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Golimumab


Generic Medicine Info
Indications and Dosage
Intravenous
Rheumatoid arthritis
Adult: In combination with methotrexate for the treatment of moderate to severe cases in patients who had an inadequate response to DMARDs: 2 mg/kg at weeks 0 and 4, followed by every 8 weeks thereafter. Doses are given via IV infusion over 30 minutes. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Ankylosing spondylitis
Adult: For active cases in patients who had an inadequate response to conventional therapy: 2 mg/kg at weeks 0 and 4, followed by every 8 weeks thereafter. Doses are given via IV infusion over 30 minutes. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Polyarticular juvenile idiopathic arthritis
Child: In combination with methotrexate: ≥2 years 80 mg/m2 at weeks 0 and 4, followed by every 8 weeks thereafter. Doses are given via IV infusion over 30 minutes. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Psoriatic arthritis
Adult: As monotherapy or in combination with methotrexate for the treatment of active cases in patients who had an inadequate response to DMARDs: 2 mg/kg at weeks 0 and 4, followed by every 8 weeks thereafter. Doses are given via IV infusion over 30 minutes. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Rheumatoid arthritis
Adult: In combination with methotrexate for the treatment of moderate to severe cases in patients who had an inadequate response to DMARDs or were not previously treated with methotrexate: 50 mg once monthly given on the same date each month. Review therapy if there is no adequate response after 3-4 doses or within 12-14 weeks of treatment. For patients weighing >100 kg who have inadequate response after 3-4 doses: May increase dose to 100 mg once monthly given on the same date each month considering the increased risk of adverse effects. Review therapy if there is no adequate response after giving 3-4 additional doses of 100 mg. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Ankylosing spondylitis
Adult: As monotherapy or in combination with methotrexate or other nonbiologic DMARDs for active cases in patients who had an inadequate response to conventional therapy: 50 mg once monthly given on the same date each month. Review therapy if there is no adequate response after 3-4 doses or within 12-14 weeks of treatment. For patients weighing >100 kg who have inadequate response after 3-4 doses: May increase dose to 100 mg once monthly given on the same date each month considering the increased risk of adverse effects. Review therapy if there is no adequate response after giving 3-4 additional doses of 100 mg. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Psoriatic arthritis
Adult: As monotherapy or in combination with methotrexate for the treatment of active and progressive cases in patients who had an inadequate response to DMARD: 50 mg once monthly given on the same date each month. Review therapy if there is no adequate response after 3-4 doses or within 12-14 weeks of treatment. For patients weighing >100 kg who have inadequate response after 3-4 doses: May increase dose to 100 mg once monthly given on the same date each month considering the increased risk of adverse effects. Review therapy if there is no adequate response after giving 3-4 additional doses of 100 mg. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Ulcerative colitis
Adult: For treatment of moderate to severe active cases in patients who had an inadequate response to conventional treatment including corticosteroids and 6-mercaptopurine, or azathioprine or are intolerant to or have contraindications for such therapies: Induction: 200 mg, followed by 100 mg at week 2. Maintenance: For patients weighing <80 kg: 50 mg (for those with adequate response) or 100 mg (for those with inadequate response) at week 6, then every 4 weeks thereafter. For patients weighing ≥80 kg: 100 mg every 4 weeks thereafter. Review therapy if there is no adequate response after 4 doses. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Non-radiographic axial spondyloarthritis
Adult: For the treatment of severe, active cases in patients who had an inadequate response or are intolerant to NSAIDs: 50 mg once monthly given on the same date each month. Review therapy if there is no adequate response after 3-4 doses or within 12-14 weeks of treatment. For patients weighing >100 kg who have inadequate response after 3-4 doses: May increase dose to 100 mg once monthly given on the same date each month considering the increased risk of adverse effects. Review therapy if there is no adequate response after giving 3-4 additional doses of 100 mg. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Polyarticular juvenile idiopathic arthritis
Child: In combination with methotrexate for patients who had an inadequate response to previous methotrexate therapy: ≥2 years weighing ≥40 kg: 50 mg once monthly given on the same date each month. Review therapy if there is no adequate response after 3-4 doses or within 12-14 weeks of treatment.
What are the brands available for Golimumab in Philippines?
Reconstitution
IV infusion: Withdraw and discard the volume of NaCl 0.9% from a 100 mL infusion bag equal to the volume of the dose to be added. Slowly add the calculated dose or volume of the drug to the infusion bag to make a final volume of 100 mL. Gently mix the solution. Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).
Contraindications
Hypersensitivity. Moderate to severe heart failure (NYHA class III or IV); active TB or other severe infections (e.g. sepsis, opportunistic infections).
Special Precautions
