NOW APPROVED

FIRST AND ONLY ONCOLYTIC VIRAL THERAPY
USED WITH NIVOLUMAB

as an immunotherapy regimen
for adults with advanced melanoma

TUDRIQEV (pronounced “TOO-drih-kev”)

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Indication and Important Safety Information

Indication

TUDRIQEV Is:
Used with nivolumab to treat adults with advanced melanoma who have previously received an anti-PD-1-based regimen.

Important Safety Information

Warnings:

Avoid touching or scratching the injection sites and dressing to prevent the transfer of TUDRIQEV. You or your caregiver should always wear gloves when replacing or changing your injection site dressings.
TUDRIQEV may cause a new or reactivation of the common cold sore (herpes simplex virus, type 1). If you develop a cold sore after treatment with TUDRIQEV, contact your doctor to provide a swab for testing. You may also call TUDRIQEV Medical Information for guidance at 1-877-375-0095.
Injections of TUDRIQEV into tumors in your liver, lung or other organs may cause injury that requires further monitoring or treatment.

Serious side effects:

TUDRIQEV may cause serious side effects. Call your healthcare provider right away if you develop any of the following signs and symptoms:

Joint pain
Headache, vision changes, dizziness or tiredness, which may be signs of inflammation of the pituitary gland
Abdominal pain, cramping, diarrhea, nausea
Fever

Drug Interactions

Tell your doctor if you have received antiviral medicine such as acyclovir. TUDRIQEV might not be effective if given within 72 hours of these medicines.

Special Population

Both men and women should use effective birth control during treatment and for 90 days after the last TUDRIQEV injection. Talk to your healthcare provider for more information.

Tell your health care provider:

If you are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment and for 90 days after your last injection of TUDRIQEV.
If you are pregnant or plan to become pregnant. For women, your healthcare provider should advise you to take a pregnancy test before starting your TUDRIQEV treatment.
If you become pregnant during your TUDRIQEV treatment.
About all the medications you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Common Side Effects:

The most common side effects of TUDRIQEV with nivolumab treatment include:

Tiredness
Chills
Diarrhea
Infection
Joint or muscle pain
Fever
Nausea
Injection Site Reactions (redness, pain, or swelling)
Flu-like illness or symptoms

These are not all of the possible side effects of TUDRIQEV. Call your health care provider if you have side effects that worsen or do not go away. You may also report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Directions for Use

TUDRIQEV is given by your healthcare provider and is not self-administered. After injection, keep the injection site(s) covered for at least 48 hours.

Herpetic infections or reactivations were observed in the clinical trials. Promptly report any suspected cold sores or herpetic infection (herpes simplex virus, type 1), such as blisters or sores on any part of your body. Contact your doctor or call Replimune Medical Information at 1-877-375-0095. You will be provided a free swab sample collection kit to be returned for testing.

Call your health care provider if you have side effects that worsen or do not go away. You may also report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.