simponi patient report

What are the risks of Simponi® (golimumab)?

Patients treated with SIMPONI® (golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

What are the reviews of Simponi (Simponi)?

Simponi has an average rating of 6.4 out of 10 from a total of 90 ratings on Drugs.com. 56% of reviewers reported a positive effect, while 29% reported a negative effect. Reviews may be edited to correct grammar/spelling, or to remove inappropriate language and content.

Does Simponi ® cause cancer?

Unusual cancers have been reported in children and teenage patients taking TNF‑blocker medicines. For children and adults taking TNF blockers, including SIMPONI ®, the chances for getting lymphoma or other cancers may increase.

How often can I get Simponi® injections?

After these 3 starter injections, SIMPONI ® requires one 100-mg injection every 4 weeks. Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI ® under the skin. SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections.

Does SIMPONI weaken immune system?

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 (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body.

How do you feel after a SIMPONI infusion?

Some people may have reactions at the spot of the injection, such as pain, redness or swelling. These reactions should stop after a month of treatment. Regularly changing the injection spot will reduce the chances of this happening. In rare cases, people experience an allergic reaction.

Does SIMPONI have a black box warning?

Simponi carries a black box warning from the U.S. Food and Drug Administration (FDA), which is the most serious warning issued by the agency. It alerts healthcare providers and patients to potentially serious side effects that can lead to injury and death.

How effective is SIMPONI?

Simponi has an average rating of 6.7 out of 10 from a total of 39 ratings for the treatment of Rheumatoid Arthritis. 62% of reviewers reported a positive experience, while 23% reported a negative experience.

Does SIMPONI cause fatigue?

FDA expands Simponi Aria labeling to include fatigue in RA, PsA.

Can SIMPONI cause weight gain?

No, neither Simponi nor Simponi Aria are known to cause weight gain. No one who used either medication reported weight gain as a side effect in clinical trials. However, both medications can, rarely, cause heart failure as a side effect.

Is SIMPONI safe?

Some reactions can be serious and life-threatening. Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.

Can SIMPONI cause hair loss?

No. Hair loss isn't a side effect of Simponi or Simponi Aria. Hair loss wasn't a side effect reported for either drug in studies. However, methotrexate, which may be prescribed with Simponi or Simponi Aria, can cause hair loss.

How long has SIMPONI been on the market?

Development Timeline for SimponiDateArticleMay 15, 2013Approval FDA Approves Simponi to Treat Ulcerative ColitisApr 24, 2009Approval Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis1 more row•Jan 28, 2021

Which is better Humira or SIMPONI?

Humira has an average rating of 6.3 out of 10 from a total of 634 ratings on Drugs.com. 54% of reviewers reported a positive effect, while 32% reported a negative effect. Simponi has an average rating of 6.3 out of 10 from a total of 92 ratings on Drugs.com.

How long does it take for SIMPONI injection to work?

While individual results may vary, SIMPONI® was proven in clinical studies to: Help people with moderately to severely active UC get their symptoms under control in as few as 6 weeks. Begin to improve the appearance of the intestinal lining in as few as 6 weeks.

How much is SIMPONI a month?

The cost for Simponi Aria intravenous solution (50 mg/4 mL) is around $2,115 for a supply of 4 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

How to cancel SIMPONI?

You can ask to cancel your registration by calling 877-CarePath (877-227-3728) Monday-Friday 8:00 am - 8:00 pm ET or by completing the form below and checking opt out in the Safe Returns ® Program Options .

What is SIMPONI used for?

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

What is the phone number for Janssen Carepath?

If you have any questions, please call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728) , Monday−Friday, 8:00 am to 8:00 pm ET. Multilingual phone support is available.

What is our privacy policy?

Our Privacy Policy governs the use of the information you provide. By providing the information and selecting the Submit button, you indicate that you read, understand, and agree to these terms.

How long does it take for a nurse to return a call?

At all other times, a nurse will return your call in about 15 minutes.

Does Simponi help with low blood count?

Low blood counts have been seen with SIMPONI ®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Can you get hives from taking Simponi?

Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI ®. Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI ® such as hives , swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

What are the side effects of Simponi?

Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.

How often is Simponi given?

For RA, PsA, and AS: SIMPONI ® 50 mg is given as an injection under the skin (subcutaneous injection) once a month.

What is SIMPONI used for?

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

When to tell your doctor about simponia?

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI ® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

Does Simponi cause cancer?

Some people treated with SIMPONI ® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI ®, tell your doctor.

How to report side effects of prescription drugs?

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Can you get hives from taking Simponi?

Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI ®. Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI ® such as hives , swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

What are the most common adverse reactions to Simponi?

Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 trials through Week 16, occurring in 7% and 6% of patients treated with SIMPONI ® as compared with 6% and 5% of patients in the control group, respectively. The rate of injection-site reactions was 6% with patients treated with SIMPONI ® compared with 2% of patients in the control group.

What is empiric antifungal therapy?

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Can SIMPONI be used for heart failure?

Some cases had a fatal outcome. Exercise caution and monitor patients with heart failure. Discontinue SIMPONI ® if new or worsening symptoms of heart failure appear.

Is SIMPONI a TNF blocker?

HEPATITIS B REACTIVATION. The use of TNF-blocking agents including SIMPONI ® has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers.

Is simponi a serious infection?

Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI ® included sepsis, pneumonia, cellulitis, abscess and hepatitis B infection. MALIGNANCIES.

Does Simponi cause lymphoma?

In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI ®, more cases of lymphoma have been observed among patients receiving TNF-blocking treatment compared with control patients. In the Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ankylosing Spondylitis (AS) clinical trials, the incidence of lymphoma per 100 patient-years of follow-up was 0.21 (95% CI: 0.03, 0.77) in the combined SIMPONI ® group compared with an incidence of 0 (95% CI: 0, 0.96) in the placebo group. In clinical trials, the incidence of malignancies other than lymphoma was not increased with exposure to SIMPONI ® and was similar to what would be expected in the general population. In controlled and uncontrolled portions of the Phase 2/3 studies in ulcerative colitis (UC) with a mean follow-up of approximately 1 year, there were no cases of lymphoma with SIMPONI ®. Short follow-up periods, such as those of 1 year or less in the studies above, may not adequately reflect the true incidence of malignancies. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI ®. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.

Can you take SIMPONI with Lupus?

Treatment with T NF blockers, including SIMPONI ®, may result in the formation of antinuclear antibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms suggestive of a lupus-like syndrome develop.

What are the most common adverse reactions to Simponi?

Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 trials through Week 16, occurring in 7% and 6% of patients treated with SIMPONI ® as compared with 6% and 5% of patients in the control group, respectively. The rate of injection-site reactions was 6% with patients treated with SIMPONI ® compared with 2% of patients in the control group.

What are the risks of taking Simponi?

Risk of infection may be higher in patients greater than 65 years of age , patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI®included sepsis, pneumonia, cellulitis, abscess and hepatitis B infection. MALIGNANCIES.

What is empiric antifungal therapy?

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

How long after simponia injection can you give a baby?

Administration of live vaccines to infants exposed to SIMPONI® in uterois not recommended for 6 months following the mother’s last SIMPONI®injection during pregnancy due to an increased risk of infection.

Does Simponi cause lymphoma?

In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI ®, more cases of lymphoma have been observed among patients receiving TNF-blocking treatment compared with control patients. In the Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ankylosing Spondylitis (AS) clinical trials, the incidence of lymphoma per 100 patient-years of follow-up was 0.21 (95% CI: 0.03, 0.77) in the combined SIMPONI ® group compared with an incidence of 0 (95% CI: 0, 0.96) in the placebo group. In clinical trials, the incidence of malignancies other than lymphoma was not increased with exposure to SIMPONI ® and was similar to what would be expected in the general population. In controlled and uncontrolled portions of the Phase 2/3 studies in ulcerative colitis (UC) with a mean follow-up of approximately 1 year, there were no cases of lymphoma with SIMPONI ®. Short follow-up periods, such as those of 1 year or less in the studies above, may not adequately reflect the true incidence of malignancies. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI ®. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.

Can you die from simponi?

Patients treated with SIMPONI® (golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI® if a patient develops a serious infection.

Can you start Simponi with TB?

The risks and benefits of treatment with SIMPONI® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI® in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Is Simponi dangerous to take?

I think that the drug Simponi is very dangerous to take and she still can't walk after 2 years after stopping the drug. She has to take infusions of IVIG gamma globulin every third week to rebuild her nerves after the erosion of the myelin of the nerves took place.

Does Simponi work for arthritis?

For Rheumatoid Arthritis: “Simponi had been the first biologic that has worked for my very active JRA (diagnosed 48 years ago) I tried every biological available, Simponi was the first medication to work within hours for my severe symptoms at the time, with no side effects. I have been using Simponi for 8 months. I pray it continues working.”

What is SIMPONI used for?

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

Can you die from taking Simponi?

HEART FAILURE. Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. If you develop new or worsening heart failure with SIMPONI ®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure.

Can simponia cause liver problems?

LIVER PROBLEMS. Serious liver problems can happen in people using TNF blockers, including SIMPONI ®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Does Simponi help with low blood count?

Low blood counts have been seen with SIMPONI ®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Most voted positive review

I've been on just about every injection that's out there for Rheumatoid Arthritis and have either been allergic to them, very bad side effects from them, or they just didn't work, so my Doctor got approval from my insurance company to allow me to have the Simponi ARIA IV and so far, it's only been a few months, but there's definitely a noticeable difference in the stiffness and pain I was enduring....

Shared reviews and ratings

I have had 2 infusions and dont feel any different and I feel like I'm more depressed .Is this medication a prerequisite for a joint replacement ?

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The opinions expressed in WebMD User-generated content areas like communities, reviews, ratings, or blogs are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of WebMD.

Most voted positive review

I have been on Simponi since July 09 (now Dec. 09), in conjunction with Methotrexate. Prior to July 09, just doing the grocery store was really difficult. My feet in particular have been quite affected by the RA. However, now I can do everything I was able to before all of this started (in the spring of 2008).

Most voted negative review

The first month I got a yeast infection after 4 days, month 2 I got another yeast infection then I started itching and burning all over my body. If I scratched a spot it welted up but then went away if I stopped scratching that area. 12 days into the 2nd shot and I am still itching all over my body and welting up.

How old is a patient with juvenile idiopathic arthritis?

patients 2 to 16 years of age with active polyarticular juvenile idiopathic arthritis (PJIA).

Which section of the label should be updated with information from Study?

submission. Section 8.4 of the label should be updated with information from Study