Iclusig is a brand-name prescription medication. It's used to treat certain types of blood cancers in adults.

Iclusig contains ponatinib. This is a type of drug called a tyrosine kinase inhibitor (TKI).

Iclusig comes as a tablet that you swallow. You'll take it once a day.

What it does

The Food and Drug Administration (FDA) has approved Iclusig to treat a type of cancer called chronic myeloid leukemia (CML) in adults. Iclusig is used when people have CML and can't take other TKIs. However, the drug isn't meant to be used in people who have just been diagnosed with CML in the chronic phase (the earliest stage of CML).

Iclusig is also approved to treat CML in adults whose cancer cells have a certain genetic mutation (an abnormal, permanent change to a gene) called T315I mutation. This type of CML is called T315I-positive CML.

In addition, Iclusig is approved to treat a kind of cancer called acute lymphoblastic leukemia (ALL) in adults. The drug is used to treat ALL that has a certain genetic mutation called the Philadelphia chromosome (Ph). This type of ALL is called Ph+ ALL. Iclusig is used to treat ALL in adults who can't take other TKIs.

Finally, Iclusig is approved to treat Ph+ ALL in adults whose cancer cells have the T315I mutation called T315I-positive Ph+ ALL.

Iclusig effectiveness

A clinical study showed that Iclusig is effective at treating certain types of CML.

This clinical study looked at people with CML in the chronic phase who had been previously diagnosed, but not recently. (The chronic phase is the first stage of CML.) These were people who weren't able to take a different TKI drug but took Iclusig. They weren't able to take a different TKI drug because the drug didn't work for them or because they couldn't tolerate the side effects.

After 12 months of treatment with Iclusig, 55% of these people had no cancer cells in their body or very few cancer cells in their body. In the study, Iclusig wasn't compared with a different drug or a placebo (treatment with no active drug).

For more information about how effective Iclusig is in helping treat other conditions, see the "Iclusig uses" section below.

Iclusig is available only as a brand-name medication. It's not currently available in generic form.

A generic drug is an exact copy of a brand-name medication. Generics tend to cost less than brand-name drugs.

Iclusig contains one active drug ingredient: ponatinib. This means ponatinib is the ingredient that makes Iclusig work.

Iclusig can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Iclusig. These lists don't include all possible side effects.

For more information on the possible side effects of Iclusig, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you've had with Iclusig, you can do so through MedWatch.

More common side effects

The more common side effects of Iclusig include:

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Iclusig can cause serious side effects, but these side effects aren't common. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include the following.

  • High blood pressure. Symptoms can include:
    • headache
    • dizziness
    • chest pain
    • confusion
    • shortness of breath
  • Pancreatitis (swelling of your pancreas). Symptoms can include:
    • pain around your belly and back
    • bloating
    • nausea or vomiting
    • losing weight without trying to
  • Peripheral neuropathy (nerve damage in your arms or legs). Symptoms can include:
    • muscle weakness in your hands or feet
    • tingling or burning sensation in your hands or feet
    • loss of feeling in your hands or feet
  • Eye problems. Examples include:
    • blurry vision
    • macular edema (swelling in your retina, which is a layer of tissue in the back of your eye)
    • bleeding in your retina
    • cataracts (cloudy spots in the lens of your eye)
    • glaucoma (an eye disease in which the pressure in your eye is high)
    • blindness
  • Hemorrhage (severe bleeding), including internal bleeding. Symptoms can include:
    • bruising easily and often
    • pink or brown urine or blood in urine
    • coughing up blood or vomit that looks like coffee grounds
    • red or black stools
    • confusion
    • headache
    • drowsiness
  • Severe edema (fluid buildup). Symptoms can include:
    • swelling in your feet, legs, hands, arms, or face
    • rapid weight gain
    • cough
    • shortness of breath
  • Abnormal heart rhythms, including atrial fibrillation (irregular or quivering heartbeat) and a heart rate that's too fast or too slow. Symptoms can include:
  • Blood disorders, including low levels of certain white blood cells, red blood cells, and platelets. Symptoms can include:
    • fever
    • frequent infections
    • fatigue
    • bruising or bleeding easily
    • shortness of breath
  • Tumor lysis syndrome (the release of substances into your bloodstream by cancer cells). Symptoms can include:
    • muscle weakness
    • fatigue
    • nausea or vomiting
    • muscle cramps
    • abnormal heart rhythms
    • seizures (changes in the electrical activity of your brain that can affect how you feel or act)
  • Reversible posterior leukoencephalopathy syndrome (a brain disorder often caused by pressure in the brain). Symptoms can include:
    • headache
    • confusion
    • vision loss
    • seizures
  • Slowed wound healing. Symptoms can include:
    • wounds that don't heal in the usual time
    • bleeding
  • Pneumonia (a type of lung infection). Symptoms can include:
    • trouble breathing
    • coughing
    • chest pain
    • fever
  • Urinary tract infections. Symptoms can include:
    • burning feeling when you urinate
    • having to urinate often
    • increased urgency to urinate
    • urine that has a strong odor
  • Pleural effusion (fluid buildup in your chest). Symptoms can include:
    • dry cough
    • chest pain
    • trouble breathing when you lay down
    • shortness of breath
    • hiccups
  • Sepsis (infection in your whole body). Symptoms can include:
    • high fever (above 101°F/38°C) or low body temperature (95°F/35°C)
    • fast heart rate
    • breathing faster than usual
    • infection