Patient with history of opportunistic infections, chronic or recurrent infection, underlying conditions predisposing to infections (e.g. diabetes), or receiving concomitant immunosuppressants; pre-existing or recent onset central or peripheral nervous system demyelinating disorders; mild heart failure (NYHA class I/II) or decreased left ventricular function; history or development of malignancy, risk factors for dysplasia or colon cancer; current haematologic disorder or significant haematologic abnormalities. Hepatitis B virus (HBV) carriers. Patient who has resided in or has travelled in areas where TB or mycoses (e.g. blastomycoses, coccidioidomycosis, histoplasmosis) are endemic. Patients undergoing surgery. Avoid vaccination with live vaccines during treatment. Not recommended to use concomitantly with anakinra, abatacept, and other biological DMARDs. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Aplastic anaemia, leucopenia, neutropenia, pancytopenia, thrombocytopenia; serious systemic hypersensitivity reactions, including anaphylaxis; antinuclear antibodies formation. Rarely, demyelinating disorders (e.g. Guillain-Barre syndrome, multiple sclerosis, optic neuritis, polyneuropathy), autoimmune disorders (e.g. lupus-like syndrome).
Gastrointestinal disorders: Dyspepsia, nausea, gastrointestinal and abdominal pain, gastrointestinal inflammatory disorders (e.g. colitis, gastritis), stomatitis.
General disorders and administration site conditions: Pyrexia, chest discomfort, asthenia, inj site reaction (e.g. bruising, erythema, irritation, induration, pain, pruritus, paraesthesia, urticaria).
Immune system disorders: Allergic reactions (e.g. bronchospasm, urticaria).
Infections and infestations: Bacterial infections (e.g. cellulitis), viral infections (e.g. influenza herpes), superficial fungal infections, abscess.
Injury, poisoning and procedural complications: Bone fractures.
Investigations: Increased ALT, AST.
Nervous system disorders: Dizziness, headache, paraesthesia.
Psychiatric disorders: Depression, insomnia.
Respiratory, thoracic and mediastinal disorders: URTI (e.g. nasopharyngitis, pharyngitis, laryngitis and rhinitis), lower respiratory tract infection (e.g. pneumonia), bronchitis, sinusitis, asthma.
Skin and subcutaneous tissue disorders: Rash, pruritus, dermatitis, alopecia.
Vascular disorders: Hypertension.
Potentially Fatal: Active TB or reactivation of latent TB, invasive fungal infections (e.g. aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, pneumocystosis), bacterial infections (e.g. sepsis, pneumonia), viral infections, or other opportunistic infections (including listeriosis and legionellosis); lymphomas and other malignancies; new onset or worsening of heart failure. Rarely, HBV reactivation.
Patient Counseling Information
Women of childbearing potential must use proven birth control methods during treatment and for at least 6 months after stopping the treatment. Do not breastfeed during therapy and for at least 6 months after the last dose.
Monitoring Parameters
Perform screening tests for TB (latent and active) before treatment initiation and during therapy; HBV or HCV before initiating treatment. Monitor HBV carriers for clinical and laboratory signs of active HBV infection during and for several months after treatment. Obtain CBC with differential. Perform skin examinations periodically during treatment, particularly in patients at increased risk for skin cancer. Assess for signs and symptoms of infection (before, during and after treatment), heart failure, hypersensitivity reactions, lupus-like syndrome, malignancy, and demyelinating disease.
Drug Interactions
Concurrent use with live vaccines or therapeutic infectious agents may lead to infections, including disseminated infections. Increased incidence of serious infections and neutropenia with anakinra and etanercept. Increased risk of infections (including serious infections) with abatacept and other biological DMARDs (e.g. rituximab).
Action
Description:
Mechanism of Action: Golimumab is a human immunoglobulin G1 kappa (IgG1) monoclonal antibody. It forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human tumour necrosis factor alpha (TNF-α), thereby interfering with the binding of TNF-α to its receptors. Golimumab also interferes with the activation of neutrophils and eosinophils, and the expression of adhesion molecules (e.g. E-selectin, vascular cell adhesion molecule [VCAM-1], intercellular adhesion molecule [ICAM-1]) necessary for leukocyte infiltration.
Pharmacokinetics:
Absorption: Bioavailability: Approx 53% (SC). Time to peak plasma concentration: Approx 2-6 days (SC).
Distribution: Distributed mainly to the circulatory system (IV). Crosses the placenta. Volume of distribution: 151 ± 61 mL/kg (IV).
Excretion: Elimination half-life: Approx 2 weeks.
Storage
Intact vial/prefilled syringes or pen: Store between 2-8°C. Do not freeze and shake. Protect from light. May be stored at room temperature of up to 25°C for a single period of up to ≤30 days; do not return to refrigerated storage once stored at room temperature. Discard if not used within 30 days of room temperature storage. Diluted solution for IV infusion: May be stored at room temperature and infuse within 6 hours of preparation. Storage recommendations may vary among countries and between individual products (refer to specific product guidelines).
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB06 - golimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
References
Brayfield A, Cadart C (eds). Golimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/03/2025.

Golimumab. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/03/2025.

Golimumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/03/2025.

Joint Formulary Committee. Golimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/03/2025.

Paediatric Formulary Committee. Golimumab. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 06/03/2025.

Simponi 45 mg/0.45 mL Solution for Injection in Pre-filled Pen (Janssen-Cilag Ltd). MHRA. https://products.mhra.gov.uk. Accessed 06/03/2025.

Simponi 50 Solution for Injection in Pre-filled Syringe (Janssen-Cilag Ltd). MHRA. https://products.mhra.gov.uk. Accessed 06/03/2025.

Simponi Aria Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/03/2025.

Simponi Injection, Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/03/2025.

Simponi Solution for Injection and IV 12.5 mg/1 mL Concentrate for Solution for Infusion (Johnson & Johnson Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/03/2025.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com
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