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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
SIMPONI ARIA (BLA-125433)
(GOLIMUMAB)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
09/29/2020 (SUPPL-31)
5 Warnings and Precautions
5.10 Vaccinations/Therapeutic Infectious AgentsLive Vaccines
(Additions and/or revisions underlined)
Avoid live vaccines in patients treated with SIMPONI ARIA. 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.
Administration of live vaccines to infants exposed to SIMPONI ARIA in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA infusion during pregnancy [see Drug Interactions (7.3) and Use in Specific Populations (8.1)].
Whenever possible update immunizations prior to initiation of treatment with SIMPONI ARIA following current immunization guidelines for patients receiving immunosuppressive agents. Advise patients to discuss with the physician before seeking any immunizations.
6 Adverse Reactions
6.1 Clinical Trials Experience(Newly added information)
Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis
Trial pJIA evaluated 127 patients with JIA with active polyarthritis [see Use in Specific Populations (8.4) and Clinical Studies (14.4)]. The adverse reactions observed were consistent with the established safety profile of SIMPONI ARIA in adult patients with RA and PsA.
Through approximately 6 months, the incidence of antibodies to golimumab with the drug-tolerant EIA method for Trials RA, PsA, AS, and pJIA was 21%, 19%, 19% and 31%, respectively. Where tested, approximately one-third to one-half were neutralizing.
Patients with RA, PsA, AS and pJIA who developed antibodies to golimumab generally had lower trough steady-state serum concentrations of golimumab [see Clinical Pharmacology (12.3)].
7 Drug Interactions
7.2 Biologic Products for RA, PsA, AS, and pJIA(Section title revised)
(Additions and/or revisions underlined)
An increased risk of serious infections has been seen in clinical RA studies of other TNF-blockers used in combination with anakinra or abatacept, with no added benefit; therefore, use of SIMPONI ARIA with other biologic products, including abatacept or anakinra, is not recommended [see Warnings and Precautions (5.6 and 5.7)]. 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, PsA, AS, and pJIA is not recommended because of the possibility of an increased risk of infection.
8 Use in Specific Populations
8.4 Pediatric Use(Additions and/or revisions underlined)
Safety and effectiveness of SIMPONI ARIA for active polyarticular juvenile idiopathic arthritis and PsA have been established in pediatric patients 2 years and older.
Use of SIMPONI ARIA in these age groups is supported by evidence from adequate and well- controlled studies of SIMPONI ARIA in adults with RA and PsA, pharmacokinetic data from adult patients with RA and PsA and pediatric patients with JIA with active polyarthritis, and safety data from a clinical study in 127 pediatric patients 2 to < 18 years of age with JIA with active polyarthritis. The observed pre-dose (trough) concentrations are generally comparable between adults with RA and PsA and pediatric patients with JIA with active polyarthritis, and the PK exposure is expected to be comparable between adult PsA and pediatric patients with PsA [see Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.2, 14.4)].
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with golimumab and other TNF-blocking agents [see Warnings and Precautions (5.2)].
The safety and effectiveness in pediatric patients below the age of 2 years have not been established in pJIA or in PsA. The safety and effectiveness of SIMPONI ARIA in pediatric patients with conditions other than pJIA and PsA have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide(Additions and/or revisions underlined)
What is SIMPONI ARIA?
SIMPONI ARIA is a prescription medicine called a TNF-blocker. SIMPONI ARIA is used to treat:
· Adults with the medicine methotrexate (MTX) to treat moderately to severely active RA.
· Active psoriatic arthritis (PsA) in people 2 years of age and older.
· Adults with active ankylosing spondylitis (AS).
· Active polyarticular juvenile idiopathic arthritis (pJIA) in people 2 years of age and older.
It is not known if SIMPONI ARIA is safe and effective in children with PsA and pJIA under 2 years of age or in children
with conditions other than PsA and pJIA.
