Possible Side Effects

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Possible
side effects

WITH VORANIGO^®

VORANIGO MAY CAUSE SERIOUS SIDE EFFECTS

Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO.

Tell your healthcare provider right away if you develop any of the following signs and symptoms of serious liver problems:

yellowing of your skin or the white part of your eyes (jaundice)
dark tea-colored urine
loss of appetite
pain on the upper right side of your stomach area
feeling very tired or weak

The most common side effects of VORANIGO include:

increased liver enzyme levels in the blood
lack of energy, tiredness
headache
COVID-19
muscle aches or stiffness
diarrhea
nausea
seizure

People taking the placebo in the INDIGO trial experienced similar rates of tiredness, headaches, COVID-19, and seizures.

Find information TO HELP YOU PLAN FOR YOUR TREATMENT JOURNEY WITH VORANIGO.

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Safety monitoring DURING VORANIGO TREATMENT IS IMPORTANT

Baseline blood tests

Before taking VORANIGO, your doctor will take a sample of your blood to check your blood counts and liver enzyme levels. This will be your baseline your doctor will compare with your other bloodwork during treatment.

Treatment adjustments

Some side effects may require you to temporarily stop treatment, take a lower dose of medication, or stop treatment altogether.

Pausing treatment

Dosage interruptions of VORANIGO due to an adverse reaction occurred in 30% of patients. 90% of these patients were able to resume treatment.

Things to know
ABOUT MONITORING AND TREATMENT WHILE TAKING VORANIGO

Before your doctor initiates VORANIGO, they will:

Take a sample of your blood to check your blood count and liver enzyme levels
If you are of childbearing age, make sure you are not pregnant

After you start VORANIGO, your doctor will take a sample of your blood about every 2 weeks. This will happen for the first 2 months of your treatment.

After that, your doctor will take another blood sample about once a month for the next 2 years while you are taking VORANIGO. Your doctor may decide to take blood samples more or less frequently depending on your results.

Your personal monitoring schedule can vary based on your glioma and how your body response to VORANIGO. Healthcare providers use follow-up visits to:

Assess your bloodwork and liver functions

Ask about possible side effects

Perform an MRI of your brain

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A PATIENT TAKING VORANIGO

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HELPFUL VORANIGO RESOURCES AND SUPPORT

Important Safety Information

What is VORANIGO?

VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.

What are the possible side effects of VORANIGO?

VORANIGO may cause serious side effects, including:

Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark tea-colored urine
- loss of appetite
- pain on the upper right side of your stomach area
- feeling very tired or weak

What is VORANIGO?

What are the possible side effects of VORANIGO?

VORANIGO may cause serious side effects, including:

Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark tea-colored urine
- loss of appetite
- pain on the upper right side of your stomach area
- feeling very tired or weak

The most common side effects of VORANIGO include:

increased liver enzyme levels in the blood
lack of energy, tiredness
headache
COVID-19
muscle aches or stiffness
diarrhea
nausea
seizure

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VORANIGO if you have certain side effects.

VORANIGO may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of VORANIGO.

Before taking VORANIGO, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have kidney problems or are on dialysis
smoke tobacco
are pregnant or plan to become pregnant. VORANIGO can harm your unborn baby

Females who are able to become pregnant:

Your healthcare provider will do a pregnancy test before you start treatment with VORANIGO
You should use effective nonhormonal birth control during treatment with VORANIGO and for 3 months after the last dose. VORANIGO may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VORANIGO
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VORANIGO

Males with female partners who are able to become pregnant:

You should use effective birth control during treatment with VORANIGO and for 3 months after the last dose
Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with VORANIGO

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if VORANIGO passes into breast milk. Do not breastfeed during treatment with VORANIGO and for 2 months after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VORANIGO may affect the way other medicines work, and other medicines may affect how VORANIGO works.

Please see Full Prescribing Information.

WITH VORANIGO®