Renflexis Side Effects
Generic Name: infliximab
Note: This document contains side effect information about infliximab. Some of the dosage forms listed on this page may not apply to the brand name Renflexis.
For the Consumer
Applies to infliximab: intravenous powder for solution
Along with its needed effects, infliximab (the active ingredient contained in Renflexis) 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:
- Black, tarry stools
- bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest pain
- cough producing mucus
- difficult, burning, or painful urination
- difficulty breathing
- dryness or soreness of the throat
- ear congestion
- frequent urge to urinate
- itching, rash
- loss of voice
- lower back or side pain
- nasal congestion
- 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
- 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
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- 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
- 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
- increase in heart rate
- increased sweating
- inflammation of the joints
- irregular heartbeat
- light-colored stools
- muscle aches
- 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
- upper right abdominal pain
- 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
- difficulty speaking
- dilated neck veins
- double vision
- heavier menstrual periods
- inability to move 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
- sensation of pins and needles
- slow or irregular breathing
- slow speech
- stabbing pain
- temporary vision loss
- vomiting of blood
- weight gain
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:
- difficulty in moving
- feeling of warmth
- muscle stiffness
- redness of the face, neck, arms and occasionally, upper chest
- Constipation, severe
For Healthcare Professionals
Applies to infliximab: intravenous powder for injection
Very common (10% or more): Viral infection (e.g., influenza, herpes virus infection)
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]
Most cases of tuberculosis occurred within the first two months after the start of infliximab therapy and may reflect recrudescence of latent disease.
Infections have been observed in all organ systems and have been reported in patients receiving infliximab alone or in combination with immunosuppressive agents.
Patients with antibodies to infliximab were more likely to have higher rates of clearance, reduced efficacy, and to experience an infusion reaction.
Crohn's patients with (+) ANA prior to infliximab were approximately 2 times as likely to develop anti-dsDNA antibodies.
Various case reports of non-Crohn's and Crohn's patient, developed clinical symptoms of a lupus-like syndrome. Symptoms resolved and antibodies disappeared when infliximab was discontinued.
Disseminated Salmonella typhimurium infection has been reported in a Fijian Indian man while undergoing his twenty-eighth week of infliximab therapy for the treatment of psoriasis and psoriatic arthritis. Patient's symptoms resolved after treatment with intravenous ciprofloxacin.
Disseminated cryptococcal infection has been reported in a 72-year-old male after his second infusion of infliximab for rheumatoid arthritis.
A 56-year-old male developed protothecosis after a stem cell transplantation coincident with infliximab therapy. He was administered infliximab for graft-versus-host disease. Two weeks later, he became lethargic and developed bilateral olecranon bursitis and bullous skin lesions. Blood cultures grew Klebsiella pneumoniae and Prototheca wickerhamii. The patient subsequently developed multiorgan failure and died after 5 weeks of hospitalization. The use of infliximab likely played a role in this case.[Ref]
Common (1% to 10%): Lower respiratory tract infection (e.g., pneumonia), dyspnea, epistaxis
Rare (less than 0.1%): Interstitial lung disease (including rapidly progressive disease, lung fibrosis, pneumonitis), adult respiratory distress syndrome
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]
In order to avoid the development of delayed severe systemic reactions, some researchers recommend multiple early infusions of infliximab (the active ingredient contained in Renflexis) if retreatment is anticipated.
Delayed hypersensitivity reactions during psoriasis studies generally occurred within 2 weeks following repeat infusion.
During one clinical trial, Crohn's disease patients were retreated following 2 to 4 years without infliximab. Patients experiencing side effects following readministration did not have infusion-related side effects associated with their initial infliximab treatment.[Ref]
Uncommon (0.1% to 1%): Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction
Very common (10% or more): Headache (up to 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
One patient reported hypoesthesia in the left leg eight hours after her first infliximab infusion.
Another patient reported dysesthesia in the distribution of the left peroneal nerve, after her 6th intravenous infliximab infusion.
Although demyelination observed in postmarketing experience did not show causal relationship between adverse events and infliximab, the neurologic side effects resolved, partially or completely, on discontinuation of therapy.
A 51-year-old female with Crohn's disease experienced meningitis coincident with infliximab therapy. The patient developed a headache, fever, arthralgia, myalgia, and meningismus after receiving an infliximab infusion. Cerebrospinal fluid analysis was remarkable for a neutrophilic pleocytosis and elevated protein. Other potential causes of meningitis were ruled out. The patient's symptoms completely resolved within 24 hours of presentation.
