Brand Name
Simponi
Generic Name
Golimumab
View Brand Information FDA approval date: April 25, 2009
Classification: Tumor Necrosis Factor Blocker
Form: Injection, Solution
What is Simponi (Golimumab)?
SIMPONI ARIA is a tumor necrosis factor blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis in combination with methotrexate.
Approved To Treat
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Brand Information
SIMPONI ARIA (golimumab)
1DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/4 mL (12.5 mg/mL) colorless to light yellow solution in a single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The most serious adverse reactions were:
- Serious Infections
- Malignancies
3.1Clinical Trials Experience
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 one, randomized, double-blind, controlled Phase 3 trial in patients with RA receiving SIMPONI ARIA by intravenous infusion (Trial RA). The protocol included provisions for patients taking placebo to receive treatment with SIMPONI ARIA at Week 16 or Week 24 either by patient response (based on uncontrolled disease activity) or by design, so that adverse events cannot always be unambiguously attributed to a given treatment. Comparisons between placebo and SIMPONI ARIA were based on the first 24 weeks of exposure.
Trial RA included 197 control-treated patients and 463 SIMPONI ARIA-treated patients (which includes control-treated patients who switched to SIMPONI ARIA at Week 16). The proportion of patients who discontinued treatment due to adverse reactions in the controlled phase of Trial RA through Week 24 was 3.5% for SIMPONI ARIA-treated patients and 0.5% for placebo-treated patients. Upper respiratory tract infection was the most common adverse reaction reported in the trial through Week 24 occurring in 6.5% of SIMPONI ARIA-treated patients as compared with 7.6% of control-treated patients, respectively.
3.2Immunogenicity
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. 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
3.3Postmarketing Experience
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 [see
Neoplasm benign and malignant: Melanoma, Merkel cell carcinoma [see
Immune system disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction) [see , sarcoidosis
Respiratory, thoracic and mediastinal disorders: Interstitial lung disease
Skin and subcutaneous tissue disorders: Skin exfoliation, lichenoid reactions, bullous skin reactions
4OVERDOSAGE
In a clinical study, 5 patients received single infusions of up to 1000 mg of SIMPONI ARIA without serious adverse reactions or other significant reactions.
5DESCRIPTION
Golimumab is a human IgG1қ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. 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 ARIA
SIMPONI ARIA is a preservative-free, colorless to light yellow solution with a pH of approximately 5.5. SIMPONI ARIA is not made with natural rubber latex. Each 4-mL vial of SIMPONI ARIA contains 50 mg golimumab, L-histidine (1.14 mg), L-histidine monohydrochloride monohydrate (6.42 mg), polysorbate 80 (0.6 mg), sorbitol (180 mg), and water for injection.
6HOW SUPPLIED/STORAGE AND HANDLING
SIMPONI ARIA
7PATIENT COUNSELING INFORMATION
See
Advise patients of the potential benefits and risks of SIMPONI ARIA. Instruct patients to read the Medication Guide before starting SIMPONI ARIA therapy and to read it each time the prescription is renewed.
8PRINCIPAL DISPLAY PANEL - 4 mL Vial Carton
NDC 57894-350-01
Simponi ARIA
50 mg/4 mL
(12.5 mg/mL)
(12.5 mg/mL)
For intravenous infusion
Single-dose vial.
Provide the enclosed Medication
