Симпони

Uses

Симпони 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

Симпони 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 Симпони 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

Симпони dosage

Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: The Симпони dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Симпони should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Симпони 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 Симпони.

Dosage in Moderately to Severely Active Ulcerative Colitis: The recommended Симпони 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 Симпони during an active infection. If an infection develops, monitor carefully, and stop Симпони if infection becomes serious

Invasive Fungal Infections: For patients who develop a systemic illness on Симпони, 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 Симпони 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 Симпони if new or worsening symptoms occur

Demyelinating Disorders: Exacerbation or new onset may occur

Lupus-like Syndrome: Discontinue Симпони 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 Симпони

Food Interaction

Симпони 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

Симпони 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

Симпони 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 Симпони in pregnant women. There is no information regarding the presence of Симпони in human milk, the effects on
breastfed infants, or the effects on milk production.

Storage Condition

Симпони 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

Innovators Monograph

You find simplified version here Симпони