Iclusig
Iclusig (ponatinib) is an oral medication used to treat certain types of chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL). It’s considered a targeted anticancer treatment. Iclusig (ponatinib) is conveniently taken once a day, but it can cause several heart or blood flow problems that can be serious.
What is Iclusig (ponatinib)?
What is Iclusig (ponatinib) used for?
How Iclusig (ponatinib) works
Iclusig (ponatinib) is a tyrosine kinase inhibitor (TKI). It blocks a certain protein in your body called BCR-ABL tyrosine kinase. This protein is found on cancer cells like CML and ALL and not on normal, healthy cells. It causes the cancer cells to grow and multiply. By blocking this protein, Iclusig (ponatinib) kills cancer cells and stops their spread.
Drug facts
Side effects of Iclusig (ponatinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Rash (up to 75%)
- Joint pain (up to 61%)
- Stomach pain (up to 54%)
- Constipation (up to 53%)
- High blood pressure (up to 53%)
- Tiredness (up to 47%)
- Headache (up to 43%)
- Dry skin (up to 42%)
- Swelling or fluid buildup (up to 41%)
- Fever (up to 40%)
- Nausea (up to 34%)
- Lower appetite (up to 31%)
Less Common Side Effects
- Diarrhea
- Vomiting
- Mouth sore or inflammation of the lining of your mouth
- Bone or muscle pain
- Cold-like symptoms
- Infection in your sinuses, throat, lungs, blood, skin, or urinary tract
- Trouble breathing
- Chills
- Dizziness
- Trouble sleeping
- Hair loss
- Weight loss
Iclusig (ponatinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clots or reduced blood flow problems: chest pain, trouble breathing, weakness on one side of the body, trouble talking, changes in vision, severe headache, leg pain or swelling
- Severe fluid buildup or heart failure: shortness of breath during rest or exercise, rapid weight gain, swelling in your arms or legs, chest pain, tiredness
- Changes in your heart rhythm: fainting, dizziness, chest pain, fast heartbeat
- Liver damage: right-sided stomach pain, tiredness, loss of appetite, yellowing of the skin or eyes
- Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
- Abnormal electrolyte levels and kidney problems: racing heart, muscle cramps or spasms, numbness, dark urine, urinating less than usual
- Problems that affect the brain: headaches, vision problems, seizures
The following Iclusig (ponatinib) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Bladder pain
bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
chills
cloudy urine
confusion
cough or hoarseness
coughing up blood
decreased urine output
difficult, burning, or painful urination
difficulty with breathing or swallowing
dilated neck veins
dizziness
fainting
frequent urge to urinate
increased menstrual flow or vaginal bleeding
indigestion
irregular breathing
joint pain, stiffness, or swelling
lightheadedness
lower back, side, or stomach pain
nervousness
nosebleeds
pains in the chest, groin, or legs, especially calves of the legs
pains in the stomach, side, or abdomen, possibly radiating to the back
pale skin
paralysis
pinpoint red spots on the skin
pounding in the ears
prolonged bleeding from cuts
rapid weight gain
rapid, shallow breathing
red or black, tarry stools
red or dark brown urine
severe headaches of sudden onset
slow or fast heartbeat
sudden loss of coordination
sudden slurred speech
sudden vision changes
tingling of the hands or feet
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual weight gain or loss
Less common
burning, numbness, tingling, or painful sensations
chest discomfort
fast, pounding, or irregular heartbeat or pulse
pain, redness, or swelling in the arms or legs
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet
Incidence not known
Blistering, peeling, loosening of the skin
bloody, black, or tarry stools
blue-green halos seen around objects
clay-colored stools
dark urine
decreased appetite
headache
indigestion
itching or skin rash
joint or muscle pain
loss of appetite
red irritated eyes
red skin lesions, often with a purple center
sensitivity of the eyes to light
sensitivity to heat
severe vomiting, sometimes with blood
stomach cramps or tenderness
sweating
trouble sleeping
unusual tiredness or weakness
vomiting of material that looks like coffee grounds, severe and continuous
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Back or bone pain
cracked lips
difficulty having a bowel movement (stool)
difficulty with moving
dryness, itching, pain, redness, swelling, tenderness, or warmth on the skin
lack or loss of strength
muscle aches, pain, or stiffness
stuffy or runny nose
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Iclusig (ponatinib)
Pros
- A pill that’s swallowed once a day
- Can be used as a treatment option in people with a certain mutation
- More precise in the way it targets cancer cells, compared to traditional chemotherapy
Cons
- Available as brand only, so can be expensive
- Contains lactose, so might not be a good option for people who are lactose intolerant
Pharmacist tips for Iclusig (ponatinib)
- Iclusig (ponatinib) can be taken with or without food. Swallow tablets whole. Don’t cut, crush, or dissolve the tablets.
- If you miss a dose of Iclusig (ponatinib), don’t try to make up that dose. Skip the missed dose, and take your next dose at your next regularly scheduled time. Don't take two doses at the same time.
- Avoid grapefruit and grapefruit juice while taking Iclusig (ponatinib). These foods or drinks can raise the levels of the medication in your body and cause more side effects.
- Iclusig (ponatinib) can cause nerve problems in the arms or legs, which can feel like burning, tingling, or a loss of feeling. Let your provider know right away if you experience these symptoms.
- Iclusig (ponatinib) can cause swelling in the arms or legs. It can also sometimes cause fluid buildup in other parts of the body, which can look like shortness of breath or rapid weight gain. Let your provider know if you develop any of these symptoms during treatment in case they need to adjust your dose.
- Since Iclusig (ponatinib) can raise your blood pressure, your provider will check your blood pressure at your regular appointments. Contact your provider if you experience confusion, headache, chest pain, or shortness of breath at any time during treatment, since these can be signs of very high blood pressure.
- Let your cancer specialist know at least 1 week before any planned surgeries. It’s possible to have problems with how well you recover from surgery while taking Iclusig (ponatinib). Because of this, your provider will tell you when to stop Iclusig (ponatinib) before your surgery and when to restart treatment.
- If you’re able to become pregnant, use birth control, such as birth control pills or condoms, while taking Iclusig (ponatinib) and for at least 3 weeks after your last dose. It’s possible for this medication to cause harm to an unborn baby.
- Ask your provider or pharmacist about the best way to handle and throw away Iclusig (ponatinib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Common questions about Iclusig (ponatinib)
In general, Iclusig (ponatinib) isn’t recommended as a first-choice option for CML because of the serious side effects it can cause. It’s typically used after at least two other similar medications haven’t worked for your cancer. But the decision to use Iclusig (ponatinib) can also depend on if you have certain mutations in your cancer that make it hard to treat with typical first-choice options. Your provider will decide when it’s best to use Iclusig (ponatinib).
You should take Iclusig (ponatinib) as instructed by your provider. How long you take Iclusig (ponatinib) therapy depends on several factors, including how well the medication is working to treat your cancer and how well you tolerate it. Don’t stop taking Iclusig (ponatinib) without first discussing with your provider.
It’s not known if Iclusig (ponatinib) can affect a human’s ability to have a baby (fertility). In animal studies, fertility decreased in females that were given Iclusig (ponatinib). It’s not known if the negative effects on fertility can be reversed. Studies didn’t show harmful effects on fertility in male animals. Although what happens in animals might not necessarily be the same in humans, it’s important to be aware of this risk. Talk to your provider if you have questions or concerns about the possible impact of Iclusig (ponatinib) on your fertility.
Iclusig (ponatinib) isn’t recommended for use in pregnancy because it might cause harm to your unborn baby. Because of this risk, it’s important to avoid getting pregnant during treatment. If you’re a woman of childbearing age, you should use birth control while taking Iclusig (ponatinib) and for 3 weeks after the last dose. Let your provider know right away if you become pregnant while taking this medication.
It isn’t recommended to breastfeed while taking Iclusig (ponatinib). We don’t know if it can pass into human breast milk, but there’s a risk of serious harm to nursing infants if it does. Because of this risk, you shouldn’t breastfeed while taking Iclusig (ponatinib) and for 6 days after your last dose. Talk with your provider about other ways to feed your baby during treatment.
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Risks and warnings for Iclusig (ponatinib)
Iclusig (ponatinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood flow problems and clots
- Risk factors: History of heart problems | At risk of heart problems | History of blood flow problems | High blood pressure | High cholesterol | High blood sugar | Older age
People taking Iclusig (ponatinib) have experienced blood clots or other sort of blockages in their blood vessels. This can cause reduced blood flow to other parts of your body. It can lead to serious or fatal problems, such as heart attack, stroke, narrowing of blood vessels in the brain, or severe peripheral vascular disease. Sometimes, urgent surgery is needed to open up the blood vessels more. These events can happen at any time after starting treatment, from a few weeks to several years.
Symptoms of a blocked vessel can include chest pain, trouble breathing, weakness on one side of the body, trouble talking, changes in vision, headache, dizziness, leg pain or swelling, or severe stomach area pain. If these symptoms happen, go to the emergency room as soon as possible.
Heart failure
- Risk factors: History of heart failure
Some people taking Iclusig (ponatinib) experienced heart failure. Some of these cases were serious or severe. Let your provider know if you have any new or worsening symptoms of heart failure, including trouble breathing, swelling of the legs or stomach area, tiredness, dizziness, or sudden weight gain. If these symptoms happen, let your provider know because they might need to adjust your dose or have you stop taking Iclusig (ponatinib).
