Simponi

>10%

Upper respiratory infections (13-16%)

1-10%

Injection site reactions, SC (6%)

Increased ALT/AST (3-4%)

Viral infections (4-5%)

Hypertension (3%)

Bronchitis (2-3%)

Rash (3%)

Sinusitis (2%)

Superficial fungal infections (2%)

Dizziness (2%)

Paresthesia (2%)

Pyrexia (2%)

Leukopenia (1%)

Bacterial infections (1%)

Constipation (1%)

Postmarketing Reports

Neoplasm benign and malignant: Melanoma, Merkel cell carcinoma

Immune system disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction), sarcoidosis

Respiratory, thoracic and mediastinal disorders: Interstitial lung disease

Skin and subcutaneous tissue disorders: Skin exfoliation, rash, bullous skin reactions

• Yes, you need a prescription for this drug.

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those listed in the Simponi Warnings section above, and any of the following:

• Blood thinners, such as Coumadin (warfarin)
• Gengraf, Neoral, or Sandimmune (cyclosporine)
• Theochron, Theolair, Theo-Dur, or Uniphyl (theophylline)

Simponi is a prescription medication for the treatment of ulcerative colitis, moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Simponi belongs to class of medications called DMARDs, or disease modifying antirheumatic drugs. These medications work by blocking tumor necrosis factors (TNFs), factors partly responsible for over-inflammation in certain diseases.

This medication comes in a once-monthly, self-injectable form to be injected under the skin (subcutaneous injection). It also comes as an injection to be given through the vein (IV) by a healthcare provider.

Common side effects include upper respiratory infection and redness at the site of injection.

Self-Injection Simponi 

Simponi is meant for use under the supervision of a physician. After proper training in injection technique, a patient may self inject with Simponi if a physician determines that it is appropriate.

A 50 mg injection of Simponi is administered once every month.

For rheumatoid arthritis: Simponi should be prescribed with methotrexate.

For psoriatic arthritis or ankylosing spondylitis: Simponi may be given with or without methotrexate or other disease modifying antirheumatic drugs (DMARDs).

For ulcerative colitis:  The recommended dosage regimen is a 200 mg injection at Week 0, followed by 100 mg at Week 2 and then maintenance therapy with 100 mg every 4 weeks.

Simponi to be given through the vein

The Simponi dosage regimen is 2 mg per kg given as an intravenous (IV) infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Simponi should be given in combination with methotrexate. Other non-biologic DMARDs, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Simponi.

The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.

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.

Serious and sometimes fatal infections may occur during treatment with golimumab. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, muscle aches, feeling very tired;

• cough, shortness of breath;

• sweating, skin sores;

• diarrhea, stomach pain, weight loss;

• increased urination, or burning when you urinate.

Call your doctor at once if you have any of these other side effects:

• skin growths or changes in skin appearance;

• shortness of breath with swelling of your ankles or feet;

• pale skin, easy bruising or bleeding;

• vision changes, neck stiffness, seizure;

• numbness or tingly feeling, weakness in your arms or legs;

• liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• lupus-like syndrome--muscle or joint pain, chest pain, patchy skin color, skin rash over your cheeks and nose (worsens in sunlight); or

• signs of psoriasis--red or scaly patches of skin, flaking, pus.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• flu symptoms, cold sores; or

• pain, itching, redness, or swelling where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rheumatoid Arthritis in Adults

Used in conjunction with methotrexate for the management of moderately to severely active rheumatoid arthritis in adults.1 2 3 4 17 24 27 28 29 37 38 39 40 41 42

Psoriatic Arthritis

Used alone or in conjunction with methotrexate for the management of active psoriatic arthritis in adults.1 5 34 35 36

Ankylosing Spondylitis

Used for the management of ankylosing spondylitis in adults with active disease.1 6 32 33

Ulcerative Colitis

Used in adults with moderately to severely active ulcerative colitis who require continuous corticosteroid therapy or who had inadequate response to or were intolerant to conventional therapies (oral aminosalicylates, oral corticosteroids, azathioprine, or mercaptopurine) to induce and maintain clinical response, to improve endoscopic appearance of the mucosa during induction therapy, to induce clinical remission, and to achieve and sustain clinical remission in those who responded to induction therapy.1 26 30

In the U.S.

• Simponi
• Simponi Aria

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Modulator

Pharmacologic Class: Tumor Necrosis Factor Inhibitor

• If you have an allergy to golimumab, polysorbate 80, or any other part of Simponi.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have an infection.
• If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, rituximab, or tocilizumab.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Simponi with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this medicine is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Simponi is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Simponi or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Simponi. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Serious Infections

Patients treated with Simponi are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease. The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the concomitant use of Simponi and these biologic products is not recommended [see Warnings and Precautions (5.6, 5.7) and Drug Interactions (7.2)].

Treatment with Simponi should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating Simponi in patients:

• with chronic or recurrent infection;
• who have been exposed to tuberculosis;
• with a history of an opportunistic infection;
• who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or
• with underlying conditions that may predispose them to infection.

