Pronunciation:

tye-VOE-za-nib

Brand Names:

• Fotivda

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Tivozanib is used to treat advanced kidney cancer (renal cell carcinoma) in patients who have received at least 2 or more cancer treatment and has come back or did not work well.

Tivozanib 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 tivozanib 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 tivozanib in the elderly.

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.

• Apalutamide
• Carbamazepine
• Enzalutamide
• Fedratinib
• Fexinidazole
• Fosphenytoin
• Itraconazole
• Lumacaftor
• Mavacamten
• Mitotane
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including asthma) in patients with this condition.

• Bleeding problems, or history of or
• Blood clotting problems (eg, arterial thromboembolism, venous thromboembolism), history of or
• Heart attack, history of or
• Heart failure, history of or
• Hypertension (high blood pressure) or
• Stroke, history of or
• Thyroid problems—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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 by your doctor. 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 unwanted effects.

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

Swallow the capsule whole with a glass of water. Do not open, break, crush, or chew it. You may take this medicine with or without food.

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 (capsules):
  • For advanced kidney cancer:
    • Adults—1.34 milligrams (mg) once a day for 21 days, followed by 7 days without treatment. 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.

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:

It is very important that your doctor check your progress at regular visits for any unwanted effects from the 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use an effective form of birth control during treatment with this medicine and for at least 1 month 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 month 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.

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).

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.

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 medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, difficulty with breathing, loss of sensation, confusion, or problems with muscle control or speech.

This medicine may increase your risk of bleeding. Tell your doctor right away if you cough up blood or have bleeding gums, difficulty with breathing or swallowing, dizziness, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools. 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 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.

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 24 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.

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 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

Agitation

back pain

black, tarry stools

bleeding from the rectum or bloody stools

bleeding gums

blood in the urine

bloody nose

blurred vision

change in consciousness

cloudy urine

collection of blood under the skin

confusion

confusion as to time, place, or person

constipation

coughing or spitting up blood

decreased urine output

deep, dark purple bruise

depressed mood

depression

difficulty in swallowing

dilated neck veins

dizziness

drowsiness

dry skin and hair

enlarged pupils

feeling cold

fever

hair loss

heavy nonmenstrual vaginal bleeding

hoarseness or husky voice

holding false beliefs that cannot be changed by fact

hostility

increased menstrual flow or vaginal bleeding

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold, clammy skin

irregular breathing

irregular heartbeat

irritability

itching

lethargy

loss of consciousness

muscle cramps, stiffness, twitching

nausea

nervousness

nosebleeds

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

paralysis

pounding in the ears

prolonged bleeding from cuts

red or dark brown urine

red or black, tarry stools

seeing, hearing, or feeling things that are not there

seizures

sensitivity to heat

severe chest pain

severe headache

slow or fast heartbeat

sore throat

stiff or sore neck

stupor

sudden loss of coordination

sudden onset of slurred speech

sudden onset of trouble breathing for no apparent reason

sudden vision changes

swelling of the face, fingers, feet, or lower legs

tightness in the chest

trouble breathing

trouble healing

trouble sleeping

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

voice changes

vomiting

vomiting of blood or material that looks like coffee grounds

weight gain or 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

Blistering, crusting, irritation, itching, or reddening of the skin

blistering, peeling, loosening of the skin

cracked, dry, scaly skin

cough

decreased appetite

diarrhea

dry, flaky, scaling skin on the scalp, eyebrows, near the ears, and around the nose

increased sensitivity of skin to sunlight

joint or muscle pain

lack or loss of strength

rash with flat lesions or small raised lesions on the skins

red, irritated eyes

redness or other discoloration of skin

severe sunburn

skin rash, encrusted, scaly and oozing

sores, ulcers, or white spots in the mouth or on the lips

swelling

swelling or inflammation of the mouth

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.