Rezlidhia

About Rezlidhia 

• Rezlidhia received approval from the US FDA administration on December 1, 2022
• Rezlidhia comprises Olutasidenib, categorized as an isocitrate dehydrogenase-1 (IDH1) inhibitor. 
• Rezlidhia is prescribed for adults with relapsed or refractory acute myeloid leukemia (AML) possessing a susceptible IDH1 mutation, as identified by an FDA-approved test.
• In acute myeloid leukemia, mutations trigger uncontrolled growth and division of myeloblasts (immature blood cells from the bone marrow). 
• Mutations in the IDH1 gene can result in the buildup of 2-hydroxyglutarate (2-HG), disrupting the maturation of immature blood cells into mature cells. 
• Rezlidhia functions by inhibiting mutated IDH1, lowering 2-HG levels, and restoring the normal differentiation of myeloid cells.
• To ensure Rezlidhia is suitable for you, your healthcare provider will conduct an FDA-approved test to check for the IDH1 mutation. 
• The safety and effectiveness of this medication in children are not known.
• Rezlidhia may lead to serious side effects such as Differentiation Syndrome. If you experience signs, your healthcare provider may use corticosteroids or hydroxyurea and monitor you in the hospital.

Strength

Capsules are delivered in a strength of Rezlidhia 150 mg respectively, for oral consumption.

Recommended Dosage

Take the Rezlidhia capsule whole, refraining from breaking, opening, or chewing them. If vomiting occurs, do not provide a replacement dose; wait until the next scheduled dose. In the event of a missed dose or deviation from the usual timing, administer the dose as soon as possible, ensuring at least an 8-hour interval before the next scheduled dose. Resume the regular schedule the following day.

• The recommended dosage for Rezlidhia is 150 mg taken orally twice daily until disease progression or unacceptable toxicity. 
• Administer the capsules approximately at the same time each day, ensuring an interval of at least 8 hours between doses. 
• Take the medication on an empty stomach, either at least 1 hour before or 2 hours after a meal. 
• For patients without disease progression or unacceptable toxicity, continue treatment for a minimum of 6 months to allow for a clinical response.

Important

Before starting Rezlidhia, evaluate blood counts and blood chemistries, including liver function tests. Monitor weekly for the first two months, bi-weekly for the third month, once in the fourth month, and bi-monthly thereafter. Promptly address any abnormalities. If toxicities arise, consider interrupting dosing or reducing the dose.

Warnings & Precautions

• Before starting Rezlidhia, it’s essential to be aware of the potential risk of differentiation syndrome, which can be fatal. If symptoms of differentiation syndrome are suspected, inform your healthcare provider immediately. 
• In such cases, treatment may involve withholding Rezlidhia, initiating corticosteroids, and closely monitoring hemodynamics until symptoms resolve. 
• Additionally, regular monitoring of liver function tests is necessary during Rezlidhia treatment to detect and manage hepatotoxicity promptly. If hepatotoxicity occurs, your healthcare provider may recommend interrupting, reducing, or discontinuing Rezlidhia based on severity. 
• Make sure to discuss your medical history and conditions with your healthcare provider before starting Rezlidhia.

Common Rezlidhia Side Effects:

• Increased aspartate aminotransferase 
• Increased alanine aminotransferase 
• Decreased potassium 
• Decreased sodium 
• Increased alkaline phosphatase 
• Increased creatinine 
• Fatigue/malaise
• Arthralgia
• Constipation
• Increased lymphocytes 
• Increased  bilirubin 
• Leukocytosis
• Increased uric acid 
• Dyspnea
• Pyrexia
• Increased lipase 
• Mucositis
• Transaminitis
• Abnormal liver function tests
• Nausea
• Feeling tired or unwell
• Joint pain
• Changes in certain blood tests

Use in Specific Population

• The use of Rezlidhia may potentially harm a developing fetus, based on animal studies. There is a lack of data on its use in pregnant women, emphasizing the importance of informing your doctor if you are pregnant, planning pregnancy, or suspect pregnancy before initiating treatment. 
• Always consult with your healthcare provider for personalized guidance regarding pregnancy and the use of Rezlidhia.
• The information lacks data on Olutasidenib in human milk. It is advised to not breastfeed during Rezlidhia treatment and for 2 weeks after the last dose due to potential adverse reactions in the child.
• The safety and effectiveness of Rezlidhia have not been established in pediatric patients. 

Storage and Handling

• Store between 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C and 30°C (59°F to 86°F).
• Protect Rezlidhia from light and moisture.
• Do not freeze.
• Avoid storing Rezlidhia in the place where it may be exposed to heat or humidity.
• Keep Rezlidhia out of the reach of children and pets.