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Overview: Besremi is used to treat a certain type of blood cancer. Common side effects include flu-like sickness, joint pain, and tiredness. Do not drive or operate heavy machinery until you know how this medicine affects you. Call your health care provider right away if you get a fever, swelling, severe stomach pain, unusual bruising, or vision problems. Get emergency help if you have chest pain, trouble breathing, or bleeding that will not stop.

Uses

What is Besremi used for?

Besremi (ropeginterferon alpha-2b) is commonly used to treat a blood cancer called polycythemia vera. 

Besremi may also be used for other conditions as determined by your health care provider.

How does Besremi work (mechanism of action)?

People with polycythemia vera produce too many red blood cells in their body. Too many red blood cells can cause blood clots and other problems. Besremi may work by making your bone marrow make fewer red blood cells. 

How is Besremi supplied (dosage forms)?

Brands and other names

  • Besremi

Dosage forms and strengths

  • 500 mcg/mL single-dose prefilled syringe

How should I store Besremi?

Besremi should be stored in the refrigerator, between 36 F and 46 F (2 C and 8 C). Keep the medicine away from heat and do not freeze it. Store Besremi in the outer packaging it comes in to keep it away from light.

Side Effects

What are the most common side effects of Besremi?

The most common side effects of Besremi are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Flu-like illness
  • Joint pain
  • Tiredness
  • Itching
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Muscle and bone pain

There may be other side effects of Besremi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Besremi?

While less common, the most serious side effects of Besremi are described below, along with what to do if they happen.

Severe Allergic Reactions. Besremi may cause allergic reactions, which can be serious. Stop using Besremi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Depression and Suicidal Thoughts and Actions. Besremi may cause depression and suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Stop using Besremi, and call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
  • Irritability or getting upset easily
  • Restlessness and agitation
  • Confusion
  • Feeling low or bad about yourself or feeling hopeless
  • Unusually grand ideas
  • Acting aggressively or impulsively

Hormone Problems. Besremi may cause problems with the hormones in your body, including hypothyroidism, hyperthyroidism, adrenal insufficiency, thyroiditis, and type 1 diabetes. Call your health care provider right away if you have any of the following symptoms.

  • Headache
  • Fast or irregular heartbeat
  • Sweating
  • Tiredness
  • Weight gain or loss
  • Hair loss
  • Changes in mood or behavior
  • Peeing more than usual
  • Feeling cold

Heart Problems. Besremi may cause heart problems, including cardiomyopathy, heart attack, and atrial fibrillation. You may be at an increased risk if you have had heart problems in the past. Tell your health care provider about any heart problems you have had. Get emergency help if you have any of the following symptoms. 

  • Chest pain or pressure
  • Fast or pounding heartbeat or a fluttering feeling in your chest (palpitations)
  • Tiredness or weakness
  • Dizziness, lightheadedness, or fainting
  • Shortness of breath

Blood Disorders. Besremi can cause blood disorders, such as low red blood cells (anemia), low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia). Keep all of your appointments to have your blood cell counts checked. Stop using Besremi and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Inflammation of the Pancreas (Pancreatitis). Besremi may cause inflammation of the pancreas, which is called pancreatitis. Symptoms include vomiting or severe pain in the upper part of your belly that travels to your back. Call your health care provider right away if you have symptoms of pancreatitis.

Inflamed Intestines. Besremi may cause inflammation of the intestines, also known as colitis. This can be severe and even life-threatening if not treated. Tell your health care provider right away if you have the following symptoms.

  • Severe stomach pain
  • Diarrhea
  • Blood or mucus in your stool 
  • Black or tarry stools
  • Fever

Lung Inflammation and Problems. Besremi can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. It may also cause other lung problems, including pneumonia. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

Eye Problems. Besremi may cause eye problems, including severe problems with your retina. These problems can cause blindness if not treated. Keep all appointments to have your eyes checked. Contact your health care provider right away if you have any of the following symptoms.

  • Eye redness, itchiness, or pain
  • Swollen or itchy eyelids
  • Feeling like you have something in your eye
  • Eye dryness, watering, or discharge
  • Vision changes, such as blurry vision or sensitivity to light

High Levels of Fats. Besremi may cause high levels of fats in your blood. This is known as hyperlipidemia. Keep all appointments with your health care provider to have your blood checked.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Besremi. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Kidney Damage. Kidney damage can happen when using Besremi. Call your health care provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Difficulty catching your breath or chest pain/pressure
  • Confusion
  • Nausea
  • Seizures

Dental Problems. Besremi may cause dental problems that can cause teeth loss. Maintain good oral hygiene, and see the dentist regularly while using Besremi.

Skin Problems. Besremi can cause skin problems. Tell your health care provider if you have itching, rash, hair loss, excessive sweating, or skin thickening or redness.

Decreased Alertness or Coordination. Besremi can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Besremi affects you.

Warnings & Precautions

Who should not use Besremi?

Allergies to Ingredients. People who are allergic to any of the following should not use Besremi.

  • Besremi
  • Ropeginterferon alfa-2b
  • Any other medicine known as an interferon
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Besremi.

Severe Mental Health Problems. Do not take this medicine if you have had serious depression, suicidal ideation, or a suicide attempt. 

Liver Problems. Besremi should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine. 

Autoimmune Disease. Besremi is not to be used by people with active serious or untreated autoimmune disease. 

Organ Transplant. If you have received an organ transplant and are on immunosuppressants, you should not use Besremi. 

What should I know about Besremi before using it?

Do not use Besremi unless it has been prescribed to you by a health care provider. Use it as prescribed. 

Do not share Besremi with other people, even if they have the same condition as you. It may harm them.

Keep Besremi out of the reach of children. Since this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Besremi may be given by a health care provider in a hospital or clinic. You may give the injection to yourself or receive it from a caregiver. Follow the “Instructions for Use” that comes with your medicine. Ask your health care provider if you have any questions.

Besremi may also cause your period (menstrual cycles) to stop or be irregular. If you think that you may be pregnant, call your health care provider right away.

What should I tell my health care provider before using Besremi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Besremi is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Mental health problems
  • Diabetes
  • Heart problems, such as a heart attack, heart failure, arrhythmias, or high blood pressure
  • Bleeding problems or a current or previous blood clot, such as a stroke
  • Current or previous low blood cell counts
  • Any current or previous cancer
  • Any health conditions that suppress your immune system
  • An infection, including hepatitis B or HIV
  • Kidney problems
  • Breathing problems
  • Hormone problems, such as high or low thyroid levels
  • Eye problems
  • Dental problems
  • Digestive or stomach problems

Other Medicines and Supplements. Besremi may interact with other medicines and supplements. Before using Besremi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Besremi may cause harm to a fetus. Your health care provider will give you a test to make sure you are not pregnant before starting to use Besremi. Use birth control while using Besremi and for at least eight weeks after your last dose. Tell your health care provider right away if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Besremi passes into breast milk. Do not breastfeed while using Besremi and for at least eight weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Besremi?

For more information about Besremi, you can visit the drugmaker’s website at www.besremi.com or call them at 800-999-2449.

Interactions

Does Besremi interact with foods or drinks?

There are no known interactions between Besremi and foods or drinks.

It is unknown if drinking alcohol will affect Besremi, but heavy drinking can slow your immune response and make it harder for your body to fight infection or cancer.

Does Besremi interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Besremi.

  • Any immunosuppressive medicine
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety

This may not be a complete list of medicines that can interact with Besremi. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Besremi?

If you or someone else has used too much Besremi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Besremi?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. If you have missed a dose and are unsure what to do, call your health care provider. 

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