Ojemda 600 mg/week (100 mg x 6) tablet

Generic name:
Tovorafenib - oral

Brand name(s)
Ojemda

This medication is used to treat a certain type of brain tumor (pediatric low-grade glioma). Tovorafenib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of tumor cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking tovorafenib 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 once a week.

If you are taking the tablet form of this medication, swallow the tablets whole with water. Do not cut, crush, or chew the tablets.

If you are taking the liquid form of this medication, read the Instructions for Use before you start taking this medication. If you have any questions, ask your doctor or pharmacist. Carefully follow the directions to mix the powder in the bottle with room-temperature water before each dose. Do not use cold water. Shake the bottle well for 60 seconds to mix the water with the powder. After mixing, carefully measure the dose using the provided special measuring device (oral syringe). Do not use a household spoon because you may not get the correct dose. Do not re-use the oral syringe. Use a new oral syringe for each dose. If not used right away, the mixed medication may be stored at room temperature for up to 15 minutes. After 15 minutes, throw away any unused mixed medication.

If you are giving this medication through a feeding tube, ask your health care professional for detailed instructions on how to properly mix and give it.

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

If you vomit right after taking a dose, you may take another dose.

Take this medication regularly to get the most benefit from it. To help you remember, take it on the same day each week.

Do not increase your dose or use 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.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Nausea, vomiting, tiredness, constipation, headache, nosebleeds, dry skin, acne, or changes in hair color 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:

• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• easy bleeding/bruising
• signs of infection (such as sore throat that doesn't go away, fever, chills)

Get medical help right away if you have any very serious side effects, including:

• vomit that looks like coffee grounds
• black stools

Tovorafenib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

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.

Before taking tovorafenib, 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 problems

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.

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

This medication may slow down a child's growth. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tovorafenib. Tovorafenib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of non-hormonal birth control during treatment and for 28 days after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 2 weeks 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.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

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.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain drugs for hepatitis C (asunaprevir, ombitasvir/paritaprevir/ritonavir), lonafarnib, mavacamten, revumenib, among others.

Other medications can affect the removal of tovorafenib from your body, which may affect how tovorafenib works. Examples include carbamazepine, clopidogrel, deferasirox, gemfibrozil, ivosidenib, leflunomide, letermovir, mifepristone, pirtobrutinib, rifampin, selpercatinib, teriflunomide, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function) 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 more than 3 days after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

See also How to Use section.

Store in the original container 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.