Simponi Other Important Considerations
- SIMPONI® is a medicine that affects your immune system. SIMPONI® can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI®, including tuberculosis , and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections.
- Your doctor should test you for TB and hepatitis B before starting SIMPONI®.
- Your doctor should monitor you closely for signs and symptoms of TB during treatment with SIMPONI®.
You should not start taking SIMPONI® if you have any kind of infection unless your doctor says it is okay.
Simponi And Simponi Aria Forms
Simponi and Simponi Aria both come as solutions:
- Simponi comes in a single-dose prefilled syringe and a SmartJect autoinjector. Youll use either form to inject Simponi subcutaneously.
- Simponi Aria comes in a single-dose vial thats given as an IV infusion by a healthcare professional. To receive Simponi Aria youll go to your doctors office, the hospital, or an infusion center.
Simponi And Simponi Aria And Overdose
If youre prescribed Simponi, its important that you do not inject more than your doctor prescribes. For some medications, taking more than the recommended amount may lead to side effects or overdose.
If youre prescribed Simponi Aria, your dose will be calculated and given to you by a healthcare professional.
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How Is Simponi Administered
Simponi is administered in a syringe or autoinjector, in 50 or 100 mg. It is injected directly under the skin , where the active ingredient is absorbed into the bloodstream comparatively slowly. The injection is initially carried out by the doctor. Later, in special training sessions, patients can learn to use the autoinjectors and syringes on themselves.
Treatment with Simponi for ulcerative colitis is divided into two different stages:
- Initial treatment: First 200 mg are injected, and after two weeks another dose of 100 mg follows.
- Maintenance treatment: Following the initial treatment, 50-100 mg Simponi are injected every four weeks. The amount depends on the body weight and the individual response to the treatment.
Loss Of Response And Immunogenicity
Secondary loss of response to anti-TNF therapy is a significant issue. With regards to infliximab and adalimumab, LOR can be due to the formation of antidrug antibodies, as the drugs evoke an immune response.21 The immunogenicity of golimumab is yet to be fully established. In the aforementioned post hoc analysis of PURSUIT, antidrug antibodies were measured using a drug sensitive assay. The incidence of antidrug antibodies at week 54 was low , but, as with infliximab and adalimumab, concomitant immunomodulator use decreased immunogenicity .20 In the LTE arm of the PURSUIT-M trial, the rate of antibody formation, albeit using the same drug-sensitive assay, remained low .8
In contrast, Detrez and colleagues9 used a drug-tolerant assay. In the four patients that developed antigolimumab antibodies, three of these had achieved partial clinical response at the time that antibodies were detected and, furthermore, the presence of antibodies was not associated with undetectable golimumab levels. However, the number of patients was small, and the duration of this study was short, and so the lack of association is difficult to interpret.
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Dosage In Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
The SIMPONI dose regimen is 50 mg administered by subcutaneous injection once a month.
For patients with rheumatoid arthritis , SIMPONI should be given in combination with methotrexate and for patients with psoriatic arthritis or ankylosing spondylitis , SIMPONI may be given with or without methotrexate or other nonbiologic Disease-Modifying Antirheumatic Drugs . For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with SIMPONI.
Whats The Dosage Of Simponi And Simponi Aria For Children
The information below describes dosages of Simponi Aria that are commonly prescribed or recommended for children. Simponi isnt prescribed for children.
Dosage for polyarticular juvenile idiopathic arthritis
Simponi Aria can be prescribed to treat active pJIA in children ages 2 years and older. Active means to currently have symptoms.
Your childs doctor will calculate the dose based on body surface area in meters squared . Theyll use your childs height and weight to figure this number out.
Your child will receive 80 mg of Simponi Aria for each m2 of their body surface area. After the first dose, theyll wait 4 weeks until their second dose. Then theyll receive a dose every 8 weeks.
Dosage for psoriatic arthritis
Simponi Aria can also be prescribed to treat active PsA in children ages 2 years and older. Active means to currently have symptoms.
The Simponi Aria dosage for treating PsA in children is the same as it is for pJIA. See the section just above for details.
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What Is The Evidence For Simponi
The safety and efficacy of Simponi were evaluated in two1,2 multi-centre, randomised, double-blind, placebo-controlled clinical trials in adults with ulcerative colitis. Below are the results from those trials.
1. Sandborn et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan 146:85-95 quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2. https://www.ncbi.nlm.nih.gov/pubmed/23735746
2. Sandborn et el. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan 146:96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14. https://www.ncbi.nlm.nih.gov/pubmed/23770005
When Should Simponi Not Be Taken
Simponi should never be used in allergic reactions to components of the drug. Simponi should also not be used for severe infections and heart failure. In addition, if there is any suspicion of any of the contraindications mentioned, a doctor must be consulted immediately.
Simponi should be taken for the last time at least six months before pregnancy.
Because Simponi affects the immune system, even small infections can be much faster and more difficult to treat. Special attention should therefore be paid to fever, cough, shortness of breath, flu-like symptoms, diarrhea, wounds, dental problems and a burning sensation when urinating.
