Applies to mitapivat: oral tablet.
Serious side effects of Mitapivat
Along with its needed effects, mitapivat 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 mitapivat:
More common
- Blurred vision
- dizziness
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
Incidence not known
- Back pain
- chills
- clay-colored stools
- confusion
- dark urine
- decreased urination
- fever
- itching, rash
- loss of appetite
- nausea
- pale skin
- stomach pain
- trouble breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Other side effects of Mitapivat
Some side effects of mitapivat 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
- Breast discomfort
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
- dry mouth
- difficulty in moving
- feeling of warmth
- muscle pain or stiffness
- pain in the joints
- pain in the lower back, bottom, hips, or upper legs
- redness of the face, neck, arms and occasionally, upper chest
- sore throat
For Healthcare Professionals
Applies to mitapivat: oral tablet.
Endocrine
Very common (10% or more): Estrone decreased in males (56.3%), estradiol decreased in males (12.5%)
Common (1% to 10%): Blood testosterone increased in males[Ref]
In 1 study, increases in serum testosterone and decreases in serum estrone and estradiol were observed in men receiving this drug; these hormone changes persisted throughout the study. Reproductive hormone analyses showed decreases in estrone and estradiol to below the lower limit of the reference range and increases in testosterone to above the upper limit of the reference range where baseline was within normal limits. In patients who discontinued this drug and had follow-up hormone measurements, the hormone changes returned close to the baseline levels 28 days after stopping this drug. In female patients, sex hormone analysis was limited due to physiologic variations in hormones during the menstrual cycle and the use of hormonal contraceptives.[Ref]
Musculoskeletal
Very common (10% or more): Back pain (included back pain, sciatica, flank pain; 15%), arthralgia (included arthralgia, joint swelling; 10%)
Frequency not reported: Rib fracture, musculoskeletal pain[Ref]
Metabolic
Very common (10% or more): Increased urate (15%)
Common (1% to 10%): Hypertriglyceridemia (included hypertriglyceridemia, blood triglycerides increased)[Ref]
Gastrointestinal
Common (1% to 10%): Gastroenteritis, constipation, dry mouth (included dry mouth, dry lip)[Ref]
Cardiovascular
Common (1% to 10%): Hot flush (included hot flush, flushing), hypertension, arrhythmia (included arrhythmia, tachycardia, heart rate increased, atrial fibrillation)
Frequency not reported: Atrial fibrillation[Ref]
Respiratory
Common (1% to 10%): Oropharyngeal pain[Ref]
Other
Common (1% to 10%): Breast discomfort[Ref]
Nervous system
Common (1% to 10%): Paresthesia[Ref]
Hematologic
Acute hemolysis with subsequent anemia was observed after abrupt interruption or discontinuation of this drug in dose-ranging study.[Ref]
Frequency not reported: Acute hemolysis, anemia[Ref]
