Note: This document contains side effect information about infliximab. Some dosage forms listed on this page may not apply to the brand name Avsola.

Applies to infliximab: intravenous powder for solution.

Serious side effects of Avsola

Along with its needed effects, infliximab (the active ingredient contained in Avsola) 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 or nurse immediately if any of the following side effects occur while taking infliximab:

More common

• Black, tarry stools
• bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain
• chills
• cough
• cough producing mucus
• difficult, burning, or painful urination
• difficulty breathing
• dizziness
• dryness or soreness of the throat
• ear congestion
• fever
• frequent urge to urinate
• headache
• hoarseness
• itching, rash
• loss of voice
• lower back or side pain
• nasal congestion
• nervousness
• pain or swelling in the arms or legs
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pounding in the ears
• slow or fast heartbeat
• sneezing
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• swollen glands
• tender, swollen glands in the neck
• tightness in the chest
• trouble swallowing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes

Rare

• Bleeding gums
• blood in the stool
• blue lips and fingernails
• blurred vision
• changes in skin color or tenderness of the foot or leg
• chest discomfort
• confusion
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast or noisy breathing
• feeling of discomfort
• general feeling of illness
• general tiredness and weakness
• high fever
• hives
• increase in heart rate
• increased sweating
• inflammation of the joints
• irregular heartbeat
• light-colored stools
• muscle aches
• nausea
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• sunken eyes
• thirst
• upper right abdominal pain
• vomiting
• weight loss
• wrinkled skin
• yellow eyes and skin

Incidence not known

• Back pain, sudden and severe
• blistering, peeling, loosening of the skin
• bloody nose
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in mental status
• clay-colored stools
• diarrhea
• difficulty speaking
• dilated neck veins
• double vision
• heavier menstrual periods
• inability to move the arms, legs, or facial muscles
• inability to speak
• loss of appetite
• muscle weakness, sudden and progressing
• red, irritated eyes
• red skin lesions, often with a purple center
• seizures
• sensation of pins and needles
• slow or irregular breathing
• slow speech
• stabbing pain
• temporary vision loss
• vomiting of blood
• weight gain

Other side effects of Avsola

Some side effects of infliximab 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

• Belching
• difficulty in moving
• feeling of warmth
• heartburn
• indigestion
• muscle stiffness
• redness of the face, neck, arms and occasionally, upper chest

Less common

• Constipation, severe

For Healthcare Professionals

Applies to infliximab: intravenous powder for injection.

General

One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache, rash)^[Ref]

Immunologic

Very common (10% or more): Viral infection (e.g., influenza, herpes virus infection)

Common (1% to 10%): Bacterial infections (e.g., sepsis, cellulitis, abscess), moniliasis

Uncommon (0.1% to 1%): Tuberculosis, fungal infections (e.g., candidiasis), vaginitis

Rare (less than 0.1%): Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (32%), sinusitis (14%), pharyngitis (12%), cough (12%), bronchitis (10%)

Common (1% to 10%): Lower respiratory tract infection (e.g., pneumonia), dyspnea, epistaxis

Uncommon (0.1% to 1%): Pulmonary edema, bronchospasm, pleurisy, pleural effusion

Rare (less than 0.1%): Interstitial lung disease (including rapidly progressive disease, lung fibrosis, pneumonitis), adult respiratory distress syndrome

Frequency not reported: Respiratory insufficiency, pulmonary embolism, shortness of breath^[Ref]

Other

Common (1% to 10%): Hot flush, flushing, fatigue, fever, chills

Uncommon (0.1% to 1%): Impaired healing, autoantibody positive

Rare (less than 0.1%): Granulomatous lesion, complement factor abnormal^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction

Rare (less than 0.1%): Anaphylactic shock, vasculitis, sarcoid-like reaction

Frequency not reported: Facial, hand, or lip edema, sore throat^[Ref]

Nervous system

Very common (10% or more): Headache (18%)

Common (1% to 10%): Vertigo, dizziness, hypoesthesia, paresthesia

Uncommon (0.1% to 1%): Seizure, neuropathy

Rare (less than 0.1%): Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), rheumatoid vasculitis, systemic vasculitis

