Side Effects

Tiredness, dizziness, cough, constipation, swelling ankles/feet/hands, nausea, or vomiting may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. 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: signs of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), numbness/tingling of arms/legs, mental/mood changes (such as confusion, depression, anxiety, memory loss), trouble sleeping, trouble speaking, difficult/unsteady walking, bone pain, easily broken bones.

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 Vitrakvi (larotrectinib) can vary among patients, depending on the type and extent of the tumor, as well as individual patient factors. Clinical response to larotrectinib can be observed as early as the first few weeks of treatment in some patients, but it may take longer in others to see a measurable response.

How long do the effects of this medicine last?

The duration of the therapeutic effects of larotrectinib is dependent on continued response to treatment, disease progression, and tolerance to the medication. Patients can remain on treatment as long as they continue to benefit and do not experience unacceptable toxicity.

Is it safe to consume alcohol while taking this medicine?

There are no specific warnings against alcohol consumption in the prescribing information for Vitrakvi. However, patients undergoing cancer treatment are generally advised to limit alcohol intake due to its potential to worsen side effects like nausea or fatigue and its overall impact on health. Patients should discuss alcohol use with their healthcare provider to understand the best approach for their individual situation.

Is this a habit forming medicine?

Larotrectinib is not considered habit-forming and does not have the potential for abuse or dependency. It is used for its specific anticancer activity and does not produce euphoria or any psychoactive effects.

Can this medicine be taken during pregnancy?

Vitrakvi is classified as FDA Pregnancy Category D, indicating there is positive evidence of human fetal risk based on adverse reaction data, but potential benefits may warrant use in pregnant women despite potential risks. Larotrectinib can cause harm to the fetus when administered to a pregnant woman, based on its mechanism of action and animal studies. Use of effective contraception is recommended for women of reproductive potential during treatment and for a period after the last dose.

Can this medicine be taken while breast-feeding?

There are no data on the presence of larotrectinib in human milk or its effects on the breastfed child or milk production. Due to the potential for serious adverse reactions in breastfeeding infants from larotrectinib, women should be advised not to breastfeed during treatment with Vitrakvi and for a period after the last dose.

Uses

Larotrectinib is used to treat cancer. It works by slowing or stopping the growth of cancer cells.

How to use Vitrakvi

Read the Patient Information Leaflet if available from your pharmacist before you start taking larotrectinib and each time you get a refill. 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 twice daily. Swallow the capsules whole with water. Do not crush or chew the capsules.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your body size, medical condition, response to treatment, 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).

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

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.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the regular time.

Precautions

Before taking larotrectinib, 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, especially of: liver disease.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using larotrectinib. Larotrectinib may harm an unborn baby. Men and women using this medication should ask about reliable forms of birth control during treatment and for 1 week 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 week 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 liver function) should be done while you are taking this medication. 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 within 6 hours of 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 the capsules at room temperature away from light and moisture. Do not store in the bathroom. Store the liquid form of this medication in the refrigerator. Do not freeze. Discard any unused liquid medication 90 days after first opening the bottle. 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.

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.

A product that may interact with this drug is: St John’s wort.

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