Your doctor will decide how much SIMPONI ARIA you will receive. Your usual schedule for receiving SIMPONI
ARIA after your first treatment should be:
o 4 weeks after your first treatment
o every 8 weeks after that
· If you miss an appointment to receive SIMPONI ARIA, make another appointment as soon as possible.
(Additions and/or revisions underlined)
Infections
Inform patients that SIMPONI ARIA may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and hepatitis B reactivation.
Malignancies
Patients should be counseled about the risk of lymphoma and other malignancies while receiving SIMPONI ARIA. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Vaccinations
Inform patients that because SIMPONI ARIA may lower the ability of their immune system to fight infections, they should avoid live vaccines. Inform pregnant patients receiving SIMPONI ARIA that their infants should not receive live vaccines for 6 months following the last infusion of SIMPONI ARIA during pregnancy. Advise patients and infants of women who received SIMPONI ARIA during pregnancy to consult a physician before receiving any immunizations.
09/24/2019 (SUPPL-28)
6 Adverse Reactions
6.3 Postmarketing Experience(additions and/or revisions are underlined)
The following adverse reactions have been identified during post-approval use of golimumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to golimumab exposure.
General Disorders and Administration Site Conditions: Infusion-related reactions
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, lichenoid reactions, bullous skin reactions
02/09/2018 (SUPPL-24)
5 Warnings and Precautions
5.9 Hematologic CytopeniasAdditions and/or revisions underlined:
There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving golimumab. Caution should be exercised …
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDEWhat are the possible side effects of SIMPONI ARIA? SIMPONI ARIA can cause serious side effects, including:
See “What is the most important information I should know about SIMPONI ARIA?”
Serious Infections.
· Some patients have an increased chance of getting serious infections while receiving SIMPONI ARIA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with SIMPONI ARIA your doctor will treat your infection and may need to stop your SIMPONI ARIA treatment. Tell your doctor right away if you have any of the following signs of an infection while taking or after taking SIMPONI ARIA:
· a fever
· feel very tired
·
have
a cough
have flu-like symptoms
· warm, red, or painful skin
· Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI ARIA and during treatment with SIMPONI ARIA. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking SIMPONI ARIA. People who had a negative TB skin test before receiving SIMPONI ARIA have developed active TB.
Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI ARIA:
cough that does not go away
low grade fever
weight lossloss of body fat and muscle (wasting)
10/20/2017 (SUPPL-20)
6 Adverse Reactions
6.1 Clinical Trials Experience(Additions and/or revisions are underlined)
Liver Enzyme Elevations
In the controlled phase of Trial PsA, through Week 24, ALT elevations greater than or equal to 5 x ULN occurred in 1.7% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients, and ALT elevations greater than or equal to 3 x ULN to < 5 x ULN occurred in 2.9% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients.
Psoriatic Arthritis
Trial PsA evaluated 480 patients. The adverse reactions were similar to those observed in patients with RA, with the exception of psoriasis (new onset or worsening, palmar/plantar and pustular), which occurred in <1% of SIMPONI ARIA-treated patients. The incidence of the adverse reactions reported in Trial PsA were similar to Trial RA with the exceptions of higher incidence in SIMPONI ARIA for ALT increased (7.9% vs. 2.1% in placebo), AST increased (5.4% vs. 2.1% in placebo), and neutrophil count decreased (4.6% vs. 2.1% in placebo).
Ankylosing Spondylitis
Trial AS evaluated 208 patients. The adverse reactions were similar to those reported in patients with RA, with the exception of the higher incidence of ALT increased, which occurred in 2.9% of SIMPONI ARIA-treated patients compared with none of the placebo-treated patients.
(Newly added subsection)
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to golimumab in the trials described below with the incidence of antibodies in other trials or to other products may be misleading.
Using an enzyme immunoassay (EIA) method, antibodies to golimumab were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial RA, of which all were neutralizing antibodies.