Other serious side effects, explained in more detail below in "Side effect details," include:

Side effect details

You may wonder how often certain side effects occur with this drug. Here's some detail on several of the side effects this drug may cause.

Allergic reaction

No allergic reactions were reported in clinical studies. However, as with most drugs, some people can have an allergic reaction after taking Iclusig. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Iclusig. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Blockages in arteries or veins

Blockages in arteries or veins are a serious side effect seen with Iclusig use. A clinical study looked at Iclusig. The drug wasn't compared with a placebo (treatment with no active drug) or a different medication. Researchers found that:

  • At least 35% of people who took Iclusig had a blockage in their arteries. These blockages were caused by atherosclerosis (buildup of plaque on the lining of arteries).
  • 6% of people who took Iclusig had a venous thromboembolism (blood clot that prevents blood from delivering oxygen to your organs) in their arteries or veins.

Blockages can lead to serious events, such as heart attacks, strokes, or organ damage. In the clinical study, these events occurred in people with and without risks factors for blockages, including people younger than age 50 years.

While you take Iclusig, your doctor will monitor you closely for signs and symptoms of a blockage. If one occurs, they'll have you stop using Iclusig for a time to treat the blockage. They'll decide if it's safe for you to restart taking Iclusig after that.

Symptoms of a blockage include the following:

  • pain or pressure in your chest
  • shortness of breath
  • headache
  • pain in your legs, arms, jaw, or neck
  • swelling in your legs
  • severe pain in your stomach
  • feeling numb or weak on one side of your body
  • trouble talking
  • loss of vision

If any of these symptoms occur, contact your doctor right away. Call 911 if your symptoms feel life-threatening.

Heart failure

New heart failure or worsening heart failure has occurred with Iclusig use. In a clinical study, 6% of people had serious or fatal heart failure while taking Iclusig. In this study, 9% of people who took Iclusig had any form of heart failure. Researchers didn't compare Iclusig to a placebo or a different medication.

While you take Iclusig, your doctor will monitor your heart function closely. If you have signs or symptoms of heart failure, they'll likely have you stop Iclusig treatment for a time. If you develop serious heart failure, they may decide that you should stop using Iclusig permanently.

Contact your doctor right away if you have any of the following heart failure symptoms:

  • pain in your chest
  • dizziness
  • feeling like you might faint
  • fast or abnormal heartbeats
  • shortness of breath

Call 911 if your symptoms feel life-threatening.

