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Besremi Side Effects

Generic name: ropeginterferon alfa-2b

Medically reviewed by Drugs.com. Last updated on Nov 16, 2023.

Note: This document contains side effect information about ropeginterferon alfa-2b. Some dosage forms listed on this page may not apply to the brand name Besremi.

Applies to ropeginterferon alfa-2b: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Risk of Serious DisordersInterferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

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:

More common

Less common

Rare

Incidence not known

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:

More common

For Healthcare Professionals

Applies to ropeginterferon alfa-2b: subcutaneous solution.

General

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

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

Frequency not reported: Renal impairment, toxic nephropathy

References

1. Product Information. BESREMi (ropeginterferon alfa-2b). PharmaEssentia USA Corp. 2021.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.