Summary
Commonly reported side effects of certolizumab include: infection and viral infection. Other side effects include: skin rash. Continue reading for a comprehensive list of adverse effects.
Applies to certolizumab: subcutaneous powder for solution, subcutaneous solution.
Warning
Subcutaneous route (Powder for Solution; Solution)
Serious Infections-Patients treated with certolizumab pegol are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before certolizumab pegol use and during therapy. Treatment for latent infection should be initiated prior to certolizumab pegol use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with certolizumab pegol should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with certolizumab pegol, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Malignancy-Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which certolizumab pegol is a member. certolizumab pegol is not indicated for use in pediatric patients.
Serious side effects of Certolizumab
Along with its needed effects, certolizumab 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 certolizumab:
More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- difficulty with breathing
- ear congestion
- fever
- frequent urge to urinate
- headache
- hoarseness
- loss of voice
- lower back or side pain
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain
- frequent urination
- pain in the arms, ankles, knees, or legs
- painful, red lumps under the skin, mostly on the legs
- rapid weight gain
- stomach pain
- tingling of the hands or feet
- tightness in the chest
- unusual weight gain or loss
Rare
- Blurred vision
- confusion
- coughing or spitting up blood
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- feeling of warmth
- general feeling of discomfort, illness, or weakness
- itching, skin rash
- joint pain or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- muscle aches
- nausea
- night sweats
- redness of the face, neck, arms, and occasionally, upper chest
- sudden high fever or low-grade fever for months
- sweating
- swelling of the lymph glands
- weakness
Incidence not known
- Blistering, peeling, or loosening of the skin
- red skin lesions, often with a purple center
- red, irritated eyes
- red, scaling, or crusted skin
- sores, ulcers, or white spots in the mouth or on the lips
Other side effects of Certolizumab
Some side effects of certolizumab 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 with moving
- muscle pain or stiffness
Less common
- Vomiting
For Healthcare Professionals
Applies to certolizumab: subcutaneous kit.
Immunologic
Uncommon (0.1% to 1%): Vasculitides, lupus erythematosus
Rare (less than 0.1%): Angioneurotic edema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum)
Rare (less than 0.1%): Opportunistic infections, sepsis, tuberculosis, and fungal infections (candidiasis, histoplasmosis, pneumocystosis)
Frequency not reported: Viral infections (herpes, papillomavirus, influenza), pneumonia, tuberculosis, cellulitis, pyelonephritis bacterial and viral infections, positive ANA titers[Ref]
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Cardiomyopathies (including heart failure), ischemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations, hypercoagulation (including thrombophlebitis, pulmonary embolism), edema (including peripheral, facial), ecchymoses (including hematoma, petechiae)
Frequency not reported: Angina pectoris, myocardial infarction, pericardial effusion, stroke
Rare (less than 0.1%): Pericarditis, atrioventricular block, cerebrovascular accident, arteriosclerosis, Raynaud's phenomenon, livedo reticularis, telangiectasia
Postmarketing reports: Systemic vasculitis[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, pharyngitis, acute bronchitis, pneumonia, inflammation
Uncommon (0.1% to 1%): Asthma, pleural effusion, respiratory tract congestion, lower respiratory tract infection, oropharyngeal dryness, cough
Rare (less than 0.1%): Interstitial lung disease, pneumonitis[Ref]
Dermatologic
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discoloration, dry skin, nail and nail bed disorders skin injuries
Rare (less than 0.1%): Skin exfoliation and desquamation, bullous conditions, hair texture disorder
Frequency not reported: Cellulitis, erythema nodosum, urticaria, pruritus
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infections, pyelonephritis
Uncommon (0.1% to 1%): Menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders, hematuria, bladder symptoms, urethral symptoms
Rare (less than 0.1%): Sexual dysfunction[Ref]
Hematologic
Common (1% to 10%): Eosinophilic disorders, leukopenia (including neutropenia, lymphopenia)
Uncommon (0.1% to 1%): Anemia, lymphadenopathy, thrombocytopenia, thrombocytosis, blood alkaline phosphatase increased, coagulation time prolonged
Rare (less than 0.1%): Pancytopenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal, ancytopenia (including aplastic anemia), erythrocytosis
Frequency not reported: Thrombophilia, hemorrhage, hypercoagulation, hematoma, blood uric acid increased, blood bilirubin increased[Ref]
Hepatic
Common (1% to 10%): Hepatitis (including hepatic enzyme increased)
Uncommon (0.1% to 1%): Hepatopathy (including cirrhosis), cholestasis
Rare (less than 0.1%): Reactivation of hepatitis B virus (HBV), including fatalities
Frequency not reported: Elevated liver enzymes[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Drug hypersensitivity (including anaphylactic shock), allergic disorders, auto-antibody positive, angioedema, allergic dermatitis, dizziness (postural), dyspnea, hot flush, hypotension, (vasovagal) syncope, autoantibody positive[Ref]
Ocular
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Visual disorder (including decreased vision), eye and eyelid inflammation, lacrimation disorder, optic neuritis
Frequency not reported: Retinal hemorrhage, uveitis[Ref]
Oncologic
Uncommon (0.1% to 1%): Blood and lymphatic system malignancies (including lymphoma and leukemia), solid organ tumors, non-melanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumors, cysts (including skin papilloma)
Rare (less than 0.1%): Gastrointestinal tumors, melanoma
Frequency not reported: Merkel cell carcinoma[Ref]
Psychiatric
Uncommon (0.1% to 1%): Anxiety, mood disorders (including associated symptoms), restlessness
Rare (less than 0.1%): Suicide attempt, delirium, mental impairment, bipolar disorder[Ref]
Renal
Uncommon (0.1% to 1%): Renal impairment
Rare (less than 0.1%): Nephropathy (including nephritis)[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia, muscle spasms, pain in extremity
Uncommon (0.1% to 1%): Muscle disorders, blood creatine phosphokinase increased[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain (including upper abdominal pain), diarrhea, dyspepsia, gastritis, nausea
Uncommon (0.1% to 1%): Ascites, gastrointestinal infections, abdominal distension, gastrointestinal fistula, odynophagia, oropharyngeal dryness, hypermotility, splenomegaly, pancreatitis, dental infections, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis
Rare (less than 0.1%): Gastrointestinal stenosis, gastrointestinal obstruction[Ref]
Nervous system
Common (1% to 10%): Headaches (including migraine), sensory abnormalities
Uncommon (0.1% to 1%): Peripheral neuropathies, dizziness, tremor, vertigo, acoustic neuritis, trigeminal neuralgia, Raynaud's phenomenon, cranial nerve inflammation, cranial nerve impairment, dysesthesia, paresthesia
Rare (less than 0.1%): Seizure, exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome[Ref]
Other
Common (1% to 10%): Pyrexia, fatigue, pain (any site), asthenia, pruritus (any site)
Uncommon (0.1% to 1%): Tinnitus, vertigo, chills, altered temperature perception, night sweats, flushing, impaired healing, malaise, ear infections
Rare (less than 0.1%): Fistula (any site)[Ref]
Local
Uncommon (0.1% to 1%): Injection site reactions (erythema, itching, hematoma, pain, swelling, bruising)[Ref]
Metabolic
Uncommon (0.1% to 1%): Electrolyte imbalance, dyslipidemia, appetite disorders, weight change, electrolyte imbalance, increased alkaline phosphatase levels
Rare (less than 0.1%): Hemosiderosis[Ref]
Endocrine
Rare (less than 0.1%): Thyroid disorders[Ref]
General
The most commonly reported side effects were upper respiratory infection (18%), urinary tract infection (18%), and rash (9%)[Ref]
