FDA approves Tibsovo
drugs.com
The U.S. Food and Drug Administration has approved Tibsovo (ivosidenib), an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with relapsed or refractory acute myeloid leukemia with an IDH1 mutation.
Important information
Tibsovo may cause serious side effects, including:
Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as one day and up to three months after starting Tibsovo. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome:
fever
cough
trouble breathing
rash
decreased urination
dizziness or lightheadedness
rapid weight gain
swelling of your arms or legs
If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine or a medicine called hydroxyurea and may monitor you in the hospital.
Tibsovo is a prescription medicine used to treat adults with acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-1 (IDH1) mutation:
when the disease has come back, or has not improved after previous treatment(s).
Your healthcare provider will perform a test to make sure that Tibsovo is right for you.
It is not known if this medicine is safe and effective in children.
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
have any heart problems, including a condition called long QT syndrome.
have problems with abnormal electrolytes, such as sodium, potassium, or magnesium levels.
have nervous system problems.
are pregnant or plan to become pregnant. Tibsovo may cause harm to your unborn baby. You should avoid becoming pregnant during treatment. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.
are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during your treatment, and for at least one month after your last dose.
Tibsovo side effects
Tibsovo may cause serious side effects, including:
Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during your treatment. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
Guillain-Barr syndrome has happened in people treated with Tibsovo. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment if you develop Guillain-Barr syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barr syndrome, including:
weakness or tingling feeling in your legs, arms, or upper body
numbness and pain on one side or both sides of your body
any changes in your ability to see, touch, hear, or taste
burning or prickling sensation
difficulty breathing
The most common side effects include:
fatigue
high white blood cell count
joint pain
diarrhea
shortness of breath
swelling of arms or legs
nausea
pain or sores in your mouth or throat
irregular heart rhythm or heartbeat (QTc prolongation)
fever
cough
low red blood cell count (anemia)
constipation
Your healthcare provider will do blood tests before you start and during treatment with Tibsovo. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment if you develop side effects.
Tibsovo may cause fertility problems in females and males, which may affect your ability to have children.
