Adalimumab-fkjp
Generic Name: adalimumab-fkjp
Brand Names:
Adalimumab
11 DESCRIPTION Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
Overview
11 DESCRIPTION Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
Uses
1 INDICATIONS AND USAGE Adalimumab-fkjp 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. J uvenile 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. A nkylosing Spondylitis (AS) ( 1.4 ): reducing signs and symptoms in adult patients with active AS.
Dosage
2 DOSAGE AND ADMINISTRATION • Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1 ): • 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 ( 2.2 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 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 ( 2.3 ): • 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 Adalimumab-fkjp. ( 5.10 , 7.3 ) *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of ADALIMUMAB-FKJP has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
Warnings
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-fkjp 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 Adalimumab-fkjp if a patient develops a serious infection or sepsis. 5 WARNINGS AND PRECAUTIONS • Serious infections: Do not start Adalimumab-fkjp during an active infection. If an infection develops, monitor carefully, and stop Adalimumab-fkjp if infection becomes serious. ( 5.1 ) • Invasive fungal infections: For patients who develop a systemic illness on Adalimumab-fkjp, 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. If reactivation occurs, stop Adalimumab-fkjp and begin antiviral 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
16 HOW SUPPLIED/STORAGE AND HANDLING Adalimumab-fkjp (adalimumab-fkjp) injection is supplied as a preservative-free, sterile, clear to slightly opalescent and colorless to pale brownish-yellow solution for subcutaneous administration.
Frequently Asked Questions
What is Adalimumab-fkjp used for?▼
1 INDICATIONS AND USAGE Adalimumab-fkjp 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. J uvenile 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. A nkylosing Spondylitis (AS) ( 1.4 ): reducing signs and symptoms in adult patients with active AS.
What are the side effects of Adalimumab-fkjp?▼
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-fkjp 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-fkjp?▼
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-fkjp 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 Adalimumab-fkjp if a patient develops a serious infection or sepsis. 5 WARNINGS AND PRECAUTIONS • Serious infections: Do not start Adalimumab-fkjp during an active infection. If an infection develops, monitor carefully, and stop Adalimumab-fkjp if infection becomes serious. ( 5.1 ) • Invasive fungal infections: For patients who develop a systemic illness on Adalimumab-fkjp, 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. If reactivation occurs, stop Adalimumab-fkjp and begin antiviral 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.