Adalimumab-afzb
Generic Name: adalimumab-afzb
Brand Names:
Abrilada
11 DESCRIPTION Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps.
Overview
11 DESCRIPTION Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps.
Uses
1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: • 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 rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis .
Dosage
2 DOSAGE AND ADMINISTRATION • Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.2 ): • 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 ( 2.3 ): 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 ( 2.4 ): • 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.
Side Effects
6 ADVERSE REACTIONS 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. upper respiratory, sinusitis), injection site reactions, headache, and rash.
Interactions
7 DRUG INTERACTIONS • 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 ABRILADA. ( 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 clearance of adalimumab, the data do not suggest the need for dose adjustment of either ABRILADA or MTX [see Clinical Pharmacology (12.3) ] .
Warnings
WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ABRILADA if a patient develops a serious infection or sepsis. 5 WARNINGS AND PRECAUTIONS • Serious infections: Do not start ABRILADA during an active infection. If an infection develops, monitor carefully, and stop ABRILADA if infection becomes serious. ( 5.1 ) • Invasive fungal infections: For patients who develop a systemic illness on ABRILADA, 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 hepatitis B virus (HBV) carriers during and several months after therapy. If reactivation occurs, stop ABRILADA and begin anti-viral therapy. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
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.
Storage
Storage and Stability Do not use beyond the expiration date on the container. ABRILADA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light.
Frequently Asked Questions
What is Adalimumab-afzb used for?▼
1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: • 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 rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis .
What are the side effects of Adalimumab-afzb?▼
6 ADVERSE REACTIONS 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. upper respiratory, sinusitis), injection site reactions, headache, and rash.
Can I take Adalimumab-afzb during pregnancy?▼
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.
What are the important warnings for Adalimumab-afzb?▼
WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ABRILADA if a patient develops a serious infection or sepsis. 5 WARNINGS AND PRECAUTIONS • Serious infections: Do not start ABRILADA during an active infection. If an infection develops, monitor carefully, and stop ABRILADA if infection becomes serious. ( 5.1 ) • Invasive fungal infections: For patients who develop a systemic illness on ABRILADA, 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 hepatitis B virus (HBV) carriers during and several months after therapy. If reactivation occurs, stop ABRILADA and begin anti-viral therapy. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.