HUMIRA SMPC PDF

Patients who develop a new infection while undergoing treatment with Humira should be monitored closely. Administration of Humira should be discontinued if a. HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use. HUMIRA safely and effectively. See full. HUMIRA safely and effectively. See full prescribing information for. HUMIRA. HUMIRA (adalimumab) injection, for subcutaneous use. Initial U.S. Approval:

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Most Recent Most Recent. Vertigo and visual impairment may occur following administration of Humira see section 4.

Revised SPC: Humira (adalimumab) Pre-filled Pen, Pre-filled Syringe and Vial –

Discontinuation of Humira therapy should be considered in patients with confirmed significant haematologic abnormalities. The European Medicines Agency concluded that benefits of Humira outweigh its risks and recommended that it be given marketing authorisation. Reduction in HS-related skin hkmira was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Anatomical therapeutic chemical ATC code. Vaccinations Similar antibody responses to the standard valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.

Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ The pivotal controlled studies involved 6, patients receiving Humira and 3, patients receiving placebo or active comparator during the controlled period.

Similar antibody responses to the standard valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a smppc in adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.

Mood alterations including depressionanxiety, insomnia. Psoriasis Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

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Worsening or new onset of psoriasis including palmoplantar pustular psoriasis 1urticaria, bruising including purpuradermatitis including eczemaonychoclasis, hyperhidrosis, alopecia 1pruritus. TNF-antagonists, such as Humira affect the immune system and their use may affect the body’s defence against infection and cancer.

Psoriatic arthritis and axial spondyloarthritis including ankylosing spondyliti s. Formation of anti-adalimumab antibodies is associated with increased clearance spmc reduced efficacy of adalimumab.

Most ALT elevations occurred with concomitant methotrexate use. At 10 years, 79 of patients originally treated with 40 mg Humira every other week were evaluated radiographically. Humira 40 mg solution for injection in pre-filled syringe.

In Period A, patients received placebo or Humira at an initial dose of mg at Week 0 and 80 mg at Week 2 and 40 mg every week starting at Week 4 to Week Paediatric Uveitis Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Available data suggest that clinical response is usually achieved within 12 weeks of treatment.

Humira 40 mg solution for injection in pre-filled syringe

Paediatric population Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight Table 1. Myocardial infarction 1arrhythmia, congestive heart failure.

In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:.

The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

Respiratory tract infections including lower and upper respiratory tract empc, pneumonia, smp, pharyngitis, nasopharyngitis and pneumonia herpes viral.

In patients not given concomitant methotrexate, the incidence was MedAdNews Extensive pharmaceutical business and marketing intelligence. The recommended adolescent HS dosing schedule is 40 mg every other week. Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission. Two weeks later Day 29 continue with a dose of 40 mg every week or 80 mg every other week given as two 40 mg injections in one day.

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Paediatric population In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. A marketing authorization decision is anticipated humia September. A total of stable responders participated in a withdrawal and retreatment evaluation in an open-label extension study.

Humira | European Medicines Agency

Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.

Radiographs of hands, wrists, and feet were obtained at baseline and Week 24 during the double-blind period when patients were on Humira or placebo and at Week 48 when all patients were on open-label Humira. Systemic infections including sepsis, candidiasis and influenzaintestinal infections including gastroenteritis viralskin and soft tissue infections including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zosterear infections, oral infections including herpes simplex, oral herpes and tooth infectionsreproductive tract infections including vulvovaginal mycotic infectionurinary tract infections including pyelonephritisfungal infections, joint infections.

With the current knowledge, a possible risk for the development of lymphomas, leukaemia, and other malignancies in patients treated with a Hukira cannot be excluded. Friday, July 21st, Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.

The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.