Simponi Information
Simponi (Golimumab)
Simponi (Golimumab) Dosage And Administration
The Simponi (Golimumab) dose regimen is 50 mg administered by subcutaneous injection once a month.
For patients with rheumatoid arthritis (RA), Simponi (Golimumab) should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Simponi (Golimumab) may be given with or without methotrexate or other non-biologic Disease Modifying Antirheumatic Drugs (DMARDs). For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with Simponi (Golimumab) .
Prior to initiating Simponi (Golimumab) and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection []. Prior to initiating Simponi (Golimumab) , patients should be tested for hepatitis B viral infection [].
Simponi (Golimumab) is intended for use under the guidance and supervision of a physician. After proper training in subcutaneous injection technique, a patient may self inject with Simponi (Golimumab) if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide (). To ensure proper use, allow the prefilled syringe or autoinjector to sit at room temperature outside the carton for 30 minutes prior to subcutaneous injection. Do not warm Simponi (Golimumab) in any other way.
Prior to administration, visually inspect the solution for particles and discoloration through the viewing window. Simponi (Golimumab) should be clear to slightly opalescent and colorless to light yellow. The solution should not be used if discolored, or cloudy, or if foreign particles are present. Any leftover product remaining in the prefilled syringe or prefilled autoinjector should not be used. NOTE: The needle cover on the prefilled syringe as well as the prefilled syringe in the autoinjector contains dry natural rubber (a derivative of latex), which should not be handled by persons sensitive to latex.
Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.
Simponi (Golimumab) Dosage Forms And Strengths
SmartJect Autoinjector
Each single dose SmartJect autoinjector contains a prefilled glass syringe (27 gauge ½ inch) providing 50 mg of Simponi (Golimumab) per 0.5 mL of solution.
Prefilled Syringe
Each single dose prefilled glass syringe (27 gauge ½ inch) contains 50 mg of Simponi (Golimumab) per 0.5 mL of solution.
Simponi (Golimumab) Contraindications
Simponi (Golimumab) Warnings And Precautions
(see )
Patients treated with Simponi (Golimumab) 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 (Golimumab) and these biologic products is not recommended [].
Treatment with Simponi (Golimumab) should not be initiated in patients with an active infection, including clinically important localized infections. The risks and benefits of treatment should be considered prior to initiating Simponi (Golimumab) in patients:
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 (Golimumab) 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 post-marketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.
The risks and benefits of TNF-blocker treatment including Simponi (Golimumab) should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma 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 (Golimumab) , 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 (Golimumab) 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 (Golimumab) -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). 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 postmarketing TNF-blocker use 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.
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 (Golimumab) group compared with the placebo group. In the controlled and uncontrolled portions of these trials, the incidence of malignancies, other than lymphoma, in Simponi (Golimumab) -treated patients was similar to that expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).
In controlled trials of other TNF-blockers in patients at higher risk for malignancies (e.g., patients with 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, 100 and 200 mg of Simponi (Golimumab) in 309 patients with severe persistent asthma, 6 patients developed malignancies other than NMSC in the Simponi (Golimumab) groups compared to none in the control group. Three of the 6 patients were in the 200 mg Simponi (Golimumab) group.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF-blockers, including Simponi (Golimumab) . 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 (Golimumab) has not been studied in patients with a history of CHF and Simponi (Golimumab) should be used with caution in patients with CHF. If a decision is made to administer Simponi (Golimumab) to patients with CHF, these patients should be closely monitored during therapy, and Simponi (Golimumab) should be discontinued if new or worsening symptoms of CHF appear.
Use of TNF-blockers, of which Simponi (Golimumab) 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 (Golimumab) . Prescribers should exercise caution in considering the use of TNF-blockers, including Simponi (Golimumab) , in patients with central or peripheral nervous system demyelinating disorders. Discontinuation of Simponi (Golimumab) should be considered if these disorders develop.
Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection.
There have been post-marketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF-blockers. In clinical studies, cases of pancytopenia, leukopenia, neutropenia, and thrombocytopenia have also occurred in Simponi (Golimumab) -treated patients. Caution should be exercised when using TNF-blockers, including Simponi (Golimumab) , in patients who have or have had significant cytopenias.
