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REZLIDHIA (olutasidenib)
- acute myeloid leukemia with IDH1 mutation
150 mg capsule
- 1 capsule (150 mg) by oral route 2 times per day
Default screening record
- 1 capsule (150 mg) by oral route 2 times per day
- 1 capsule (150 mg) by oral route once daily
- None
Contraindicated
- None
Severe
Moderate
- None
- Lactation
Contraindicated
- Abnormal hepatic function tests
- Pregnancy
Severe
Moderate
- Child-pugh class A hepatic impairment
- Child-pugh class B hepatic impairment
REZLIDHIA (olutasidenib)
- acute myeloid leukemia with IDH1 mutation
- Elevated serum lipase
- Hyperbilirubinemia
- Hyperuricemia
- Hypokalemia
- Hyponatremia
- Increased alkaline phosphatase
- Increased aspartate transaminase
- Leukocytosis
- Lymphocytosis
- Arthralgia
- Constipation
- Diarrhea
- Dyspnea
- Fatigue
- Fever
- Malaise
- Nausea
- Skin rash
- Stomatitis
More Frequent
Severe
Less Severe
- Cholangitis
- Cholestasis
- Differentiation syndrome
- Acute abdominal pain
- Anorexia
- Cough
- Edema
- Headache disorder
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- None
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Olutasidenib
Safety and effectiveness not established in pediatric patients.
- 1 Day – 18 Years
- Safety and effectiveness not established in pediatric patients.
Olutasidenib
- Severity Level:
D
- Additional Notes: Based on animal data, developmental toxicity is possible
Contraindicated
Olutasidenib
Insuff data avail; mfg rec avoid during tx and for 2 weeks after last dose
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Insuff data avail; mfg rec avoid during tx and for 2 weeks after last dose |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Olutasidenib
General-Elderly may have greater incidence of hepatotoxicity and hypertension compared to patients younger than 65 years of age.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | Y | Y | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- Olutasidenib may cause a serious (possibly fatal) condition called differentiation syndrome. Get medical help right away if you develop any signs of differentiation syndrome, such as fever, cough, shortness of breath, decreased urination, rapid weight gain, or swelling of arms/legs.
| Acute myeloid leukemia with IDh1 mutation | |
| C92.0 | Acute myeloblastic leukemia |
| C92.00 | Acute myeloblastic leukemia, not having achieved remission |
| C92.02 | Acute myeloblastic leukemia, in relapse |
| 0-9 | A-Z |
|---|---|
| C92.0 | Acute myeloblastic leukemia |
| C92.00 | Acute myeloblastic leukemia, not having achieved remission |
| C92.02 | Acute myeloblastic leukemia, in relapse |
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