Simponi Aria (golimumab) is a prescription medication used to treat several autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. It functions by blocking tumor necrosis factor-alpha (TNF-alpha), a protein that causes inflammation in the body. While effective, Simponi Aria can cause side effects, some of which may be serious. It is manufactured by Janssen Biotech, Inc.
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.
Common and Mild Side Effects
Many side effects associated with Simponi Aria are mild and temporary, often resolving as the body adjusts to the medication. Common mild side effects include:
- Upper respiratory infection, such as the common cold
- Skin-related side effects, such as skin rash or itching
- Viral infection, such as flu or oral herpes
- Stuffy or runny nose and sore throat
- Constipation
- Dizziness
- Numbness, tingling, or weakness in arms, hands, feet, or legs
- Increased level of liver enzymes
- Infusion or injection site reactions
Serious Side Effects and Precautions
While less common, Simponi Aria can cause serious side effects that require immediate medical attention. It is important to be aware of these potential risks and to contact your doctor promptly if you experience any concerning symptoms. Serious side effects include:
- Serious Infections: Simponi Aria affects your immune system. You may get infections more easily, even serious or fatal infections. This is because golimumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you have ever had tuberculosis or hepatitis B, Simponi Aria can cause these conditions to come back or get worse. Symptoms of an infection can vary but may include chills, cough (which may include blood), diarrhea, fatigue, fever, muscle aches, and shortness of breath.
- Risk of Cancer: 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 Crohn's disease or 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.
- Allergic Reactions: 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.
- Blood Disorders: Simponi Aria can lower the number of platelets, which are necessary for proper blood clotting.
- Heart Failure: 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).
- Nervous System Problems: Check with your doctor right away if you have more than one of these symptoms: 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).
- Lupus-like Syndrome: 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.
- Liver Problems: 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.
Precautions to Take
- Tuberculosis Test: You or your child 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.
- Avoid Infections: If you can, avoid people with infections.
- Dental Care: 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.
- Hygiene: 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.
- Avoid Injury: 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.
- Vaccinations: Do not have any live vaccines (immunizations) while you are being treated with golimumab. Check with your doctor before having any vaccines. You should have completed any needed vaccines before starting treatment with this medicine.
- Pregnancy and Breastfeeding: Tell your doctor if you have a baby and you have received this medicine while you are pregnant. Tell your child's doctor before your child receives a vaccine. This medicine may increase the risk for infections in children for up to 6 months after birth.
- Other Medications: 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.
- Sun Sensitivity: This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
Weight Gain and Simponi Aria
Weight gain is not a commonly reported side effect of Simponi Aria in clinical trials. However, sudden weight gain (such as gaining 3 to 5 pounds over a day or two) can be a symptom of new or worsening heart failure, a rare but serious side effect of Simponi Aria.
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It’s also important to note that methotrexate, a medication sometimes prescribed with Simponi or Simponi Aria, can cause weight gain.
Weight gain can also be related to symptoms of the conditions these drugs are prescribed to treat, such as rheumatoid arthritis.
Other Potential Side Effects
- Eye Symptoms: Simponi Aria can affect the eyes in rare cases, causing symptoms such as blurred vision, eye pain, or redness.
- Nausea: Nausea is a common side effect of Simponi Aria, although it is usually mild and goes away on its own.
- Hair Loss: Hair loss has been reported as a possible side effect of Simponi Aria, although it is not common.
Boxed Warnings
Simponi and Simponi Aria have boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). They alert doctors and patients about drug effects that may be dangerous.
- Risk of Cancer: Simponi and Simponi Aria belong to a group of drugs called tumor necrosis factor (TNF) blockers. This kind of drug raises the risk of certain cancers in children and young adults. These can include leukemia, lymphoma, and skin cancer.
- Risk of Serious Infection: Simponi and Simponi Aria work by weakening your immune system to help reduce symptoms caused by certain autoimmune conditions. This raises your risk of infection, including serious infections such as tuberculosis (TB). These infections have led to hospitalization and, in very rare cases, have caused death.
Managing Side Effects
If you experience side effects from Simponi Aria, it's important to communicate with your doctor. They can provide guidance on managing these effects and determine whether any adjustments to your treatment plan are necessary.
- For mild allergic reactions: If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep taking Simponi or Simponi Aria.
- For serious allergic reactions: If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.
- For injection site reactions: Following these tips may lower your risk of injection site reactions with Simponi: Remove Simponi from the refrigerator and let it sit at room temperature for at least 30 minutes before injecting it. Rotate the site where you inject Simponi with each dose. Do not inject Simponi into skin that is bruised, hard, damaged, scarred, or tender.
Drug Interactions
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.
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Other drugs may interact with golimumab, including prescription and over-the-counter medicines, vitamins, and herbal products.
Simponi Aria Dosage and Administration
Simponi Aria is given as an infusion into a vein. After an initial first dose, the suggested dose for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 2 mg/kg given as an IV infusion every eight weeks. Depending on the patient’s health and how well they respond to Simponi Aria, the length of the course of therapy may also change. When taking Simponi Aria, it’s crucial to adhere to your healthcare provider’s dosage and delivery recommendations. Never change the medication’s dosage or regularity without first talking to a healthcare professional.
Important Considerations
- Medical History: Before taking Simponi or Simponi Aria, discuss your health history with your doctor. Simponi or Simponi Aria may not be right for you if you have certain medical conditions or other factors affecting your health.
- Pregnancy and Breastfeeding: It’s not known if Simponi or Simponi Aria treatment is safe during pregnancy or while breastfeeding. If you’re pregnant or breastfeeding, or planning to, talk with your doctor before treatment with either of these drugs. If you have a baby and had treatment with Simponi or Simponi Aria during pregnancy, talk with your child’s doctor before they receive any vaccines during their first 6 months.
- Alcohol: It should be safe to drink alcohol during treatment with Simponi or Simponi Aria. However, alcohol can worsen symptoms of inflammatory conditions, such as rheumatoid arthritis, which Simponi and Simponi Aria are used to treat.
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