Taking KIMMTRAK
Starting KIMMTRAK
How will I receive KIMMTRAK?
KIMMTRAK will be given to you by intravenous (IV) infusion, meaning into your vein, for 15 to 20 minutes.
How often will I receive KIMMTRAK?
KIMMTRAK is given weekly. Your dose should increase over the first three visits so your body has a chance to get used to KIMMTRAK. This also aims to reduce your risk of side effects. After these first three visits, your doses will likely remain the same and may be referred to as maintenance doses. Your doctor will decide how many treatments you need.
Why do I need to receive KIMMTRAK every week?
To maximize your opportunity to experience the survival benefit seen in the clinical trial, you must receive KIMMTRAK weekly, as prescribed.
In the clinical trial, patients could miss up to two infusions without an impact on the effectiveness.
Click here for definitions of important terms
you’ll find throughout this website.
Step-up dose and monitoring schedule
The starting dose is 20 mcg for week 1. The dose increases to 30 mcg for week 2
and 68 mcg for week 3 and beyond.
- * If patient has not had a grade 2 (moderate, severe, or life threatening) cytokine release syndrome side effect with their previous dose.
- † If patient has not had low blood pressure that required medical intervention with their most recent dose.
- ‡ The recommendations above are based on the clinical trial protocol. Your doctor may adjust what to monitor and at what frequency.
The first 3 doses
What can I expect when I receive KIMMTRAK?
KIMMTRAK can cause side effects that can be very serious and require management by a healthcare provider. In the clinical trial, side effects related to KIMMTRAK, such as cytokine release syndrome (CRS) and rash, were generally predictable (expected to occur), able to be managed, and usually happened during the first few doses.
To manage potential side effects, your doctor may give you IV fluids, medicine, or supplemental oxygen. You will be monitored during and after your infusion so any side effects can be treated as soon as possible.
Before your infusion, your doctor may adjust your other medications.
Monitoring after the first 3 doses
How can I prepare for my first 3 treatments?
Talk to your care team to find out what to expect when you get your infusion. It is helpful to make a list of questions you may have ahead of time so you can be fully prepared.
While the infusion time for KIMMTRAK is approximately 15 to 20 minutes, you will need to be observed for at least 16 hours following each of the first 3 doses. Planning is especially important for the first few weeks. You might want to bring the following:
A book, audio book, iPad, laptop, or whatever helps you pass the time or get some work done. Remember chargers for electronic devices.
Wear comfortable clothes so you can feel relaxed. Avoid tight-fitting clothes that may rub against your skin. Don’t wear jewelry, a watch, or anything else that may be irritating if you have a skin reaction.
A snack and something to drink.
If allowed by the infusion facility, bring someone with you to keep you company.
Your own blanket or sweater from home in case you feel cold.
Will I still have side effects after my maintenance doses?
Although side effects happen less frequently after the first few doses, they may still occur following maintenance doses. The most common side effects that occurred in the clinical trial included CRS, rash, fever, itching, tiredness, nausea, chills, stomach pain, swelling, low blood pressure (symptoms may include dizziness or light-headedness), dry skin, headache, vomiting, and abnormal liver blood tests.
Monitoring after maintenance doses
- Your vital signs (temperature, heart rate, breathing rate, and blood pressure) will be taken at least twice after each infusion.
Note: If you did not tolerate KIMMTRAK well and experienced more side effects than anticipated, you may need to be monitored longer.
You may be able to move to an infusion center in your community to receive your weekly treatment.
- An infusion center closer to home may be more convenient to you and anyone who helps you with your treatments.
- Talk to your healthcare team to see if this is an option for you.
You may feel tired or fatigued after each infusion as your immune system becomes activated.
- Until you know how you will feel after each infusion, you may not want to make plans.
- Tell those who count on you that you may need extra rest.
In the clinical trial primary analysis, 3.3% (8 out of 245) of
patients stopped taking KIMMTRAK due to treatment-related
side effects.
Your scans may not present the whole picture
- With immunotherapies, including KIMMTRAK, it is possible that tumors may not shrink, but stay the same or even appear larger on scans.
- Your doctor may determine that you are receiving benefit from the treatment based on not only your scans, but also how you are feeling, and other assessments of your overall health.
Questions to ask your doctor
Consider discussing the following questions with your doctor to help determine if KIMMTRAK may be the right treatment for you:
Thinking about KIMMTRAK?
- Am I a candidate for KIMMTRAK?
- Could KIMMTRAK help me live longer?
- What are the possible side effects and safety considerations of KIMMTRAK?
- How soon can I start KIMMTRAK?
Where will I go to receive KIMMTRAK?
- Which healthcare professionals will oversee my treatment?
- Who do I contact with questions and/or concerns?
- What can I expect at the treatment center?
What to expect when taking KIMMTRAK
Indication
Important Safety Information Including Boxed Warning
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.
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:
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.
