This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
- It is used to treat cancer.
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug and for 2 weeks after the last dose.
This drug may interact with other drugs or health problems.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Sometimes, dabrafenib is taken with trametinib. If your child is taking dabrafenib with trametinib, be sure you know the side effects that can happen with each drug. When these drugs are taken together, the chance of certain side effects may be raised. These side effects can be severe and sometimes deadly. This includes bleeding, bleeding in the brain, blood clots, eye problems, fever, heart problems (like heart failure), high blood sugar, other cancers, and severe skin reactions like Stevens-Johnson syndrome. Talk with the doctor about the chance of side effects with your child’s drugs.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Be careful if your child has low levels of an enzyme called G6PD. Anemia may happen. Low levels of G6PD may be more likely in patients of African, South Asian, Middle Eastern, and Mediterranean descent.
- This drug may add to the chance of getting some types of cancer. Talk with the doctor.
- Have your child’s skin checked. Tell your child’s doctor if your child has any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
- If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
- Check your child’s blood sugar as you have been told by the doctor.
- This drug may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. If you have questions, talk with the doctor before your child takes this drug.
- If your child is of childbearing age, a pregnancy test will need to be done before starting this drug to make sure your child is not pregnant.
If your child is or may be sexually active:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Have your child use birth control without hormones in it like a condom. Have your child do this while taking this drug and for some time after the last dose. Ask the doctor how long your child must use birth control. If your child becomes pregnant, call the doctor right away.
- If your child’s sex partner is pregnant or may get pregnant, they must use a condom during sex while your child takes this drug and for some time after the last dose. They must use a condom even if your child has had a vasectomy. Ask the doctor how long your child needs to use a condom. If your child’s sex partner is pregnant or gets pregnant, call the doctor right away.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
- Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or throwing up.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of high blood sugar like confusion, feeling sleepy, unusual thirst or hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Fever or chills.
- Dark urine or yellow skin or eyes.
- Eye pain.
- Redness or irritation of the palms of hands or soles of feet.
- Chest pain or pressure.
- Severe eye problems have happened with this drug. Sometimes, this has led to loss of eyesight. Call the doctor right away if your child has blurred eyesight, loss of eyesight, or other changes in eyesight. Call the doctor right away if your child sees color dots or halos or if bright lights bother your child.
- This drug may cause heart failure. Your child’s heart function will need to be checked while taking this drug. Call the doctor right away if your child has signs of heart problems like a cough or shortness of breath that is new or worse, swelling of the ankles or legs, an abnormal heartbeat, weight gain of more than 5 pounds in 24 hours, dizziness, or passing out.
- Skin reactions are common with this drug. However, severe skin reactions may also happen. This may include Stevens-Johnson syndrome (SJS). Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
- An immune system problem called hemophagocytic lymphohistiocytosis (HLH) has happened with this drug. Call the doctor right away if your child has a fever, swollen gland, rash, or swelling in the stomach area or severe stomach pain.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Hair loss.
- Change in skin to hard and thick.
- Pimples (acne).
- Dry skin.
- Back, muscle, or joint pain.
- Nose or throat irritation.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Give this drug at the same time of day.
- Give this drug on an empty stomach. Give at least 1 hour before or 2 hours after a meal.
- Talk with the doctor about having your child drink lots of fluids and other ways to prevent fluid loss. If your child has a lot of fluid loss, your child may have more side effects from this drug.
- If your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.
- If your child throws up after taking a dose, do not repeat the dose. Give the next dose at your child’s normal time.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Have your child swallow whole. Do not let your child chew, open, or crush.
Tablets for suspension:
- Do not let your child swallow whole, chew, or crush.
- Before using, be sure you know how to mix and measure the dose of this drug. Talk with the doctor or pharmacist if you are not sure.
- To mix this drug, place the number of tablets needed for a dose into a cup. Add 5 mL of water if the dose is 1 to 4 tablets. Add 10 mL of water if the dose is 5 to 15 tablets. Gently stir with the handle of a teaspoon until the tablets are fully mixed. It may take at least 3 minutes.
- The mixed drug will be cloudy white.
- Give your child the dose within 30 minutes after mixing. Throw away any part not used within 30 minutes of mixing.
- After giving this drug, add 5 mL water to the empty cup and stir with the handle of a spoon to loosen any of this drug left in the cup. Have your child drink to be sure the whole dose is taken.
- Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
- Give a missed dose as soon as you think about it.
- If it is less than 6 hours until the next dose, skip the missed dose and go back to the normal time.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Tablets for suspension:
- If this drug comes in a bottle, keep the lid tightly closed. Each bottle has 2 desiccants (protects the drug from moisture). Keep them in the bottle. Do not eat the desiccants.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
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