Liver damage

Liver damage and liver failure have occurred with Iclusig use. In clinical studies, 29% of people who took Iclusig had some form of liver damage. This side effect occurred within 3 months for half the people who took Iclusig. In this study, 11% of people who took Iclusig had serious liver damage that led to conditions such as encephalopathy (a disorder in which toxins build up in your brain). Researchers didn't compare Iclusig to a placebo or a different medication.

Liver damage symptoms include:

  • loss of appetite
  • yellowing of your skin or the whites of your eyes
  • dark-colored urine
  • bruising or bleeding easily
  • fatigue

If you have any of symptoms of liver damage while taking Iclusig, call your doctor right away.

While you take Iclusig, your doctor will test your liver health regularly. They do this by checking levels of liver enzymes (special proteins) in your blood. High levels of these enzymes are often related to liver damage.

If you have high levels of liver enzymes in your blood, your doctor may have you stop taking Iclusig for a time. Your doctor will monitor your enzyme levels and decide if and when it's safe for you to continue Iclusig treatment.

As with all medications, the cost of Iclusig can vary. To find current prices for Iclusig in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require a prior authorization before approving coverage for Iclusig. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the information and let you and your doctor know if your plan will cover Iclusig.

If you're not sure if you'll need to get prior authorization for Iclusig, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Iclusig, or if you need help understanding your insurance coverage, help is available.

Takeda Pharmaceutical Company Limited, the manufacturer of Iclusig, offers a program called Takeda Oncology 1Point. This program may be able to help you find assistance to lower what you pay for Iclusig. For more information and to find out if you're eligible for support, call 844-817-6468 (844-T1POINT) or visit the program website.

The Food and Drug Administration (FDA) approves prescription drugs such as Iclusig to treat certain conditions. Iclusig may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Iclusig for chronic myeloid leukemia

Iclusig is FDA-approved to treat chronic myeloid leukemia (CML) in adults.

CML is a slow developing type of cancer that affects your white blood cells. Immature white blood cells, called blasts, grow and multiply out of control. These blasts crowd out normal blood cells that your body needs. In CML, these blasts mature into abnormal granulocytes. Granulocytes are white blood cells that fight infections, such as bacterial infections.

In people with chronic myeloid leukemia who can't use another tyrosine kinase inhibitor drug

Iclusig is used to treat CML in adults who can't use a different tyrosine kinase inhibitor (TKI) drug for their cancer.

Iclusig belongs to the TKI drug class. A class of drugs is a group of medications that work in a similar way. TKIs are a type of targeted therapy used to treat CML. Targeted therapy is a treatment that targets specific cells or proteins to treat cancer.

Iclusig is used for people who can't take a different TKI. This can occur if other TKI drugs don't work for them any longer. It can also occur if these drugs cause too many side effects that aren't tolerable.

Iclusig can be used for CML in the following phases in adults:

  • Chronic phase. This is the first stage of CML, and it's when most people are diagnosed. In the chronic phase, symptoms are usually mild, if there are any at all.
  • Accelerated phase. This is the second stage of CML. In the accelerated phase, the number of cancer cells in your blood increases. You may also have more side effects, such as weight loss and fever.
  • Blast phase. This is the third, most severe stage of CML. In the blast phase, there are large numbers of cancerous cells in your blood. You may also have more severe side effects.

Note: Iclusig isn't meant to be used in people who are newly diagnosed with CML. The drug is meant to be used in people with CML who have already tried other drugs after being diagnosed.

Effectiveness

A clinical study showed that Iclusig is effective at treating certain types of CML.

This clinical study looked at people with CML in the chronic phase who had been previously diagnosed, but not recently. (The chronic phase is the first stage of CML.) These were people who weren't able to take a different TKI drug but took Iclusig. They weren't able to take a different TKI drug because the drug didn't work for them or because they couldn't tolerate the side effects.

After 12 months of treatment with Iclusig, 55% of these people had no cancer cells in their body or very few cancer cells in their body. In the study, Iclusig wasn't compared with a different drug or a placebo (treatment with no active drug).

Iclusig for acute lymphoblastic leukemia

Iclusig is FDA-approved to treat acute lymphoblastic leukemia (ALL). The drug is used to treat ALL in adults whose cancer cells have a certain gene mutation called the Philadelphia chromosome (Ph+ ALL).

