KIMMTRAK tebentafusp-tebn Injections for Intravenous Use 100 mcg/0.5ml

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The promising potential to live longer through KIMMTRAK

KIMMTRAK® (tebentafusp-tebn) is the first and only FDA-approved treatment that, in a randomized clinical trial, was proven to significantly extend overall survival for HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

HLA-A, human leukocyte antigen-A.

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The promising potential to live longer through KIMMTRAK

KIMMTRAK® (tebentafusp-tebn) is the first and only FDA-approved treatment that, in a randomized clinical trial, was proven to significantly extend overall survival for HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

HLA-A, human leukocyte antigen-A.

Learn moreRight Arrow

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Ask your doctor if KIMMTRAK is right for you. Learn more.

Proven Results Icon PROVEN RESULTS

KIMMTRAK was proven to extend median overall survival in patients with metastatic uveal melanoma

The largest international, phase 3 trial of 378 HLA-A*02:01–positive adult patients with metastatic uveal melanoma compared KIMMTRAK with investigator’s choice of checkpoint inhibitors (pembrolizumab or ipilimumab) or chemotherapy (dacarbazine).

KIMMTRAK was studied in a phase 3 trial of HLA-A*02:01–positive adult patients with metastatic uveal melanoma

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a Median is the middle number from all patients in the study.

The main result measured was overall survival of all patients in the trial

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KIMMTRAK showed significant* improvement in median overall survival compared to the other treatments studied in the trial (pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01–positive adult patients with metastatic uveal melanoma.

* KIMMTRAK was proven to extend median overall survival by 6 months in patients with metastatic uveal melanoma (21.7 months with KIMMTRAK vs 16.0 months with the other treatments studied). Median is the middle number from all patients in the study.

Mechanism of Action Icon HOW KIMMTRAK WORKS

Harnessing the power of your immune system

KIMMTRAK is a breakthrough new therapy indicated for the treatment of HLA-A*02:01–positive adult patients with uveal melanoma that has spread to other parts of the body or can’t be removed with surgery.

Immunotherapy at work

KIMMTRAK is not chemotherapy or radiation therapy—it is an immunotherapy† treatment designed to mobilize and activate the T cells of your own immune system to fight uveal melanoma tumor cells.‡

KIMMTRAK Immunotherapy Work Flow
Immune System Defination
Immune System Defination Mobile Version
†
Immunotherapy is a type of therapy that works along with your own immune system to help the body fight cancer and other diseases.
‡
KIMMTRAK, like other immunotherapies, has a risk of side effects, some of which are serious. Talk to your doctor to get a full understanding of what to expect when taking KIMMTRAK.
†
Immunotherapy is a type of therapy that works along with your own immune system to help the body fight cancer and other diseases.
‡
KIMMTRAK, like other immunotherapies, has a risk of side effects, some of which are serious. Talk to your doctor to get a full understanding of what to expect when taking KIMMTRAK.
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Knowing your HLA-A*02:01 status helps you and your doctor decide which treatment is right for you—including KIMMTRAK

  • Ask your doctor about a simple blood test to show whether or not you have the HLA-A*02:01 gene
  • Nearly half of adults are HLA-A*02:01 positive, and your status doesn't change over time
  • If you're HLA-A*02:01 positive, you may be eligible for KIMMTRAK, the first and only FDA-approved treatment specifically for adults who have mUM and are HLA-A*02:01 positive

ACT NOW. Request the test.

Dosing and Administration Icon TAKING KIMMTRAK

Once-weekly KIMMTRAK

KIMMTRAK is given once weekly in the form of an IV infusion over 15-20 minutes.

When you receive KIMMTRAK:

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Half Hour Content
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Side effects such as cytokine release syndrome or rash are most likely to occur during the first 3 doses.

Looking to download information about metastatic uveal melanoma and treatment with KIMMTRAK?

Download IconClick to download the patient education brochure

What to expect when taking KIMMTRAK

Knowing what side effects to expect and when they are most likely to occur can help you prepare.

