GOLIMUMAB

Background and Date of Approval

Golimumab is a monoclonal antibody (a protein that binds to a specific target) and received approval for medical use on 24 April 2009.

Uses

Golimumab Injection has been developed to treat various inflammatory conditions like rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis and moderate to severe ulcerative colitis.

How is it administered?

Golimumab is available as a prefilled syringe with an autoinjector in the dose 50mg. For adults with rheumatoid arthritis, psoriatic arthritis and ankylosing Spondylitis, the recommended dose is 50mg subcutaneous injection once a month. For patients with ulcerative colitis, the recommended dose is 200 mg initially administered by subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 100 mg every 4 weeks.

Side Effects

The common side effects that are likely to occur while you are on the treatment with Golimumab Injection are fever, tiredness, cough, flu like symptoms, warm, red or painful skin, weight loss, loss of body fat and muscle, upper respiratory tract infection, mouth sores, injection site reaction. If you experience allergies, sickness, infection, vision trouble, bleeding or bruising during this treatment, report to your doctor immediately.

Warnings

Do not receive Golimumab Injection if you are having an active infection. Contact your healthcare provider right away if you develop any symptoms of infection while on treatment with Golimumab. Golimumab is not recommended if you are allergic to any of its ingredients, have a history of tuberculosis, heart problems, Hepatitis B, demyelinating disease, nervous system disorders, lupus or cancer. During this treatment your physician may monitor your vitals to prevent serious complications. Inform your health care provider if you are about to undergo any dental or surgical procedures. Seek immediate medical attention if you notice vision changes, tingling, dark urine, yellowing of skin, red, scaly patches on skin, unusual bruising, breathing trouble, hives or chest pain.

Precautions

Ask your health care provider for advice if you are pregnant, think you might be pregnant, planning to have a baby, or breastfeeding your baby. Golimumab is probably unsafe during pregnancy as your baby might be at higher risk of infection for 6 months after birth. Tell your doctor before you breastfeed your baby. Your doctor will decide whether you should receive Golimumab Injection or breastfeed depending on your condition. Discuss effective contraceptive methods with your healthcare provider and consider using them for at least 6 months after the last dose of Golimumab.

Word of Advice

Golimumab may cause tiredness and visual disturbances. Avoid driving or operating machinery during treatment. Inform your healthcare provider before receiving any vaccines and disclose all concurrent medications and herbal supplements.

References

Janssen Pharmaceutical Companies, U.S. Food and Drug Administration, [Revised on Sep 2019] [Accessed on 21st Sep 2022], https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf Ahmed A. Negm, & Daniel E. Furst, NSAIDs, Antirheumatic Drugs, Nonopioid Analgesics, & Drugs Used in Gout, Lange’s Basic and Clinical Pharmacology, 14th Edition, 2018, 642-666.

Frequently Asked Questions

What should you know before starting treatment with Golimumab Injection?

Before starting treatment with Golimumab, it is important to get tested for pregnancy, Hepatitis B, active and latent tuberculosis and the presence of other infections.

Is it safe to use Golimumab Injection by yourself?

You can inject Golimumab Injection by yourself only after receiving proper training from your healthcare provider.

Is it safe to undergo a surgery during the treatment with Golimumab Injection?

Golimumab Injection is associated with increased risk of bleeding and bruising. Hence it is advisable to consult your healthcare practitioner before going for surgery or dental procedure during this treatment. Your doctor might recommend to discontinue the treatment for the time-being.

What should you not take with Golimumab injection?

It is not recommended to live vaccines while on treatment with Golimumab Injection. Tell your healthcare provider if you are taking any prescription medicines, over-the counter drugs, vitamins or herbal supplements.

How to store Golimumab injection?

Store Golimumab injection in a refrigerator in its original container away from light. Do not freeze the injection. Do not use if the injection was stored at room temperature for 30 days.

Who should not take Golimumab injection?

Golimumab Injection is not recommended for patients who are allergic to Golimumab and its ingredients, natural rubber latex. Tell your healthcare provider if you have been diagnosed with any food allergies or sensitivities.

How long does it take for Golimumab to work?

Golimumab can take about 2 weeks to start showing improvement. Some patients might experience effects shortly after receiving the first dose. It can take up to 12 weeks to achieve desired results with Golimumab Injection.

Available Brands 2

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS