Overview: Cavhanza is used to treat a type of blood cancer called chronic myeloid leukemia (CML). Common side effects may include nausea, rash, and headaches. Call your health care provider right away if you get a fever, rash, swelling, unexplained bleeding, or severe diarrhea. Cavhanza is a tablet that you can swallow whole or dissolve in your mouth.
Uses
What is Cavhanza used for?
Cavhanza (nilotinib) is commonly used to treat a certain type of blood cancer called chronic myeloid leukemia (CML).
Cavhanza may also be used for other conditions as determined by your health care provider.
How does Cavhanza work (mechanism of action)?
Cavhanza is a type of medicine known as a tyrosine kinase inhibitor (TKI). It works by targeting specific proteins on cancer cells. By blocking the action of these proteins, nilotinib can cause cancer cells to die and can prevent cancer cells from growing or spreading.
How is Cavhanza supplied (dosage forms)?
Brands and other names
- Cavhanza
Dosage forms and strengths
- 60 mg, 80 mg orally disintegrating tablets
How should I store Cavhanza?
Cavhanza should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep Cavhanza in its original container. To help protect it from moisture, do not remove the desiccant from the container.
Side Effects
What are the most common side effects of Cavhanza?
The most common side effects of Cavhanza are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Nausea, vomiting, diarrhea, or constipation
- Rash or itching
- Headache
- Tiredness
- Cough
- Joint pain
- Infection in the nose or throat, sore throat, or common cold symptoms
- Fever or night sweats
- Blood disorders (see below)
There may be other side effects of Cavhanza that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Cavhanza?
While less common, the most serious side effects of Cavhanza are described below, along with what to do if they happen.
Severe Allergic Reactions. Cavhanza may cause allergic reactions, which can be serious. Stop taking Cavhanza and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Heart Rhythm Changes. Cavhanza may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Keep all medical appointments while taking Cavhanza. Your health care provider will likely have your heart rhythm checked before you start the medicine and while you are taking it. Tell your health care provider right away if you feel lightheaded, faint, or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.
Tumor Lysis Syndrome. Cavhanza can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while taking Cavhanza and to keep all appointments for blood work so your health care provider can see how your body is responding to Cavhanza. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking Cavhanza.
- Nausea and vomiting
- Weakness
- Swelling or fluid retention
- Shortness of breath
- Muscle cramps
- Seizures
Blood Disorders. Cavhanza can cause blood disorders, low platelet levels (thrombocytopenia), low levels of red blood cells (anemia), and low levels of certain white blood cells called neutrophils (neutropenia). Keep all of your appointments, including those for lab work, while you are taking Cavhanza. Get help right away if you have any of the following symptoms of blood disorders.
- Fever, chills, or other signs of an infection
- Shortness of breath
- Pale or yellowish skin
- Unexplained bruising or bleeding
- Unusual weakness or tiredness
- Cold hands and feet
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Headache
- Fast or abnormal heartbeat
Heart Attack and Stroke. Cavhanza can increase your risk of a heart attack or stroke that can lead to death. This risk is higher in people who already have heart disease and with longer use of Cavhanza and higher doses. Do not take Cavhanza if you have had a recent heart attack without talking to your health care provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
Inflammation of the Pancreas (Pancreatitis). Cavhanza may cause inflammation of the pancreas, which is called pancreatitis. Your health care provider will likely check blood tests regularly to monitor your pancreas while you are taking this medicine. Keep all appointments, including those for lab work. Get medical help right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Cavhanza. Your health care provider will likely check blood tests regularly to monitor your liver while you are taking this medicine. Keep all appointments, including those for lab work. Call your health care provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Severe Bleeding. Cavhanza can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while taking Cavhanza.
- Pink, red, or brown urine (pee)
- Vomit with blood that looks like coffee grounds
- Red or black stools (looks like tar)
- Coughing up blood or blood clots
- Changes in your vision
- Sudden headache
- Sudden confusion
- Loss of consciousness
Fluid Retention (Edema). Cavhanza can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Call your health care provider right away if you have any of the following symptoms.
