Quizartinib

Generic name: Quizartinib

Drug class: Tyrosine kinase inhibitors (TKIs)

Dosage forms: Capsule

Root of administration: Oral

Dose: 30 mg

Mechanism of action: Quizartinib works by binding to and inhibiting the activity of FLT3, which plays a role in the growth and survival of leukemia cells. By blocking FLT3, quizartinib helps to inhibit the signaling pathways that promote the proliferation of cancer cells and promote their apoptosis (programmed cell death).

Drug usage cases: Quizartinib is used in combination with other medicines (eg, cytarabine, anthracycline) and alone as maintenance therapy to treat acute myeloid leukemia in patients with a FLT3-ITD mutation. Your doctor will test for the presence of this mutation. This medicine is available only under a restricted distribution program called Vanflyta® REMS (Risk Evaluation and Mitigation Strategy) Program.

Drug contra indications: 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 quizartinib 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 quizartinib in the elderly. Interactions with Medicines: 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. Interactions with Food/Tobacco/Alcohol: 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.

Side effects: Gastrointestinal effects: Nausea, vomiting, diarrhea, and abdominal pain are common side effects of quizartinib. These symptoms can usually be managed with supportive care and sometimes with anti-nausea or anti-diarrheal medications. Fatigue: Feeling tired or fatigued is a common side effect of quizartinib. It is important to get enough rest and to communicate any significant fatigue or weakness to your healthcare provider. Electrolyte abnormalities: Quizartinib may cause changes in electrolyte levels, such as decreased potassium and magnesium levels. Regular monitoring of electrolytes may be necessary, and supplementation may be required. QT interval prolongation: Quizartinib may prolong the QT interval on an electrocardiogram (ECG), which can increase the risk of a rare but serious heart rhythm called torsades de pointes. ECG monitoring may be performed prior to starting treatment and periodically during treatment. Infections: Quizartinib can increase the risk of developing infections. It is important to promptly report any signs of infection, such as fever, cough, or difficulty breathing, to your healthcare provider. Myelosuppression: Quizartinib may cause a decrease in blood cell counts, including red blood cells, white blood cells, and platelets. This can increase the risk of anemia, infections, and bleeding. Regular blood tests are typically performed to monitor blood cell counts during treatment. Liver toxicity: Quizartinib can potentially cause liver toxicity, leading to elevated liver enzyme levels. Regular liver function tests are usually conducted to monitor liver health.

Warnings: QT Prolongation, Torsades de Pointes, and Cardiac Arrest. Quizartinib prolongs the QT interval in a dose- and concentration-related manner. Prior to quizartinib administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform ECG to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter. Torsades de pointes and cardiac arrest have occurred in patients receiving quizartinib. Do not administer quizartinib to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome. Do not initiate treatment with quizartinib or escalate the quizartinib dose if the QT interval corrected by Fridericia’s formula (QTcF) is greater than 450 ms. Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required. Reduce the quizartinib dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure. Because of the risk of QT prolongation, quizartinib is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS.

Use during pregnancy or 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. 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. Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.