Simponi SC Injection 50 mg/0.5 ml

Simponi SC Injection 50 mg/0.5 ml Uses, Dosage, Side Effects, Food Interaction and all others data.

Simponi SC Injection 50 mg/0.5 ml 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. Simponi SC Injection 50 mg/0.5 ml 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. The exact mechanism by which golimumab treats ulcerative colitis is unknown. Simponi SC Injection 50 mg/0.5 ml modulated the in vitro 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).

Simponi SC Injection 50 mg/0.5 ml inhibits the activity of the cytokine, tumor necrosis factor alpha (TNFα). In areas such as the joints and blood, increased TNFα is associated with chronic inflammation seen in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Thus golimumab decreases the inflammation in these conditions. Concerning ulcerative colitis, the physiological effects of golimumab has yet to be determined.

Simponi SC Injection 50 mg/0.5 ml
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Simponi SC Injection 50 mg/0.5 ml
Availability	Prescription only
Generic	Golimumab
Golimumab Other Names	Golimumab
Related Drugs	Remicade, Inflectra, Avsola, Renflexis, Entyvio, Humira, Cosentyx, Zeposia, Colazal, aspirin
Weight	50 mg/0.5 ml
Type	SC Injection
Formula	C₆₅₃₀H₁₀₀₆₈N₁₇₅₂O₂₀₂₆S₄₄
Weight	146943.1937 Da
Protein binding	Plasma protein binding was not quantified.
Groups	Approved
Therapeutic Class	Drugs used for Rheumatoid Arthritis
Manufacturer	UniMed UniHealth Pharmaceuticals Ltd.
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

Simponi SC Injection 50 mg/0.5 ml is a tumor necrosis factor (TNF) blocker used for the treatment of adult patients with:

Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
Active ankylosing spondylitis (AS)
Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, achieving and sustaining clinical remission in induction responders

Pediatric Use: Effectiveness of Simponi SC Injection 50 mg/0.5 ml in pediatric patients less than 18 years of age has not been established.

Simponi SC Injection 50 mg/0.5 ml is also used to associated treatment for these conditions: Active Polyarticular Juvenile Idiopathic Arthritis (pJIA), Psoriatic arthritis aggravated, Severe Ulcerative Colitis, Active Ankylosing spondylitis, Moderate Ulcerative colitis, Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis

How Simponi SC Injection 50 mg/0.5 ml works

As a human monoclonal antibody, golimumab binds and inhibits soluble and transmembrane human TNFα. Inhibition of TNFα prevents it binding to its receptors, which prevents both leukocyte infiltration through prevention of cell adhesion proteins such as E-selectin, ICAM-1 and VCAM-1, and pro-inflammatory cytokine secretion such as IL-6, IL-8, G-CSF and GM-CSF in vitro. Consequently, in patients with chronic inflammatory conditions, decreases in ICAM-1 and IL-6 as well as C-reactive protein (CRP), matrix metalloproteinase 3 (MMP-3), and vascular endothelial growth factor (VEGF) were observed.

Dosage

Simponi SC Injection 50 mg/0.5 ml dosage

Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: The Simponi SC Injection 50 mg/0.5 ml dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Simponi SC Injection 50 mg/0.5 ml should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Simponi SC Injection 50 mg/0.5 ml may be given with or without methotrexate or other nonbiologic 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 SC Injection 50 mg/0.5 ml.

Dosage in Moderately to Severely Active Ulcerative Colitis: The recommended Simponi SC Injection 50 mg/0.5 ml induction dosage regimen is a 200-mg subcutaneous injection at Week 0, followed by 100 mg at Week 2, and then maintenance therapy with 100 mg every 4 weeks.

Side Effects

Most common adverse reactions (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions

Toxicity

The FDA label includes a black box warning of serious infections and malignancy. Specifically there have been hospitalizations or death from infections such as bacterial sepsis, tuberculosis (TB), and invasive fungal (histoplasmosis) and other opportunistic infections. Additionally in children and adolescents taking golimumab, there have been lymphoma and other malignancies observed.

Precaution

Serious Infections: Do not start Simponi SC Injection 50 mg/0.5 ml during an active infection. If an infection develops, monitor carefully, and stop Simponi SC Injection 50 mg/0.5 ml if infection becomes serious

Invasive Fungal Infections: For patients who develop a systemic illness on Simponi SC Injection 50 mg/0.5 ml, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic

Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Simponi SC Injection 50 mg/0.5 ml and begin antiviral therapy

Malignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers

Congestive Heart Failure: Worsening, or new onset, may occur. Stop Simponi SC Injection 50 mg/0.5 ml if new or worsening symptoms occur

Demyelinating Disorders: Exacerbation or new onset may occur

Lupus-like Syndrome: Discontinue Simponi SC Injection 50 mg/0.5 ml if symptoms develop

Hypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur

Interaction

Abatacept: Increased risk of serious infection
Anakinra: Increased risk of serious infection
Live vaccines/therapeutic infectious agents: Avoid use with Simponi SC Injection 50 mg/0.5 ml

Food Interaction

No interactions found.

Simponi SC Injection 50 mg/0.5 ml Drug Interaction

Major: methotrexateUnknown: lubiprostone, aspirin, onabotulinumtoxinA, celecoxib, calcium / vitamin d, sulfamethoxazole / trimethoprim, ubiquinone, copper gluconate, duloxetine, aluminum chloride hexahydrate topical, estradiol, omega-3 polyunsaturated fatty acids, multivitamin, glycerin, acetaminophen, bioflavonoids, cyanocobalamin, ascorbic acid, cholecalciferol

Simponi SC Injection 50 mg/0.5 ml Disease Interaction

Major: infections, malignancies, neurologic reactions, tuberculosisModerate: CHF, hematologic abnormalities, hepatitis B

Volume of Distribution

After IV administration, golimumab has a volume of distribution of about 58 to 126 mL/kg. This means that golimumab stays mostly in the circulatory system.

Elimination Route

After subcutaneous administration, golimumab can achieve maximum serum concentrations in 2 to 6 days and has an approximate bioavailability of 53%. In healthy volunteers, the maximum average concentration reached was 3.2 ± 1.4 μg/mL.

Half Life

Simponi SC Injection 50 mg/0.5 ml has a long half-life of about 2 weeks.

Clearance

After one IV dose of golimumab, the systemic clearance was about 4.9 to 6.7 mL/day/kg.

Elimination Route

The route of elimination for golimumab has yet to be determined.

Pregnancy & Breastfeeding use

There are no adequate and well-controlled trials of Simponi SC Injection 50 mg/0.5 ml in pregnant women. There is no information regarding the presence of Simponi SC Injection 50 mg/0.5 ml in human milk, the effects on
breastfed infants, or the effects on milk production.

Storage Condition

Simponi SC Injection 50 mg/0.5 ml must be refrigerated at 2ºC to 8ºC 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