Cancer cells with the Philadelphia chromosome make a protein that helps cancer cells grow and divide.

ALL is a type of cancer that affects your white blood cells. In ALL, the cancer develops and can worsen quickly if not treated. Immature white blood cells, called blasts, grow and multiply out of control. These blasts crowd out blood cells that your body needs. The blasts mature into white blood cells that make antibodies (a type of protein) and other immune system cells.

Iclusig is used to treat Ph+ ALL in adults if they can't take other TKI drugs. This can occur if TKI drugs don't work to treat their cancer. It can also occur if the drugs cause too many side effects that aren't tolerable.

In a clinical study, 41% of people with Ph+ ALL who couldn't take a different TKI had a complete or partial response to Iclusig. This group included people who had Ph+ ALL with and without the T315I mutation. If Ph+ ALL cancer cells have the T315I mutation, they stop responding to other drugs. This means the drugs are no longer effective for the people's cancer. Iclusig wasn't compared with a placebo.

Off-label use for Iclusig

In addition to the uses listed above, Iclusig may be prescribed off-label. Off-label drug use is when a drug that's approved for one use is used for a different one that's not approved.

Iclusig for lung cancer (under study)

Iclusig isn't FDA-approved to treat lung cancer. However, there's currently an ongoing study that's testing the effectiveness of Iclusig for this condition. It's not known yet whether this drug will be helpful in treating lung cancer.

The Iclusig dosage your doctor prescribes will depend on how your body responds to the drug.

Typically, your doctor will start you on the usual dosage. Then they'll adjust it over time to reach the amount that's right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Iclusig comes as tablets that you swallow. The drug is available in the following strengths: 15 mg, 30 mg, and 45 mg.

Dosage for leukemia

The usual starting dosage of Iclusig for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) is the same.

Typically, your doctor will recommend taking one 45-mg tablet of Iclusig once a day. They may reduce your dosage based on how your body responds to the drug.

What if I miss a dose?

If you miss a dose of Iclusig, wait and take your next dose at the regular time. Don't take two doses in 1 day. This will increase your risk for serious side effects. (For more about side effects, see the "Iclusig side effects" section above.)

Medication reminders can help make sure that you don't miss a dose.

Will I need to use this drug long term?

Iclusig is meant to be used as a long-term treatment. If you and your doctor determine that Iclusig is safe and effective for you, you'll likely take it long term.

There's no known interaction between Iclusig and alcohol.

However, both Iclusig and alcohol can cause liver damage and pancreas problems on their own. An example of these pancreas problems is inflammation (swelling) of the pancreas. It's possible that drinking heavily while taking Iclusig could increase your risk for these serious effects.

Alcohol and Iclusig can also cause similar side effects when taken separately. Drinking heavily while taking Iclusig could increase your risk for these common side effects, including:

Talk with your doctor about whether drinking alcohol during Iclusig treatment is safe for you.

Iclusig can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Iclusig and other medications

Below is a list of medications that can interact with Iclusig. This list doesn't contain all drugs that may interact with Iclusig.

Before taking Iclusig, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Iclusig and certain antifungal drugs

Antifungal drugs are used to treat fungal infections. Taking Iclusig with certain antifungal drugs can increase the level of Iclusig in your body. This is because certain antifungal drugs prevent Iclusig from being broken down. High levels of Iclusig increase your risk for serious side effects. (For more about side effects, see the "Iclusig side effects" section above.)

Examples of antifungal drugs that can increase the level of Iclusig in your body include:

  • ketoconazole (Extina, Ketozole, Xolegel)
  • itraconazole (Onmel, Sporanox, Tolsura)
  • posaconazole (Noxafil)
  • voriconazole (Vfend)

If you need to take an antifungal drug during Iclusig treatment, your doctor may lower your Iclusig dosage. They'll also monitor you more closely for side effects.

Iclusig and certain antiviral drugs

Antiviral drugs are used to treat infections caused by viruses, such as hepatitis or HIV. Taking Iclusig with certain antiviral drugs can increase the level of Iclusig in your body. This is because certain antiviral drugs prevent the breakdown of Iclusig. Your risk for serious side effects is higher when the level of Iclusig in your body increases. (For more about side effects, see the "Iclusig side effects" section above.)

Examples of antiviral drugs that can increase the level of Iclusig in your body include:

  • indinavir (Crixivan)
  • lopinavir/ritonavir (Kaletra)
  • ritonavir (Norvir)
  • nelfinavir (Viracept)
  • saquinavir (Invirase)

If you need to take one of these antiviral drugs during Iclusig treatment, your doctor may decrease your Iclusig dosage. They'll also monitor you more closely for side effects.

Iclusig and certain seizure drugs

Seizures are changes in the electrical activity of your brain that can affect how you feel or act. Taking Iclusig with certain drugs used to treat seizures can decrease the level of Iclusig in your body. This is because some seizure drugs cause your body to break down Iclusig faster than normal. Having a lower level of Iclusig in your body can make the drug less effective in treating cancer.

Examples of seizure drugs that can lower Iclusig levels include:

If you need to take one of these seizure drugs during Iclusig treatment, your doctor may monitor you more closely to make sure Iclusig is working for you.

Iclusig and St. John's wort

Taking Iclusig with St. John's wort can decrease the level of Iclusig in your body. This is because St. John's wort causes your body to break down Iclusig faster than normal. Having a lower level of Iclusig in your body can make the drug less effective for you.

If you're thinking about taking St. John's wort during your Iclusig treatment, first talk with your doctor. They can review the risks and benefits of this combination with you.

Iclusig and grapefruit

Taking Iclusig with grapefruit or grapefruit juice can increase the level of Iclusig in your body. This is because grapefruit contains a chemical that prevents your body from breaking down Iclusig. Having a higher level of Iclusig in your body increases your risk for serious side effects. (For more about side effects, see the "Iclusig side effects" section above.)

If you need to consume grapefruit or grapefruit juice during Iclusig treatment, your doctor may prescribe a lower dosage of Iclusig. Otherwise, it's best to avoid grapefruit and grapefruit juice while taking Iclusig.

Other drugs are available that can treat leukemia. Some may be better suited for you than others. If you're interested in finding an alternative to Iclusig, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions.

Alternatives for leukemia

There are other drugs available to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The best drug for you will depend on the different factors of your cancer, including its genetic makeup.

Examples of other drugs that may be used to treat these forms of leukemia include:

  • imatinib (Gleevec)
  • dasatinib (Sprycel)
  • nilotinib (Tasigna)
  • bosutinib (Bosulif)
  • omacetaxine (Synribo)
  • blinatumomab (Blincyto)
  • inotuzumab ozogamicin (Besponsa)

You may wonder how Iclusig compares with other medications that are prescribed for similar uses. Here we look at how Iclusig and Sprycel are alike and different.

Ingredients

Iclusig contains the active drug ponatinib. Sprycel contains the active drug dasatinib.

Uses

Iclusig and Sprycel are both used to treat certain types of blood cancers.

Iclusig is approved by the Food and Drug Administration (FDA) to treat:

  • chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults, if no other tyrosine kinase inhibitor (TKI) drugs are effective or safe for them
  • CML or Ph+ ALL with the T315I gene mutation in adults

Iclusig isn't meant to be used in people with newly diagnosed CML.

Sprycel is approved by the FDA to treat newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) in the chronic phase. It's also used for Ph+ CML in adults if other drug therapy isn't safe or effective for them.

Sprycel is also FDA-approved to treat Ph+ ALL in adults if other drug therapy isn't safe or effective for them.

In addition, Sprycel is approved for use in children ages 1 year and older with:

  • Ph+ CML in the chronic phase
  • Ph+ ALL that's newly diagnosed. Sprycel is used with chemotherapy for this condition.

Drug forms and administration

Iclusig and Sprycel both come as tablets that you swallow and are taken once a day.