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following Simponi (Golimumab) administration. Some of these reactions occurred after the first administration of Simponi (Golimumab) . If an anaphylactic or other serious allergic reaction occurs, administration of Simponi (Golimumab) should be discontinued immediately and appropriate therapy instituted.
Simponi (Golimumab) Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data described below are based on 5 pooled, randomized, double-blind, controlled Phase 3 trials in patients with RA, PsA, and AS (Studies RA-1, RA-2, RA-3, PsA, and AS) []. These 5 trials included 639 control-treated patients and 1659 Simponi (Golimumab) -treated patients including 1089 with RA, 292 with PsA, and 278 with AS. The proportion of patients who discontinued treatment due to adverse reactions in the controlled Phase 3 trials through Week 16 in RA, PsA and AS was 2% for Simponi (Golimumab) -treated patients and 3% for placebo-treated patients. The most common adverse reactions leading to discontinuation of Simponi (Golimumab) in the controlled Phase 3 trials through Week 16 were sepsis (0.2%), alanine aminotransferase increased (0.2%), and aspartate aminotransferase increased (0.2%).
The most serious adverse reactions were:
Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 RA, PsA and AS trials through Week 16, occurring in 7% and 6% of Simponi (Golimumab) -treated patients as compared with 6% and 5% of control-treated patients, respectively.
The following adverse reactions have been identified during post-approval use of Simponi (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 Simponi (Golimumab) exposure.
Simponi (Golimumab) Drug Interactions
Live vaccines should not be given concurrently with Simponi (Golimumab) [].
Infants born to women treated with Simponi (Golimumab) during their pregnancy may be at increased risk of infection for up to 6 months. Administration of live vaccines to infants exposed to Simponi (Golimumab) is not recommended for 6 months following the mother's last Simponi (Golimumab) injection during pregnancy (].
Simponi (Golimumab) Use In Specific Populations
It is not known whether Simponi (Golimumab) is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Simponi (Golimumab) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
In the pre- and post-natal development study in cynomolgus monkeys in which golimumab was administered subcutaneously during pregnancy and lactation, golimumab was detected in the breast milk at concentrations that were approximately 400-fold lower than the maternal serum concentrations.
Simponi (Golimumab) Overdosage
In a clinical study, 5 patients received protocol-directed single infusions of 10 mg/kg of intravenous Simponi (Golimumab) 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 (Golimumab) . There were no Simponi (Golimumab) overdoses in the clinical studies.
Simponi (Golimumab) Description
Simponi (Golimumab) is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Simponi (Golimumab) was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. Simponi (Golimumab) is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
The Simponi (Golimumab) drug product is a sterile solution of the golimumab antibody supplied as either a single dose prefilled syringe (with a passive needle safety guard) or a single dose prefilled autoinjector. The Type 1 glass syringe has a coated stopper. The fixed stainless steel needle (5 bevel, 27G, half-inch) is covered with a needle shield to prevent leakage of the solution through the needle and to protect the needle during handling prior to administration. The needle shield is made of a dry natural rubber containing latex.
Simponi (Golimumab) does not contain preservatives. The solution is clear to slightly opalescent, colorless to light yellow with a pH of approximately 5.5. Simponi (Golimumab) is provided in one strength: 50 mg of the golimumab antibody in 0.5 mL of solution. Each 0.5 mL of Simponi (Golimumab) contains 50 mg of the golimumab antibody, 0.44 mg of L-histidine and L-histidine monohydrochloride monohydrate, 20.5 mg of sorbitol, 0.08 mg of polysorbate 80, and Water for Injection.
Simponi (Golimumab) Clinical Pharmacology
Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a cytokine protein). There was no evidence of the golimumab antibody binding to other TNF superfamily ligands; in particular, the golimumab antibody did not bind or neutralize human lymphotoxin. Golimumab did not lyse human monocytes expressing transmembrane TNF in the presence of complement or effector cells.
Elevated TNFα levels in the blood, synovium, and joints have been implicated in the pathophysiology of several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. TNFα is an important mediator of the articular inflammation that is characteristic of these diseases. Golimumab modulated the biological effects mediated by TNF in several bioassays, including the expression of adhesion proteins responsible for leukocyte infiltration (E-selectin, ICAM-1 and VCAM-1) and the secretion of proinflammatory cytokines (IL-6, IL-8, G-CSF and GM-CSF).
