Applies to glasdegib: oral tablet.
Warning
Oral route (Tablet)
Warning: Embryo-Fetal ToxicityGlasdegib can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Glasdegib is embryotoxic, fetotoxic, and teratogenic in animals. Conduct pregnancy testing in females of reproductive potential prior to initiation of glasdegib treatment. Advise females of reproductive potential to use effective contraception during treatment with glasdegib and for at least 30 days after the last dose. Advise males of the potential risk of glasdegib exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with glasdegib and for at least 30 days after the last dose to avoid potential drug exposure.
Serious side effects of Glasdegib
Along with its needed effects, glasdegib 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 while taking glasdegib:
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
Other side effects of Glasdegib
Some side effects of glasdegib 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
For Healthcare Professionals
Applies to glasdegib: oral tablet.
Hematologic
Very common (10% or more): Anemia (43%), hemorrhage (e.g., petechiae, epistaxis, hematoma, contusion, rectal hemorrhage, anal hemorrhage, ecchymosis, gingival bleeding, hematuria, mouth hemorrhage, purpura, cerebral hemorrhage, eye contusion, eye hemorrhage, gastric hemorrhage, GI hemorrhage, hematemesis, hemoptysis, implant site hematoma, injection site bruising, retroperitoneal hematoma, thrombotic thrombocytopenic purpura, tracheal hemorrhage, conjunctival hemorrhage, disseminated intravascular coagulation, eyelid hematoma, hematochezia, hemorrhage intracranial, hemorrhoidal hemorrhage, lower GI hemorrhage, retinal hemorrhage, subdural hematoma) (36%), febrile neutropenia (31%0, thrombocytopenia (30%), platelet count decreased (15%), white blood cell count decreased (11%)[Ref]
Musculoskeletal
Very common (10% or more): Musculoskeletal pain (e.g., pain in extremity, arthralgia, back pain, myalgia, musculoskeletal pain, musculoskeletal chest pain, neck pain, bone pain (30%), creatine phosphokinase (CPK) increased (16%), muscle tightness/spasm (15%)[Ref]
Metabolic
Very common (10% or more): Hyponatremia (54%), hypomagnesemia (33%), edema (e.g., edema peripheral, edema, fluid overload, fluid retention, swelling face) (30%), decreased appetite (21%), hypokalemia (15%), weight loss (13%)[Ref]
Hepatic
Very common (10% or more): AST increased (28%), alkaline phosphatase increased (23%)[Ref]
Respiratory
Very common (10% or more): Dyspnea (e.g., dyspnea, hypoxia, bronchospasm, respiratory failure (23%), pneumonia (e.g., pneumonia, pneumonia aspiration, lung infection) (19%), cough (18%)[Ref]
Other
Very common (10% or more): Asthenia/fatigue (36%), pyrexia (18%)[Ref]
Nervous system
Very common (10% or more): Dysgeusia/ageusia (21%), dizziness (18%), headache (12%)[Ref]
Renal
Very common (10% or more): Creatinine increased (96%), renal insufficiency (e.g., acute kidney injury, blood creatinine increased, oliguria, renal failure) (19%)[Ref]
Cardiovascular
Very common (10% or more): Atrial arrhythmia (e.g., atrial fibrillation, bradycardia, tachycardia, sinus tachycardia) (13%), chest pain (e.g., chest pain, non-cardiac chest pain) (12%)
Common (1% to 10%): QT interval prolongation[Ref]
Dermatologic
Very common (10% or more): Rash (e.g., rash, pruritus, erythema, skin ulcer, rash maculopapular, rash pruritic (20%)
Common (1% to 10%): Alopecia[Ref]
Gastrointestinal
Very common (10% or more): Nausea (29%), mucositis (e.g., mucosal inflammation, oropharyngeal pain, stomatitis, anal ulcer, gingival pain, laryngeal inflammation, esophagitis, oral pain, aphthous ulcer, mouth ulceration, pharyngeal inflammation) (21%), constipation (20%), diarrhea (18%), vomiting (18%)
Common (1% to 10%): Loose tooth, toothache[Ref]