A drug-tolerant enzyme immunoassay (drug-tolerant EIA) method for detecting antibodies to golimumab was developed and validated. This method is approximately 16-fold more sensitive than the original EIA method with less interference from golimumab in serum. The incidence of antibodies to golimumab with the drug-tolerant EIA method for Trials RA, PsA and AS was 21%, 19% and 19%, respectively. Where tested, approximately one-third were neutralizing.
Patients with RA, PsA and AS who developed anti-golimumab antibodies generally had lower trough steady-state serum concentrations of golimumab.
7 Drug Interactions
7.1 Methotrexate(Additions and/or revisions are underlined)
SIMPONI ARIA should be used with MTX for the treatment of RA. Following IV administration, concomitant administration of methotrexate decreases the clearance of SIMPONI ARIA by approximately 9% based on population pharmacokinetics (PK) analysis. In addition, concomitant administration of methotrexate decreases the SIMPONI ARIA clearance by reducing the development of antibodies to golimumab.
SIMPONI ARIA may be used with or without MTX for the treatment of PsA or AS.
(Subsection title has been revised; Additions and/or revisions are underlined)
The concomitant use of SIMPONI ARIA with biologics approved to treat RA, PsA or AS is not recommended because of the possibility of an increased risk of infection.
8 Use in Specific Populations
8.1 Pregnancy(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Risk Summary
There are no adequate and well-controlled trials of SIMPONI ARIA in pregnant women. Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. There are clinical considerations for the use of SIMPONI ARIA in pregnant women [see Clinical Considerations]. In an animal reproductive study, golimumab administered by the subcutaneous route to pregnant monkeys, during the period of organogenesis, at doses that produced exposures approximately 200 times the maximum recommended human dose (MRHD) had no adverse fetal effects.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and of miscarriage is 15-20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Golimumab crosses the placenta during pregnancy. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants. Consequently, these infants may be at increased risk of infection…
Data
Human Data
Limited data on use of SIMPONI ARIA in pregnant women from observational studies, published case reports, and postmarketing surveillance are insufficient to inform a drug associated risk.
Animal Data
In an embryofetal developmental toxicology study in which pregnant cynomolgus monkeys were treated with golimumab during the period of organogenesis from gestation days (GD) 20 to 51, exposures up to 200 times greater than the exposure at the MRHD (on an area under the curve (AUC) basis with maternal subcutaneous doses up to 50 mg/kg twice weekly) produced no evidence of fetal malformations or embryotoxicity. There was no evidence of maternal toxicity. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation.
In a pre- and postnatal developmental study in which pregnant cynomolgus monkeys were treated with golimumab from gestation day 50 to postpartum day 33, maximal drug concentrations up to 33 times greater than that found with the MRHD (on a maximum blood concentration (Cmax) basis at steady-state with maternal subcutaneous doses up to 50 mg/kg twice weekly) were not associated with any evidence of developmental defects in infants. There was no evidence of maternal toxicity. Golimumab was present in fetal serum at the end of the second trimester and in neonatal serum from the time of birth and for up to 6 months postpartum.
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Risk Summary
There is no information regarding the presence of SIMPONI ARIA in human milk, the effects on breastfed infants, or the effects on milk production. Maternal IgG is known to be present in human milk. If golimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to golimumab are unknown. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for SIMPONI ARIA and any potential adverse effects on the breast-fed infants from SIMPONI ARIA, or from the underlying maternal condition.
Data
Animal Data
In the pre- and postnatal development study in cynomolgus monkeys…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(Additions and/or revisions are underlined)
What is SIMPONI ARIA?
SIMPONI ARIA is a prescription medicine called a TNF-blocker. SIMPONI ARIA is used in adults
with the medicine methotrexate (MTX) to treat moderately to severely active RA
to treat active psoriatic arthritis (PsA) alone or with MTX
to treat active ankylosing spondylitis (AS)
It is not known if SIMPONI ARIA is safe and effective in children under 18 years of age.
