Golimumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Rheumatoid arthritis Initial: 2 mg/kg over 30 min. 2nd dose is given 4 wk later, and then every 8 wk thereafter. SC Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Non-radiographic axial spondyloarthritis 50 mg once mthly (100 mg may be given in patients >100 kg) on the same date each mth. Reconsider continued therapy if no response after 3-4 doses or w/in 12-14 wk of treatment. Ulcerative colitis Initial: 200 mg, followed by 100 mg after 2 wk, then 50 mg (<80 kg) or 100 mg (≥80 kg) every 4 wk thereafter. Reconsider continued therapy if no response after 4 doses or w/in 12-14 wk of treatment.
Dosage Details
Intravenous
Rheumatoid arthritis
Adult: Initially, 2 mg/kg via infusion over 30 min, given in combination w/ methotrexate. Second dose is given 4 wk later, and then every 8 wk thereafter.

Subcutaneous
Rheumatoid arthritis
Adult: 50 mg once mthly on the same date each mth given in combination w/ methotrexate. 100 mg may be given in patients >100 kg (w/ consideration on increased risk of adverse effects). Continued therapy should be reconsidered if there is no adequate response after 3-4 doses or w/in 12-14 wk of treatment.

Subcutaneous
Ankylosing spondylitis, Non-radiographic axial spondyloarthritis, Psoriatic arthritis
Adult: 50 mg once mthly on the same date each mth given alone or in combination w/ other non-biological DMARDs. 100 mg may be given in patients >100 kg (w/ consideration on increased risk of adverse effects). Continued therapy should be reconsidered if there is no adequate response after 3-4 doses or w/in 12-14 wk of treatment.

Subcutaneous
Juvenile idiopathic arthritis
Child: ≥40 kg: 50 mg once mthly on the same date each mth. Continued therapy should be reconsidered if there is no response after 3-4 doses or w/in 12-14 wk of treatment.

Subcutaneous
Ulcerative colitis
Adult: Initially, 200 mg, followed by 100 mg after 2 wk, then 50 mg (<80 kg) or 100 mg (≥80 kg) every 4 wk thereafter. Continued therapy should be reconsidered if there is no adequate response after 4 doses or w/in 12-14 wk of treatment.
Reconstitution
IV infusion: Withdraw and discard a volume of NaCl from the 100 mL infusion bag equal to the volume of the drug to be added. Slowly add the calculated dose or volume of the drug (using the 50 mg/4mL vial) to the infusion bag to produce a final volume of 100 mL.
Contraindications
Hypersensitivity to golimumab. Severe infections (e.g. active TB, sepsis, opportunistic infections), moderate to severe heart failure (NYHA class III/IV). Lactation. Concomitant use w/ anakinra, abatacept, and other biologic DMARDs.
Special Precautions
Patient w/ history of latent/active TB, opportunistic infection, or malignancy; chronic or recurrent infection, residence/travel on areas of endemic TB or mycoses (e.g. histoplasmosis, coccidioidomycosis, blastomycosis), conditions that may predispose to infection (e.g. DM), pre-existing or recent nervous system demyelinating disorder, decreased LVEF, haematologic disorder. Childn. Pregnancy.
Adverse Reactions
Significant: Pancytopenia, leucopenia, aplastic anaemia, thrombocytopenia, serious systemic hypersensitivity reactions (e.g. anaphylaxis). Rarely, demyelinating disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, polyneuropathy, optic neuritis), lupus-like syndrome.
Nervous: Dizziness, weakness, asthenia.
CV: HTN.
GI: Abdominal pain, nausea, dyspepsia.
Resp: Nasopharyngitis, pharyngitis, laryngitis, rhinitis.
Hepatic: Increased aminotransferases.
Immunologic: Viral infection (e.g. herpes, influenza).
Others: Inj site reactions (e.g. erythema, urticaria, induration, pain, bruising, pruritus, irritation, paraesthesia).
Potentially Fatal: Bacterial (e.g. TB, sepsis, pneumonia) and invasive fungal infections, new onset or worsening CHF. Rarely, HBV reactivation, malignancy (e.g. lymphoma).
MonitoringParameters
Screen for TB prior to and periodically during treatment; and hepatitis B virus (HBV) prior to, during, and for several mth following therapy. Monitor CBC w/ differential; signs and symptoms of infection, malignancy, lupus-like syndrome, hypersensitivity reaction, and worsening of heart failure.
Drug Interactions
Increased steady-state trough concentration w/ methotrexate. May cause changes in serum concentration and therapeutic effect of narrow therapeutic index drugs (e.g. ciclosporin, theophylline, warfarin). Concurrent use w/ live vaccines or therapeutic infectious agents may result in clinical infections.
Potentially Fatal: Increased incidence of serious infection and neutropenia w/ anakinra. Increased incidence of serious infection w/ abatacept and other biologic DMARDs (e.g. rituximab, tocilizumab).
Action
Description: Golimumab, a recombinant human monoclonal antibody of the IgG1 subclass, binds to tumour necrosis factor alpha (TNF-α). It inhibits the induction of interleukins (IL-6 and -8), granulocyte-colony stimulating factor, and granulocyte-macrophage colony stimulating factor, which are proinflammatory cytokines responsible for several chronic inflammatory diseases. It also interferes w/ the expression of adhesion molecules (e.g. E-selectin, vascular cell adhesion molecule, intercellular adhesion molecule) necessary for leukocyte infiltration.
Pharmacokinetics:
Absorption: Bioavailability: Approx 53% (SC). Time to peak plasma concentration: Approx 2-6 days (SC).
Distribution: Distributed mainly to circulatory system (IV). Volume of distribution: 58-126 mL/kg (IV).
Excretion: Terminal elimination half-life: Approx 2 wk.
Storage
Store between 2-8°C. Protect from light. Do not shake or freeze.
ATC Classification
L04AB06 - golimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
References
Anon. Golimumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2017.

Buckingham R (ed). Golimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2017.

Joint Formulary Committee. Golimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Golimumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 08/05/2017.

Simponi Aria Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/05/2017.

Simponi Injection, Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/05/2017.

Disclaimer: This information is independently developed by MIMS based on Golimumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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