Liver damage
Iclusig (ponatinib) can cause liver damage that can lead to life-threatening liver failure. This liver injury can happen at any time, but can generally start in the first few months of treatment. Your provider will monitor your liver health through lab work at the start of treatment as well as regularly while you’re taking Iclusig (ponatinib). Let your provider know if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, or yellowing of the eyes or skin, as these can be signs of liver problems.
Pancreatitis (inflammation of the pancreas)
- Risk factors: History of pancreatitis | Alcohol abuse
Some people taking Iclusig (ponatinib) can develop higher blood levels of lipase (a protein that’s made by the pancreas), which can occur with or without pancreatitis. It can happen within days to months or even years after starting treatment. If you’ve had pancreatitis before, you might be at higher risk of developing it again during treatment. Your provider will monitor your lipase levels while you’re taking Iclusig (ponatinib) and adjust your dose if they get too high. Let your provider know immediately if you have sudden pain in your stomach that happens with nausea and vomiting. This can be a symptom of pancreatitis.
Eye problems
In clinical studies, some people taking Iclusig (ponatinib) developed eye problems like dry eye, eye pain, and blurred vision. Rarely, serious eye problems that could lead to blindness occurred. You’ll need to complete eye exams before you start Iclusig (ponatinib) and during your treatment. Let your provider know if you experience blurred vision, dry eye, or eye pain.
Change in heart rhythm
Taking Iclusig (ponatinib) can cause changes in your heart’s rhythm. While most events aren’t serious, some cases can be life-threatening or require that you go to the hospital. Let your provider know if you experience dizziness, an unusually fast or slow heartbeat, or chest pain. These can be symptoms of a change in your heart rhythm.
Low blood counts
Iclusig (ponatinib) can cause the levels of your red blood cells, white blood cells, and platelets to drop. When these cell counts are lower than normal, you have a higher risk of anemia, bleeding, bruising, and infections. Your provider will check your blood counts often while you’re taking Iclusig (ponatinib). Let your provider know right away if you experience fevers, chills, or bleeding and bruising that doesn’t stop or go away because you might need to have your dose lowered or stop this medication.
Tumor lysis syndrome
- Risk factors: Higher tumor burden | Dehydration | Kidney damage
Though rare, some people developed a condition called tumor lysis syndrome (TLS) after starting Iclusig (ponatinib). This condition happens when many cancer cells die quickly and break down in your body. This causes a rapid release of the cells’ contents like uric acid and electrolytes. Large amounts of these contents in the blood can cause serious kidney damage and abnormal heart rhythms, which can be dangerous if not treated right away. People with a lot of cancerous cells in their body (high tumor burden), dehydration, or a history of kidney damage are at greater risk. To reduce your risk of TLS, drink plenty of water while taking Iclusig (ponatinib). Tell your provider right away if you experience any symptoms of TLS, such as urinating less than usual or have dark urine, muscle cramps, or a racing heartbeat.
Problems that affect your brain
Rarely, people who’ve taken Iclusig (ponatinib) have developed rare, life-threatening problems that affect the brain. Symptoms typically show soon after starting Iclusig (ponatinib) and can include headaches, vision problems, changes in thinking or alertness, and seizures. Let your provider know immediately if you experience any of these symptoms, so they can run tests to see what the problem is.
Iclusig (ponatinib) dosage
Typical dosage for Iclusig (ponatinib)
The typical starting dose is 45 mg by mouth once daily. This dose might differ if you have liver problems.
During treatment, your dose might change based on how your cancer responds to Iclusig (ponatinib) or if you’re taking certain medications that interact with Iclusig (ponatinib).
Interactions between Iclusig (ponatinib) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Varicella Virus Vaccine, Live
- Zoster Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine
- Apalutamide
- Atazanavir
- Bacillus of Calmette and Guerin Vaccine, Live
- Boceprevir
- Carbamazepine
- Ceritinib
- Cholera Vaccine, Live
- Clarithromycin
- Cobicistat
- Conivaptan
- Dengue Tetravalent Vaccine, Live
- Enzalutamide
- Fosphenytoin
- Idelalisib
- Indinavir
- Influenza Virus Vaccine, Live
- Itraconazole
- Ketoconazole
- Lopinavir
- Lumacaftor
- Mitotane
- Nefazodone
- Nelfinavir
- Phenytoin
- Poliovirus Vaccine, Live
- Posaconazole
- Rifampin
- Ritonavir
- Saquinavir
- Smallpox Vaccine
- St John's Wort
- Telaprevir
- Telithromycin
- Tipranavir
- Typhoid Vaccine, Live
- Voriconazole
- Yellow Fever Vaccine
What are alternatives to Iclusig (ponatinib)?
Iclusig (ponatinib) images
