Golimumab
Generic Name: golimumab
Brand Names:
Simponi
11 DESCRIPTION Golimumab is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions.
Overview
11 DESCRIPTION Golimumab is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions.
Uses
1 INDICATIONS AND USAGE SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1 ) adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2 ) adult patients with active ankylosing spondylitis (AS) ( 1.3 ) adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) ( 1.4 ) 1.1 Rheumatoid Arthritis SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Dosage
2 DOSAGE AND ADMINISTRATION RA, PsA, and AS : 50 mg administered by subcutaneous injection once a month ( 2.2 ) UC : The recommended dosage and administration by subcutaneous injection in adults and pediatric patients weighing at least 15 kg is shown in the table ( 2.3 ) Recommended Dosage Weight for Patients with UC Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greater For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL).
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) ] Congestive Heart Failure [see Warnings and Precautions (5.3) ] Demyelinating Disorders [see Warnings and Precautions (5.4) ] Hepatitis B Reactivation [see Warnings and Precautions (5.5) ] Autoimmunity [see Warnings and Precautions (5.6) ] Hematologic Cytopenias [see Warnings and Precautions (5.10) ] Hypersensitivity Reactions [see Warnings and Precautions (5.12) ] Most common adverse reactions in adults (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech,...
Interactions
7 DRUG INTERACTIONS Abatacept: Increased risk of serious infection ( 5.1 , 5.7 , 7.2 ) Anakinra: Increased risk of serious infection ( 5.1 , 5.8 , 7.2 ) Live vaccines/therapeutic infectious agents: Avoid use with SIMPONI ( 5.11 , 7.3 ). 7.1 Methotrexate For the treatment of RA, SIMPONI should be used with methotrexate (MTX) [see Clinical Studies (14.1) ] . Since the presence or absence of concomitant MTX did not appear to influence the efficacy or safety of SIMPONI in the treatment of PsA or AS, SIMPONI can be used with or without MTX in the treatment of PsA and AS [see Clinical Studies (14.2 , 14.3) and Clinical Pharmacology (12.3) ] .
Warnings
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ( 5.1 ) Discontinue SIMPONI if a patient develops a serious infection or sepsis ( 5.1 ) Perform test for latent TB; if positive, s... 5 WARNINGS AND PRECAUTIONS Serious Infections: Do not start SIMPONI during an active infection. If an infection develops, monitor carefully, and stop SIMPONI if infection becomes serious ( 5.1 ) Invasive Fungal Infections: For patients who develop a systemic illness on SIMPONI, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic ( 5.1 ) Malignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers ( 5.2 ) Congestive Heart Failure: Worsening, or new onset, may occur. 4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. An observational study of northern European births observed similar unadjusted rates of major birth defects in infants exposed in utero to golimumab compared to no treatment or non-biologic systemic therapy. However, this study had important limitations (see Data ) .
Storage
Storage and Handling Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect ® autoinjector.
Frequently Asked Questions
What is Golimumab used for?▼
1 INDICATIONS AND USAGE SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1 ) adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2 ) adult patients with active ankylosing spondylitis (AS) ( 1.3 ) adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) ( 1.4 ) 1.1 Rheumatoid Arthritis SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
What are the side effects of Golimumab?▼
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) ] Congestive Heart Failure [see Warnings and Precautions (5.3) ] Demyelinating Disorders [see Warnings and Precautions (5.4) ] Hepatitis B Reactivation [see Warnings and Precautions (5.5) ] Autoimmunity [see Warnings and Precautions (5.6) ] Hematologic Cytopenias [see Warnings and Precautions (5.10) ] Hypersensitivity Reactions [see Warnings and Precautions (5.12) ] Most common adverse reactions in adults (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech,...
Can I take Golimumab during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. An observational study of northern European births observed similar unadjusted rates of major birth defects in infants exposed in utero to golimumab compared to no treatment or non-biologic systemic therapy. However, this study had important limitations (see Data ) .
What are the important warnings for Golimumab?▼
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ( 5.1 ) Discontinue SIMPONI if a patient develops a serious infection or sepsis ( 5.1 ) Perform test for latent TB; if positive, s... 5 WARNINGS AND PRECAUTIONS Serious Infections: Do not start SIMPONI during an active infection. If an infection develops, monitor carefully, and stop SIMPONI if infection becomes serious ( 5.1 ) Invasive Fungal Infections: For patients who develop a systemic illness on SIMPONI, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic ( 5.1 ) Malignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers ( 5.2 ) Congestive Heart Failure: Worsening, or new onset, may occur. 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.