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Axitinib (Oral route)

Pronunciation:

ax-I-ti-nib

Brand Names:

  • Inlyta

Dosage Forms:

  • Tablet

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Axitinib treats late stage kidney cancer in patients who have received at least one cancer treatment that did not work. It is an antineoplastic agent (cancer medicine).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of axitinib in the pediatric population. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of axitinib in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

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 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.

  • Atazanavir
  • Boceprevir
  • Bosentan
  • Carbamazepine
  • Clarithromycin
  • Conivaptan
  • Dexamethasone
  • Efavirenz
  • Etravirine
  • Fosphenytoin
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Modafinil
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Voriconazole

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Heart failure, history of or
  • Hypertension (high blood pressure) or
  • Stomach or bowel fistula (a hole or opening) or
  • Thyroid problems Use with caution. May make these conditions worse.
  • Blood clotting problems, history of or
  • Deep vein thrombosis (blood clot in the leg), history of or
  • Heart attack, history of or
  • Pulmonary embolism (blood clot in the lung), history of or
  • Retinal artery or vein occlusion (blood clot in the eye), history of or
  • Transient ischemic attack, history of Use with caution. May make side effects become worse.
  • Liver disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor, even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole with a glass of water. Do not break, crush, or chew it.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For kidney cancer:
      • Adults At first, 5 milligrams (mg) two times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
      • Children Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Use an effective form of birth control to keep from getting pregnant. Men should use condoms during sexual intercourse. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.

Your blood pressure should be checked regularly during therapy with this medicine. The symptoms of high blood pressure are blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.

This medicine may cause serious heart and blood vessel problems. Call your doctor right away if you have chest pain or discomfort, numbness or weakness on one side of your body, pain or discomfort in your arms, jaw, back or neck, shortness of breath, trouble talking, or vision changes.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Check with your doctor right away if you have severe stomach burning, cramps, or pains, bloody or black, tarry stools, trouble breathing, heartburn, indigestion, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

This medicine may increase your chance of bleeding and cause a delay in wound healing. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine at least 24 hours before surgery.

This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Check with your doctor right away if you have headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are using this medicine.

This medicine may cause a serious skin problem called hand-foot syndrome. Check with your doctor right away if you have a skin rash or any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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
Abdominal or stomach pain
bleeding gums
bloody nose
blurred vision
cloudy urine
confusion
constipation
coughing up blood
decreased urination
depressed mood
difficult or labored breathing
difficulty with swallowing
dizziness
dry mouth
dry skin and hair
fainting
feeling cold
hair loss
hoarseness or husky voice
incoherent speech
increased menstrual flow or vaginal bleeding
increased urination
lightheadedness
loss of appetite
metallic taste
muscle cramps and stiffness
muscle weakness
nausea
nervousness
nosebleeds
paralysis
pounding in the ears
rapid breathing
red or black, tarry stools
red or dark brown urine
redness, swelling, or pain of the skin
scaling of the skin on the hands and feet
slow or fast heartbeat
sunken eyes
thirst
tightness in the chest
tingling of the hands and feet
ulceration of the skin
unusual tiredness or weakness
vomiting
weight gain or loss
wrinkled skin
Less common
Anxiety
bleeding from the gums or nose
bleeding from the rectum
bloody, black or tarry stools
change in vision
chest pain or discomfort
extreme drowsiness
eye pain
heartburn
inability to speak
indigestion
numbness or tingling in the face, arms, hands, or legs
pain in the chest, groin, or legs
pain or discomfort in the arms, jaw, back, or neck
pain, redness, or swelling in the arm or leg
pale skin
ringing in the ears
seizures
sensitivity to heat
severe headaches of sudden onset
severe stomach pain, cramping, or burning
slurred speech
sudden loss of coordination
sudden onset of slurred speech
sudden shortness of breath or troubled breathing
sudden vision changes
sweating
temporary blindness
trouble sleeping
trouble speaking, thinking, or walking
troubled breathing with exertion
uncomfortable swelling around the anus
unusual bleeding or bruising
vomiting of material that looks like coffee grounds
weakness in the arm or leg on one side of the body

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
Belching
change in taste
cough
cracked lips
decreased appetite
diarrhea
difficulty with moving
itching skin or rash
joint pain
lack or loss of strength
loss of taste
muscle aches or pain
pain in the arms or legs
sore throat
sores, ulcers, or white spots on the lips, tongue, or inside the mouth
stomach discomfort or upset
swelling or inflammation of the mouth
swollen joints
upper stomach pain
voice changes
Less common
Burning sensation of the tongue
continuous ringing or buzzing or other unexplained noise in the ears
flushing or redness of the skin
hearing loss
thinning of the hair
unusually warm skin

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.


Last Updated: 9/15/2016
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