Gilteritinib

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About This Drug

Gilteritinib is used to treat cancer. It is given orally (by mouth).

Possible Side Effects

  • Nausea and vomiting (throwing up)
  • Soreness of the mouth and throat. You may have red areas, white patches, or sores in your mouth that hurt.
  • Diarrhea (loose bowel movements)
  • Tiredness
  • General discomfort, a feeling of being unwell
  • Fever
  • Swelling of your legs, ankles and/or feet
  • Changes in your liver function
  • Joint, muscle and bone pain
  • Feeling dizzy
  • Headache
  • Pneumonia
  • Trouble breathing
  • Cough
  • Rash
  • Low blood pressure

Note: Each of the side effects above was reported in 20% or greater of patients treated with gilteritinib. Not all possible side effects are included above.

Warnings and Precautions

  • Changes in your central nervous system can happen. The central nervous system is made up of your brain and spinal cord. You could feel extreme tiredness, agitation, confusion, have hallucinations (see or hear things that are not there), trouble understanding or speaking, loss of control of your bowels or bladder, eyesight changes, numbness or lack of strength to your arms, legs, face, or body, seizures or coma. If you start to have any of these symptoms let your doctor know right away.
  • Abnormal heartbeat/EKG
  • Inflammation of your pancreas

Note: Some of the side effects above are very rare. If you have concerns and/or questions, please discuss them with your medical team.

How to Take Your Medication

  • Swallow the medicine whole with or without food. Do not break or crush tablets.
  • Take this medicine at approximately the same time each day.
  • Missed dose: If you miss a dose, and it is less than 12 hours until your next dose, then skip the missed dose and go back to your normal schedule. If you miss a dose, and it is more than 12 hours  until your next dose, take the missed dose. Do not take 2 doses within 12 hours. Do not take 2 doses at the same time or extra doses. Do not replace a vomited dose. If you vomit a dose or miss a dose, contact your doctor.
  • Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
  • Storage: Store this medicine in the original container at room temperature.
  • Disposal of unused medicine: Do not flush any expired and/or unused medicine down the toilet or drain unless you are specifically instructed to do so on the medication label. Some facilities have take-back programs and/or other options. If you do not have a take-back program in your area, then please discuss with your nurse or your doctor how to dispose of unused medicine.

Treating Side Effects

  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • Mouth care is very important. Your mouth care should consist of routine, gentle cleaning of your teeth or dentures and rinsing your mouth with a mixture of 1/2 teaspoon of salt in 8 ounces of water or 1/2 teaspoon of baking soda in 8 ounces of water. This should be done at least after each meal and at bedtime.
  • If you have mouth sores, avoid mouthwash that has alcohol. Also avoid alcohol and smoking because they can bother your mouth and throat.
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help or stop lessen these symptoms.
  • If you throw up or have diarrhea, you should drink more fluids so that you do not become dehydrated (lack of water in the body from losing too much fluid).
  • If you have diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
  • Ask your nurse or doctor about medicine that can lessen or stop your diarrhea.
  • Manage tiredness by pacing your activities for the day.
  • Be sure to include periods of rest between energy-draining activities.
  • If you are dizzy, get up slowly after sitting or lying.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • If you get a rash do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.

Food and Drug Interactions

  • This drug may interact with grapefruit and grapefruit juice. Talk to your doctor as this could make side effects worse.
  • Check with your doctor or pharmacist about all other prescription medicines and over-the-counter medicines and dietary supplements (vitamins, minerals, herbs and others) you are taking before starting this medicine as there are known drug interactions with gilteritinib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplements to make sure that there are no interactions.
  • Avoid the use of St. John’s Wort while taking gilteritinib as this may lower the levels of the drug in your body, which can make it less effective.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Headache that does not go away
  • Tiredness that interferes with your daily activities
  • Feeling dizzy or lightheaded
  • Extreme tiredness, agitation or confusion
  • Seizures
  • Hallucinations
  • Trouble understanding or speaking
  • Loss of control of bowels or bladder
  • Blurry vision or changes in your eyesight
  • Numbness or lack of strength to your arms, legs, face, or body
  • Have a seizure or coma
  • Feeling that your heart is beating fast or in a not normal way (palpitations)
  • Wheezing or trouble breathing
  • Coughing up yellow, green, or bloody mucus
  • Pain in your mouth or throat that makes it hard to eat or drink
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Pain in your abdomen that does not go away
  • Diarrhea, 4 times in one day or diarrhea with lack of strength or a feeling of being dizzy
  • Weight gain of 5 pounds in one week (fluid retention)
  • Swelling of your legs, ankles and/or feet
  • Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
  • New rash and/or itching
  • Rash that is not relieved by prescribed medicines
  • Pain that does not go away, or is not relieved by prescribed medicines
  • Extreme muscle weakness that interferes with normal activities
  • If you think you may be pregnant or may have impregnated your partner

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 6 months after treatment. Men with female partners of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 4 months after your cancer treatment. Let your doctor know right away if you think you may be pregnant or may have impregnated your partner.
  • Breastfeeding warning: Women should not breast feed during treatment and for 2 months after treatment because this drug could enter the breast milk and cause harm to a breastfeeding baby.
  • Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

New December 2018