Monitoring

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Simponi. Discontinue Simponi if a patient develops a serious infection, an opportunistic infection, or sepsis. For a patient who develops a new infection during treatment with Simponi, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor them.

Serious Infection in Clinical Trials

In controlled Phase 3 trials through Week 16 in patients with RA, PsA, and AS, serious infections were observed in 1.4% of Simponi-treated patients and 1.3% of control-treated patients. In the controlled Phase 3 trials through Week 16 in patients with RA, PsA, and AS, the incidence of serious infections per 100 patient-years of follow-up was 5.7 (95% CI: 3.8, 8.2) for the Simponi group and 4.2 (95% CI: 1.8, 8.2) for the placebo group. In the controlled Phase 2/3 trial through Week 6 of Simponi induction in UC, the incidence of serious infections in Simponi 200/100 mg-treated patients was similar to the incidence of serious infections in placebo-treated patients. Through Week 60, the incidence of serious infections was similar in patients who received Simponi induction and 100 mg during maintenance compared with patients who received Simponi induction and placebo during the maintenance portion of the UC trial. Serious infections observed in Simponi-treated patients included sepsis, pneumonia, cellulitis, abscess, tuberculosis, invasive fungal infections, and hepatitis B infection.

Tuberculosis

Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF blockers, including patients who have previously received treatment for latent or active tuberculosis. Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating Simponi and periodically during therapy.

Treatment of latent tuberculosis infection prior to therapy with TNF blockers has been shown to reduce the risk of tuberculosis reactivation during therapy. Prior to initiating Simponi, assess if treatment for latent tuberculosis is needed; an induration of 5 mm or greater is a positive tuberculin skin test, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

Consider anti-tuberculosis therapy prior to initiation of Simponi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.

Cases of active tuberculosis have occurred in patients treated with Simponi during and after treatment for latent tuberculosis. Monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.

Consider tuberculosis in the differential diagnosis in patients who develop a new infection during Simponi treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

In the controlled and uncontrolled portions of the Phase 2 RA and Phase 3 RA, PsA, and AS trials, the incidence of active TB was 0.23 and 0 per 100 patient-years in 2347 Simponi-treated patients and 674 placebo-treated patients, respectively. Cases of TB included pulmonary and extrapulmonary TB. The overwhelming majority of the TB cases occurred in countries with a high incidence rate of TB. In the controlled Phase 2/3 trial of Simponi induction through Week 6 in UC, no cases of TB were observed in Simponi 200/100 mg-treated patients or in placebo-treated patients. Through Week 60, the incidence per 100 patient-years of TB in patients who received Simponi induction and 100 mg during the maintenance portion of the UC trial was 0.52 (95% CI: 0.11, 1.53). One case of TB was observed in the placebo maintenance group in a patient who received Simponi intravenous (IV) induction.

Invasive Fungal Infections

If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Consider appropriate empiric antifungal therapy, and take into account both the risk for severe fungal infection and the risks of antifungal therapy while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. To aid in the management of such patients, consider consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections.

Hepatitis B Virus Reactivation

The use of TNF blockers including Simponi has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive). 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.

All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consultation with a physician with expertise in the treatment of hepatitis B is recommended before initiating TNF-blocker therapy. The risks and benefits of treatment should be considered prior to prescribing TNF blockers, including Simponi, to patients who are carriers of HBV. Adequate data are not available on whether antiviral therapy can reduce the risk of HBV reactivation in HBV carriers who are treated with TNF blockers. Patients who are carriers of HBV and require treatment with TNF blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.

In patients who develop HBV reactivation, TNF blockers should be stopped and antiviral therapy with appropriate supportive treatment should be initiated. The safety of resuming TNF blockers after HBV reactivation has been controlled is not known. Therefore, prescribers should exercise caution when considering resumption of TNF blockers in this situation and monitor patients closely.

Malignancies

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which Simponi is a member. 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 that are usually associated with immunosuppression, and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months (range 1 to 84 months) after the first dose of TNF-blocker therapy. Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.

The risks and benefits of TNF-blocker treatment, including Simponi, should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated nonmelanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy.

In the controlled portions of clinical trials of TNF blockers, including Simponi, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with patients in the control groups. During the controlled portions of the Phase 2 trials in RA, and the Phase 3 trials in RA, PsA and AS, 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 the controlled and uncontrolled portions of these clinical trials in 2347 Simponi-treated patients with a median follow-up of 1.4 years, the incidence of lymphoma was 3.8-fold higher than expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).1 Through Week 60 of the UC trials, there were no cases of lymphoma with Simponi. Patients with RA and other chronic inflammatory diseases, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF-blocking therapy. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including Simponi, in rheumatoid arthritis and other indications. Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.

Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Nearly all of the reported TNF blocker associated cases have occurred in patients with Crohn's disease or ulcerative colitis. The majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. The potential risk with the combination of AZA or 6-MP and Simponi should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF blockers cannot be excluded.