What should I tell my doctor before starting treatment with SIMPONI ARIA?
are breastfeeding or plan to breastfeed.
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
The most common side effects of SIMPONI ARIA include:
abnormal liver tests
decreased blood cells that fight infection
What are the ingredients in SIMPONI ARIA?
Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sorbitol, and water for injection. SIMPONI ARIA is preservative-free and is not made with natural rubber latex.
10/20/2017 (SUPPL-21)
6 Adverse Reactions
6.1 Clinical Trials Experience(Additions and/or revisions are underlined)
Liver Enzyme Elevations
In the controlled phase of Trial PsA, through Week 24, ALT elevations greater than or equal to 5 x ULN occurred in 1.7% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients, and ALT elevations greater than or equal to 3 x ULN to < 5 x ULN occurred in 2.9% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients.
Psoriatic Arthritis
Trial PsA evaluated 480 patients. The adverse reactions were similar to those observed in patients with RA, with the exception of psoriasis (new onset or worsening, palmar/plantar and pustular), which occurred in <1% of SIMPONI ARIA-treated patients. The incidence of the adverse reactions reported in Trial PsA were similar to Trial RA with the exceptions of higher incidence in SIMPONI ARIA for ALT increased (7.9% vs. 2.1% in placebo), AST increased (5.4% vs. 2.1% in placebo), and neutrophil count decreased (4.6% vs. 2.1% in placebo).
Ankylosing Spondylitis
Trial AS evaluated 208 patients. The adverse reactions were similar to those reported in patients with RA, with the exception of the higher incidence of ALT increased, which occurred in 2.9% of SIMPONI ARIA-treated patients compared with none of the placebo-treated patients.
(Newly added subsection)
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to golimumab in the trials described below with the incidence of antibodies in other trials or to other products may be misleading.
Using an enzyme immunoassay (EIA) method, antibodies to golimumab were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial RA, of which all were neutralizing antibodies.
A drug-tolerant enzyme immunoassay (drug-tolerant EIA) method for detecting antibodies to golimumab was developed and validated. This method is approximately 16-fold more sensitive than the original EIA method with less interference from golimumab in serum. The incidence of antibodies to golimumab with the drug-tolerant EIA method for Trials RA, PsA and AS was 21%, 19% and 19%, respectively. Where tested, approximately one-third were neutralizing.
Patients with RA, PsA and AS who developed anti-golimumab antibodies generally had lower trough steady-state serum concentrations of golimumab.
7 Drug Interactions
7.1 Methotrexate(Additions and/or revisions are underlined)
SIMPONI ARIA should be used with MTX for the treatment of RA. Following IV administration, concomitant administration of methotrexate decreases the clearance of SIMPONI ARIA by approximately 9% based on population pharmacokinetics (PK) analysis. In addition, concomitant administration of methotrexate decreases the SIMPONI ARIA clearance by reducing the development of antibodies to golimumab.
SIMPONI ARIA may be used with or without MTX for the treatment of PsA or AS.
(Subsection title has been revised; Additions and/or revisions are underlined)
The concomitant use of SIMPONI ARIA with biologics approved to treat RA, PsA or AS is not recommended because of the possibility of an increased risk of infection.
8 Use in Specific Populations
8.1 Pregnancy(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Risk Summary
There are no adequate and well-controlled trials of SIMPONI ARIA in pregnant women. Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. There are clinical considerations for the use of SIMPONI ARIA in pregnant women [see Clinical Considerations]. In an animal reproductive study, golimumab administered by the subcutaneous route to pregnant monkeys, during the period of organogenesis, at doses that produced exposures approximately 200 times the maximum recommended human dose (MRHD) had no adverse fetal effects.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and of miscarriage is 15-20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Golimumab crosses the placenta during pregnancy. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants. Consequently, these infants may be at increased risk of infection…
Data
Human Data
Limited data on use of SIMPONI ARIA in pregnant women from observational studies, published case reports, and postmarketing surveillance are insufficient to inform a drug associated risk.
