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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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
Along with its needed effects, ropeginterferon alfa-2b 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
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
