| FIELD OF APPLICATION | DETAILS |
|---|---|
| Generic Name | Golimumab-sldi |
| Active Ingredient | Golimumab-sldi |
| US Brand Names | IMMGOLIS, IMMGOLIS INTRI |
| Drug Category | Rheumatology, Gastroenterology |
| Drug Class | Tumor Necrosis Factor Blocker |
| Route of Administration | Subcutaneous Injection |
| FDA Approval Status | Approved by the FDA (May 15, 2026) Approved |
Golimumab-sldi Overview
Golimumab-sldi is a prescription biologic medication used to treat chronic autoimmune conditions. As an FDA-approved biosimilar, it is highly similar to its original reference product and provides the exact same medical benefits. Specialists prescribe this medicine to reduce severe inflammation and prevent permanent tissue damage in adults.
It primarily treats joint inflammation in rheumatoid arthritis and intestinal swelling in ulcerative colitis. It is delivered as an injection under the skin, allowing patients to manage their chronic conditions effectively.
What Is Golimumab-sldi and How Does It Work
Golimumab-sldi is an immunosuppressant that calms an overactive immune system. In autoimmune diseases, the immune system mistakenly attacks healthy tissues like joint linings or intestines.
A key protein driving this attack is Tumor Necrosis Factor alpha. When your body makes too much of it, it causes massive inflammation, swelling, and pain, eventually destroying bone and organ tissue.
Golimumab-sldi works as a targeted blocker. It is made of specialized antibodies that bind tightly to circulating Tumor Necrosis Factor proteins, preventing them from attaching to healthy cells. By neutralizing this protein, the drug breaks the cycle of inflammation. This rapid reduction in swelling stops joint destruction and allows the intestines to heal.
Is Golimumab-sldi FDA Approved
Yes, golimumab-sldi is officially approved by the United States Food and Drug Administration. It received FDA approval on May 15, 2026. As an approved biosimilar, it was strictly tested to prove it is as safe and effective as the original brand-name medication.
What Is Golimumab-sldi Used For
- It treats moderately to severely active rheumatoid arthritis in adults. For this condition, it must be taken in combination with methotrexate.
- It treats moderately to severely active ulcerative colitis in adults who have not responded well to other treatments.
- It helps reduce symptoms, induce clinical remission, and heal the intestinal lining in ulcerative colitis patients.
Before Taking Golimumab-sldi Contraindications and Precautions
Because this medicine changes how your immune system works, it is not safe for everyone. Your doctor will run tests to ensure your body can handle the treatment safely.
Who Should Not Take Golimumab-sldi
- Anyone with an active infection, especially serious infections like tuberculosis or deep fungal infections.
- People with severe heart failure. This medication can make congestive heart failure worse.
- Anyone who has had a severe allergic reaction to golimumab products or any inactive ingredients in the injection.
Golimumab-sldi Pregnancy and Fertility
- Pregnancy: Tell your doctor if you are pregnant. Golimumab-sldi crosses the placenta, especially during the third trimester, meaning your baby could be born with a weakened immune system.
- Breastfeeding: It is unknown how much medication passes into breast milk. You and your doctor must weigh the benefits against the risk of suppressing the baby’s immune system.
- Infant Vaccines: If you used this medication while pregnant, your baby must wait at least six months before receiving any live vaccines.
Tell Your Doctor Before Taking Golimumab-sldi
- Tell your doctor if you have a history of chronic infections, hepatitis B, or have lived in areas where certain fungal infections are common.
- Disclose if you have any nervous system disorders like multiple sclerosis.
- Inform your doctor if you have a history of cancer.
- Provide a complete list of your medications, especially other biologic drugs.
Golimumab-sldi Dosage and Administration
This medication is given as an injection just under the skin. After proper training, many patients inject the medication themselves at home.
Standard Golimumab-sldi Dosing
- Rheumatoid Arthritis: The standard dose is 50 mg given exactly once a month. It is given alongside a prescription for methotrexate.
- Ulcerative Colitis: The starting dose is usually 200 mg. Two weeks later, you take 100 mg. After that, the maintenance dose is 100 mg given once every 4 weeks.
- Pediatric Dosing: This formulation is only approved for adults 18 years and older.
How Golimumab-sldi Is Administered
- Remove the syringe or pen from the refrigerator and let it sit at room temperature for 30 minutes. Do not warm it in the microwave.
- Wash your hands and clean the injection site with an alcohol swab.
- Inject into the fatty tissue of your middle thighs or lower stomach area.
- Rotate your injection sites each month to prevent skin thickening.
Golimumab-sldi Clinical Efficacy and Research
Clinical studies show that golimumab biosimilars effectively control chronic inflammation. Rheumatoid arthritis patients taking golimumab with methotrexate saw major improvements in joint swelling, pain, and physical function compared to taking methotrexate alone. X-rays showed a significant slowing of permanent bone damage.
For ulcerative colitis, studies demonstrate that the medication helps patients achieve clinical remission, stopping symptoms like abdominal pain. Endoscopy tests showed that the medicine successfully healed the ulcers lining the large intestine.
Golimumab-sldi Side Effects and Safety Profile
This medication carries an FDA Black Box Warning for serious infections and cancer. It may increase the risk of life-threatening infections, including tuberculosis and invasive fungal infections, and should be stopped if a severe infection develops. Lymphoma and other cancers, some fatal, have also been reported.
