Simponi

Indications

Golimumab is a biologic medicine used to reduce inflammation in long-term immune conditions: rheumatoid arthritis (usually with Methotrexate), psoriatic arthritis, ankylosing spondylitis and related spine arthritis, and moderate to severe ulcerative colitis. It is used when standard treatments have not worked well enough.

How It Works

Golimumab is a monoclonal antibody, a laboratory-made protein that targets one specific substance. It binds to and blocks tumour necrosis factor alpha (TNF-alpha), a chemical messenger that drives inflammation in these diseases. Blocking TNF-alpha reduces joint pain, swelling and stiffness, slows joint damage, and calms bowel inflammation.

Dosage and Administration

Golimumab is given as an injection under the skin, usually once a month, from a prefilled pen or syringe; one form is given as a drip into a vein in hospital. The dose and schedule are as prescribed by a specialist. Patients may be trained to self-inject at home.

Interactions

• Live vaccines (such as yellow fever, oral polio, MMR, BCG) must not be given during treatment; babies exposed in the womb should not receive live vaccines for several months after birth unless the doctor advises.
• Should not be combined with other biologic medicines such as Anakinra, Abatacept or other TNF blockers, due to high infection risk.
• Other immunosuppressants add to infection risk; Methotrexate is commonly used with it under supervision.

Contraindications

• Allergy to Golimumab or any ingredient (including latex for some pen caps).
• Active tuberculosis or other serious infections such as sepsis.
• Moderate or severe heart failure.

Side Effects

Common effects include upper respiratory infections (colds, sinusitis), injection site redness or pain, raised liver tests, high blood pressure, dizziness and tingling. It increases the risk of serious infections including tuberculosis, fungal infections and hepatitis B reactivation. Rarely it may cause nerve or blood disorders, worsening heart failure, lupus-like illness or certain cancers such as lymphoma or skin cancer.

Get urgent medical help if there is fever, persistent cough, night sweats or weight loss, signs of a severe allergic reaction (swelling of the face, difficulty breathing), shortness of breath or swollen ankles, yellowing of the skin, unusual bruising or bleeding, or numbness or weakness in the limbs.

Pregnancy and Lactation

Women should use effective contraception during treatment and for at least 6 months after the last dose. It should be used in pregnancy only if clearly needed, as the medicine crosses the placenta. Discuss breastfeeding with the specialist before starting.

Precautions and Warnings

• Screening for tuberculosis and hepatitis B is done before starting.
• Report any infection promptly; treatment may be paused.
• Use with care in heart failure, nerve disorders such as multiple sclerosis, blood disorders and past cancer.
• Protect the skin from sun and have regular skin checks.

Overdose

No specific overdose effects are known. If too much is given, the patient is monitored for side effects and treated as needed.

Therapeutic Class

Biologic immunosuppressant, TNF-alpha inhibitor (monoclonal antibody).

Storage

Store in a refrigerator at 2 to 8°C; do not freeze. Keep in the outer carton to protect from light. It may be kept at room temperature for a limited time as stated on the pack. Keep out of the reach of children.