HUMIRA SMPC PDF

Humira is a medicine that acts on the immune system and is used to treat the following conditions:. Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist. Humira contains the active substance adalimumab.

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HUMIRA is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. Jaffe , M. Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids.

No new safety risks were identified for adult patients with non-infectious uveitis treated with HUMIRA every other week. The orphan drug designation provides HUMIRA the potential to be granted seven years of market exclusivity for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

It is currently being used to treat more than , patients worldwide 4 across 14 globally approved indications and 10 U. Both trials were double-masked, randomized and placebo-controlled. The primary endpoint in the VISUAL-I and VISUAL-II studies was time to treatment failure TF , defined as having one or more of the following components present in at least one eye: increase in anterior chamber cells or vitreous haze, new chorioretinal or vascular lesions, or decrease in visual acuity.

Median time to TF was prolonged by 87 percent, from 3 months for placebo to 5. These serious infections include tuberculosis TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People at risk of TB may be treated with medicine for TB. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. Common side effects of HUMIRA include injection site reactions redness, rash, swelling, itching, or bruising , upper respiratory infections including sinus infections , headaches, rash, and nausea.

HUMIRA EU Therapeutic Indications 5 HUMIRA is approved for use in adults with moderate to severe active rheumatoid arthritis, severe active ankylosing spondylitis AS , severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, active moderate to severe hidradenitis suppurativa, and non-infectious intermediate, posterior and panuveitis in adults.

HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death.

A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28, people worldwide and markets medicines in more than countries.

For further information on the company and its people, portfolio and commitments, please visit www. Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements.

AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.

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HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis JIA in children 2 years of age and older. Psoriatic arthritis PsA in adults. Ankylosing spondylitis AS in adults. Moderate to severe Crohn's disease CD and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.

Moderate to severe Crohn's disease CD and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough. Moderate to severe hidradenitis suppurativa HS in adults. In adults, to help get moderate to severe ulcerative colitis UC under control induce remission and keep it under control sustain remission when certain other medicines have not worked well enough.

To treat moderate to severe chronic plaque psoriasis Ps in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. To treat non-infectious intermediate middle part of the eye , posterior back of the eye and panuveitis all parts of the eye UV in adults.

See SmPC for full details Globally, prescribing information varies; refer to the individual country product label for complete information. Contact s U. The information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on AbbVie's website for historical purposes only. AbbVie assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.

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FREDERIC BEIGBEDER 13.99 PDF

Prescribing Information (PI) - Humira (adalimumab)

You are viewing BNF. Moderate or severe heart failure ; severe infections. Demyelinating disorders risk of exacerbation ; development of malignancy ; do not initiate until active infections are controlled discontinue if new serious infection develops ; hepatitis B virus—monitor for active infection ; history of malignancy ; mild heart failure discontinue if symptoms develop or worsen ; predisposition to infection. Active tuberculosis should be treated with standard treatment for at least 2 months before starting adalimumab. Patients who have previously received adequate treatment for tuberculosis can start adalimumab but should be monitored every 3 months for possible recurrence. In patients without active tuberculosis but who were previously not treated adequately, chemoprophylaxis should ideally be completed before starting adalimumab. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with adalimumab.

GEMHVO MV PDF

HUMIRA is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. Jaffe , M. Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids. No new safety risks were identified for adult patients with non-infectious uveitis treated with HUMIRA every other week. The orphan drug designation provides HUMIRA the potential to be granted seven years of market exclusivity for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

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