al effusion and symptoms, respiratory tract congestion and inflammation, cough
Rare
interstitial lung disease, pneumonitis
Gastrointestinal disorders
Uncommon
ascites, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis, dyspepsia, abdominal distension, oropharyngeal dryness
Rare
odynophagia, hypermotility
Hepatobiliary disorders
Common
hepatitis (including hepatic enzyme increased)
Uncommon
hepatopathy (including cirrhosis), cholestasis, blood bilirubin increased
Rare
cholelithiasis
Skin and subcutaneous tissue disorders
Common
rash
Uncommon
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 discolouration, dry skin, nail and nail bed disorders
Rare
skin exfoliation and desquamation, bullous conditions, hair texture disorder
Musculoskeletal, connective tissue and bone disorders
Uncommon
muscle disorders, blood creatine phosphokinase increased
Renal and urinary disorders
Uncommon
renal impairment, blood in urine, bladder and urethral symptoms
Rare
nephropathy (including nephritis)
Reproductive system and breast disorders
Uncommon
menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders
Rare
sexual dysfunction
General disorders and administration site conditions
Common
pyrexia, pain (any site), asthaenia, pruritis (any site), injection site reactions
Uncommon
chills, influenza-like illness, altered temperature perception, night sweats, flushing
Rare
fistula (any site)
Investigations
Uncommon
blood alkaline phosphatase increased, coagulation time prolonged
Rare
blood uric acid increased
Injury, poisoning and procedural complications
Uncommon
skin injuries, impaired healing
*These events have been related to the class of TNF-antagonists, but incidence with Cimzia is not known.
The additional following ADRs have been observed uncommonly with Cimzia in other indications: gastrointestinal stenosis and obstructions, general physical health deterioration, abortion spontaneous and azoospermia.
Infections
The incidence of new cases of infections in placebo-controlled clinical trials in rheumatoid arthritis was 0.91 per patient-year for all Cimzia-treated patients and 0.72 per patient-year for placebo-treated patients. The infections consisted primarily of upper respiratory tract infections, herpes infections, urinary tract infections, and lower respiratory tract infections (see sections 4.3 and 4.4).
In the placebo-controlled clinical trials, there were more new cases of serious infection in the Cimzia treatment groups (0.06 per patient-year; all doses), compared with placebo (0.02 per patient-year). Serious infections included tuberculosis and invasive opportunistic infections (e.g. pneumocystosis, fungal oesophagitis, nocardiosis and herpes zoster disseminated). There is no evidence of an increased risk of infections with continued exposure over time (see section 4.4).
Malignancies and lymphoproliferative disorders
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