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SIMPONI 50mg/0.5ml SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE (GOLIMUMAB)

GOLIMUMAB

FDA/BL/245-05010 GOLIMUMAB 50MG/0.5ML antineoplastic and immunomodulating agents INN generic

What it does

Golimumab is a medication that helps reduce inflammation in the body.

Commonly used for: rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/BL/245-05010
Registration date
2024-05-05
Expiry date
2029-02-01
Status
Valid
Active ingredient
GOLIMUMAB
Dosage form
GOLIMUMAB
Strength
50MG/0.5ML
Pack size
-
Therapeutic class
-
ATC class (WHO)
L04AB - Tumor necrosis factor alpha (TNF-alpha) inhibitors
RxNorm RxCUI
819300
Manufacturer / MAH
Baxter
Country of origin
-
Manufacturer location
927 S Curry Pike, Bloomington, IN 47403, USA

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:39 · updated 2026-10-20 04:00:10

Drug Interactions

3
Check interactions

Pharmacodynamic Warnings

Golimumab appears in TABLE 15: Drugs that cause myelosuppression

Severe (3)

Golimumab - increases risk of generalised infection (possibly life-threatening)

Abatacept is predicted to increase the risk of generalised infection (possibly life-threatening) when given with monoclonal antibodies (golimumab). Avoid. Theoretical Abemaciclib

Severe Theoretical

Golimumab - increases risk of generalised infection (possibly life-threatening)

Anakinra is predicted to increase the risk of generalised infection (possibly life-threatening) when given with monoclonal antibodies (golimumab). Avoid. Theoretical Andexanet alfa.

Severe Theoretical

Golimumab - increases risk of immunosuppression

Filgotinib is predicted to increase the risk of immunosuppression when given with monoclonal antibodies (adalimumab, certolizumab pegol, golimumab, infliximab, rituximab, sarilumab, secukinumab, tocil

Severe Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Golimumab is a medication that helps reduce inflammation in the body.

What it treats

  • rheumatoid arthritis
  • ankylosing spondylitis
  • ulcerative colitis

How it works

It works by blocking a substance in the body that causes inflammation.

Who it's for

This medication is for adults who have certain autoimmune conditions.

Cautions

  • • Be cautious if you are taking other medications that affect blood cell production.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Golimumab

BNF-referenced

Golimumab is a fully human monoclonal antibody that inhibits tumor necrosis factor-alpha (TNF-alpha), a cytokine involved in systemic inflammation. It is used primarily in the treatment of autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. By blocking TNF-alpha, Golimumab reduces inflammation and alters the immune response, leading to improvement in symptoms and slowing disease progression.

Indications

  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Ulcerative colitis
  • Crohn's disease

Dosage

Children: Golimumab is not routinely used in the pediatric population for the treatment of autoimmune diseases. For specific pediatric dosing guidelines, refer to the BNF for Children.

Adults: For adults, the initial dose of Golimumab is typically 50 mg administered subcutaneously, followed by maintenance doses of 50 mg every 4 weeks. Refer to the BNF for specific dosing adjustments based on individual patient circumstances and treatment response.

Mechanism of action

Golimumab binds specifically to TNF-alpha, preventing it from interacting with its receptors on the cell surface. This action inhibits the downstream signaling pathways that lead to inflammation and immune system activation, thereby reducing the inflammatory response associated with various autoimmune conditions.

Pharmacodynamics

Golimumab’s pharmacodynamic effects are primarily related to its ability to inhibit TNF-alpha. This results in decreased levels of pro-inflammatory cytokines, reduced infiltration of inflammatory cells into affected tissues, and overall reduction in inflammation. Clinically, this translates to improved symptoms and physical function in patients with autoimmune diseases.

Pharmacokinetics

Golimumab exhibits linear pharmacokinetics with a half-life of approximately 14 days. It is administered via subcutaneous injection, with peak plasma concentrations occurring within 5 to 10 days post-injection. The drug is predominantly eliminated through the reticuloendothelial system, and its clearance can be affected by factors such as body weight and presence of anti-drug antibodies.

Contra-indications

  • Active tuberculosis
  • Predisposition to infections
  • Demyelinating disorders
  • History of malignancy
  • Hepatitis B virus infection

Adverse effects

  • Infections (including severe infections)
  • Headache
  • Cystitis
  • Skin reactions
  • Skin ulcers
  • Neutropenia
  • Thrombocytopenia
  • Bone marrow disorders
  • Demyelination
  • Lupus-like syndromes
  • Sepsis
  • Fever

Interactions

  • Severe interaction with abatacept (increases risk of generalised infection)
  • Severe interaction with anakinra (increases risk of generalised infection)
  • Severe interaction with filgotinib (increases risk of immunosuppression)

Precautions

  • Monitor for signs of infection
  • Screen for tuberculosis before initiation
  • Discontinue if new serious infection develops
  • Assess for heart failure symptoms
  • Ensure immunizations are current before starting therapy

Pregnancy

Use with caution; potential risk in human studies is unclear.

Breast-feeding

Limited data; should be used with caution.

Storage

Store below 25°C, do not freeze. Protect from light.

Formulations

  • Solution for injection, 50 mg per 1 ml pre-filled syringe
  • Solution for injection, 50 mg per 1 ml pre-filled pen
BNF 85 (British National Formulary) p.1250 BNF for Children 2019-2020 p.691 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.