Vanflyta Oral: Side Effects, Uses, Warnings

Side Effects

Nausea, vomiting, diarrhea, abdominal pain, mouth sores, decreased appetite, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, pale skin, easy bruising/bleeding.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

How long does it take for this medicine to take effect?

The onset of action for quizartinib, like other tyrosine kinase inhibitors, can vary depending on several factors, including the specific disease burden, the patient’s overall health status, and the presence of the FLT3-ITD mutation. Clinical responses may be observed within weeks of starting treatment, as evidenced by reductions in leukemic cell counts and improvements in blood counts. However, the exact timing for individual responses can vary.

How long do the effects of this medicine last?

The duration of quizartinib’s effects depends on continuous drug exposure and adherence to the prescribed treatment regimen. The half-life of quizartinib allows for once-daily dosing, but the sustained effect on leukemic cells requires ongoing treatment. Resistance or disease progression can affect the long-term efficacy of the medication.

Is it safe to consume alcohol while taking this medicine?

While specific studies on the interaction between quizartinib and alcohol may not be widely available, it is generally advisable for patients undergoing cancer treatment to minimize or avoid alcohol consumption. Alcohol can interfere with the metabolism of many medications, potentially affecting their efficacy or increasing the risk of side effects, and can also contribute to overall health decline in patients with cancer.

Is this a habit forming medicine?

Quizartinib is not associated with habit formation or addictive behaviors. It is a targeted cancer therapy designed for the treatment of specific genetic mutations in acute myeloid leukemia and does not possess psychoactive properties or induce dependency.

Can this medicine be taken during pregnancy?

Quizartinib may have potential teratogenic effects and is likely contraindicated during pregnancy. Tyrosine kinase inhibitors can harm fetal development due to their mechanisms of action on cellular growth and angiogenesis. Women of childbearing potential should use effective contraception during treatment and for a specified period after the last dose. The risks and benefits of using quizartinib during pregnancy should be carefully considered, and treatment should only be initiated if the potential benefit justifies the potential risk to the fetus.

Can this medicine be taken while breast-feeding?

The excretion of quizartinib in human milk is unknown, but many drugs, especially those with low molecular weights, are excreted in breast milk. Given the potential for serious adverse reactions in nursing infants from quizartinib, breastfeeding is not recommended during treatment and for a specified period following the last dose. Women should be advised to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother’s health.

Uses

Quizartinib is used to treat acute myeloid leukemia (AML). It works by slowing or stopping the growth of cancer cells.

How to use Vanflyta 17.7 Mg Tablet Antineoplastic – Protein-Tyrosine Kinase Inhibitors

Read the Medication Guide and Warning Card provided by your pharmacist before you start taking quizartinib and each time you get a refill. Carry the Warning Card with you at all times. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush, chew, or split the tablets.

The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

If you vomit after taking a dose, do not take another dose. Take your next dose at the regular time. Do not double the dose to catch up.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Warnings

Quizartinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Do not use quizartinib if you have certain heart problems (long QT syndrome, fast/irregular heartbeat). Before using quizartinib, tell your doctor or pharmacist of all the drugs you take and if you have certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), or family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Do not use quizartinib if you have low levels of potassium or magnesium in the blood.

To lower your risk, your doctor will order certain blood tests (potassium/magnesium levels) and a heart test (EKG) before and during treatment with quizartinib. Get medical help right away if you have fast/irregular heartbeat, severe dizziness, or fainting.

To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the VANFLYTA REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country’s regulations.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Other medications can affect the removal of quizartinib from your body, which may affect how quizartinib works. Examples include apalutamide, bosentan, enzalutamide, levoketoconazole, lumacaftor, mitotane, nafcillin, rifamycins (such as rifampin, rifapentine), St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Precautions

Before taking quizartinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Quizartinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using quizartinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using quizartinib. Quizartinib may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 7 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for 1 month after stopping this medication. Consult your doctor before breast-feeding.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, blood mineral levels, EKG) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Vanflyta 17.7 Mg Tablet Antineoplastic – Protein-Tyrosine Kinase Inhibitors