Frequency not reported: Dysesthesia, meningitis, brain infarction, neuritis, peripheral neuropathy, Miller Fisher syndrome^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (21%), abdominal pain (12%), diarrhea (12%), dyspepsia (10%)

Common (1% to 10%): Gastrointestinal hemorrhage, gastroesophageal reflux, constipation, vomiting

Uncommon (0.1% to 1%): Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis

Frequency not reported: Abdominal hernia, abscess, intestinal obstruction, proctalgia, ileus, abdominal hernia, abscess, intestinal obstruction, peritonitis, proctalgia^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, palpitation, chest pain

Uncommon (0.1% to 1%): Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia, peripheral ischemia

Rare (0.01% to 0.1%): Cyanosis, pericardial effusion, circulatory failure, vasospasm

Very rare (less than 0.01%): Heart block

Frequency not reported: Myocardial ischemia/myocardial infarction occurring during or within 2 hours of infusion^[Ref]

Dermatologic

Very common (10% or more): Rash (10%)

Common (1% to 10%): Ecchymosis, new onset or worsening psoriasis including pustular psoriasis (primarily palms and soles), urticaria, pruritus, hyperhidrosis, dry skin, fungal dermatitis, alopecia

Uncommon (0.1% to 1%): Bullous eruption, onychomycosis, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation, cellulitis, eczema/seborrhea, furunculosis, verruca

Rare (0.01% to 0.1%): Petechia, granulomatous lesion

Very rare (less than 0.01%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, necrotizing fasciitis, bullous skin lesions, aggressive cutaneous T-cell lymphomas

Postmarketing reports: Worsening of symptoms of dermatomyositis, lichenoid reactions^[Ref]

Oncologic

Rare (less than 0.1%): Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukemia, melanoma

Very rare (0.01% to 0.01%): Breast cancer, colorectal cancer

Frequency not reported: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn's disease and ulcerative colitis), Merkel cell carcinoma

Frequency not reported: Nonmelanoma skin cancer, neoplasms (basal cell and breast)^[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal, transaminases increased

Uncommon (0.1% to 1%): Hepatitis, hepatocellular damage, cholecystitis, cholelithiasis

Rare (less than 0.1%): Autoimmune hepatitis, jaundice

Frequency not reported: Liver failure, autoimmune hepatitis, biliary pain, cytomegalovirus^[Ref]

Hematologic

Common (1% to 10%): Neutropenia, leucopenia, lymphadenopathy

Uncommon (0.1% to 1%): Thrombocytopenia, lymphopenia, lymphocytosis, thrombophlebitis, hematoma, pyelonephritis

Rare (less than 0.1%): Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura,

Frequency not reported: Aplastic anemia, splenic infarction, splenomegaly^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain

Uncommon (0.1% to 1%): Tendon injury

Frequency not reported: Intervertebral disk herniation, infective arthritis, swelling of fingers, paresthesia in the forearm region^[Ref]

Renal

Common (1% to 10%): Kidney infarction (less than 2%)

Uncommon (0.1% to 1%): Renal calculus, renal failure

Very rare (less than 0.01%): IgA nephropathy, pyelonephritis^[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration

Frequency not reported: Extra-high levels of VLDL-triglycerides^[Ref]

Local

Very common (10% or more): Injection site reaction (e.g., erythema, pruritus, rash, mild to moderate pain) (27%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, moniliasis

Frequency not reported: Menstrual irregularity, herpes simplex, endometritis, dysuria, urethral obstruction^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Uncommon (0.1% to 1%): Keratitis, periorbital edema, hordeolum

Rare (0.01% to 0.1%): Endophthalmitis

Very rare (less than 0.01%): Retrobulbar optic neuritis of the left eye, orbital cellulitis, third nerve palsy, transient visual loss associated with infliximab (the active ingredient contained in Avsola) administration (during or within 2 hours of infusion)

Frequency not reported: Transient visual loss occurring during or within 2 hours of infusion^[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia

Uncommon (0.1% to 1%): Amnesia, agitation, confusion, somnolence, nervousness

Rare (less than 0.1%): Apathy

Frequency not reported: Suicide attempt^[Ref]