Etveza

Etveza Adverse Reactions

etanercept

Manufacturer:

Sunshine Guojian

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Adverse Reactions
The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Infections and infestations: Very common: Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections).
Uncommon: Serious infections (including pneumonia, cellulitis, septic arthritis, sepsis and parasitic infection).
Rare: Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial and atypical mycobacterial infections and Legionella).
Not known: Listeria, hepatitis B reactivation.
Neoplasms benign, malignant and unspecified (including cysts and polyps): Uncommon: Non-melanoma skin cancers.
Rare: Lymphoma, melanoma.
Not known: Leukaemia, Merkel cell carcinoma.
Blood and lymphatic system disorders: Uncommon: Thrombocytopenia.
Rare: Anaemia, leukopenia, neutropenia, pancytopenia.
Very rare: Aplastic anaemia.
Immune system disorders: Common: Allergic reactions, autoantibody formation*.
Uncommon: Systemic vasculitis (including anti-neutrophilic cytoplasmic antibody positive vasculitis).
Rare: Serious allergic/anaphylaxis reactions (including angioedema, bronchospasm), sarcoidosis.
Not known: Macrophage activation.
Nervous system disorders: Rare: Seizures.
CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis.
Very rare: Peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy.
Eye disorders: Uncommon: Uveitis, scleritis.
Cardiac disorders: Rare: Worsening of congestive heart failure.
Respiratory, thoracic and mediastinal disorders: Uncommon: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*.
Hepatobiliary disorders: Rare: Elevated liver enzymes, autoimmune hepatitis.
Skin and subcutaneous tissue disorders: Common: Pruritus.
Uncommon: Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset or worsening and pustular, primarily palms and soles).
Rare: Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme.
Very rare: Toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Rare: Subacute cutaneous lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome.
General disorders and administration site conditions: Very common: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling).
Common: Fever.
The common adverse reactions are the local reactions of the injection site, including erythema, itching, pain and swelling. The injection site reactions were generally occurred in the first month of treatment and subsequently decreased in frequency. The mean duration of injection site reactions is 3 to 5 days. Other adverse reactions are headache, vertigo, rash, cough, abdominal pain, upper respiratory tract infection, elevated blood pressure, increase of the percentage of peripheral lymphocytes, rhinitis, fever, arthralgia, myalgia, sleepy, facial swelling, elevated transaminase and so on. Most of previously mentioned adverse reactions do not need to be treated.
The adverse reactions of its similar product reported in foreign literatures are: Infections: The most common infection is upper respiratory tract infections. In a placebo controlled clinical study, the incidence of serious infection was not significantly increased. The incidence of serious infections of study drug group is also similar to that of control group in an open labeled study. The RA patients who experienced a serious adverse reaction(s) were often accompanied with other diseases (such as diabetes mellitus, congestive heart failure, active or chronic infections). No serious infections occurred in domestic clinical studies.
Autoantibodies: In foreign clinical studies, ANA and Anti-double strand DNA antibody were reported to be generated in the patients treated with Etanercept. Compared to the patients received MTX, there was no significant difference in newly generated autoantibodies between two groups. However, the long term influences of Etanercept on human autoimmune diseases are not clear.
Malignant Tumors: It has been observed very rare cases of lymphoma occurred in foreign patients who received Etanercept and the incidence is related positively to the severity of rheumatoid arthritis. Other observed tumors include colon, breast, lung and prostate cancers and the incidence rates are similar to those of normal people.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in