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The Smartject Autoinjector: Designed To Keep The Needle Out Of Sight
Patients will hear a first click when the dose begins to dispense and a second click when the injection is complete and the needle has retracted.
SIMPONI® is intended for use under the guidance and supervision of a physician. Patients may self-inject SIMPONI® after physician approval and proper training.
Prior to initiating SIMPONI®, and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection. Prior to initiating SIMPONI®, patients should be tested for hepatitis B viral infection.
Simponi And Simponi Aria Dosage
Simponi and Simponi Aria are brand-name prescription medications. The Food and Drug Administration has approved these drugs to treat certain autoimmune diseases:
- Simponi and Simponi Aria are approved to treat the following conditions in adults:
- moderate to severe rheumatoid arthritis when taken with methotrexate
- moderate to severe ulcerative colitis in adults under certain conditions
biosimilar forms of the drugs.
Simponi and Simponi Aria both come as solutions. Youll inject Simponi subcutaneously using either a single-dose prefilled syringe or a SmartJect autoinjector. Simponi Aria is given as an IV infusion by a healthcare professional. To receive Simponi Aria youll go to your doctors office, the hospital, or an infusion center.
For information about the dosage of Simponi and Simponi Aria, including their strengths and how to take them, keep reading. For a comprehensive look at Simponi and Simponi Aria and their uses, see this article.
This article describes typical dosages for Simponi and Simponi Aria provided by the drugs manufacturer. When taking Simponi or Simponi Aria, always follow the dosage prescribed by your doctor.
This section discusses the typical dosage of Simponi and Simponi Aria.
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Golimumab In Uc: Efficacy And Safety Data
In addition, a placebo-controlled Phase III maintenance trial was completed that evaluated safety and efficacy of subcutaneous golimumab maintenance treatment in patients with moderately to severely active UC.16 Patients who achieved a clinical response with golimumab induction therapy were subsequently randomized to treatment with 50 mg or 100 mg golimumab every 4 weeks or placebo, with a 54-week follow-up. The complex study design consisted of monthly assessments in order to ensure clinical response using the partial Mayo Clinic score and the full Mayo Clinic score at week 30 and week 54. Patients who did not respond to golimumab induction treatment received open-label treatment with 100 mg golimumab at 4-week treatment intervals. It was shown that treatment with golimumab was able to maintain clinical responses through week 54 in 47.0% and 49.7% of patients who received 50 mg or 100 mg golimumab every 4 weeks, respectively, versus 31.2% in the placebo group . Clinical remission and mucosal healing at week 30 and week 54 among golimumab induction responders were seen in a significantly higher percentage of patients receiving active treatment with 50 mg and 100 mg golimumab versus placebo. Clinical remission at week 30 and week 54 was 15.6%, 23.2%, and 27.8% in the placebo, golimumab 50 mg, and golimumab 100 mg groups, respectively . Based on these outcomes, the FDA advised golimumab maintenance therapy every 4 weeks at a dose of 100 mg.
Which Diseases Does Simponi Work On
Simponi was approved for the treatment of rheumatic diseases in 2009. It improves the underlying inflammatory processes in rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.
Since 2013, Simponi has also been used for the treatment of the inflammatory bowel disease ulcerative colitis. Large-scale studies are currently examining whether Simponi is also effective in patients with Crohn’s disease. The drug is currently not yet approved for the treatment of Crohn’s disease .
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What Is A Loading Dose And Do Simponi And Simponi Aria Require One
A loading dose means that you take a higher dose at the beginning of treatment. This higher dose helps to manage symptoms more quickly.
Simponi and Simponi Aria both use a loading dose. But instead of the dose being higher, you take either drug more often in the beginning to get the same effect.
For more information about Simponi and Simponi Aria loading doses, talk with your doctor.
The dosage of Simponi or Simponi Aria youre prescribed may depend on several factors. These include:
- the kind and severity of the condition youre using Simponi or Simponi Aria to treat
- whether youre using Simponi or Simponi Aria
- other conditions you may have
Golimumab For Intravenous Infusion
U.S. Food and Drug Administration -Approved Indications for Simponi Aria
- Adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate
- Active psoriatic arthritis in patients 2 years of age and older
- Adult patients with active ankylosing spondylitis
- Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
- Oligoarticular juvenile idiopathic arthritis
Intravenous golimumab is available as Simponi Aria and contains the same mechanism of action and labeled black box warning and precautions as subcutaneous golimumab . The most common adverse reactions include upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash. Live vaccines should not be given with Simponi Aria.
Intravenous Golimumab for Active Psoriatic Arthritis and Active Ankylosing Spondylitis
Intravenous Golimumab (Simponi Aria for Active Articular Juvenile Idiopathic Arthritis
Intravenous Golimumab for Rheumatoid Arthritis
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Study Design And Treatment
During the 6-week golimumab induction phase, patients received SC golimumab on day 0 and day 14 . Those responding to induction, assessed by PMS change from baseline at week 6, were eligible to receive maintenance SC golimumab 50 or 100mg every 4 weeks ±5 days, for a total of 54 weeks of treatment, with a 12-week follow-up at the Investigators discretion. Dose adjustment was not allowed.