Following subcutaneous administration of Simponi (Golimumab) to healthy subjects and patients with active RA, the median time to reach maximum serum concentrations (T) ranged from 2 to 6 days. A subcutaneous injection of 50 mg Simponi (Golimumab) to healthy subjects produced a mean maximum serum concentration (C) of approximately 2.5 µg/mL. Simponi (Golimumab) exhibited dose-proportional pharmacokinetics (PK) in patients with active RA over the dose range of 0.1 to 10.0 mg/kg following a single intravenous (IV) dose. Following a single IV administration over the same dose range in patients with active RA, mean systemic clearance of Simponi (Golimumab) was estimated to be 4.9 to 6.7 mL/day/kg, and mean volume of distribution ranged from 58 to 126 mL/kg. The volume of distribution for Simponi (Golimumab) indicates that Simponi (Golimumab) is distributed primarily in the circulatory system with limited extravascular distribution. Median terminal half-life values were estimated to be approximately 2 weeks in healthy subjects and patients with active RA, PsA or AS. By cross-study comparisons of mean AUCvalues following an IV or subcutaneous administration of Simponi (Golimumab) , the absolute bioavailability of subcutaneous Simponi (Golimumab) was estimated to be approximately 53%.
When 50 mg Simponi (Golimumab) was administered subcutaneous to patients with RA, PsA, or AS every 4 weeks, serum concentrations appeared to reach steady state by Week 12. With concomitant use of methotrexate (MTX), treatment with 50 mg Simponi (Golimumab) subcutaneous every 4 weeks resulted in a mean steady-state trough serum concentration of approximately 0.4–0.6 µg/mL in patients with active RA, approximately 0.5 µg/mL in patients with active PsA, and approximately 0.8 µg/mL in patients with active AS. Patients with RA, PsA, and AS treated with Simponi (Golimumab) 50 mg and MTX had approximately 52%, 36% and 21% higher mean steady-state trough concentrations of golimumab, respectively compared with those treated with Simponi (Golimumab) 50 mg without MTX. The presence of MTX also decreased anti-golimumab antibody incidence from 7% to 2% []. For RA, Simponi (Golimumab) should be used with MTX. In the PsA and AS trials, the presence or absence of concomitant MTX did not appear to influence clinical efficacy and safety parameters [].
Population PK analyses indicated that concomitant use of NSAIDs, oral corticosteroids, or sulfasalazine did not influence the apparent clearance of Simponi (Golimumab) .
Population PK analyses showed there was a trend toward higher apparent clearance of Simponi (Golimumab) with increasing weight. However, across the PsA and AS populations, no meaningful differences in clinical efficacy were observed among the subgroups by weight quartile. The RA trial in MTX-experienced and TNF-blocker-naïve patients (Study RA-2) did show evidence of a reduction in clinical efficacy with increasing body weight, but this effect was observed for both tested doses of Simponi (Golimumab) (50 mg and 100 mg). Therefore, there is no need to adjust the dosage of Simponi (Golimumab) based on a patient's weight.
Population PK analyses suggested no PK differences between male and female patients after body weight adjustment in the RA and PsA trials. In the AS trial, female patients showed 13% higher apparent clearance than male patients after body weight adjustment. Subgroup analysis based on gender showed that both female and male patients achieved clinically significant response at the proposed clinical dose. Dosage adjustment based on gender is not needed.
Population PK analyses indicated that PK parameters of Simponi (Golimumab) were not influenced by age in adult patients. Patients with age ≥ 65 years had apparent clearance of Simponi (Golimumab) similar to patients with age
Patients who developed anti-Simponi (Golimumab) antibodies generally had lower steady-state serum trough concentrations of Simponi (Golimumab) .
No formal study of the effect of renal or hepatic impairment on the PK of golimumab was conducted.