Animal Data
In an embryofetal developmental toxicology study in which pregnant cynomolgus monkeys were treated with golimumab during the period of organogenesis from gestation days (GD) 20 to 51, exposures up to 200 times greater than the exposure at the MRHD (on an area under the curve (AUC) basis with maternal subcutaneous doses up to 50 mg/kg twice weekly) produced no evidence of fetal malformations or embryotoxicity. There was no evidence of maternal toxicity. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation.
In a pre- and postnatal developmental study in which pregnant cynomolgus monkeys were treated with golimumab from gestation day 50 to postpartum day 33, maximal drug concentrations up to 33 times greater than that found with the MRHD (on a maximum blood concentration (Cmax) basis at steady-state with maternal subcutaneous doses up to 50 mg/kg twice weekly) were not associated with any evidence of developmental defects in infants. There was no evidence of maternal toxicity. Golimumab was present in fetal serum at the end of the second trimester and in neonatal serum from the time of birth and for up to 6 months postpartum.
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Risk Summary
There is no information regarding the presence of SIMPONI ARIA in human milk, the effects on breastfed infants, or the effects on milk production. Maternal IgG is known to be present in human milk. If golimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to golimumab are unknown. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for SIMPONI ARIA and any potential adverse effects on the breast-fed infants from SIMPONI ARIA, or from the underlying maternal condition.
Data
Animal Data
In the pre- and postnatal development study in cynomolgus monkeys…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(Additions and/or revisions are underlined)
What is SIMPONI ARIA?
SIMPONI ARIA is a prescription medicine called a TNF-blocker. SIMPONI ARIA is used in adults
with the medicine methotrexate (MTX) to treat moderately to severely active RA
to treat active psoriatic arthritis (PsA) alone or with MTX
to treat active ankylosing spondylitis (AS)
It is not known if SIMPONI ARIA is safe and effective in children under 18 years of age.
What should I tell my doctor before starting treatment with SIMPONI ARIA?
are breastfeeding or plan to breastfeed.
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
The most common side effects of SIMPONI ARIA include:
abnormal liver tests
decreased blood cells that fight infection
What are the ingredients in SIMPONI ARIA?
Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sorbitol, and water for injection. SIMPONI ARIA is preservative-free and is not made with natural rubber latex.
01/30/2017 (SUPPL-19)
5 Warnings and Precautions
5.2 MalignanciesMalignancies in Adult Patients
Additions underlined:
… Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including SIMPONI ARIA. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer ...
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions underlined:
The following adverse reactions have been identified during post-approval use of golimumab. Because these reactions are reported voluntarily from a population of uncertain size …
Neoplasms benign, malignant and unspecified: Melanoma, Merkel cell carcinoma …
02/22/2016 (SUPPL-17)
6 Adverse Reactions
Post-Marketing ExperienceHypersensitivity Reactions
- In postmarketing experience, serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following administration of the subcutaneous and intravenous formulations of golimumab including SIMPONI ARIA. Hypersensitivity reactions including hives, pruritis, dyspnea, and nausea, were reported during infusion and generally within an hour after infusion. Some of these reactions occurred after the first administration of golimumab. If an anaphylactic or other serious allergic reaction occurs, administration of SIMPONI ARIA should be discontinued immediately and appropriate therapy instituted.
01/08/2016 (SUPPL-15)
5 Warnings and Precautions
Malignancies
Malignancies in Adult Patients
- *section updated
Congestive Heart Failure
- … Some cases had a fatal outcome.
Autoimmunity
- Treatment with TNF blockers, including SIMPONI ARIA, may result in the formation of antinuclear antibodies (ANA). Rarely, treatment with TNF blockers, may result in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SIMPONI ARIA, treatment should be discontinued.