Side effects and risks

Iclusig and Sprycel contain different drugs. Therefore, they can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Iclusig, with Sprycel, or with both drugs (when taken individually).

  • Can occur with Iclusig:
    • dry skin
    • pain in your arms, legs, or back
    • pain or blisters in your mouth
    • upper respiratory infections such as the common cold
    • cough
    • dizziness
    • hair loss
    • peripheral edema (swelling in the feet, legs, hands, or arms)
    • chills
    • lack of appetite
    • weight loss
    • insomnia (trouble sleeping)
  • Can occur with Sprycel when used in adults:
    • few unique side effects
  • Can occur with both Iclusig and Sprycel when used in adults:

Serious side effects

These lists contain examples of serious side effects that can occur with Iclusig, with Sprycel, or with both drugs (when taken individually).

Effectiveness

Iclusig and Sprycel have similar FDA-approved uses. They're both used to treat Ph+ CML or Ph+ ALL in adults if they can't take other drug therapies. However, these drugs are each used if a person can't take different types of drug therapies.

These drugs haven't been directly compared in clinical studies for Ph+ CML or Ph+ ALL, but studies have found both Iclusig and Sprycel to be effective for treating certain types of CML and ALL.

Costs

Iclusig and Sprycel are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Iclusig costs significantly more than Sprycel. The actual price you'll pay for either drug depends on your dosage, your insurance plan, your location, and the pharmacy you use.

You should take Iclusig according to your doctor's or healthcare provider's instructions.

Iclusig comes as a tablet that you swallow.

When to take

You'll take Iclusig once a day, at any time of the day.

Medication reminders can help make sure that you don't miss a dose.

Taking Iclusig with food

You can take Iclusig with or without food.

Can Iclusig be crushed, split, or chewed?

You should swallow Iclusig tablets whole.

Don't crush, split, or chew the tablets. This could change how well the drug works or cause side effects to be more severe. (For more about side effects, see the "Iclusig side effects" section above.)

Iclusig contains ponatinib, which belongs to a class of drugs called tyrosine kinase inhibitors (TKIs). A class of drugs is a group of medications that work in a similar manner. The TKI drug class works to treat cancer in a targeted way, by attacking very specific parts of cancer cells. Therefore, Iclusig is considered a targeted therapy.

Iclusig works to treat two types of leukemia: chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).

Iclusig for chronic myeloid leukemia

Iclusig is used to treat CML in adults.

CML is a type of bone marrow cancer that involves blood cells. Some cancerous blood cells in the bone marrow contain a genetic mutation (an abnormal, permanent change to a gene) called BCR-ABL. The BCR-ABL genetic mutation causes blood cells to grow and divide without stopping.

The BCR-ABL gene produces a type of protein called a tyrosine kinase. The tyrosine kinase helps cancer cells grow. Iclusig inhibits (blocks) that tyrosine kinase, which causes cancer cells to stop growing and eventually die.

Iclusig is used to treat CML in the each of the following phases in adults:

  • Chronic phase: the first stage of CML, in which symptoms are mild, if you have any symptoms
  • Accelerated phase: the second stage of CML, in which you start having more symptoms and the number of cancerous cells in your blood increases
  • Blast phase: the third, most severe stage of CML, in which you have the most severe side effects, and the number of cancerous cells in your blood is very high

While Iclusig can treat CML in the chronic phase, it isn't meant to be used as the first drug someone takes for their cancer. That's because Iclusig has much more serious side effects than other drugs in the TKI drug class. (For more about side effects, see the "Iclusig side effects" section above.) Because of this, Iclusig shouldn't be used in people who have just been diagnosed with CML. The drug is meant to be a treatment option for people who have tried other TKIs that didn't work for them.

Iclusig is also used to treat CML that has another specific mutation, called T315I. This mutation helps cancer cells survive treatment with other TKI drugs. Iclusig is the only TKI that can stop the growth of CML with the T315I mutation.

Iclusig for acute lymphoblastic leukemia

Iclusig is used to treat ALL in adults.

