Besremi Side Effects

Generic name: ropeginterferon alfa-2b

Medically reviewed by Drugs.com. Last updated on Aug 1, 2024.

Note: This document provides detailed information about Besremi Side Effects associated with ropeginterferon alfa-2b. Some dosage forms listed on this page may not apply specifically to the brand name Besremi.

Applies to ropeginterferon alfa-2b: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 8 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some people to be anxious, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have blurred vision, chest pain, confusion, lightheadedness, dizziness, or fainting, fast or irregular heartbeat, sudden fainting, trouble breathing, or unusual tiredness or weakness. These may be symptoms of serious heart problems.

This medicine may lower the number of white blood cells in the blood. This will increase your chance of getting an infection. It can also lower the number of platelets in the blood. Platelets are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Pancreatitis (swelling of the pancreas) may occur while using this medicine. Check with your doctor right away if you have bloating, sudden and severe stomach pain, chills, constipation, nausea, pains in stomach, side, or abdomen, possibly radiating to the back, vomiting, fever, or lightheadedness, or yellow eyes or skin.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 12 weeks or more after you start using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause tooth and gum problems, which can lead to tooth loss. It may also cause dry mouth, which may cause teeth or mouth problems, if you take this medicine for a lone time. Brush your teeth well (2 times a day) and have regular visits to your dentist during treatment with this medicine.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

This medicine may cause dizziness, drowsiness, or seeing, hearing, or feeling things that are not there. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may affect your menstrual cycles. Talk with your doctor if you have any concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Besremi

Along with its needed effects, ropeginterferon alfa-2b (the active ingredient contained in Besremi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ropeginterferon alfa-2b:

Other side effects of Besremi

Some side effects of ropeginterferon alfa-2b may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ropeginterferon alfa-2b: subcutaneous solution.

General adverse events

The more commonly reported adverse reactions have included leukopenia, thrombocytopenia, influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.^[Ref]

Hematologic

• Very common (10% or more): Leukopenia (18%), neutropenia (16%), thrombocytopenia (12%)

Psychiatric

• Very common (10% or more): Depression (20%), sleep disorder (20%)
• Common (1% to 10%): Serious neuropsychiatric reactions
• Frequency not reported: Depression, depressive symptoms, depressed mood, listlessness

In the clinical development program (n=178), depression, depressive symptoms, depressed mood, and listlessness occurred in 17 patients; 3.4% of the patients recovered with temporary drug interruption and 2.8% stopped treatment.

Endocrine

• Common (1% to 10%): Hyperthyroidism, hypothyroidism, autoimmune thyroiditis/thyroiditis

In the clinical development program, Hyperthyroidism was reported in 8 patients (4.5%), hypothyroidism in 7 patients (3.9%), and autoimmune thyroiditis/thyroiditis occurred in 5 patients (2.8%).

Cardiovascular

• Very common (10% or more): Edema (16%), hypertension (16%)
• Frequency not reported: Atrial fibrillation

Gastrointestinal

• Very common (10% or more): Diarrhea (33%), nausea (28%), abdominal pain (20%)
• Common (1% to 10%): Pancreatitis

Respiratory

• Very common (10% or more): Nasopharyngitis (43%), upper respiratory tract infection (27%)
• Frequency not reported: Pulmonary toxicity

Immunologic

• Very common (10% or more): Influenza-like illness (59%)

Musculoskeletal

• Very common (10% or more): Arthralgia (47%), musculoskeletal pain (41%), muscle spasms (16%)

Ocular

• Common (1% to 10%): Cataract, dry eye
• Frequency not reported: Ophthalmologic toxicity

Hepatic

• Very common (10% or more): Transaminase elevations (16%)

Metabolic

• Very common (10% or more): Decreased appetite (18%)
• Common (1% to 10%): Hyperlipidemia/hypertriglyceridemia/dyslipidemia

Dermatologic

• Very common (10% or more): Pruritus (45%), hyperhidrosis (29%), alopecia (16%), rash (16%)
• Frequency not reported: Dermatologic toxicity

Genitourinary

• Very common (10% or more): Urinary tract infection (16%)

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions

Nervous system

• Very common (10% or more): Headache (39%), dizziness (22%)

Local

• Very common (10% or more): Local administration site reactions (26%)

Renal

• Frequency not reported: Renal impairment, toxic nephropathy

In clinical trials, less than 1% of patients experienced renal impairment or toxic nephropathy.

See also:

Further information

Besremi side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer