Adalimumab

Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: 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 RA. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) ( 1.3 ): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. …

• Administer by subcutaneous injection Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis : Adults: 40 mg every other week
• Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week
• Juvenile Idiopathic Arthritis : Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease : Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29
• Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis : Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29
• Discontinue in patients without evidence of clinical remission by eight weeks (Day 57)
• Plaque Psoriasis or Adult Uveitis : Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. …

Adalimumab-aacf is a clear and colorless to pale yellow solution available as: Pen (Adalimumab-aacf Pen) Injection: 40 mg/0.8 mL in a single-dose pen. Prefilled Syringe Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe. Single-Dose Institutional Use Vial Kit Injection: 40 mg/0.8 mL in a single-dose, glass vial kit for institutional use only. …

• The safety and effectiveness of Adalimumab-aacf have been established for: reducing signs and symptoms of moderately to severely active polyarticular JIA
• In pediatric patients 2 years of age and older. the treatment of moderately to severely active Crohn's disease
• In pediatric patients 6 years of age and older. Pediatric assessments for Adalimumab-aacf demonstrate that Adalimumab-aacf is safe and effective for pediatric patients in indications for which HUMIRA (adalimumab) is approved. …

A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies RA-I through IV. No overall difference in effectiveness was observed between these patients and younger patients. The frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. …

• Advise the patient or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use )
• Infections Inform patients that Adalimumab-aacf may lower the ability of their immune system to fight infections
• Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions ] . …

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Abatacept: Increased risk of serious infection. ( 5.1 , 5.11 , 7.2 ) Anakinra: Increased risk of serious infection. ( 5.1 , 5.7 , 7.2 ) Live vaccines: Avoid use with Adalimumab-aacf. ( 5.10 , 7.3 ) 7.1 Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent adalimumab clearance, the data do not suggest the need for dose adjustment of either Adalimumab-aacf or MTX [see Clinical Pharmacology ( 12.3 )] . …

Serious infections: Do not start Adalimumab-aacf during an active infection. If an infection develops, monitor carefully, and stop Adalimumab-aacf if infection becomes serious. ( 5.1 ) Invasive fungal infections: For patients who develop a systemic illness on Adalimumab-aacf, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. ( 5.1 ) Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls ( 5.2 ) Anaphylaxis or serious hypersensitivity reactions may occur ( 5.3 ) Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Malignancies [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Hepatitis B Virus Reactivation [see Warnings and Precautions ( 5.4 )] Neurologic Reactions [see Warnings and Precautions ( 5.5 )] Hematological Reactions [see Warnings and Precautions ( 5.6 )] Heart Failure [see Warnings and Precautions ( 5.8 )] Autoimmunity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>10%) are infections (e.g. …

8.1 Pregnancy Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab. …

Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.