INDICATION & IMPORTANT SAFETY INFORMATION
INDICATION
TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Accidental exposure of TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients.
Herpetic infection or reactivation: Patients with suspected herpetic infections should contact their healthcare provider for assessment and antiviral treatment of the suspected herpetic infection as clinically warranted.
Injection procedure complications: Complications related to injection procedure have occurred, including hemorrhage, infection, and visceral injury. Patients should be monitored for signs and symptoms of visceral injury (eg, pneumothorax) during and after TUDRIQEV administration and managed according to clinical practice.
Immune-mediated events: In clinical studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo have been reported in patients treated with TUDRIQEV and nivolumab.
Adverse Reactions
Most common non-laboratory adverse reactions reported in more than 10% of patients were fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.
Serious adverse reactions occurring in >1% patients include pleural effusion (n=3), acute kidney injury (n=2), arthralgia (n=2), atrial fibrillation (n=2), atrial flutter (n=2), cancer pain (n=2), hypophysitis (n=2), immune-mediated enterocolitis (n=2), pyrexia (n=2), sepsis (n=2), urinary tract infection (n=2), and myocardial infarction (n=2). Serious adverse reactions leading to death include myocardial infarction (n=1) and multiple organ dysfunction (n=1).
Drug interactions
Patients receiving systemic antiviral treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy.
Special Populations
Advise females and males of reproductive potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the last dose.
Please report any adverse event or product quality complaint related to a Replimune product by calling 1-877-375-0095.
Please see full Prescribing Information.