When taking KIMMTRAK, the following side effects are common:

  • Cytokine release syndrome is a serious reaction of the immune system that can be managed with certain medications.
    • Symptoms of cytokine release syndrome may include fever, tiredness or weakness, vomiting, chills, nausea, low blood pressure, dizziness and light-headedness, headache, wheezing and trouble breathing, and rash.
    • In clinical studies, initial symptoms of cytokine release syndrome usually happened within 8 hours after the first dose.
    • In clinical studies, cytokine release syndrome usually happened less often after the first 3 doses.
  • Rash
    • Patients may have itching, swelling, peeling, and/or dry skin.
    • In the studies, most rashes became milder or went away over time.
  • Abnormal liver blood tests
    • Your healthcare provider will do blood tests to check your liver before you start KIMMTRAK and during treatment with KIMMTRAK.

In clinical studies, few patients (3.3%) stopped treatment due to side effects

  • Side effects were generally predictable and could be managed with certain medications.
  • Side effects usually happened less often after the first three doses.

The most common side effects of KIMMTRAK include:

  • cytokine release syndrome
  • rash
  • fever
  • itching
  • tiredness
  • nausea
  • chills
  • stomach pain
  • swelling
  • low blood pressure (symptoms may include dizziness or light-headedness)
  • dry skin
  • headache
  • vomiting
  • abnormal liver blood tests

These are not all the possible side effects of KIMMTRAK; please see the Patient Information for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

Chart
Be sure to tell your
healthcare team about
any side effects you may
experience so they can
help you manage them.
Chart Mobile VersionBe sure to tell your healthcare team about any side effects you may experience so they can
help you manage them.
Download IconClick to download the what to expect brochure

Customer Support Icon PATIENT SUPPORT

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KIMMTRAK CONNECT® is here for you

The KIMMTRAK CONNECT team is here to help you know what to expect and how to manage your treatment experience and to provide encouragement. Every patient is unique. KIMMTRAK CONNECT provides services and support tailored to your specific needs.

Watch this video to learn more about what KIMMTRAK CONNECT has to offer.

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KIMMTRAK CONNECT provides:
Customized supportCustomized support
Financial assistanceFinancial assistance
Help with transportation and schedulingHelp with patient and site of care coordination
You can call KIMMTRAK CONNECT at 844-775-CARE (844-775-2273)

Indication and Important Safety Information Including Boxed Warning

Usage

KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

Important Safety Information

What is the most important information I should know about KIMMTRAK?

KIMMTRAK can cause serious side effects that can be severe or life threatening and usually happen within the first three infusions, including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS may include:
    • fever
    • tiredness or weakness
    • vomiting
    • chills
    • nausea
    • low blood pressure
    • dizziness and light-headedness
    • headache
    • wheezing and trouble breathing
    • rash

Tell your healthcare provider right away if you get any of these symptoms. Your healthcare provider will check for these problems during treatment with KIMMTRAK. Your healthcare provider may temporarily stop or completely stop your treatment with KIMMTRAK if you have severe side effects.

See "KIMMTRAK can cause other serious side effects" for more information.

Before receiving KIMMTRAK, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. KIMMTRAK may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with KIMMTRAK.
      For females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start treatment with KIMMTRAK.
    • Use an effective form of birth control during treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.
  • are breastfeeding or plan to breastfeed. It is not known if KIMMTRAK passes into your breast milk. Do not breastfeed during the treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

KIMMTRAK can cause other serious side effects, including:
  • Skin reactions. KIMMTRAK may cause skin reactions that require treatment. Tell your healthcare provider if you get symptoms of skin reactions—such as rash, itching, or skin swelling—that are severe and do not go away.
  • Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start KIMMTRAK and during treatment with KIMMTRAK. Tell your healthcare provider if you get symptoms of liver problems such as right-sided abdominal pain or yellowing of the skin or eyes.
The most common side effects of KIMMTRAK include:
  • cytokine release syndrome (CRS)
  • rash
  • fever
  • itching
  • tiredness
  • nausea
  • chills
  • stomach pain
  • swelling
  • low blood pressure (symptoms may include dizziness or light-headedness)
  • dry skin
  • headache
  • vomiting
  • abnormal liver blood tests

These are not all the side effects possible with KIMMTRAK.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

Please read the accompanying Patient Information Leaflet before you receive KIMMTRAK and discuss any questions you have with your healthcare provider.

Please see KIMMTRAK Patient Information.

Important Safety Information Including
Boxed Warning

What is the most important information I should know about KIMMTRAK?
KIMMTRAK can cause serious side effects that can be severe or life threatening and usually happen within the first three infusions, including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS may include:

Usage

KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.