A 28-year-old female with a 7-year history of Crohn disease experienced acute neuropathy with multiple conduction blocks coincident with infliximab therapy. Infliximab (5 mg/kg, 4 infusions in 2 years) therapy was added to azathioprine (150 mg per day) 5 years into her disease. Three weeks after the overall fourth dose of infliximab treatment, she developed left radial nerve palsy and slight weakness of left foot flexion and extension. Neurologic examination and motor nerve conduction studies were positive for acute neuropathy with multiple conduction blocks.
A 66-year-old male with rheumatoid arthritis experienced West Nile virus (WNV) coincident with infliximab therapy. The patient presented with a 2-day history of fever, headache, confusion, agitation, nausea, malaise, myalgias, gait instability, and rapidly worsening lower extremity weakness. He had received infliximab 3 weeks prior to symptom onset. His only other medications were amlodipine (5 mg per day) and methotrexate (15 mg per week). WNF was confirmed by with cerebral spinal fluid positive for WNV IgM antibodies by ELISA capture technique. The patient eventually died due to WNF infection.
A 41-year-old female with erosive rheumatoid arthritis experienced neurosarcoidosis coincident with infliximab therapy. She had been successfully treated with infliximab 3 mg/kg every 6 to 8 weeks together with methotrexate, without side effects. Approximately five years later, after receiving an infliximab infusion, she experienced feeling tired, a low grade fever, and headache. Two weeks later, she presented without any neurological symptoms besides headache. She was hospitalized one week later. The headache remained unchanged and 4 weeks after admission, she developed diplopia. At neuron-ophthalmological examination, nerve palsy of the left eye and a severe papilledema in both eyes were observed. Further, bilateral granulomatous iridocyclitis and retinal periphlebitis, typical for sarcoidosis, were noted. The sarcoidosis diagnosis was supported by the increased activity in the mediastinal lymph nodes bilaterally and in the parotid glands observed with In-DTPA-octreotide scintigraphy. She received a ventriculoperitoneal shunt 5 weeks after being admitted. Following surgery, the patient became free of headache and the pathological ophthalmologic changes slowly subsided.
A 62-year-old female reported she was hospitalized for five days due to a reaction characterized by shaking uncontrollably due to taking infliximab. The patient did not know the date of admission stating it was a long time ago when she was in her twenties. The patient reported being diagnosed with Crohn's disease at age 21.[Ref]
Very common (10% or more): Nausea (up to 21%), abdominal pain (up to 12%), diarrhea (up to 12%), dyspepsia (up to 10%)
Common (1% to 10%): Tachycardia, palpitation, chest pain
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]
A higher incidence of mortality and hospitalization for worsening heart failure have been reported among patients with moderate to severe (NYHA class III-IV) heart failure treated with the higher dose of infliximab (10 mg/kg). At 1 year, eight patients in the infliximab 10 mg/kg group had died compared with four deaths each in the infliximab 5 mg/kg and the placebo group.
Heart failure (n=18) reported in postmarketing experience developed on average 6 months after initiation of infliximab therapy.
Bradycardia with second degree atrioventricular (AV) block has been reported to occur, as soon as 30 minutes into the infliximab infusion, in a 52-year-old woman with fistulizing Crohn's disease who had no previous history of cardiac disease. The bradycardia, and second degree AV block, persisted for 36 hours after infliximab was discontinued. After a cardiology consult, and placement of a pacemaker, patient resumed her infliximab therapy without adverse events reported.
A 70-year-old man with fistulizing Crohn's disease, and a prior history of coronary artery disease and taking atenolol, developed dyspnea, chest heaviness, and dizziness while receiving his third infusion of infliximab. He had reported chills and pruritus during previous infusions of infliximab. He presented with a drop in heart rate with ECG showing type 2 Sinoatrial block. Patient received a permanent pacemaker. Infliximab therapy was stopped and patient had surgery for fistulizing Crohn's disease.[Ref]
Very common (10% or more): Rash (up to 10%)
Rare (0.01% to 0.1%): Petechia, granulomatous lesion
Necrotizing fasciitis resulting in death has been reported in a 54-year-old man with rheumatoid arthritis receiving infliximab every 8 weeks along with intramuscular methotrexate weekly dosage. Blood cultures and skin swabs grew hemolytic group A streptococcus.
Bullous skin lesions have been reported in a 72-year-old white man one day after his fourth dose of infliximab for the treatment of severe rheumatoid arthritis. Although proximity of symptoms point to infliximab, causality was not definitive.
Two cases of aggressive cutaneous T-cell lymphomas that progressed rapidly have been reported during therapy with infliximab. Sezary syndrome developed in one patient after 18 months of treatment and systemic anaplastic large cell lymphoma with cutaneous involvement developed in the other patient four weeks following the third dose of infliximab.
