IntravenousRheumatoid arthritisAdult: 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.
SubcutaneousRheumatoid arthritisAdult: 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.
SubcutaneousAnkylosing spondylitis, Non-radiographic axial spondyloarthritis, Psoriatic arthritisAdult: 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.
SubcutaneousJuvenile idiopathic arthritisChild: ≥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.
SubcutaneousUlcerative colitisAdult: 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.
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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.
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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.
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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.
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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).
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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.
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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).
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Description:
Mechanism of Action: 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.
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Store between 2-8°C. Protect from light. Do not shake or freeze.
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L04AB06 - golimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
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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.
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