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HUMIRA (adalimumab) Injection

2014-01-23 09:43:32 来源: 作者: 【大中小】浏览:415次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HUMIRA safely and effectively. See full prescribing information for HUMIRA. HUMIRA (adalimumab) Injection, Solution for Subcutaneous use Initial U.S. Approval: 2002
WARNINGS: See full prescribing information for complete boxed warning. SERIOUS INFECTIONS • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • HUMIRA should be discontinued if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting HUMIRA. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.
RECENT MAJOR CHANGES
Boxed Warning 11/2009 Warnings and Precautions, Serious Infections (5.1) 12/2008 Warnings and Precautions, Malignancies (5.2) 11/2009
INDICATIONS AND USAGE
HUMIRA is a tumor necrosis factor (TNF) blocker indicated for treatment of: Rheumatoid Arthritis (RA) (1.1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. Juvenile Idiopathic Arthritis (1.2) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. Psoriatic Arthritis (1.3) Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function. Ankylosing Spondylitis (1.4) Reducing signs and symptoms in patients with active disease. Crohn’s Disease (1.5) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Plaque Psoriasis (1.6) The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
DOSAGE AND ADMINISTRATION
HUMIRA is administered by subcutaneous injection. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.1) 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. Juvenile Idiopathic Arthritis(2.2) 15 kg (33 lbs) to <30 kg (66 lbs): 20 mg every other week ≥30 kg (66 lbs): 40 mg every other week Crohn's Disease (2.3) Initial dose (Day 1) is 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Plaque Psoriasis (2.4) 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
DOSAGE FORMS AND STRENGTHS
40 mg/0.8 mL in a single-use prefilled pen (HUMIRA Pen) (3) 40 mg/0.8 mL in a single-dose prefilled glass syringe (3) 20 mg/0.4 mL in a single-dose prefilled glass syringe (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Serious infections – do not start HUMIRA during an active infection. If an infection develops, monitor carefully, and stop HUMIRA if infection becomes serious (5.1) Malignancies – are seen more often than in controls, and lymphoma is seen more often than in the general population (5.2) Anaphylaxis or serious allergic reactions may occur (5.3) Hepatitis B virus reactivation – monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HUMIRA and begin anti-viral therapy (5.4) Demyelinating disease, exacerbation or new onset, may occur (5.5) Cytopenias, pancytopenia – advise patients to seek immediate medical attention if symptoms develop, and consider stopping HUMIRA (5.6) Heart failure, worsening or new onset, may occur (5.8) Lupus-like syndrome – stop HUMIRA if syndrome develops (5.9)
ADVERSE REACTIONS
Most common adverse reactions (incidence >10%): infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Abbott Laboratories at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Anakinra – increased risk of serious infection ( 5.7, 7.1) Live vaccines – should not be given with HUMIRA (5.10, 7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Physicians are encouraged to enroll pregnant patients in the HUMIRA pregnancy registry by calling 1-877-311-8972 (8.1)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
Revised: 11/2009

FULL PRESCRIBING INFORMATION: CONTENTS*

Sections or subsections omitted from the full prescribing information are not listed

WARNINGS

RECENT MAJOR CHANGES

1 INDICATIONS AND USAGE

1.2 Juvenile Idiopathic Arthritis

2 DOSAGE AND ADMINISTRATION

2.1 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

2.2 Juvenile Idiopathic Arthritis

2.5 General Considerations for Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.3 Hypersensitivity Reactions

5.4 Hepatitis B Virus Reactivation

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.2 Juvenile Idiopathic Arthritis

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.2 Instruction on Injection Technique

MEDICATION GUIDE

FULL PRESCRIBING INFORMATION

WARNINGS

SERIOUS INFECTIONS

Patients treated with HUMIRA 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.

HUMIRA 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 HUMIRA use and during therapy. Treatment for latent infection should be initiated prior to HUMIRA 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.

The risks and benefits of treatment with HUMIRA 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 HUMIRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.