Description
Golimumab-sldi injection is used together with other medicines (eg, methotrexate) to treat moderate to severe rheumatoid arthritis. This medicine is also used to treat moderate to severe ulcerative colitis.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of golimumab-sldi injection in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of golimumab-sldi injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving golimumab-sldi injection.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Adalimumab
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anakinra
- Anifrolumab-fnia
- Azathioprine
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mercaptopurine
- Methotrexate
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rituximab
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Vedolizumab
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Aspergillosis (fungus infection), history of or
- Blastomycosis (fungus infection), history of or
- Blood or bone marrow problems (eg, aplastic anemia, cytopenia, pancytopenia), history of or
- Candidiasis (fungus infection), history of or
- Coccidioidomycosis (fungus infection), history of or
- Congestive heart failure or
- Guillain-Barré syndrome (nervous system disorder), history of or
- Histoplasmosis (fungus infection), history of or
- Legionellosis (bacterial infection), history of or
- Leukopenia or neutropenia (low white blood cells) or
- Listeriosis (bacterial infection), history of or
- Multiple sclerosis, history of or
- Optic neuritis (eye problem) or
- Pneumocystosis (fungus infection), history of or
- Polyneuropathy (nerve problem) or
- Psoriasis or
- Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
- Cancer (eg, colon, lymphoma, skin), active or history of or
- Chronic obstructive pulmonary disease (COPD) or
- Diabetes or
- Hepatitis B, history of or
- Immune system problem or
- Primary sclerosing cholangitis (bile duct disease) or
- Tuberculosis, history of or
- Granulomatosis polyangiitis (blood vessels are inflamed)—May increase chance for side effects.
- Infection, active or not completely going away or
- Tuberculosis, active—Should not be used in patients with these conditions.
Proper Use
Immgolis Intri™: A nurse or other trained health professional will give you this medicine (together with methotrexate) in a hospital. It is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV will need to stay in place for 30 minutes.
Immgolis™: A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under your skin, usually in the stomach, thighs, back of upper arms. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, thick, scaly, hard, or areas with scars or stretch marks.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use Immgolis™ prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Allow 30 minutes for the syringe to warm up to room temperature. Do not warm it any other way.
- Check the liquid in the syringe. It should be clear to slightly colorless to light yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake. Do not use it if it has been dropped.
- Remove the needle cover. Do not put the cover back on. Do not touch the needle. Inject within 5 minutes of removing the needle cover.
- Gently pinch the skin. Use a quick, dart-like motion to insert the needle into the pinched skin at a 45 degree angle.
- Push the plunger all the way down until it stops. The safety guard will cover the needle and lock into place.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled syringe):
- For rheumatoid arthritis:
- Adults—50 milligrams (mg) injected under the skin once a month.
- Children—Use and dose must be determined by your doctor.
- For ulcerative colitis:
- Adults—At first, 200 milligrams (mg) injected under the skin at Week 0. Then, 2 weeks later, a dose of 100 mg is given. A maintenance dose of 100 mg is given at Week 6 and every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect Immgolis™ from direct light. Keep the medicine in the original package until you are ready to use it. You may also store the medicine in the original carton at room temperature for 15 days. Do not put it back in the refrigerator once you have stored it at room temperature, and throw away unused medicine after 15 days.
Throw away used syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
Golimumab-sldi can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
Do not have any live vaccines (immunizations) while you are being treated with golimumab-sldi. Tell your doctor if you have a baby and you have received this medicine while you are pregnant. Your child should not have live any vaccines 6 months after the last dose of this medicine. Check with your doctor before having any vaccines, this medicine may increase the risk for infections.
Do not take other medicines for arthritis unless you talk to your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), adalimumab (Humira®), certolizumab (Cimzia®), etanercept (Enbrel®), infliximab (Remicade®), rituximab (Rituxan®), or tocilizumab (Actemra®). Using any of these together with this medicine may increase your chance of having serious side effects.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor right away if you or your child has chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of a heart condition called congestive heart failure (CHF).
Check with your doctor right away if you have blurred vision, difficulty controlling your bladder or bowels, difficulty with walking, feeling sad or depressed, forgetfulness, muscle cramps, numbness or tingling in your arms, legs, or face, slurred speech or problems with swallowing, or unusual tiredness or weakness. These may be signs of a nervous system disease called multiple sclerosis (MS).
This medicine may increase your risk of getting certain types of cancer, including lymphoma, leukemia, skin cancer, and colon cancer. Some teenagers and young adults with ulcerative colitis developed a rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL). Check with your doctor right away if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss.
This medicine may increase your risk of having a lupus-like syndrome. Check with your doctor right away if you have chest pain, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, a rash on the cheeks or arms that is worse in the sun, or severe tiredness.
The needle cover of the Immgolis™ prefilled syringe contains dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Body aches or pain
- chills
- ear congestion
- fever
- headache
- hoarseness
- loss of voice
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble breathing
- trouble in swallowing
- unusual tiredness or weakness
- voice changes
Less common
- Black, tarry stools
- blurred vision
- chest pain or tightness
- cough producing mucus
- dizziness
- lower back or side pain
- nervousness
- painful or difficult urination
- pounding in the ears
- slow or fast heartbeat
- sores, ulcers, or white spots on lips or in mouth
- unusual bleeding or bruising
Rare
- Pain or tenderness around eyes and cheekbones
- stomach pain
Incidence not known
- Bleeding gums
- blood in the urine or stools
- change in size, shape or color of the existing mole
- decreased urine output
- dilated neck veins
- flaking and falling off of the skin
- flushing
- hives, itching, skin rash
- mole that leaks fluids or bleeds
- nausea and vomiting
- new mole
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- skin blisters
- swelling of the face, fingers, feet, or lower legs
- weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Rare
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80011883
