What are the possible complications 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. Discontinue SIMPONI® if a patient develops a serious infection.
What is Simponi® (golimumab)?
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.
How can I get additional support with Simponi® treatment?
Janssen CarePath provides the additional support you may need to help you get started with SIMPONI ® treatment, once you and your doctor have decided that SIMPONI ® is right for you. A personally assigned Janssen CarePath Care Coordinator will work closely with you and your doctor to provide the support you need.
Is SIMPONI covered by Medicare?
Do Medicare prescription drug plans cover Simponi? No. In general, Medicare prescription drug plans (Part D) do not cover this drug.
Can you gain weight with SIMPONI?
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.
How much is a SIMPONI injection?
GOLIMUMAB is used to treat rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis. It is also used to treat ulcerative colitis. The lowest GoodRx price for the most common version of Simponi is around $5,423.76, 31% off the average retail price of $7,934.31.
Does SIMPONI cause liver damage?
There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF blockers.
Can you drink alcohol on SIMPONI?
Alcohol. There's no known interaction between golimumab and alcohol, so it's fine to have a drink if you're taking this medication.
Does SIMPONI cause fatigue?
FDA expands Simponi Aria labeling to include fatigue in RA, PsA.
How long does it take Simponi to start working?
Simponi can take about 2 weeks before patients start to feel its effects. Some patients notice a benefit shortly after their first dose, while in others it can take several weeks. It can take 4 to 12 weeks before patients feel a lot of benefit.
How long does Simponi infusion take?
The intravenous infusion will be given to you by a healthcare professional. This procedure usually takes about 30 minutes. After you receive your first dose, you will get your second dose 4 weeks later and the following doses every 8 weeks.
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.
Does Simponi cause depression?
In clinical trials, serious depression including suicidality has been reported in patients treated with SIMPONI.
Is golimumab safe?
Conclusions: SC golimumab safety up to 3 years remained consistent with that of other TNF antagonists. Golimumab 100 mg showed numerically higher incidences of serious infections, demyelinating events and lymphoma than 50 mg; safety follow-up up to year 5 continues.
Can you take antibiotics while on Simponi?
You should not receive Simponi Aria while you have an infection or while you are on antibiotics. Simponi Aria can be restarted once you have completed your antibiotic course and your infection has resolved.
Can probiotics make you put on weight?
You may be actively consuming a probiotic strain that promotes weight gain while expecting it to help you lose weight. Some strains of probiotics encourage obesity. One such strain is the Lactobacillus Acidophilus which may alter the bacteria in the gut to promote cellular growth (4).
Does 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.
Do prebiotics make you gain weight?
Besides making you feel full, prebiotic fiber can also reduce the amount of fat your body absorbs from the food you eat. The overall effect is a decrease in “metabolizable energy”, which is defined as energy consumed minus the loss in feces and urine.
What probiotic strain causes weight gain?
Lactobacillus acidophilus is one strain known to cause weight gain, as well as promoting obesity. It does this by altering the bacteria levels in the gut and promotes cellular growth.
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.
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 a TNF blocker?
TNF-blocking agents, of which SIMPONI ® is a member, have been associated with rare cases of new-onset or ex acerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported with SIMPONI ®. Exercise caution in considering the use of SIMPONI ® in patients with these disorders. Consider discontinuation if these disorders develop.
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 simponia 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.
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.
Does Janssen CarePath take Simponi ARIA?
We understand how important it is for your patients to take SIMPONI ARIA® medication as you’ve prescribed. Janssen CarePath offers ongoing support that may help your patients stay on track with their SIMPONI ARIA® treatment.
Is simponia aria 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 ARIA® included sepsis, pneumonia, cellulitis, and abscess. MALIGNANCIES.
Can you use Simponi Aria with abatacept?
The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections, therefore the use of SIMPONI ARIA® in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. The concomitant use of SIMPONI ARIA® with biologics approved to treat RA is not recommended because of the possibility of an increased risk of infection.