Because this drug suppresses your immune system, it carries risks. Most side effects are minor, but serious complications require immediate medical attention.
Golimumab-sldi Common Side Effects
- Upper respiratory infections like sinus infections or colds.
- Redness, swelling, or itching at the injection site.
- High blood pressure.
- Mild dizziness or headaches.
- Abnormal liver blood tests.
Serious Golimumab-sldi Adverse Events
- Hepatitis B Reactivation: If you carry this virus, the drug can cause it to wake up and cause severe liver damage.
- Nervous System Problems: Rare cases of new or worsening multiple sclerosis.
- Heart Failure: Shortness of breath, sudden weight gain, or swelling in your lower legs.
- Lupus-like Syndrome: A new rash on your cheeks or arms that worsens in the sun.
Managing Golimumab-sldi Side Effects
To manage minor injection site pain, apply a cold compress afterward. To protect yourself from infections, wash your hands frequently and avoid sick people. If you develop a fever, extreme tiredness, or warm, red skin, call your doctor immediately. Do not wait for your next appointment.
Golimumab-sldi Interactions and What to Avoid
Combining this medication with other immune-suppressing drugs can be dangerous.
Golimumab-sldi Interactions
- Other Biologic Drugs: Never combine this with other biologic medicines. Using two biologics drastically increases your risk of severe infections without adding medical benefit.
- Live Vaccines: Do not get any live vaccines while on this medication. Your suppressed immune system cannot handle them safely.
- Immune-Suppressants: Tell your doctor if you take daily steroids like prednisone, as this also increases your infection risk.
Golimumab-sldi Food and Alcohol
- No specific foods must be avoided. However, eating properly cooked food reduces your risk of foodborne illnesses, which is important with a suppressed immune system. Heavy alcohol use should be avoided to protect your liver.
Golimumab-sldi Missed Dose Overdose and Storage
Proper timing and storage are critical to keeping your disease in remission.
Missed Dose of Golimumab-sldi
If you forget your injection, take it as soon as you remember. Then, schedule your next dose 4 weeks from that new date. Do not inject two doses at once.
Golimumab-sldi Overdose and Emergency
Overdoses are rare. If you accidentally inject more than your prescribed dose, monitor yourself for signs of illness or infection and contact your doctor. If you experience throat swelling or trouble breathing, call emergency services immediately.
How to Store Golimumab-sldi
- Store unpunctured pens or syringes in the refrigerator between 36 degrees and 46 degrees Fahrenheit.
- Keep it in its original carton to protect it from light.
- Do not freeze the medicine.
- You can store the carton at room temperature for a single period of up to 30 days. Once it reaches room temperature, do not put it back in the refrigerator.
Golimumab-sldi Patient Management and Monitoring
Your healthcare team will monitor you closely to catch any potential issues early.
Tests Before Starting Golimumab-sldi
- A tuberculosis skin test or blood test is strictly required.
- Blood tests to check for the hepatitis B virus.
- Baseline blood work to check your liver function and blood cell counts.
Monitoring During Golimumab-sldi Treatment
- Routine physical exams to check for signs of infection.
- Periodic blood tests to monitor your liver enzymes.
- Yearly TB testing, as you can still catch TB while on the medication.
Golimumab-sldi Dos and Donts
- Do keep a calendar to track your injection days.
- Do tell all your doctors, including your dentist, that you take an immunosuppressant.
- Don’t stop taking your other arthritis medicines unless told to do so.
- Don’t ignore signs of a common cold or fever. Report illnesses promptly.
Frequently Asked Questions
What is the difference between a biosimilar and the original drug?
A biosimilar is an FDA-approved medicine that is highly similar to a brand-name biologic. It has no clinically meaningful differences in safety or effectiveness and works in the same way in the body.
How long does it take for this medication to work?
Some patients may notice improvement within a few weeks. However, it can take several months of regular treatment to experience the medication’s full benefits.
Can I inject the medicine while I have a cold?
If you have a minor cold without a fever, you may be able to continue treatment. However, if you have a fever, a serious infection, or are taking antibiotics, contact your doctor before using the injection. Your doctor may recommend delaying treatment until you recover.
Why do I need to take methotrexate with this injection?
For rheumatoid arthritis, methotrexate may be used with certain TNF blockers because the combination can provide better disease control than either medicine alone. Methotrexate may also help reduce the development of antibodies against the biologic.
Can this medication cure my arthritis or colitis?
No. This medication does not cure rheumatoid arthritis or ulcerative colitis. It helps control symptoms, reduce inflammation, and may help keep the disease in remission.
Does the injection hurt?
You may feel a brief pinch, pressure, or stinging during the injection. Allowing the medicine to reach room temperature before injecting may help reduce discomfort.
What happens if the medicine gets too warm?
Storage requirements vary by medication. If the medicine has been left outside the recommended temperature range or for longer than the allowed time, do not use it until you have confirmed with your pharmacist or healthcare provider that it is still safe to use.
References
- U.S. FDA Golimumab-sldi prescribing information.
- U.S. FDA Drugs@FDA Golimumab-sldi approval details.
Legal Disclaimer
The information provided in this clinical reference is for educational purposes only and does not constitute medical advice. Consult a qualified healthcare provider before starting or changing any medication regimen.



