Other Brands/Names

Simponi

Mechanism of Action

Golimumab is a medication classified as a tumour necrosis factor inhibitor (TNF inhibitor) and is prescribed to relieve inflammation associated with specific medical diseases. This medication functions by suppressing the effects of TNF, a protein that is secreted by the body in response to inflammation. The objective of this medication is to inhibit the impact of an excessive amount of TNF protein produced by the immune system in response to inflammation, thereby reducing damage to cells and tissues. By suppressing the effects of TNF, the process of inflammation can be reduced, thereby slowing down or preventing cell and tissue damage.

Indications

Golimumab is a pharmaceutical agent used to relieve the symptoms associated with several autoimmune disorders. These disorders involve the immune system incorrectly attacking healthy tissues, resulting in pain, inflammation, and damage. The conditions that Golimumab targets include:

• Rheumatoid arthritis is an autoimmune disorder characterised by the immune system's attack on the joints, resulting in pain, swelling, and reduced joint mobility
• Ankylosing spondylitis is an autoimmune disorder characterised by the immune system's attack on the spinal joints and other regions, resulting in discomfort and degeneration of joints
• Psoriatic arthritis is a medical disorder characterised by joint pain, swelling, and the presence of scales on the skin
• Ulcerative colitis is a medical conditions characterised by inflammation and ulceration of the gastrointestinal system
• Polyarticular juvenile idiopathic arthritis (pcJIA) is a persistent inflammatory illness that affects children, typically under the age of 16. It is characterised by inflammation in at least one joint for a duration of about 6 months, with no identifiable alternative causes

This medication can be used as the only treatment or in conjunction with methotrexate.

Contraindications

This medication is contraindicated for those with the following medical conditions:

• Hypersensitivity (excessive immune system reaction) to golimumab
• Severe infections (such as tuberculosis, sepsis, and opportunistic infections)
• Moderate-to-severe liver function disorders
• Severe heart failure (NYHA classification III/IV)
• Pregnant and breastfeeding mothers

Side Effects

Golimumab may induce numerous adverse effects, including:

• Pain or itching at the injection site
• Flu or cold-like symptoms
• Skin rash
• Dizziness and high blood pressure

Severe adverse effects require rapid medical attention, such as:

• Extreme fatigue
• Joint pain
• Chest pain
• Difficulty breathing
• Swelling of the feet
• Visual impairment
• Weak hands or feet
• Red bumps on the skin and pus
• Pale skin
• Swelling of the eyes, face, lips, tongue, mouth, or throat

Preparations

A ready-to-use injection form of golimumab is available for injection into the layers under the skin or blood vessels. Golimumab can be administered through an injection into a blood vessel or under the skin layer as a treatment for ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis. Simponi (brand name Golimumab) is available in the following forms: prefilled syringe injection for 50 mg/0.5 mL, 100 mg/mL, and intravenous 50 mg/4 mL. Additionally, the Simponi SmartJect autoinjector is available in 50 mg/0.5 mL and 100 mg/mL.

Dosage

Doctor or a healthcare professional will administer golimumab subcutaneously or intravenously. Usually, a doctor administers the initial subcutaneous injection of golimumab. After that, the doctor will authorize either you, as the patient, or your family to administer the medication independently.

The following information outlines the standard dosage of golimumab, which is determined by the specific medical condition being treated:

Rheumatoid arthritis

• IV injection in adults:

The initial dose is 2 mg/kgBW, administered via infusion over a 30-minute period in conjunction with methotrexate. The second dose is administered four weeks later, and thereafter, it is administered every eight weeks.

• SC injections in adults:
  

 In conjunction with methotrexate, administer a monthly dose of 50 mg on the same date. Given to patients who weigh more than 100 kg, the maximum permissible dosage is 100 mg.

Ankylosing spondylitis, Non-radiographic axial spondyloarthritis, and Psoriatic arthritis

• SC injections in adults:

It is possible to administer a 50 mg dose on the same date each month as a standalone medication or in conjunction with other non-biological disease-modifying antirheumatic pharmaceuticals. The maximum permissible dosage for patients weighing more than 100 kg is 100 mg.

Juvenile idiopathic arthritis

• SC injection in children weighing ≥40 kg:

Administer a single dose of 50 mg once per month on the same date.

Ulcerative colitis

• SC injections in adults:

The initial dosage is 200 milligrams, with a subsequent dose of 100 mg after two weeks. Next, patients weighing less than 80 kg should receive 50 mg, while those weighing 80 kg or more should receive 100 mg every four weeks.

Safety of Drugs

• Pregnancy:

The FDA has classified golimumab as Category C when it is ready for injection, indicating a potential risk of causing issues during pregnancy. Therefore, category C medications should only be considered if the advantages for both mother and baby outweigh the potential risks they provide.

• Breasfeeding:

Golimumab's potential for absorption into breast milk remains unknown. Do not use this medication if you are breastfeeding; consult with your doctor before starting the treatment.

Drug Interactions

Golimumab should not be administered in conjunction with other biologic preparations for rheumatoid arthritis therapy, such as abatacept and anakinra, or with live vaccines, as it may raise the risk of severe infections.

Golimumab may induce following adverse effects when administered concurrently with other medications:

• Increased blood levels of golimumab when used with methotrexate
• Increased levels and therapeutic effects of ciclosporin, theophylline, or warfarin
• Increased risk of neutropenia and serious infections if used with anakinra
• Increased risk of serious infections if used with abatacept, rituximab, or tocilizumab

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