Description
Glasdegib is used together with low-dose cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults 75 years of age and older or who have other medical conditions that prevent the use of standard chemotherapy. Glasdegib is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of glasdegib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glasdegib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Azithromycin
- Bedaquiline
- Boceprevir
- Bosentan
- Buprenorphine
- Buserelin
- Carbamazepine
- Cenobamate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clomipramine
- Clothiapine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Congestive heart failure or
- Electrolyte imbalance or
- Heart or blood vessel disease, history of—Use with caution. May increase risk for more side effects.
- Heart rhythm problems (eg, long QT syndrome), history of—Use with caution. May make this condition worse.
- Kidney disease, severe or
- Liver disease, moderate to severe—Use has not been studied in patients with these conditions.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change your dose or stop taking this medicine without first asking your doctor.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food or without food at about the same time each day. Swallow the tablet whole. Do not break, crush, or chew it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For acute myeloid leukemia:
- Adults—100 milligrams (mg) once a day on Days 1 to 28 (1 cycle) in combination with cytarabine 20 mg injected under the skin 2 times a day on Days 1 to 10 of each cycle. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For acute myeloid leukemia:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 12 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses of this medicine within 12 hours. If you vomit after you take a dose, do not take an extra dose. Just take your next dose at your regular time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 30 days after the last dose. Male patients who have female partners should use effective birth control (even after a vasectomy) during treatment with this medicine and for at least 30 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant.
Do not donate blood or blood products or sperm while you are using this medicine and for at least 30 days after the last dose.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- chills
- confusion
- cough
- coughing up blood
- decreased frequency or amount of urine
- difficult or labored breathing
- difficulty in swallowing
- dizziness or fainting
- drowsiness
- dry mouth
- fainting
- fast, slow, or irregular heartbeat
- fever
- headache
- increased blood pressure
- increased menstrual flow or vaginal bleeding
- increased thirst
- lightheadedness
- loss of appetite
- loss of consciousness
- lower back or side pain
- mood or mental changes
- muscle pain or cramps
- muscle spasms (tetany) or twitching seizures
- nausea
- nervousness
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- pounding heartbeat
- prolonged bleeding from cuts
- rapid, shallow breathing
- red or black, tarry stools
- red or dark brown urine
- seizures
- sneezing
- sore throat
- stomach pain
- swelling of the face, hands, ankles, or lower legs
- tightness in the chest
- trembling
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weakness or heaviness of the legs
- weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bone or muscle pain
- change in taste
- constipation
- cracked lips
- decreased appetite
- diarrhea
- loose tooth
- loss of taste
- skin rash
- thinning or loss of hair
- toothache
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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