What is Ivosidenib?
Ivosidenib is a drug that targets a gene mutation known as IDH1 and can affect the bone marrow. IDH1 mutations prevent young blood cells from forming into healthy adult cells. This can lead to symptoms of AML (acute myeloid leukaemia).
Ivosidenib should only be used in adults who have an IDH1 mutation. You will be tested by your doctor for this gene. Ivosidenib can be used to treat AML when other treatments have failed or stopped working.
Ivosidenib can also be used to treat AML among adults aged 75 and older with newly diagnosed AML who cannot receive certain chemotherapy treatments due to other health issues. Ivosidenib can also be used to treat bile-duct cancer after other medicines have been tried. Ivosidenib can be used in other ways not mentioned in this guide.
Side effects of Ivosidenib
If you experience any of the following signs and symptoms of an allergic reaction: hives, difficulty breathing, lip or throat swelling and difficulty swallowing; it is wise to seek medical advice immediately: hives; difficulty with your breathing; swelling lips or face or throat swelling or lips/face/tongue erupting in an extreme case (for instance).
Ivosidenib may cause a condition known as differentiation syndrome. This can affect blood cells, and if left untreated, it can be fatal. This condition can occur anywhere from 1 day to 3 months following the start of ivosidenib.
If you experience any of the following symptoms, seek medical assistance immediately:
- A fever, a cough;
- Dizziness;
- Rash;
- Reduced urination
- Rapid weight gain
- Swelling in the arms or legs.
Ivosidenib can cause serious side effects. If you experience:
- Shortness of breath or sudden dizziness.
- Jaundice
- Fluid buildup around the abdomen—rapidly gaining weight, stomach pain, bloating, and difficulty breathing when lying down
- Low red blood cells (anaemia)--pale or pale skin, fatigue, feeling lightheaded, shortness of breath, and cold hands and/or feet
- High white blood cell counts can be accompanied by fever, weakness, bruising or bleeding, nausea, and loss of appetite. Weight loss may also occur.
- Nervous system problems: numbness, pain, or tingling; weakness or burning sensations; vision or hearing difficulties; difficulty breathing.
Should any side effects arise during treatment for cancer, your course of therapy could be altered or cancelled altogether.
Ivosidenib can cause the following side effects:
- Heartbeats irregular;
- Nausea, vomiting, and loss of appetite are symptoms that may accompany stomach pain.
- Diarrhoea, constipation;
- Fever, tiredness;
- Low red blood cell count or high white cell count
- Shortness of breath, cough
- Sores on your tongue or throat
- Rash;
- Abnormal liver function tests
- Joint or muscle pain
- Swelling in the arms or legs.
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Similar/related drugs
Durvalumab, Venclexta, Ventoclax, Azacitidine, Vincristine, Imfinzi, and Cytarabine
Warnings
Ivosidenib may cause a condition known as differentiation syndrome. This can affect blood cells, and if left untreated, it can be fatal. This condition can occur anywhere from 1 day to 3 months following the start of ivosidenib.
If you experience any of the following symptoms: dizziness or nausea, difficulty breathing, swelling, rapid growth, rash or decreased urination, fever and/or headache, coughing, difficulty breathing, difficulty swallowing, difficulty with your breathing, a rapid weight increase, dizziness or nausea, nausea, swelling, rapid weight gain
Before you take this drug
If you have an allergy to ivosidenib, it is best not to use it.
Tell your doctor about any of the following:
- Heart disease
- Long-QT syndrome
- Nervous disorders
- An electrolyte imbalance is a low level of sodium, potassium, or magnesium in the blood.
- Cirrhosis, or other liver diseases
- Kidney disease (or dialysis if you have it)
Can harm an unborn child. Use contraception, and inform your doctor immediately if you fall pregnant.
Ivosidenib may reduce the effectiveness of hormonal birth control, such as birth-control pills, and other forms, such as skin patches, vaginal rings, and injections. Barrier birth control can be used to prevent pregnancy. These include a condom, diaphragm, or cervical cap.
Ivosidenib may reduce the likelihood of pregnancy for either the mother or father. Women who are pregnant should use birth control because ivosidenib can harm the unborn child. Do not breastfeed while taking ivosidenib or for 1 month following your last dose.
How to take Ivosidenib?
Read all instructions or guides that come with your medication and follow all directions. Follow the directions on the label. Do not chew or crush the tablet. Take your medicine every day at the same time, with or without eating.
Ivosidenib should not be stopped or changed without consulting your doctor. Take ivosidenib with plenty of fluids. Ivosidenib should not be taken with high-fat foods such as bacon, butter, cheese, or whole milk.
Do not take another dose if you vomit soon after taking ivosidenib. Do not miss your next scheduled dose. Your heart function may require medical testing. Store at room temperature to avoid heat and moisture damage.
Details on dosage
Adult dose for acute myeloid leukaemia:
Take 500 mg once daily.
Duration of treatment: until disease progression or unacceptable toxicities
Comments:
For patients who do not have disease progression or unacceptable toxicities, the therapy should be continued for at least six months in order to give time for a clinical response.
Combination regimen: This drug should be administered on Cycle 1 Day 1 when combined with Azacitidine. The manufacturer's product information should be consulted for azacitidine.
Uses:
In combination with azacitidine or as monotherapy for newly diagnosed acute myeloid leukaemia with an IDH1 mutation detected by US FDA-approved tests in patients aged 75 years or older or Comorbidities that prevent intensive induction therapyfor the treatment of patients who have relapsed AML or are refractory to it and whose IDH1 mutation has been detected by an FDA-approved US test
Adult dose for cholangiocarcinoma biliary tract:
Take 500 mg once daily.
Duration of treatment: until disease progression or unacceptable toxicities
Use: To treat patients with locally advanced or metastatic cholangiocarcinoma that has been previously treated and has an IDH1 mutant as detected by the US FDA-approved IDH1 test.
What happens if I miss the dose?
If you miss a dose, take it as soon as possible. Skip the missed dose when your next dose is less than 12 hours away. Do not take more than one dose within 12 hours.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
Ivosidenib may cause serious heart problems if it is taken with other medications for asthma, high blood pressure, depression, mental illness, or cancer.
Ivosidenib can be affected by other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the other medications you take.
