Iclusig (ponatinib) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat the following specific types of leukemia that have progressed in adults:

Here are some fast facts about Iclusig:

  • Active ingredient: ponatinib
  • Drug class: kinase inhibitor
  • Drug form: oral tablet

Iclusig is typically taken as a long-term treatment.

Similar to other drugs, Iclusig can cause side effects. Learning about a medication’s side effects can help you and your doctor decide whether to add it to your treatment plan.

Read on to learn about potential common, mild, and serious side effects. For a general overview of Iclusig, including details about its uses, see this article.

Iclusig can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Iclusig in clinical trials:

Mild side effects can occur with Iclusig. This list doesn’t include all possible mild side effects of the drug. For more details, you can refer to Iclusig’s prescribing information.

Mild side effects that have been reported with Iclusig include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Iclusig and want to tell the FDA about it, visit MedWatch.

Iclusig may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more details, you can refer to Iclusig’s prescribing information.

If you develop serious side effects while taking Iclusig, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* To learn more, see the “Side effect specifics” section below.
Iclusig has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA).
‡ An allergic reaction is possible after taking Iclusig. However, this side effect wasn’t reported in clinical trials.

Iclusig may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Should I expect hair loss with Iclusig?

Possibly, though not everyone who takes Iclusig has hair loss. It wasn’t one of the more common side effects seen in the drug’s clinical trials.

Iclusig is a targeted therapy. Some people taking targeted therapies to treat cancer may experience hair loss. Skin and hair side effects, such as hair loss or thinning, occur with many targeted therapies. However, these aren’t common side effects of Iclusig.

Talk with your doctor if you’re concerned about changes in your hair after starting Iclusig treatment. They may recommend ways to support healthy hair growth. These may include eating nutritious foods and using self-care techniques if you’re stressed.

Can Iclusig cause brain problems?

It isn’t clear. A serious brain problem called posterior reversible encephalopathy syndrome (PRES) has been reported in people who took Iclusig. (With PRES, the activity of your nervous system is disrupted. This causes swelling in your brain.)

It isn’t known for sure if Iclusig was the cause of PRES in these reports. This is because PRES wasn’t seen in the drug’s clinical trials. It was only reported after the drug became approved for use.

Tell your doctor right away if you think you have symptoms of PRES. These may include:

If you have PRES, your doctor will likely have you pause or stop Iclusig treatment. Talk with your doctor if you have questions about brain problems while taking Iclusig.

Does Iclusig cause problems with wound healing or damage to the intestines?

Possibly. These problems weren’t seen in the drug’s clinical trials. However, they’ve been reported in people who took Iclusig after the drug was approved by the Food and Drug Administration (FDA). These possible problems and their symptoms include:

  • Problems with wound healing, especially after a surgery. If you have a scheduled surgery, your doctor may recommend you not take Iclusig for at least 1 week before the surgery. You’ll also likely wait until any surgical incisions (cuts) heal before you restart Iclusig treatment. This will likely be at least 2 weeks after the surgery.
  • Perforations (tears or holes) in the digestive tract. Tell your doctor right away if you have severe abdominal pain, vomiting, or changes in your bowel movements. These symptoms could be a sign of a perforation in your digestive tract. If this occurs, your doctor will have you stop Iclusig treatment permanently.

Talk with your doctor or pharmacist if you have questions about the possible side effects of Iclusig.

Learn more about some of the side effects that Iclusig may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Iclusig.

Ocular side effects

Iclusig treatment may cause ocular (eye-related) side effects in some people. The most commonly reported ocular side effects were eye pain or dryness. Macular degeneration and vision loss were also reported. However, they occurred less often. (With macular degeneration, you lose your vision slowly due to changes in your retina [the deepest layer of the eye]).

Symptoms of vision problems can include:

  • eye pain
  • blurry vision
  • dry eyes
  • floaters” (seeing lines or dots)

Severe ocular side effects, such as swelling or bleeding in the retina, were rare in Iclusig’s clinical trials.

What you can do

Before you start Iclusig, your doctor may have you get an eye exam to check for any problems. You’ll continue to have eye exams regularly while you’re taking Iclusig. This is to monitor for ocular side effects.

