Axitinib (Oral Route)
Original Article: http://www.mayoclinic.com/health/drug-information/DR603593
US Brand Names
Axitinib is an anticancer medicine that is used to treat kidney cancer (advanced renal cell carcinoma) in patients who have received at least one cancer treatment that did not work.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of axitinib in the elderly.
|All Trimesters||D||Studies 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.|
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.
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.
- St John's Wort
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
- Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism, retinal artery or vein occlusion), history of or
- Heart attack, history of or
- Hypertension (high blood pressure) or
- Stomach or bowel problems (e.g., fistula, perforation) or
- Thyroid problems or
- Transient ischemic attack, history of—Use with caution. May make these conditions worse.
- Brain metastasis (cancer that has spread to the brain), untreated or
- Stomach or bowel bleeding, active or recent—This medicine has not been studied in these patients and should not be given to patients with these conditions.
- Kidney disease, end stage or
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed, 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. To do so may increase the chance of side effects.
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.
This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
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 advanced 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.
- For advanced kidney cancer:
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.
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.
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 problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.
Your blood pressure should be checked regularly during treatment with this medicine. Your doctor may need to treat you if you develop high blood pressure while you are using this medicine. Symptoms of high blood pressure are blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant . If you think you have become pregnant while using this medicine, tell your doctor right away.
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.
Check with your doctor right away if you start having severe abdominal or 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 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 having surgery.
This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using this medicine and check with your doctor right away if you start having 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. Your doctor may adjust the dose or stop treatment for a short time.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
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 (e.g., St. John's wort) or vitamin supplements.
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
- Bleeding gums
- Bloody nose
- Blurred vision
- Cloudy urine
- Coughing up blood
- Decreased urination
- Depressed mood
- Difficult or labored breathing
- Difficulty with swallowing
- Dry mouth
- Dry skin and hair
- Feeling cold
- Hair loss
- Hoarseness or husky voice
- Increase in heart rate
- Increased menstrual flow or vaginal bleeding
- Muscle cramps and stiffness
- Pounding in the ears
- Prolonged bleeding from cuts
- 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
- Shortness of breath
- Slow or fast heartbeat
- Sunken eyes
- Tightness in the chest
- Tingling of the hands and feet
- Ulceration of the skin
- Unusual tiredness or weakness
- Weight gain
- Wrinkled skin
- Abdominal or stomach pain
- Bleeding after defecation
- 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
- Inability to speak
- Numbness or tingling in the face, arms, hands, or legs
- Pain or discomfort in the arms, jaw, back, or neck
- Pain, redness, or swelling in the arm or leg
- Pains in the chest, groin, or legs, especially calves of the legs
- Pale skin
- Ringing in the ears
- Sensitivity to heat
- Severe abdominal or stomach pain, cramping, or burning
- Severe headaches of sudden onset
- Slurred speech
- Sudden loss of coordination
- Sudden onset of shortness of breath for no apparent reason
- Sudden onset of slurred speech
- Sudden shortness of breath or troubled breathing
- Sudden vision changes
- Temporary blindness
- Trouble breathing
- 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, severe and continuing
- Weakness in the arm or leg on one side of the body, sudden and severe
- Weight loss
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
- Change in taste
- Cracked lips
- Decreased appetite
- Difficulty with moving
- Itching skin
- 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 abdominal or stomach pain
- Voice changes
- Continuing 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.