Pronunciation:

ax-I-ti-nib

Brand Names:

• Inlyta

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Axitinib is used together with other medicines (eg, avelumab, pembrolizumab) as first-line treatment of advanced renal cell carcinoma (RCC), a type of kidney cancer. This medicine is also used alone to treat advanced kidney cancer in patients who have received at least one cancer treatment (cancer medicine given by mouth or injection) but did not work well.

Axitinib is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed.

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. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Levoketoconazole
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Abametapir
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Asciminib
• Atazanavir
• Avacopan
• Belumosudil
• Berotralstat
• Boceprevir
• Bosentan
• Carbamazepine
• Ceftobiprole Medocaril
• Ceritinib
• Cholera Vaccine
• Clarithromycin
• Conivaptan
• Crizotinib
• Daridorexant
• Darolutamide
• Ebola Zaire Vaccine, Live
• Efavirenz
• Elexacaftor
• Eltrombopag
• Enasidenib
• Enzalutamide
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Fosphenytoin
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lanreotide
• Lazertinib
• Lefamulin
• Letermovir
• Lonafarnib
• Lopinavir
• Lumacaftor
• Mavorixafor
• Mitotane
• Mobocertinib
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nirogacestat
• Octreotide
• Omaveloxolone
• Pacritinib
• Palbociclib
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Repotrectinib
• Ribociclib
• Rifampin
• Ritonavir
• Rotavirus Vaccine, Live
• Saquinavir
• Selpercatinib
• Sotorasib
• St John's Wort
• Suzetrigine
• Taurursodiol
• Tazemetostat
• Telaprevir
• Telithromycin
• Tocilizumab
• Tovorafenib
• Treosulfan
• Tucatinib
• Voclosporin
• Vonoprazan
• Vorasidenib
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Mavacamten

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 problems (a hole or opening) or
• Thyroid problems—Use with caution. May make these conditions worse.

• Blood clotting problems (eg, deep vein thrombosis, pulmonary thromboembolism), history of or
• Diabetes or
• Heart attack, history of or
• Hyperlipidemia (high cholesterol in the blood) or
• Retinal artery or vein occlusion (blood clot in the eye), history of or
• Stroke, history of or
• Transient ischemic attack, history of—Use with caution. May make side effects become worse.

• Brain cancer, untreated or
• Stomach or bowel bleeding, active, recent—Use has not been studied. Should not be used in patients with these conditions.

• End-stage kidney disease or
• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use with caution. This medicine has not been studied in patients with this condition.

• Surgery, recent—Use with caution. May cause side effects to become worse.

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. Take each dose at least 12 hours apart.

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 (axitinib alone):
    • Adults—At first, 5 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For kidney cancer (axitinib with avelumab):
    • Adults—At first, 5 milligrams (mg) 2 times a day together with avelumab 800 mg every 2 weeks. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For kidney cancer (axitinib with pembrolizumab):
    • Adults—At first, 5 milligrams (mg) 2 times a day together with pembrolizumab 200 mg every 3 weeks. 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 a dose, take your next dose at the normal time. Do not take extra medicine to make up for the missed dose.

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 your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 1 week after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

This medicine may cause blood clots (eg, deep vein thrombosis, pulmonary embolism). Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, or trouble breathing.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, irregular or trouble breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, unusual tiredness or weakness, or weight gain. These may be symptoms of a serious heart problem (eg, heart failure).

This may increase the levels of protein in your urine, which may lead to kidney damage. Tell your doctor right away if you have cloudy urine.

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.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

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.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine at least 2 days before having a surgery. Wait for at least 2 weeks after major surgery, or until adequate wound healing before taking this medicine again.

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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

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

Bleeding gums

bloody nose

blurred vision

chest tightness

clay colored stools

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

fever

hair loss

headache

hoarseness or husky voice

incoherent speech

increased menstrual flow or vaginal bleeding

increased urination

itching skin or rash

lightheadedness

loss of appetite

metallic taste

muscle cramps, stiffness, or 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

stomach pain or tenderness

sunken eyes

swelling of the feet or lower legs

thirst

tingling of the hands and feet

ulceration of the skin

unusual tiredness or weakness

vomiting

weight gain or loss

wrinkled skin

yellow eyes or 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

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

sweating

temporary blindness

trouble sleeping

trouble speaking, thinking, or walking

trouble breathing

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

joint pain or swelling

lack or loss of strength

loss of taste

muscle aches or pain

pain in the arms or legs

sore throat

stomach discomfort or upset

swelling or inflammation of the mouth

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.