Tell your doctor if you notice any eye discomfort or vision changes. Depending on how severe the problem is, you and your doctor will decide whether you should continue taking Iclusig.

Neuropathy

Iclusig treatment may cause neuropathy (nerve damage). With neuropathy, you may experience the following symptoms in different parts of your body:

Peripheral neuropathy (nerve problems that mainly affect your hands and feet) was a common side effect in the drug’s clinical trials. This side effect was typically mild to moderate. However, it was severe in some people. Nearly half of those who developed this side effect took Iclusig for about 5 months before it started.

In rare cases, cranial neuropathy (nerve problems in the brain) occurred. This type of neuropathy can affect your ability to feel and move. About half of the people who had this side effect were taking Iclusig for over 2 years before it occurred.

What you can do

Tell your doctor if you think you have symptoms of neuropathy. They may prescribe medication or physical therapy to help ease your symptoms.

If this side effect is severe, your doctor may have you pause treatment until your symptoms get better. After this has happened, you and your doctor will decide whether you should continue taking Iclusig. If you continue treatment, your doctor may prescribe a lower dosage for you. (To learn more about Iclusig’s dosage, see this article.)

Tumor lysis syndrome

Tumor lysis syndrome (TLS) is a possible side effect of taking Iclusig. TLS occurs when numerous cancer cells break down quickly, releasing contents that can be dangerous in high amounts. An example of this is uric acid.

Symptoms of TLS may include:

TLS was a rare, serious side effect in Iclusig’s clinical trials. It’s important to note that TLS may also lead to kidney failure.

What you can do

To help reduce the risk of serious TLS, be sure to keep yourself hydrated by drinking plenty of fluids. Talk with your doctor about how much water you should drink each day while taking Iclusig.

If you have symptoms of TLS, tell your doctor. They may recommend getting treatment and IV fluids in a hospital.

Boxed warnings

Iclusig has several boxed warnings that are described below. Boxed warnings are the strongest type of warnings from the Food and Drug Administration (FDA). Iclusig’s boxed warnings help warn healthcare professionals and patients about the most serious risks of taking the drug.

The below side effects were not commonly reported in clinical trials. However, it’s important to seek immediate medical attention if you think you have any of these side effects. This is because they can be serious and even life threatening.

Heart failure

Heart failure may occur while taking Iclusig. With heart failure, your heart isn’t able to efficiently pump blood to the rest of your body. If you’ve ever had heart problems, you may have an increased risk of developing this side effect.

Symptoms of heart failure may include:

What you can do

Tell your doctor if you think you have symptoms of heart failure. If you have heart failure, they’ll prescribe treatment to manage it. If your heart failure is severe, they may pause your Iclusig treatment, reduce your dosage,* or have you stop taking the drug.

* To learn more about Iclusig’s dosage, see this article.

Artery blockages

Iclusig may cause a blockage in an artery (a type of blood vessel that carries oxygen throughout the body). This may occur due to a blood clot or due to stenosis (narrowing) of an artery. Artery blockages can lead to stroke.

Symptoms of a stroke may include:

  • weakness on one side of your body
  • trouble speaking
  • confusion
  • loss of consciousness

What you can do

Be sure to seek immediate medical care if you think you have symptoms of an artery blockage.

Depending on the severity of your blockage, your doctor will likely pause your treatment, reduce your dosage, or have you stop taking Iclusig.

Liver damage and liver failure

Liver problems, including liver failure, may happen during Iclusig treatment. Some people have had severe increases in liver enzymes in their blood with Iclusig treatment. Increased liver enzymes can be a sign of liver damage.

Symptoms of this side effect may include:

What you can do

Tell your doctor if you think you have symptoms of liver problems. They may reduce your dosage* or have you stop Iclusig treatment temporarily or permanently.

* To learn more about Iclusig’s dosage, see this article.

Blood clot in a deep vein

Iclusig may cause blood clots in a deep vein. (A deep vein is a type of blood vessel that’s deep beneath your skin. It’s typically in a limb, such as your arm or leg). Symptoms may include warmth, swelling, or pain in a limb.