What Is The Position Of Golimumab In Current Uc Treatment
In most inflammatory bowel disease clinics, infliximab is the anti-TNF agent of choice as rescue therapy for hospitalized patients with severe UC. However, the question needs to be answered how golimumab should be positioned in respect of infliximab and adalimumab for the treatment of moderate to severe UC. Up to now, no prospective head to head comparison has been performed in UC between infliximab, adalimumab, and golimumab, although most clinical experience has been gained with infliximab. Based on indirect evidence, golimumab and adalimumab seem to be more or less comparable in terms of mode of delivery, efficacy, and safety. Infliximab leads to higher remission rates and mucosal healing, at least in the short term.3,4 An advantage of golimumab over infliximab might be the subcutaneous route of administration. An advantage of golimumab over adalimumab is the 4-week dosing schedule for maintenance treatment compared with the 2-week dosing interval that is being used for adalimumab. The decision on which anti-TNF agent to use in daily practice for the treatment of moderate to severe UC will be dependent on long-term real-life results, center and physicians personal experience, the pricing and reimbursement of the different products, and patients preferences. With time, long-term clinical efficacy and adverse events of the different anti-TNF agents will help to determine which drug will be most suitable for long-term care in UC patients.
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Demographics And Baseline Characteristics
The PURSUIT-M LTE was conducted at sites in Eastern Europe, North America, Asia Pacific, South Africa, Western Europe, and Israel. Baseline patient demographics and disease characteristics were generally similar when comparing all patients treated at Week 0 of an induction study with those patients treated in the LTE . On entry into the LTE, median values for golimumab-treated patients were as follows: partial Mayo score of 1.0, a Mayo score of 2.0, an IBDQ score of 191.0, an endoscopy subscore of 1.0, a CRP concentration of 1.6 mg/L, a fecal calprotectin concentration of 132.0 mg/kg, and a fecal lactoferrin concentration of 21.3 g/mL .
Baseline demography and disease characteristics at Week 0 of an induction study patients treated in the LTE.
Of the 666 patients treated in the LTE, 43.8% discontinued the study agent . The majority of patients who discontinued therapy were receiving placebo and discontinued at the study unblinding. In the golimumab 100 mg group, 38.8% of patients discontinued the study agent, while in the golimumab 50 mg group, 29.0% discontinued the study agent. The majority of golimumab-treated patients who discontinued treatment did so due to AEs or unsatisfactory therapeutic effect . Overall, 63% of patients who were receiving golimumab at the beginning of the LTE remained on treatment through the end of the study .
Before Taking This Medicine
You should not use Simponi if you are allergic to golimumab.
To make sure Simponi is safe for you, tell your doctor if you have ever had:
active or chronic infections
if you are scheduled to receive any vaccine.
Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
Using Simponi may increase your risk of developing autoimmune disorders or cancer, including skin cancer. Talk to your doctor about this risk and what symptoms to watch for.
Simponi may cause a rare type of lymphoma of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. Anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.
Tell your doctor if you are pregnant or plan to become pregnant. Your baby could have an increased risk of infection for up to 6 months if you use Simponi during pregnancy.
If you use Simponi during pregnancy, your newborn baby should not receive a live vaccine for at least 6 months after you last received a dose of this medicine.
You should not breastfeed while using this medicine.
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Who Can Take Simponi
Simponi has been licensed for use in the UK in adults who have moderate to severe ulcerative colitis and have not responded to other medications. The safety of Simponi use in under 18s hasnt yet been established.
Before taking Simponi you should tell your doctor all of your symptoms and if you believe you may currently have any infections.
You should also tell your doctor if you are on any other medications, over-the-counter medicines, vitamins or supplements, including herbal supplements.
You should especially tell your doctor if you are taking:
- Or any other biologic medications not listed
If you are considered eligible to take Simponi your doctor will carry out some tests. This include tests for tuberculosis and hepatitis B. If these tests come back clear and your doctor has no other concerns then you may be eligible for Humira.
Report A Janssen Product Quality Complaint
You may contact the Medical Information Center by calling 1-800-JANSSEN to speak to a clinical expert regarding your question or to report a product quality complaint.
Report a Janssen COVID-19 Vaccine Product Quality Complaint
Report a Product Quality Complaint to Janssen at 1-800-565-4008 or 1-908-455-9922 .
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Can I Take Simponi With Other Medication
However, you should also tell your doctor if you are on any other medications, over-the-counter medicines, vitamins or supplements, including herbal supplements, before you start taking Simponi.
You should especially tell your doctor if you are taking:
- Allergic reactions
Children and adults taking TNF blockers – such as Simponi – there may be an increased risk in getting lymphoma or other cancers. You should tell your doctor if you have had, or develop, lymphoma or other cancers.
Some people taking Simponi have developed some types of skin cancer during or after treatment.