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Simponi (Golimumab) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Methotrexate

For the treatment of RA, SIMPONI should be used with methotrexate (MTX) [ see Clinical Studies ]. Since the presence or absence of concomitant MTX did not appear to influence the efficacy or safety of SIMPONI in the treatment of PsA or AS, SIMPONI can be used with or without MTX in the treatment of PsA and AS [ see Clinical Studies and Clinical Pharmacology ].

Biologic Products for RA, PsA, and/or AS

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 with abatacept or anakinra is not recommended [ see Warnings and Precautions (5.5 and 5.6) ]. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF-blocker. There is insufficient information to provide recommendations regarding the concomitant use of SIMPONI and other biologic products approved to treat RA, PsA, or AS.

Live Vaccines

Live vaccines should not be given concurrently with SIMPONI [ see Warnings and Precautions ].

Cytochrome P450 Substrates

The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFalpha) during chronic inflammation. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as golimumab, the formation of CYP450 enzymes could be normalized. Upon initiation or discontinuation of SIMPONI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

OVERDOSAGE

In a clinical study, 5 patients received protocol-directed single infusions of 10 mg/kg of intravenous SIMPONI 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. There were no SIMPONI overdoses in the clinical studies.

CONTRAINDICATIONS

None.

REFERENCES

  1. SEER [database online]. US Population Data — 1969—2004. Bethesda, MD: National Cancer Institute. Release date: January 3, 2007. Available at: http//seer.cancer.gov/popdata/.

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