What you can do

If you think you have symptoms of a blood clot, seek immediate medical care. Your doctor may pause your Iclusig treatment, reduce your dosage, or have you stop taking the medication.

Your doctor may have you take an anticoagulant drug (blood thinner) to help prevent blood clots while you’re taking Iclusig.

Allergic reaction

As with most drugs, Iclusig can cause an allergic reaction in some people. However, this side effect wasn’t reported in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your lips, eyelids, feet, or hands
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Iclusig. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Iclusig comes with several warnings and precautions.

Boxed warnings

Iclusig has boxed warnings about risks of the following:

These are serious warnings from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Iclusig. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

Allergic reaction. If you’ve had an allergic reaction to Iclusig or any of its ingredients, your doctor will likely not prescribe Iclusig. Ask your doctor what other medications may be better options for you.

High blood pressure. Iclusig may cause high blood pressure. If you already have high blood pressure, taking this drug may make your condition more severe. Your doctor may want you to check your blood pressure more often at home. They may also change or raise the dosages of any blood pressure medications you take.

Pancreatitis or heavy alcohol consumption. Iclusig may cause pancreatitis (inflammation of the pancreas) as a side effect. If you’ve ever had pancreatitis, you may have an increased risk of having this side effect. If you drink alcohol heavily or have ever done so, this also increases your risk of pancreatitis.

Talk with your doctor about whether it’s safe for you to take Iclusig. If so, they’ll likely monitor you closely for symptoms of pancreatitis, such as abdominal pain. They’ll also order blood tests to monitor for signs of pancreatitis.

Surgery. Iclusig may cause problems with wound healing, such as surgical incisions (cuts). Due to this risk, your doctor will typically recommend not taking Iclusig for at least 1 week before a scheduled surgery. They’ll likely have you wait until your incision is healed before restarting Iclusig treatment. This will typically be at least 2 weeks after the surgery.

High uric acid. If you have a medical condition that causes a high uric acid level, taking Iclusig may further increase uric acid. Talk with your doctor about this before starting Iclusig treatment. They may test your uric acid level and treat it with medication before prescribing Iclusig.

Alcohol with Iclusig

Alcohol isn’t known to interact with Iclusig.

However, it’s not a good idea to drink a lot of alcohol while taking this medication. Doing so may increase your risk of certain side effects or make them worse. This is because Iclusig may cause some of the same side effects as alcohol. Some examples include headache, nausea, vomiting, and liver problems.*

Talk with your doctor if you have questions about drinking alcohol while taking Iclusig.

* Iclusig has a boxed warning for liver damage and liver failure. This is a serious warning from the FDA. To learn more, see the “Side effect specifics” section above.

Pregnancy and breastfeeding while taking Iclusig

Iclusig is not recommended for people who are pregnant or breastfeeding.

Pregnancy

Iclusig is likely not safe to take during pregnancy. Based on animal studies, the drug is likely to cause harmful effects to the developing fetus. However, Iclusig hasn’t been studied in human pregnancies.

If you’re female* and can become pregnant, your doctor will have you take a pregnancy test before you start taking Iclusig. They’ll also recommend you use birth control during Iclusig treatment and for at least 3 weeks after your last dose.

The drug’s manufacturer doesn’t provide any guidance for males* who take Iclusig and have sexual partners who can become pregnant. Talk with your doctor about your need for birth control, such as condoms, while you’re taking Iclusig.

Breastfeeding

Iclusig is likely not safe to take while breastfeeding. It isn’t known if the drug passes into breast milk or how it could affect a child who is breastfed.

Due to the possible risk of harm, your doctor will likely recommend you do not breastfeed during Iclusig treatment. This also includes at least 6 days after your last dose.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

It can be overwhelming to read about the potential side effects of Iclusig. Some side effects can be serious and even life threatening. However, keep in mind that not everyone experiences serious side effects while taking Iclusig. And there are ways to monitor and manage many of the drug’s more common side effects.

You and your doctor will weigh these risks as you consider the best treatment option for your leukemia.

If you’d like to learn more about Iclusig, talk with your doctor or pharmacist. They can help answer any questions you have about this medication’s side effects.

Besides talking with your doctor, you can do some additional reading on your own. These articles might help:

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.