Can you take TNF inhibitors with Lupus?
Treatment with TNF blockers, including SIMPONI ARIA®, may result in the formation of antinuclear antibodies. Rarely, treatment with TNF blockers may result in a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
Is golimumab fatal?
Malignancies, some fatal, have been reported in children, adolescents, and young adult patients treated with golimumab. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Can TNF blocker be used for leukemia?
Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI ARIA®. 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.
Does SIMPONI ARIA work for hepatitis B?
HEPATITIS B REACTIVATION. The use of TNF blockers, of which SIMPONI ARIA ® is a member, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers.
How often is SIMPONI given?
MTX is used as directed. For RA, PsA, and AS: SIMPONI ® 50 mg is given as an injection under the skin (subcutaneous injection) once a month. For UC: SIMPONI ® begins with 3 starter injections under the skin (subcutaneous injection): Two 100-mg injections on the first day of treatment, followed by one 100-mg injection 2 weeks later.
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.
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.
How often should I inject Simponi?
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. Important Safety Information For SIMPONI ®.
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.
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.
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 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.
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.
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.
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.
Can you test for TB before using Simponi?
Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before SIMPONI® use and during therapy. Treatment for latent infection should be initiated prior to SIMPONI® use.
Is simponia 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.
What is golimumab?from drugs.com
Golimumab is used to treat rheumatoid arthritis and ankylosing spondylitis in adults.
What are the side effects of Golimumab?from drugs.com
Golimumab side effects. Get emergency medical help if you have signs of an allergic reaction: hives, itching; nausea; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat. You may get infections more easily, even serious or fatal infections.
What is the medication used for ulcerative colitis?from drugs.com
Golimumab is also used to treat ulcerative colitis (UC) in adults when other medicines have not worked or could not be tolerated. Golimumab is sometimes given with methotrexate or a steroid medicine. Golimumab may also be used for purposes not listed in this medication guide.
How long can a baby be on golimumab?from drugs.com
Your baby could have an increased risk of infection for up to 6 months if you use golimumab during pregnancy. If you use golimumab during pregnancy, your newborn baby should not receive a live vaccine for at least 6 months after you last received a dose of golimumab. You should not breastfeed while using golimumab.
What to tell your doctor about tuberculosis?from drugs.com
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.
What other medications affect golimumab?from drugs.com
This list is not complete. Other drugs may affect golimumab, including prescription and over-the-counter medicines, vitamins, and herbal products.
Does Golimumab weaken the immune system?from drugs.com
Golimumab can weaken your immune system. Your blood will need to be tested often.
How much does Simponi Janssen CarePath save?
Simponi Janssen CarePath Savings Program: Most eligible commercially insured patients may pay only $5 per infusion with savings of up to $20,000 per calendar year; for additional information contact the program at 877-227-3728.
What is Simponi used for?
Simponi (golimumab) is a member of the TNF alfa inhibitors drug class and is commonly used for Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis, and others .
How much does Simponi cost?
The cost for Simponi subcutaneous solution (50 mg/0.5 mL) is around $5,508 for a supply of 0.5 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
Does Simponi Janssen accept savings cards?
Simponi Janssen CarePath Savings Program Rebate: Eligible commercially insured patients may submit a rebate request if the pharmacy does not accept the Savings Card; for additional assistance contact the program at 877-227-3728.
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.
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 .
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.
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.
Can you get numbness from TNF blockers?
Rarely, people using TNF blockers, including SIMPON I ®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
Does Janssen CarePath work with Simponi?
We understand how important it is for you to take the Janssen medication your doctor prescribed. Janssen CarePath provides ongoing support to help you stay on track with your SIMPONI ® treatment. Learn more
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.
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.
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.
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.
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.
Can you start Simponi if you have a history of HIV?
You should not start SIMPONI ® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as: