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.

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

• Black, tarry stools
• bladder pain
• bleeding gyms
• blindness
• blood in the urine or stools
• blurred vision
• bone pain
• chest pain
• chills
• cough
• decreased vision
• diarrhea
• discouragement
• dizziness
• dry eyes
• ear congestion
• feeling sad or empty
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• itching skin
• joint pain
• loss of appetite
• loss of interest or pleasure
• loss of voice
• loss or thinning of the hair
• lower back or side pain
• muscle aches and pains
• nausea
• nervousness
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• shivering
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sweating
• swelling
• swollen glands
• trouble breathing
• trouble concentrating
• trouble sleeping
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Bloating
• constipation
• darkened urine
• dry skin and hair
• fainting
• feeling cold
• hoarseness or husky voice
• indigestion
• muscle cramps and stiffness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• sensitivity to heat
• weight gain or loss
• yellow eyes or skin

Rare

• Agitation
• coma
• confusion
• decreased urine output
• irritability
• lethargy
• muscle twitching
• seizures
• stupor
• swelling of the face, ankles, or hands

Incidence not known

• Change in vision
• chest tightness
• difficulty swallowing
• dry mouth
• hives, itching, skin rash
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• tooth loss

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

• Difficulty in moving
• feeling of constant movement of self or surroundings
• increased sweating
• lack or loss of strength
• muscle spasm or stiffness
• pain in the joints
• red streaks on the skin
• sensation of spinning
• swelling, tenderness, or pain at the injection site

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