During the controlled portions of the Phase 2 trial in RA, and the Phase 3 trials in RA, PsA and AS, the incidence of malignancies other than lymphoma per 100 patient-years of follow-up was not elevated in the combined Simponi group compared with the placebo group. In the controlled and uncontrolled portions of these trials, the incidence of malignancies, other than lymphoma, in Simponi-treated patients was similar to that expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).1 In the 6-week placebo-controlled portions of the Simponi Phase 2/3 clinical trials in UC, the incidence of non-lymphoma malignancies (excluding nonmelanoma skin cancer) was similar between the Simponi and the placebo group. Through Week 60, the incidence of non-lymphoma malignancies (excluding nonmelanoma skin cancer) was similar to the general U.S. population according to the SEER database (adjusted for age, gender, and race).1 Short follow-up periods, such as those of one year or less in the studies above, may not adequately reflect the true incidence of malignancies.

It is not known if Simponi treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. In patients with newly diagnosed dysplasia treated with Simponi, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including Simponi. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

In controlled trials of other TNF blockers in patients at higher risk for malignancies (e.g., patients with chronic obstructive pulmonary disease [COPD], patients with Wegener's granulomatosis treated with concomitant cyclophosphamide) a greater portion of malignancies occurred in the TNF-blocker group compared to the controlled group. In an exploratory 1-year clinical trial evaluating the use of 50 mg, 100 mg, and 200 mg of Simponi in 309 patients with severe persistent asthma, 6 patients developed malignancies other than NMSC in the Simponi groups compared to none in the control group. Three of the 6 patients were in the 200-mg Simponi group.

Congestive Heart Failure

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including Simponi. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. Simponi has not been studied in patients with a history of CHF and Simponi should be used with caution in patients with CHF. If a decision is made to administer Simponi to patients with CHF, these patients should be closely monitored during therapy, and Simponi should be discontinued if new or worsening symptoms of CHF appear.

Demyelinating Disorders

Use of TNF blockers, of which Simponi is a member, has been associated with rare cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS) and peripheral demyelinating disorders, including Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported in patients treated with Simponi [see Adverse Reactions (6.1)]. Prescribers should exercise caution in considering the use of TNF blockers, including Simponi, in patients with central or peripheral nervous system demyelinating disorders. Discontinuation of Simponi should be considered if these disorders develop.

Autoimmunity

Treatment with TNF blockers, including Simponi, may result in the formation of antinuclear antibodies (ANA) and, rarely, in the development of a lupus-like syndrome [see Adverse Reactions (6.1)]. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Simponi, treatment should be discontinued.

Use with Abatacept

In controlled trials, the concurrent administration of another TNF blocker and abatacept was associated with a greater proportion of serious infections than the use of a TNF blocker alone; and the combination therapy, compared to the use of a TNF blocker alone, has not demonstrated improved clinical benefit in the treatment of RA. Therefore, the combination of TNF blockers, including Simponi, and abatacept is not recommended [see Drug Interactions (7.2)].

Use with Anakinra

Concurrent administration of anakinra (an interleukin-1 antagonist) and another TNF blocker was associated with a greater portion of serious infections and neutropenia and no additional benefits compared with the TNF-blocker alone. Therefore, the combination of anakinra with TNF blockers, including Simponi, is not recommended [see Drug Interactions (7.2)].

Switching Between Biological Disease-Modifying Antirheumatic Drugs

Care should be taken when switching from one biological product to another biological product since overlapping biological activity may further increase the risk of infection.

Hematologic Cytopenias

There have been postmarketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers. In clinical trials, cases of pancytopenia, leukopenia, neutropenia, and thrombocytopenia have also occurred in Simponi-treated patients. Caution should be exercised when using TNF blockers, including Simponi, in patients who have or have had significant cytopenias.

Vaccinations/Therapeutic Infectious Agents

Live Vaccines

Patients treated with Simponi may receive vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on the response to live vaccination, or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections.

Therapeutic Infectious Agents

Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with Simponi.

Non-live Vaccines

In the Phase 3 PsA trial, after pneumococcal vaccination, a similar proportion of Simponi-treated and placebo-treated patients were able to mount an adequate immune response of at least a 2-fold increase in antibody titers to pneumococcal polysaccharide vaccine. In both Simponi-treated and placebo-treated patients, the proportions of patients with response to pneumococcal vaccine were lower among patients receiving MTX compared with patients not receiving MTX. The data suggest that Simponi does not suppress the humoral immune response to the pneumococcal vaccine.

Hypersensitivity Reactions

In postmarketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following Simponi administration. Some of these reactions occurred after the first administration of Simponi. If an anaphylactic or other serious allergic reaction occurs, administration of Simponi should be discontinued immediately and appropriate therapy instituted.

In a clinical trial, 5 patients received protocol-directed single infusions of 10 mg/kg of intravenous Simponi without serious adverse reactions or other significant reactions. The highest weight patient was 100 kg and, therefore, received a single intravenous infusion of 1000 mg of Simponi.

1. SEER [database online]. US Population Data – 1969–2004. Bethesda, MD: National Cancer Institute. Release date: January 3, 2007. Available at: http//seer.cancer.gov/popdata/.

Do not receive a "live" vaccine while using Simponi, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

If you use Simponi during pregnancy, your baby should not receive a live vaccine for the first 6 months after birth.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.