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Prescribing Information

IFX SC offers more consistent steady-state levels than IFX IV1

Theoretical pharmacokinetic advantages and disadvantages between IFX IV and IFX SC

Theoretical IV vs Sc Pk Profile

With IV, drug levels peak rapidly and then gradually decline1

  • Rapid fluctuations in drug concentration associated with IV administration may trigger immune responses due to the abrupt
    changes in exposure to the drug
  • On the other hand, the immediacy and magnitude of peak concentrations after IFX IV may be the most relevant
    pharmacokinetic parameters for inducing remission in acute severe UC or complex CD, including perianal CD

With SC, release of the drug is gradual and sustained1

  • SC offers a smoother PK profile with drug level stability, contrasting with the peak and trough concentrations in IV therapy
  • This stability may prevent low trough levels tied to IFX IV, reducing immunogenicity and helping to ensure treatment
    persistence
UC

LIBERTY UC Trial

ZYMFENTRA maintained elevated, steady and stable, IFX trough levels in patients with UC2

  • Post-Week 10, serum concentrations in the ZYMFENTRA™ group rose until Week 14 and stayed stable through Week 54 due to biweekly dosing
  • During the SC maintenance phase, mean range (CV%) of observed trough was 14.6 to 16.3 μg/mL in the ZYMFENTRA group

– This is well above the minimum therapeutic threshold of 3 μg/mL and above the >7 μg/mL associated with mucosal healing

Mean IFX serum concentration in patients with UC

Liberty UC Mean IFX

Study Note: From Week 0 through Week 10, patients were in the induction phase with IFX IV. In the treatment group, post-Week 10, patients were given ZYMFENTRA for maintenance. During Week 22 through Week 54, dose adjustments were allowed for patients who initially responded but then lost response according to the loss of response criteria.

Current evidence does not establish a direct correlation between the pharmacokinetic attributes of ZYMFENTRA and its clinical efficacy. The prognostic relevance of serum drug concentrations should be interpreted within the complete clinical context, not as the sole predictor of therapeutic outcomes.

CD

LIBERTY CD Trial

ZYMFENTRA maintained elevated, steady and stable, IFX trough levels in patients with CD2

  • Post-Week 10, serum concentrations in the ZYMFENTRA group rose until Week 14 and stayed stable through Week 54 due to biweekly dosing
  • During the SC maintenance phase, mean range (CV%) of observed trough was 13.3 to 14.8 μg/mL in the ZYMFENTRA group

– This is well above the minimum therapeutic threshold of 3 μg/mL and above the >7 μg/mL associated with mucosal healing

Mean IFX serum concentration in patients with CD

Liberty CD Mean IFX

Study Note: From Week 0 through Week 10, patients were in the induction phase with IFX IV. In the treatment group, post-Week 10, patients were given ZYMFENTRA for maintenance. During Week 22 through Week 54, dose adjustments were allowed for patients who initially responded but then lost response according to the loss of response criteria.

Current evidence does not establish a direct correlation between the pharmacokinetic attributes of ZYMFENTRA and its clinical efficacy. The prognostic relevance of serum drug concentrations should be interpreted within the complete clinical context, not as the sole predictor of therapeutic outcomes.

CD=Crohn’s disease; CV%=coefficient of variation (standard deviation as a percentage of the mean); IFX=infliximab; IV=intravenous; SC=subcutaneous; UC=ulcerative colitis; W=week.

References: 1. Little RD, Ward MG, Wright E, et al. Therapeutic drug monitoring of subcutaneous infliximab in inflammatory bowel disease—understanding pharmacokinetics and exposure response relationships in a new era of subcutaneous biologics. J Clin Med. 2022;11(20):6173 doi: 10.3390/jcm11206173 2. Data on file. Celltrion, Inc.

Important Safety Information

WARNING: SERIOUS INFECTIONS and MALIGNANCY

Contraindications

Warnings and Precautions

Common Adverse Reactions (≥3%)

Drug Interactions

For more information, see full Prescribing Information including BOXED WARNING.