Simponi (Golimumab) Clinical Studies
The efficacy and safety of Simponi (Golimumab) were evaluated in 3 multicenter, randomized, double-blind, controlled trials (Studies RA-1, RA-2, and RA-3) in 1542 patients ≥ 18 years of age with moderately to severely active RA, diagnosed according to the American College of Rheumatology (ACR) criteria, for at least 3 months prior to administration of study agent. Patients were required to have at least 4 swollen and 4 tender joints. Simponi (Golimumab) was administered subcutaneously at doses of 50 mg or 100 mg every 4 weeks. Double-blinded controlled efficacy data were collected and analyzed through Week 24. Patients were allowed to continue stable doses of concomitant low dose corticosteroids (equivalent to ≤ 10 mg of prednisone a day) and/or NSAIDs and patients may have received oral MTX during the trials.
Study RA-1 evaluated 445 patients who were previously treated (at least 8 to 12 weeks prior to administration of study agent) with one or more doses of a biologic TNF-blocker without a serious adverse reaction. Patients may have discontinued the biologic TNF-blocker for a variety of reasons. Patients were randomized to receive placebo (n = 150), Simponi (Golimumab) 50 mg (n = 147), or Simponi (Golimumab) 100 mg (n = 148). Patients were allowed to continue stable doses of concomitant MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the trial. The use of other DMARDs including cytotoxic agents or other biologics was prohibited.
Study RA-2 evaluated 444 patients who had active RA despite a stable dose of at least 15 mg/week of MTX and who had not been previously treated with a biologic TNF-blocker. Patients were randomized to receive background MTX (n = 133), Simponi (Golimumab) 50 mg + background MTX (n = 89), Simponi (Golimumab) 100 mg + background MTX (n = 89), or Simponi (Golimumab) 100 mg monotherapy (n = 133). The use of other DMARDs including SSZ, HCQ, cytotoxic agents, or other biologics was prohibited.
Study RA-3 evaluated 637 patients with active RA who were MTX-naïve and had not previously been treated with a biologic TNF-blocker. Patients were randomized to receive MTX (n = 160), Simponi (Golimumab) 50 mg + MTX (n = 159), Simponi (Golimumab) 100 mg + MTX (n = 159), or Simponi (Golimumab) 100 mg monotherapy (n = 159). For patients receiving MTX, MTX was administered at a dose of 10 mg/week beginning at Week 0 and increased to 20 mg/week by Week 8. The use of other DMARDs including SSZ, HCQ, cytotoxic agents, or other biologics was prohibited.
The primary endpoint in Study RA-1 and Study RA-2 was the percentage of patients achieving an ACR 20 response at Week 14 and the primary endpoint in Study RA-3 was the percentage of patients achieving an ACR 50 response at Week 24.
In Studies RA-1, RA-2, and RA-3, the median duration of RA disease was 9.4, 5.7, and 1.2 years; and 99%, 75%, and 54% of the patients used at least one DMARD in the past, respectively. Approximately 77% and 57% of patients received concomitant NSAIDs and low dose corticosteroids, respectively, in the 3 pooled RA trials.
The safety and efficacy of Simponi (Golimumab) were evaluated in a multi-center, randomized, double-blind, placebo-controlled trial in 405 adult patients with moderately to severely active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite NSAID or DMARD therapy (Study PsA). Patients in this study had a diagnosis of PsA for at least 6 months with a qualifying psoriatic skin lesion of at least 2 cm in diameter. Previous treatment with a biologic TNF-blocker was not allowed. Patients were randomly assigned to placebo (n = 113), Simponi (Golimumab) 50 mg (n = 146), or Simponi (Golimumab) 100 mg (n = 146) given subcutaneously every 4 weeks. Patients were allowed to receive stable doses of concomitant MTX (≤ 25 mg/week), low dose oral corticosteroids (equivalent to ≤ 10 mg of prednisone a day), and/or NSAIDs during the trial. The use of other DMARDs including SSZ, HCQ, cytotoxic agents, or other biologics was prohibited. The primary endpoint was the percentage of patients achieving ACR 20 response at Week 14. Placebo-controlled efficacy data were collected and analyzed through Week 24.
Patients with each subtype of PsA were enrolled, including polyarticular arthritis with no rheumatoid nodules (43%), asymmetric peripheral arthritis (30%), distal interphalangeal (DIP) joint arthritis (15%), spondylitis with peripheral arthritis (11%), and arthritis mutilans (1%). The median duration of PsA disease was 5.1 years, 78% of patients received at least one DMARD in the past, and approximately 48% of patients received MTX, and 16% received low dose oral steroids.
