Tovorafenib (toe-voe-RAF-en-ib)

Treats low-grade glioma (LGG).

Brand Name(s):

Ojemda

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole with water. Do not chew, cut, or crush it.
• Oral liquid:
  • Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
  • You may take or give this medicine by mouth or through a feeding tube.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is 3 days or less , take it as soon as you remember and take the next dose at your regular dosing time. If it is more than 3 days , skip the missed dose and go back to your regular dosing schedule. If you vomit after taking your medicine, take another dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in its original package. Do not remove the tablets from blisters until right before use.
• Throw away the bottle, including unused oral liquid and oral dosing syringe after taking or giving a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicine can affect how tovorafenib works. Tell your doctor if you are using midazolam or birth control pills.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 28 days after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 2 weeks after the last dose.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, or skin problems.
• This medicine may cause the following problems:
  • Bleeding problems
  • Serious skin reactions, including maculopapular rash
  • Liver problems
  • Slowed growth in children
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding gums, coughing up blood, unusual nosebleeds, red or dark brown urine, or red or black, tarry stools
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Increased sensitivity of the skin to sunlight, severe sunburn, skin rash, dry skin
• Slow growth in children

If you notice these less serious side effects, talk with your doctor:

• Changes in hair color
• Constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088