Identifying and Managing Side Effects
If you think you may be experiencing any side effects while taking TALZENNA, be sure to tell your healthcare provider right away. Depending on your symptoms, your healthcare provider may adjust your dose or tell you to stop taking TALZENNA.
Your healthcare provider may also share tips that may help you manage your side effects. Do not change your dose or stop taking TALZENNA without first talking with your healthcare provider.
It’s important to remember that everyone responds to treatment differently, so you may or may not experience some of the side effects described here.
Serious side effects
TALZENNA may cause serious side effects, including: Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).
Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with TALZENNA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with TALZENNA.
Symptoms of low blood cell counts are common during treatment with TALZENNA, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with TALZENNA:
- weight loss
- frequent infections
- blood in urine or stool
- shortness of breath
- feeling very tired
- bruising or bleeding more easily
Monitoring Your Therapy and Side Effects
Your healthcare provider will take blood tests to check your blood cell counts:
- before treatment with TALZENNA
- every month during treatment with TALZENNA
- weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with TALZENNA until your blood cell counts improve
Common Side Effects
The most common side effects of TALZENNA include tiredness or weakness, low number of red or white blood cells, nausea, low number of platelets, headache, loss of appetite, diarrhea, vomiting, and hair loss.
These are not all of the possible side effects of TALZENNA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Managing Side Effects
Here you can find some helpful tips to manage common TALZENNA side effects. Please note that these tips are not specific to TALZENNA. You should consult your healthcare provider before making any changes to your diet or exercise routine.
During treatment, you go through a lot. Patients taking TALZENNA may experience tiredness or weakness. In addition to the instructions provided by your healthcare team, these tips may help manage your symptoms:
- Build a balanced schedule to make sure you are keeping active while still getting enough rest
- Eat well and drink plenty of fluids
- Find support groups that are designed to help you manage stress and work through situations—mental and physical—that can contribute to making you tired
TALZENNA can cause the number of white blood cells to decrease (neutropenia), putting you at risk for infection. Stress, poor nutrition, and lack of sleep may also increase your risk of infection.
Some steps you can take to protect yourself against infection during treatment are:
- Washing your hands often
- Following food safety guidelines
- Minimizing exposure to people who might be sick or who have recently had a live vaccine
Your healthcare team should check your white blood cell counts before and during treatment. If you experience symptoms, like fever, tell your doctor right away.
Patients taking TALZENNA may experience nausea and vomiting, which can lead to loss of appetite, malnourishment, and dehydration. If you’re feeling nauseated or are vomiting, it’s best to talk to your healthcare team.
In addition to your healthcare team’s instructions, following these tips may help you feel better:
- Try to eat 5 or 6 small meals a day instead of 3 large ones
- Because dehydration may contribute to nausea, sip water throughout the day
- Consider relaxation techniques, such as deep breathing
Platelets are cells that help your blood clot and stop bleeding. When taking TALZENNA, you may also have low blood-platelet counts (thrombocytopenia), which may cause bruising and bleeding.
If you develop thrombocytopenia during treatment, these tips may help you manage some symptoms:
- Be careful when taking over-the-counter medicines, such as aspirin, that can increase your risk of bleeding
- Moisturize with lotion and lip balm to keep skin from cracking
Make sure to tell your doctor if you notice abnormal bruising or bleeding while taking TALZENNA.
Different types of headaches can be common when you have cancer. Patients taking TALZENNA may experience headaches. Consider keeping track of your headaches—when they happen, how long they last, and what triggers them. This may help your doctor assess the type and cause of your headache.
In addition to what your doctor recommends, it’s also important to:
- Get enough sleep
- Eat well
- Find activities that can help you reduce stress
Starting and Taking TALZENNA
TALZENNA is a convenient once-daily oral treatment. The recommended TALZENNA starting dose is a 1-mg, once-daily capsule, taken with or without food. TALZENNA is also available in 0.25-mg capsules to facilitate dose reductions. While you’re taking TALZENNA, your healthcare provider will monitor you and may adjust or stop your dose of TALZENNA if you experience certain side effects.
Please see Important Safety Information to learn more.
What to Tell Your Healthcare Provider Before You Start TALZENNA
Before taking TALZENNA, tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems
- are pregnant or plan to become pregnant. TALZENNA can harm your unborn baby, and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with TALZENNA. Tell your healthcare provider right away if you are pregnant or become pregnant during treatment with TALZENNA - If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with TALZENNA - Females who are able to become pregnant should use effective birth control during treatment with TALZENNA and for at least 7 months after receiving the last dose of TALZENNA. Talk to your healthcare provider about forms of birth control that may be right for you - Males with female partners who are pregnant or are able to become pregnant should use effective birth control during treatment with TALZENNA and for at least 4 months after receiving the last dose of TALZENNA
- are breastfeeding or plan to breastfeed. It is not known if TALZENNA passes into your breast milk. Do not breastfeed during treatment with TALZENNA and for at least 1 month after receiving the last dose of TALZENNA. Talk to your healthcare provider about the best way to feed your baby during this time
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Taking TALZENNA and certain other medicines can affect how TALZENNA works and may cause side effects. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
HOW TO TAKE TALZENNA
Take TALZENNA exactly as your healthcare provider tells you to.
Do not change your dose or stop taking TALZENNA without first talking with your healthcare provider.
Take TALZENNA 1 time a day.
Take TALZENNA with or without food.
Swallow TALZENNA capsules whole. Do not dissolve or open TALZENNA capsules.
Your healthcare provider may change your dose of TALZENNA or tell you to stop taking TALZENNA depending on how you respond to treatment.
If you miss a dose of TALZENNA or vomit, take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.
If you take too much TALZENNA, call your healthcare provider or go to the nearest hospital emergency room right away.
Where can i get talzenna?
You can get TALZENNA through certain specialty pharmacy providers (SPPs). These pharmacies handle medicines that are often not stocked at regular neighborhood pharmacies. Your doctor's office can help you find an SPP that works with your insurance.
TALKING TO YOUR DOCTOR
It’s important to partner with your healthcare provider throughout the process to determine the treatment plan that is right for you. If you are considering or have been prescribed TALZENNA, you may want to ask your doctor the following questions during your next conversation.
- How will I know if TALZENNA is working?
- What are the potential side effects I may experience while taking TALZENNA?
- What's the best way to notify you if I experience side effects?
- How often will I need to come in for exams or monitoring while taking TALZENNA?
- Will I have to make any lifestyle changes?
- What support resources are available for myself and my family?
- What are my next steps?