Besremi (Ropeginterferon Alfa-2b-Njft) - Uses, Side Effects, and More

What are the most common side effects of Besremi?

The most common side effects of Besremi are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

• Flu-like symptoms 
• Joint pain
• Tiredness
• Itching
• Infections
• Muscle and bone pain
• Changes in certain lab tests, such as increased liver enzymes and low red blood cell levels (anemia)
• Fever
• Weight loss

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 or skin rash
• Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Mental Health Problems. Besremi may cause mental health problems, including 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 and stop using Besremi right away. 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
• Trouble sleeping

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

• Fast or irregular heartbeat
• Sweating or skin changes
• Tiredness 
• Weight gain or loss
• Hair loss
• Changes in mood or behavior
• Peeing more than usual
• Feeling cold or hot
• Feeling very thirsty or hungry

Heart and Blood Vessel Problems. Besremi may cause heart problems, including cardiomyopathy, heart attack, and atrial fibrillation. It may also cause a blood clot and could lead to a venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). You may be at higher risk if you have had heart problems or blood clots in the past. 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, weakness, or numbness
• Dizziness, lightheadedness, or fainting
• Shortness of breath or trouble breathing
• Swelling, pain, redness, or discoloration in your arms, legs, or feet
• Confusion
• Slurred speech or trouble understanding speech
• Vision changes
• Trouble with balance or coordination

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). These problems can sometimes be severe. Keep all appointments for blood work. Call your health care provider right away if you have any of the following symptoms of blood disorders.

• Fever or chills
• Shortness of breath
• Pale or yellowish skin
• Easy bruising or bleeding, including frequent nosebleeds or bleeding gums or tongue
• Frequent infection
• Unusual weakness or tiredness
• Dizziness, lightheadedness, or feeling like you are about to pass out
• Fast or abnormal heartbeat
• Peeing often or burning or stinging when you pee 
• Coughing up mucus

Inflammation of the Pancreas (Pancreatitis). Besremi may cause inflammation of the pancreas, which is called pancreatitis. Symptoms include fever, nausea and vomiting, bloating, 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 any of the following symptoms.

• 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 or shortness of breath. 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 Cholesterol and Blood Fats. Besremi may cause high levels of cholesterol or fats in your blood. This is known as hyperlipidemiaor hypertriglyceridemia. 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. Keep all appointments to have your blood checked. 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
• Trouble catching your breath or chest pain/pressure
• Confusion
• Nausea
• Seizures

Dental Problems. Besremi may cause dental problems that can lead to tooth 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, dry skin, acne, 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.