The safety and efficacy of Simponi (Golimumab) were evaluated in a multi-center, randomized, double-blind, placebo-controlled trial in 356 adult patients with active ankylosing spondylitis according to modified New York criteria for at least 3 months (Study AS). Patients had symptoms of active disease [defined as a Bath AS Disease Activity Index (BASDAI) ≥ 4 and VAS for total back pain of ≥ 4, on scales of 0 to 10 cm] despite current or previous NSAID therapy. Patients were excluded if they were previously treated with a biologic TNF-blocker or if they had complete ankylosis of the spine. Patients were randomly assigned to placebo (n = 78), Simponi (Golimumab) 50 mg (n = 138), or Simponi (Golimumab) 100 mg (n = 140) administered subcutaneously every 4 weeks. Patients were allowed to continue stable doses of concomitant MTX, sulfasalazine (SSZ), hydroxychloroquine (HCQ), low dose corticosteroids (equivalent to
The primary endpoint was the percentage of patients achieving an ASsessment in Ankylosing Spondylitis (ASAS) 20 response at Week 14. Placebo-controlled efficacy data were collected and analyzed through Week 24.
In Study AS, the median duration of AS disease was 5.6 years, median duration of inflammatory back pain was 12 years, 83% were HLA-B27 positive, 24% had prior joint surgery or procedure, and 55% received at least one DMARD in the past. During the trial, the use of concomitant DMARDs and/or NSAIDs was as follows: MTX (20%), SSZ (26%), HCQ (1%), low dose oral steroids (16%), and NSAIDs (90%).
Simponi (Golimumab) How Supplied/storage And Handling
Each Simponi (Golimumab) prefilled autoinjector or prefilled syringe is packaged in a light-blocking, cardboard outer carton. Simponi (Golimumab) is available in packs of 1 prefilled syringe NDC 57894-070-01 or 1 prefilled SmartJect autoinjector NDC 57894-070-02.
Prefilled SmartJect Autoinjector
Each single dose SmartJect autoinjector contains a prefilled glass syringe (27 gauge ½ inch) providing 50 mg of Simponi (Golimumab) per 0.5 mL of solution.
Prefilled Syringe
Each single dose prefilled glass syringe (27 gauge ½ inch) contains 50 mg of Simponi (Golimumab) per 0.5 mL of solution.
Storage and Stability
Simponi (Golimumab) must be refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use Simponi (Golimumab) beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector.
Simponi (Golimumab) Patient Counseling Information
See FDA-Approved Patient Labeling (
The first self-injection should be performed under the supervision of a qualified healthcare professional. If a patient or caregiver is to administer Simponi (Golimumab) , he/she should be instructed in injection techniques and their ability to inject subcutaneously should be assessed to ensure the proper administration of Simponi (Golimumab) (.
Prior to use, remove the prefilled syringe or the prefilled SmartJect autoinjector from the refrigerator and allow Simponi (Golimumab) to sit at room temperature outside of the carton for 30 minutes and out of the reach of children.
Do not warm Simponi (Golimumab) in any other way. For example, do not warm Simponi (Golimumab) in a microwave or in hot water.
Do not remove the prefilled syringe needle cover or SmartJect autoinjector cap while allowing Simponi (Golimumab) to reach room temperature. Remove these immediately before injection.
Do not pull the autoinjector away from the skin until you hear a first "click" sound and then a second "click" sound (the injection is finished and the needle is pulled back). It usually takes about 3 to 6 seconds but may take up to 15 seconds for you to hear the second "click" after the first "click". If the autoinjector is pulled away from the skin before the injection is completed, a full dose of Simponi (Golimumab) may not be administered.
A puncture-resistant container for disposal of needles and syringes should be used. Patients or caregivers should be instructed in the technique of proper syringe and needle disposal, and be advised not to reuse these items.
Manufactured by:Janssen Biotech, Inc.Horsham, PA 19044US License No. 1864
© Janssen Biotech, Inc. 2011
Simponi (Golimumab)
Simponi (Golimumab)
Simponi (Golimumab)
Simponi (Golimumab)
