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simponi patient assistance form

by Dr. Chester Orn Published 2 years ago Updated 1 year ago
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What support is available for Simponi® treatment?

Janssen CarePath provides ongoing support that may help you stay on track with your SIMPONI ® treatment. Documents and websites to help you with enrollment, cost support, coverage, and more. Moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate (MTX) Active psoriatic arthritis (PsA), alone or with the medicine MTX

Can Simponi ® be used with biologics approved to treat RA?

The concomitant use of SIMPONI ® with biologics approved to treat RA, PsA, or AS is not recommended because of the possibility of an increased risk of infection. People receiving SIMPONI ® can receive vaccinations, except for live vaccines.

Can I self-inject Simponi?

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.

Are there any risks in taking Simponi®?

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.

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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.

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.

How long does SIMPONI take to work for RA?

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.

Is there a generic for SIMPONI?

There is currently no generic for Simponi (golimumab), so it can be expensive, even with insurance.

Will Medicare pay for biologics?

Biologics—usually large, complex molecules produced in a living system—are some of the most expensive drugs available, and spending for biologics is growing in Medicare Part D because they treat diseases common among Medicare beneficiaries. Biologics are estimated to cost Part D upwards of $12 billion annually.

Does Simponi Aria gain weight?

Does Simponi or Simponi Aria 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.

Do you have to take biologics forever?

You don't need to stop taking biologics for a minor procedure like removal of a skin cancer lesion. But your doctor might recommend stopping your biologic for a few weeks before open surgery like a knee or hip replacement. That's because these drugs can increase your risk for infection.

What is the safest biologic for rheumatoid arthritis?

The RA drug with the least side effects is hydroxychloroquine (Plaquenil). “We don't consider it immunosuppressive, and it doesn't cause elevated liver markers or kidney issues like some of the other drugs,” says Dr. Sharmeen.

What is the most effective biologic for rheumatoid arthritis?

Many people never need biologic DMARDs because conventional DMARDs control their disease well. The American College of Rheumatology recommends methotrexate over a biologic as the first choice for most people with inflammatory autoimmune diseases like rheumatoid arthritis and psoriatic arthritis.

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.

Can SIMPONI cause liver problems?

numbness or tingly feeling, weakness in your arms or legs; pale skin, easy bruising or bleeding; liver problems--right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Does SIMPONI cause depression?

In clinical trials, serious depression including suicidality has been reported in patients treated with SIMPONI.

What is the difference between Simponi and Simponi aria?

Simponi and Simponi Aria for psoriatic arthritis Simponi is approved for use in adults alone or in combination with methotrexate. Simponi Aria is approved to treat PsA in adults as well. But the medication can also be used in children ages 2 years and older. PsA is a type of autoimmune condition.

What are the side effects of Simponi?

Common side effects of Simponi include: dizziness, cold symptoms (stuffy nose, sneezing, sore throat), or. injection site reactions (redness, itching, pain, or swelling).

How do you bill Simponi aria?

The product-specific HCPCS code for SIMPONI ARIA® is J1602, Injection, golimumab, 1 mg, for intravenous use. It is important to note that this code represents 1 mg or 1/50th of a vial. You should be sure to bill 50 units of J1602 on the claim form when indicating that a single 50-mg vial of SIMPONI ARIA® was used.

What is the drug Simponi used for?

It is injected under the skin to reduce signs and symptoms of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, such as joint swelling, pain, fatigue, and length of morning stiffness. Golimumab is commonly known as Simponi®. It can also be given as an infusion.

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.

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.

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 ®.

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.

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.

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 do you have to wait to get a simponia?

Advise patients to discuss with the physician before seeking any immunizations. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to SIMPONI ARIA® .

Can you start SIMPONI ARIA with TB?

Consider the risks and benefits of treatment with SIMPONI ARIA® prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI ARIA® 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 ARIA®, 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 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.

Does SIMPONI ARIA cause demyelinating disorders?

Use of TNF blockers, including SIMPONI ARIA®, has been associated with rare cases of new-onset or exacerbation 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 in patients treated with golimumab. Exercise caution in considering the use of SIMPONI ARIA® in patients with these disorders. Consider discontinuation if these disorders develop.

Can SIMPONI ARIA be used for heart failure?

Exercise caution in CHF patients receiving SIMPONI ARIA® and monitor them closely during therapy. Discontinue SIMPONI ARIA® if new or worsening symptoms of heart failure appear.

Can you take SIMPONI ARIA before TNF blocker?

All patients should be tested for HBV infection before initiating TNF- blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing SIMPONI ARIA® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI ARIA®. Discontinue SIMPONI ARIA® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI ARIA®, and monitor patients closely.

Does SIMPONI ARIA reactivate HBV?

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. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants.

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.

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.

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.

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.

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.

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.

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:

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.

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.

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 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.

Can SIMPONI cause death?

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.

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.

Where can I get Simponi?

SIMPONI ® is available from a wide range of pharmacies. Janssen CarePath can connect you to a pharmacy and coordinate delivery to your patient’s home or your office.

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 Janssen CarePath?

Janssen CarePath provides the additional support your patients may need to get started with SIMPONI ® treatment you have prescribed. A personally assigned Janssen CarePath Care Coordinator will work closely with you and your patients to provide personalized support.

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.

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 SIMPONI cause serious infections?

SERIOUS INFECTIONS. 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.

Does Janssen CarePath take Simponi?

We understand how important it is for your patients to take SIMPONI ® medication as you’ve prescribed. Janssen CarePath offers support that may help your patients get started and stay on track with their SIMPONI ® treatment you have prescribed.

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.

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.

What is SIMPONI 50 mg?

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.

What are the symptoms of simponia?

Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as: feel very tired. dark urine. skin or eyes look yellow.

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 ®.

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.

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