A 40-year-old female with Crohn disease experienced acne coincident with infliximab therapy. The patient had been administered infliximab 5 mg/kg with rapid and effective symptomatic control. Several weeks after initiating infliximab therapy, the patient developed a papulopustular eruption on the face and back with some comedones. The eruption persisted, albeit with fluctuating severity, and dermatological opinion was obtained. Histology was consistent with the clinical diagnosis of acne and other Crohn disease-associated dermatoses were excluded. Infliximab was not discontinued because of the excellent control of the bowel disease. Instead, the patient was treated with minocycline 100 mg daily.
A 70-year-old male with rheumatoid arthritis (RA) experienced a primary cutaneous Nocardia otitidiscaviarum infection after a skin injury coincident with infliximab therapy. He was treated for RA with infliximab (3 mg/kg) for 3 years, as well as methotrexate (20 mg/week), and corticosteroids. Two weeks before the 18th infusion of infliximab, he was injured, and had a deep wound in his right palm. The hand lesion was not inflamed, but an erythematous pustular lesion appeared on the anterior side of his right forearm. Two weeks later the lesion spontaneously drained and formed a cutaneous nonpainful ulcer covered by white pus, with erythematous periphery. Nocardia otitidiscaviarum was subsequently isolated from the ulcer and biological samples showed inflammation. Infliximab therapy was discontinued. He was treated with combination clindamycin and ofloxacin antibiotic therapy for 3 months. Twenty days later, the skin ulcer had completely healed.
A 63-year-old female with a history of rheumatoid arthritis (RA) experienced atypical varicella exanthema coincident with infliximab therapy. The patient presented with a 10-day history of pruritic generalized papulovesicles which quickly progressed to flaccid vesicles, pustules, or erosions accompanied by fever and sore throat. Her RA had been treated with methotrexate (10 mg per week) and bucillamine (200 mg per day) for 6 years. Despite this medication, her RA was poorly controlled, so infliximab (3 mg/kg) was additionally administered twice, separated by 2-weekly intervals. Two days after the second course of infliximab therapy, a cutaneous eruption developed abruptly. Polymerase chain reaction showed varicella zoster virus. Based on these findings, the patient was diagnosed with varicella and was promptly started on a course of intravenous acyclovir and prophylactic antibiotics for 7 days. Three weeks later, her recovery was complete with minimal scars.
A 60-year-old male with a 5-year history of diffuse polyarthritis experienced leprosy and type 1 leprosy reaction coincident with infliximab therapy. The patient had been given 3 courses of infliximab; the last had been given 3 months prior to admission. One month after he received the first dose of infliximab, the patient developed a rash on 1 extremity that progressed to all extremities. Results of a skin biopsy suggested leprosy or Hansen disease. He was treated with multidrug therapy (MDT) of dapsone (100 mg daily), clofazimine (50 mg daily), and rifampin (300 mg monthly). One month after starting this treatment, the patient developed "reversal," or type 1, reactions. After 4 years, the cutaneous lesions had resolved, and MDT was withdrawn. Results of a skin biopsy performed 5 years after diagnosis showed advanced regression of the lesion with no residual bacilli.
A 37-year-old female with Crohn disease developed palmoplantar pustulosis (PPP) coincident with infliximab therapy. The patient was given a regimen of infliximab of 5 mg/kg resulting in complete remission of her bowel symptoms. One month later, she experienced classic PPP together with a mild psoriasiform eruption on the lower legs. In particular, the patient's feet were painful, which adversely affected her mobility. As treatment, she was prescribed betamethasone dipropionate twice daily, polythene occlusion at night, and soap-free wash and moisturizer. Over the following 3 to 4 weeks, the patient improved clinically and symptomatically and did not need additional psoriasis therapy.
Alopecia areata has been reported in a 51-year-old white woman with rheumatoid arthritis and Sjogren syndrome after 11 months of infliximab therapy. The hair loss eventually involved 100% of the scalp as well as her eyebrows and eyelashes.[Ref]
Very rare (0.01% to 0.01%): Breast cancer, colorectal cancer
Clinical trials of infliximab have reported a 3-fold higher incidence than expected in the general population of developing lymphomas among rheumatoid arthritis patients. Among patients diagnosed with Crohn's disease and rheumatoid arthritis, there is 6-fold higher incidence than expected in the general population. Patients with highly active disease and/or chronic exposure to immunosuppressants may be at a higher risk (up to several fold) than the population at large for the development of lymphoma.
During a controlled clinical trial studying the use of infliximab in 157 patients with moderate to severe COPD who were either current smokers or ex-smokers, 9 patients developed a malignancy, including 1 lymphoma.
Acute lymphoblastic leukemia has been diagnosed in a patient eight days after receiving a third infusion of infliximab 5 mg/kg for the treatment of Crohn's disease. A causal relationship was not clearly established.
Postmarketing adverse events reports have included lymphoproliferative disorders (n=8) that developed, on average, 8 weeks after initiation of therapy with infliximab. The majority of cases (81%) were non-Hodgkin's lymphomas.
A meta-analysis has reported that there is dose-dependent increased risk of malignancies in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.
A 75-year-old male with ankylosing spondylitis experienced Sezary syndrome coincident with infliximab therapy. He had been initially treated with nonsteroidal antiinflammatory drugs, then with prednisone 10 mg daily for 6 months, and thereafter treatment was switched to infliximab 3 mg/kg at 2 monthly intervals. After 17 months of this therapy, he was diagnosed with Sezary syndrome. Cutaneous lesions partially remitted following infliximab discontinuation and methotrexate treatment.[Ref]
Common (1% to 10%): Hepatic function abnormal, transaminases increased
Frequency not reported: Liver failure, autoimmune hepatitis, biliary pain, cytomegalovirus[Ref]
Severe hepatic reactions have occurred between weeks two to more than a year after initiation of infliximab.
In general, patients who developed elevated ALT and AST were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant medications.
Cholestatic liver disease has been reported in a 44-year-old woman 19 days after a single dose of infliximab.
A 45-year-old female with a history of Crohn disease experienced cytomegalovirus hepatitis coincident with infliximab therapy. She had been administered mercaptopurine 50 mg per day for the past 8 years until intravenous infliximab 5 mg/kg at 4 to 8 week intervals was added for better control of the disease. Approximately one year later, the patient was admitted to the hospital with a 4-week history of daily fever and chills unresponsive to several courses of empirical antimicrobial therapy. Histological examination of a liver biopsy specimen showed intranuclear inclusion bodies, confirmed by cytomegalovirus by paraffin immunoperoxidase staining with antibody against this virus. After intravenous ganciclovir 5 mg/kg twice daily therapy, the patient's symptoms and laboratory values improved within a few days.[Ref]
Uncommon (0.1% to 1%): Thrombocytopenia, lymphopenia, lymphocytosis, thrombophlebitis, hematoma, pyelonephritis
Some cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia had a fatal outcome.[Ref]
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]
Common (1% to 10%): Kidney infarction (less than 2%)
Uncommon (0.1% to 1%): Renal calculus, renal failure
Uncommon (0.1% to 1%): Dehydration
Frequency not reported: Extra-high levels of VLDL-triglycerides[Ref]
Very common (10% or more): Injection site reaction (up to 27%)(mainly erythema, pruritus, rash, and pain of mild to moderate severity)[Ref]
Common (1% to 10%): Urinary tract infection, moniliasis
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 Renflexis) administration (during or within 2 hours of infusion)
Frequency not reported: Transient visual loss occurring during or within 2 hours of infusion[Ref]
A 55-year-old woman diagnosed with rheumatoid arthritis developed decreased vision in the left eye accompanied by pain with eye movement 3 days after her 9th infusion (at 1 year of treatment) with infliximab. Patient's vision slowly improved and her visual field deficit resolved after treatment with 1 g methylprednisolone injection per day for 3 days followed by a tapering dose of oral prednisone over 10 days.
A week after the seventh infusion of infliximab 5 mg/kg, a 45-year-old woman with type 2 diabetes mellitus and Crohn's disease developed pain and blurred vision in the left eye. Visual acuity was 20/70. Patient recovered after treatment with intravenous methylprednisolone, followed by a tapering dose of oral prednisone. On examination 3 months later she had 20/20 visual acuity, normal color vision, mild residual left-sided headache, and a normal-appearing optic nerve in the left eye.
A 42-year-old male developed severe unilateral orbital cellulitis while receiving infliximab therapy for ankylosing spondylitis during a clinical trial. Cultures showed Staphylococcus aureus. Infliximab therapy was stopped and the patient made a full recovery after receiving appropriate antibiotic therapy. Infliximab treatment was resumed after three weeks.
A 47-year-old male with rheumatoid arthritis experienced third nerve palsy coincident with infliximab therapy. He received monthly infusions of 300 mg of infliximab for the disease. He initially presented with painless ptosis of his right upper eyelid along with double vision in left and up gaze. Brain magnetic resonance imaging (MRI) showed gadolinium enhancement of the cisternal segment of the right oculomotor nerve. After stopping infliximab therapy, the diplopia and ptosis gradually resolved during 3 months. Repeat MRI imaging showed resolution of the oculomotor nerve enhancement.[Ref]
Uncommon (0.1% to 1%): Amnesia, agitation, confusion, somnolence, nervousness
Rare (less than 0.1%): Apathy
Frequency not reported: Suicide attempt[Ref]
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