathy), irregular heart rhythm, or heart attack (chest pain; pain in your jaw, neck, or back; shortness of breath). If you have severe heart problems or have had a recent stroke or heart attack, avoid using Besremi (ropeginterferon alfa-2b).
- Low blood cell counts: low red blood cell, white blood cell, and platelet levels. This can raise your risk for bleeds and infections. Symptoms of blood problems include small, flat, red spots under your skin; easy bleeding or bruising; feeling tired; headache; pale skin; shortness of breath; and frequent infections.
Risk of side effects to many other parts of your body
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.
- Lung problems: shortness of breath, pneumonia, inflammation of your lungs, high blood pressure in the blood vessels that feed your lungs, or lung failure.
- Liver damage: yellowing of the skin or whites of the eyes, dark urine, stomach pain, low appetite, nausea, or vomiting.
- Pancreatitis (inflammation of the pancreas): yellowing of the skin or whites of the eyes, nausea, vomiting, upper stomach pain, or fever.
- Colitis (inflammation of the colon): ulcerative colitis, bleeding, or lack of blood supply to the colon. These colon problems can happen as early as 3 months after starting Besremi (ropeginterferon alfa-2b). Symptoms include stomach pain, bloody diarrhea, and fever. Colitis can go away within 1 to 3 weeks after stopping the medication.
- Kidney damage: swelling in the legs, ankles, or feet; changes in urine color; changes in how often you urinate; or weakness.
- Eye problems: cataract, dry eye, or vision changes. More severe problems, like blockages in the eye blood vessels or bleeding in your eyes, can lead to blindness.
- Mouth and teeth problems: dy mouth or other problems that can lead to loss of teeth.
- Skin problems: skin redness, skin inflammation, acne, psoriasis, or thickened skin.
Severe allergic reactions
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.
Besremi (ropeginterferon alfa-2b) dosage
Typical dosage for Besremi (ropeginterferon alfa-2b)
The starting dose depends on whether you've previously taken a different first-choice medication for PV called hydroxyurea (Hydrea).
- Haven't taken hydroxyurea (Hydrea) before: The typical starting dose of Besremi (ropeginterferon alfa-2b) is 100 mcg injected under the skin every 2 weeks.
- Switching from hydroxyurea (Hydrea) to Besremi (ropeginterferon alfa-2b) treatment: The typical starting dose of Besremi (ropeginterferon alfa-2b) is 50 mcg injected under the skin every 2 weeks while you continue hydroxyurea (Hydrea). Your provider will slowly lower your dose of hydroxyurea (Hydrea) over 3 months. At the same time, your provider will also slowly raise the dose of Besremi (ropeginterferon alfa-2b). This will help transition your treatment from hydroxyurea (Hydrea) to Besremi (ropeginterferon alfa-2b).
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.
Besremi (ropeginterferon alfa-2b) contraindications
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.
- Current or history of severe mental health problems (e.g., severe depression, suicidal thoughts, suicidal attempt)
- Severe allergic reaction to interferons
- Moderate or severe liver problems
- Current or history of serious or untreated autoimmune problems
- Have received a transplant and currently taking immunosuppressants
