Tibsovo

Tibsovo is a prescription medication used to treat acute myeloid leukemia (AML) which contains a particular gene mutation.

Tibsovo belongs to a group of drugs called small molecule inhibitors and works by inhibiting abnormal forms of an enzyme in the body called isocitrate dehydrogenase-1 (IDH-1).

This medication comes in tablet form and is taken once a day, with or without food. Do not take Tibsovo with a high fat meal. Swallow Tibsovo tablets whole.

Common side effects include feeling tired, joint pain, and diarrhea.

Tibsovo is a prescription medicine used to treat acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in:

• adults with newly diagnosed AML who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments.
• adults with AML 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 Tibsovo is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tibsovo. See the “Tibsovo Precautions” section.

Common side effects of Tibsovo include the following:

• increases in white blood cell count
• diarrhea
• nausea
• redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis)
• constipation
• vomiting
• stomach pain
• feeling tired
• swelling of the arms, legs, hands, or feet
• fever
• chest pain
• abnormal heart rhythm
• decreased appetite
• joint pain
• muscle pain
• headache
• nerve pain
• cough
• difficulty breathing
• fluid buildup in the space between the lungs and the chest cavity (pleural effusion)
• rash
• low blood pressure

This is not a complete list of Tibsovo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• drugs that can cause an arrhythmia called Torsades des Point such as
  • certain anti-arrhythmia medications including
    • procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics including
    • levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics including
    • clarithromycin (Biaxin), erythromycin (EES, others)
  • certain azole antifungals including
    • ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  • certain antidepressants including
    • amitriptyline, desipramine (Norpramin), imipramine (Tofranil), doxepin (Silenor), fluoxetine (Prozac, Sarafem, Symbyax), sertraline (Zoloft), venlafaxine (Effexor XR)
  • certain antipsychotics including
    • haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
  • and other medications including
    • cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig, arsenic trioxide (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)
• birth control pills

This is not a complete list of Tibsovo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tibsovo including the following:

• 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 1 day and up to 3 months after starting Tibsovo. Tell your healthcare provider right away if you have some or all 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
• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Tibsovo. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation:
  • feeling faint
  • lightheadedness
  • dizziness
  • feeling like your heart is beating irregularly or quickly
• Guillain-Barre syndrome. Guillain-Barre syndrome happens when your immune system attacks the part of your nervous system which connects the brain to the rest of your body. Tell your healthcare provider right away if you have some or all of the following symptoms of Guillain-Barre syndrome.
  • 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

Do not take Tibsovo if you:

• are allergic to Tibsovo or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tibsovo, high fat foods should be avoided when taking your Tibsovo dose since it may cause higher amounts of Tibsovo in the blood. Examples of high fat foods include:

• 2 eggs fried in butter
• 2 strips of bacon
• 2 slices of white bread with butter
• 1 croissant with 1 slice of cheese
• 8 ounces of whole milk

Before taking Tibsovo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tibsovo or to any of its ingredients
• 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
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on animal studies, Tibsovo may cause harm to your unborn baby. You should avoid becoming pregnant during treatment with Tibsovo. Tell your doctor right away if you think you might be pregnant while taking Tibsovo.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Tibsovo passes into your breast milk. Do not breastfeed during your treatment with Tibsovo and for at least 1 month after your last dose of Tibsovo.

• Take Tibsovo exactly as your healthcare provider tells you to.

• Do not change your dose or stop taking Tibsovo without talking to your healthcare provider.

• Take Tibsovo 1 time a day about the same time each day.

• Swallow Tibsovo tablets whole. Do not split, crush, or chew the tablet.

• Tibsovo can be taken with or without food.

• Do not take Tibsovo with a high-fat meal. An example of a high-fat meal includes (approximately 1,000 calories and 58 grams of fat).

• If you vomit after taking a dose of Tibsovo, do not take an additional dose. Take your next dose at your usual time.

• If you miss a dose of Tibsovo or did not take it at the usual time, take your dose as soon as possible and at least 12 hours before your next dose. Return to your normal schedule the following day. Do not take 2 doses of Tibsovo within 12 hours.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Tibsovo for the treatment of AML is 500 mg once daily for 6 months or until the disease progresses or the medication is no longer tolerable.

If you take too much Tibsovo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Tibsovo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Tibsovo and all medicines out of the reach of children.

WARNING: DIFFERENTIATION SYNDROME

Patients treated with Tibsovo have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.