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For US healthcare professionals only

Prescribing Information

UC
LIBERTY UC Trial

Safety profile of ZYMFENTRA comparable to placebo1

  • No significant, meaningful difference was seen in the overall safety profile between ZYMFENTRA™ 120 mg and placeboa
  • No new adverse events were identified during treatment with ZYMFENTRA
Safety Profile Uc 1st Table

aReported in at least 3% of ZYMFENTRA-treated subjects and at a higher rate than placebo.

bZYMFENTRA 120 mg administered subcutaneously starting at Week 10 and every 2 weeks thereafter for up to Week 54.

cIncludes: COVID-19 and COVID-19 pneumonia.

dIncludes: anemia and iron deficiency anemia.

eSome subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject. Symptoms in individual subjects included one or more of injection site bruising, edema, erythema, induration, pain, pruritus and swelling.

fIncludes: abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort.

CD
LIBERTY CD Trial

No new safety issues emerged with ZYMFENTRA treatment1

  • No significant, meaningful difference was seen in the overall safety profile between ZYMFENTRA 120 mg and placeboa
Safety Profile Cd 2nd Table

aReported in at least 3% of ZYMFENTRA-treated subjects and at a higher rate than placebo.

bZYMFENTRA 120 mg administered subcutaneously starting at Week 10 and every 2 weeks thereafter for up to Week 54.

cIncludes: upper respiratory tract infection, acute sinusitis, chronic sinusitis, influenza like illness, nasopharyngitis, pharyngitis, pharyngitis streptococcal, rhinitis, rhinorrhea, rhinovirus infection, sinusitis, tonsillitis.

dSome subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject. Symptoms in individual subjects included one or more of injection site bruising, edema, erythema, induration, pain, pruritus, rash, swelling, warmth.

eIncludes: hypertension and essential hypertension.

fIncludes: urinary tract infection, pyelonephritis.

CD=Crohn’s disease; CDAI=Crohn’s Disease Activity Index; IV=intravenous; SES-CD=Simplified Endoscopic Activity Score for Crohn’s Disease; UC=ulcerative colitis.

Reference: 1. ZYMFENTRA™ Prescribing Information, Celltrion, Inc., 2023.

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.