ALL is another type of bone marrow cancer. With this cancer, certain white blood cells, called lymphocytes, grow rapidly and out of control. The condition is called acute because it typically worsens very quickly.

Iclusig is used to treat ALL that has the Philadelphia chromosome-positive (Ph+) genetic mutation. This mutation refers to the BCR-ABL gene. The BCR-ABL gene produces a BCR-ABL protein called a tyrosine kinase, which is a special type of protein that helps cancer cells grow and divide.

Iclusig inhibits (blocks) the BCR-ABL tyrosine kinase protein. This causes cancer cells to stop growing and then eventually die.

Iclusig is also used to treat ALL that has the T315I mutation. This mutation helps cancer cells not be affected by other TKI drugs. Iclusig is the only TKI that can treat ALL with the T315I mutation.

How long does it take to work?

Iclusig starts working in the body shortly after you start taking it. However, the timing of when Iclusig kills cancer cells is different for each person.

In a clinical study, half of the people with CML in the chronic phase had a partial or complete reduction in the number of cancer cells in their blood after 2.8 months of treatment. A partial response means that a very low number of cancer cells are seen in the blood. And a complete response means there are no detectable cancer cells in the blood. Iclusig wasn't compared with a placebo (treatment with no active drug) or a different medication.

In the same study, half of the people with ALL or CML in the accelerated phase or blast phase had a complete reduction in the number of cancer cells in their blood after 0.7 to 1.0 month of treatment. They also had no symptoms of leukemia by that time.

Your doctor will check your blood regularly to see if Iclusig is working to treat your cancer.

There haven't been enough studies in humans to know if Iclusig is safe to take during pregnancy. However, in animal studies, harm to the fetus did occur when pregnant females took Iclusig.

Therefore, taking Iclusig while you're pregnant isn't recommended. Before you begin taking Iclusig, your doctor will give you a pregnancy test to make sure it's safe for you to start treatment.

If you become pregnant during Iclusig treatment, call your doctor right away.

Taking Iclusig while you're pregnant isn't recommended.

It's important for women to use an effective form of birth control while taking Iclusig and for at least 3 weeks after their last dose of Iclusig.

If you're of childbearing age, talk with your doctor about the best form of birth control for you.

It's not known if Iclusig passes into breast milk. However, because of how serious the side effects can be when you take Iclusig, breastfeeding isn't recommended during Iclusig treatment. You shouldn't breastfeed during Iclusig treatment and for at least 6 days after your last dose.

If you're breastfeeding and considering taking Iclusig, talk with your doctor about other ways to safely feed your baby.

Here are answers to some frequently asked questions about Iclusig.

Is Iclusig a type of chemotherapy?

No, Iclusig isn't considered a chemotherapy drug. Instead, Iclusig is referred to as a targeted therapy. Targeted therapy drugs are used to attack only certain parts of cancer cells.

Chemotherapy drugs work differently than targeted therapies. Chemotherapy attacks most of the cells in your body that grow quickly, not just cancer cells. Because of this difference, targeted therapies and chemotherapies usually cause different side effects.

Targeted therapies are often prescribed for you based on very specific details of your cancer. For example, Iclusig is a targeted therapy that can treat certain leukemias with the T315I mutation. (A mutation is an abnormal, permanent change to a gene.)

Targeted therapies, such as Iclusig, and chemotherapy drugs are sometimes used together to treat cancer.

Will I have lab tests while I'm using Iclusig?

Yes. During Iclusig treatment, your doctor will monitor how well your body is responding to the drug. They'll do complete blood cell tests regularly. These tests will show whether the number of cancer cells in your blood is decreasing. This will tell your doctor if Iclusig is effective for your cancer.

Your doctor will also do lab tests to make sure Iclusig isn't causing organ damage. Every few weeks or months, they'll do lab tests to check your blood cells, liver, pancreas, and heart. If any of these lab tests suggest that you're having severe side effects from Iclusig, your doctor may reduce your dosage or stop your treatment for a time.

Will Iclusig make me lose my hair?

