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Inlyta

Generic Name: axitinib (Oral route)

ax-I-ti-nib

Commonly used brand name(s)

In the U.S.

  • Inlyta

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Inlyta

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).

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

Before Using Inlyta

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.

Pediatric

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.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
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.

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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
  • 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 Inlyta

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.

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 Inlyta

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 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.

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 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.

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.

Inlyta Side Effects

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
  • joint pain
  • lack or loss of strength
  • loss of taste
  • muscle aches or pain
  • pain in the arms or legs
  • rash
  • 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.

See also: Side effects (in more detail)

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