- Chest pain
- Irregular heartbeat
- Shortness of breath
- Stretched or shiny skin
- Swollen body parts, such as the belly or ankles
- Rapid weight gain
Slowed Growth in Children. Cavhanza, when taken by children, can slow down growth. Talk to your child’s healthcare provider if you have concerns about your child’s growth.
Warnings & Precautions
Who should not use Cavhanza?
Allergies to Ingredients. People who are allergic to any of the following should not take Cavhanza.
- Cavhanza
- Nilotinimb
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Cavhanza.
Low Magnesium or Potassium Levels. If you have low magnesium levels (hypomagnesemia) or potassium levels (hypokalemia), you should not take Cavhanza. Low levels of magnesium or potassium can increase your risk for abnormal heart rhythms that can be life threatening. See the Side Effects section for more details.
Heart Rhythm Problems. If you have certain heart rhythm problems known as long QT syndrome or QT prolongation, you should not take Cavhanza.
What should I know about Cavhanza before using it?
Do not take Cavhanza unless it has been prescribed to you by a health care provider. Take it as prescribed.
Cavhanza tablets can be swallowed whole, dissolved on your tongue and then swallowed, or chewed and then swallowed. However, you should not crush Cavhanza before taking it. Contact your pharmacist if you have questions about how to take Cavhanza.
Do not share Cavhanza with other people, even if they have the same condition as you. It may harm them.
Do not change your dose or stop taking Cavhanza without being told to do so by your health care provider. Your health care provider may use a special test to see if you should stop taking it. Even if your health care provider tells you to stop taking Cavhanza, they will likely continue to monitor you for years after you stop taking it. Some people have pain including muscle, joint, extremity (hands and feet), bone, or spine pain that is worse or happens more often than it did before stopping the medicine.
Keep Cavhanza out of the reach of children.
The active ingredient in Cavhanza is nilotinib. There are other prescription products that have nilotinib in them. These may not be interchangeable with Cavhanza. Always check the medicine and the label on your prescriptions before using them to make sure you are using the correct one. Call your healthcare provider if your medicine looks different than usual or if the directions change, and you do not understand why.
What should I tell my health care provider before using Cavhanza?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Cavhanza is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Prior surgery to remove any part of your stomach
- Problems with electrolyte levels, especially potassium and magnesium
- Heart problems, including heart attack and abnormal heart rhythms
- Pancreatitis
- Get dehydrated easily
- Liver problems
- Bleeding problems
- Anyone in your family having any heart problems or QT prolongation
- Blood clot problems, including a stroke or any other issues with decreased blood flow to the brain
Other Medicines and Supplements. Cavhanza may interact with other medicines and supplements. Before taking Cavhanza, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Cavhanza may cause harm to a fetus. You should take a pregnancy test before you start taking Cavhaza to be sure you are not pregnant. Use effective birth control while you are taking Cavhanza and for 2 weeks after your last dose. Tell your health care provider if you are pregnant, think you are pregnant, or plan to become pregnant.
Breastfeeding. You should not breastfeed while taking Cavhaza and for 2 weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Cavhanza?
For more information about Cavhanza, you can visit the drugmaker’s website at www.flexpharmausa.com or call them at 651-209-1184.
Interactions
Does Cavhanza interact with foods or drinks?
Eating certain fruits and or drinking certain juices can increase your blood levels of Cavhanza and increase your risk for side effects. Avoid eating or drinking things made from grapefruit while taking Cavhanza. Ask your health care provider if there are other foods you should avoid.
It is unknown if drinking alcohol will affect Cavhanza, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. Both Cavhanza and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.
Does Cavhanza interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Cavhanza.
- Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem, such as a medicine used to control your heart rate or rhythm (antiarrhythmic)
- Itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
- Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
- A statin, such as atorvastatin (Lipitor and others) or rosuvastatin (Crestor), which is a medicine to lower cholesterol
- St. John’s wort, which is a supplement that may be used for depression
Many other medicines may alter the blood levels of Cavhanza, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Cavhanza. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Cavhanza?
If you or someone else has used too much Cavhanza, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Cavhanza?
If you miss a dose, skip the missed dose and take your next dose when it is due. Do not take double or extra doses.
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