Iclusig might make you lose your hair. In clinical studies, between 6% and 11% of people who took Iclusig had hair loss.

Talk with your doctor about your hair loss concerns. They may recommend ways to help decrease how much hair you lose.

Can I take Iclusig if I have heart problems?

You may be able to take Iclusig if you have heart problems. However, serious side effects, such as heart failure and blood clots, have been seen in a clinical study of Iclusig. These side effects occurred in people with and without risk factors for heart problems.

Tell your doctor about any past heart problems you've had. These include:

Your doctor will discuss with you the risks and benefits of taking Iclusig if you have heart problems. They'll also monitor your heart health more closely if you have a history of heart problems and take Iclusig.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

  • Blockages in arteries. Blockages in arteries (a type of blood vessel) have occurred in at least 35% of people who have taken Iclusig. These blockages can lead to serious events such as fatal heart attacks or strokes. The blockages can occur in people with or without risk factors for them. If you develop a blockage in your artery, your doctor will have you stop taking Iclusig right away.
  • Venous thromboembolism. Venous thromboembolism (a blood clot in a vein) has occurred in at least 6% of people who have taken Iclusig. These blood clots can lead to serious events, such as organ damage and a lack of oxygen. If you develop a blood clot, you doctor may have you stop taking Iclusig for a time or permanently.
  • Heart failure. Heart failure has occurred in 9% of people who have taken Iclusig. Some cases have been fatal. If you have new or worsening heart failure, your doctor may have you stop taking Iclusig for a time or permanently.
  • Liver damage and liver failure. Liver damage and liver failure have occurred in people who've taken Iclusig. Some cases have been fatal. If you develop liver damage, your doctor may have you stop taking Iclusig for a time.

Other warnings

Before taking Iclusig, talk with your doctor about your health history. Iclusig may not be right for you if you have certain medical conditions. These include:

  • Surgery. Taking Iclusig may reduce your body's ability to recover from wounds and injury. If you're planning to have surgery, you should stop taking Iclusig at least 1 week before the procedure. Talk with your doctor if you have a surgery scheduled so they can review your medications.
  • Pregnancy. Taking Iclusig while you're pregnant isn't recommended. For more information, please see the "Iclusig and pregnancy" section above.
  • Breastfeeding. Breastfeeding isn't recommended during Iclusig treatment. For more information, please see the "Iclusig and breastfeeding" section above.

Note: For more information about the potential negative effects of Iclusig, see the "Iclusig Side effects" section above.

Using more than the recommended dosage of Iclusig can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Iclusig from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Iclusig tablets at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Iclusig and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

The Food and Drug Administration (FDA) has approved Iclusig to treat:

It's also approved to treat CML or Ph+ ALL with the T315I mutation in adults.

Iclusig should not be used for newly diagnosed CML in the chronic phase in adults.

Mechanism of action

Iclusig is a third-generation tyrosine kinase inhibitor. It inhibits the tyrosine kinase activity of the BCR-ABL gene. The BCR-ABL gene is formed when two chromosomes fuse to create the Philadelphia chromosome.

The BCR-ABL protein is found in most CML cancer cells and some ALL cancer cells. Inhibiting its activity prevents cells cancer cell growth and division.

Some cancer cells also have a T315I-mutated BCR-ABL tyrosine kinase. Iclusig is the only drug in its class with activity against this mutation.

Pharmacokinetics and metabolism

Iclusig reaches peak plasma concentrations within 6 hours of oral ingestion. Absolute oral bioavailability is unknown, but administration with a meal does not alter exposure, compared with administration after fasting.

Iclusig is almost completely plasma protein-bound (>99%). At least 64% of Iclusig metabolism occurs via CYP3A4, CYP2C8, CYP2D6, and CYP3A5, with the remainder occurring via esterases and amidases.

Terminal half-life is approximately 24 hours. Elimination is primarily via fecal route.

Contraindications

There are no contraindications to Iclusig use.

Storage

Iclusig tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C) in the original child-resistant container. Keep away from children.

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 other 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.