Pronunciation:

ix-AZ-oh-mib

Brand Names:

• Ninlaro

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Proteasome Inhibitor

Uses of This Medicine:

Ixazomib is used in combination with lenalidomide and dexamethasone to treat multiple myeloma (a type of bone marrow cancer) in patients who have received at least one prior treatment. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Ixazomib 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 ixazomib 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 ixazomib 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 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
• Carbamazepine
• Conivaptan
• Enzalutamide
• Fedratinib
• Fexinidazole
• Fosphenytoin
• Itraconazole
• 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:

• Heart disease or
• Peripheral neuropathy (nerve problem) or
• Thrombocytopenia (low count of platelets)—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, moderate or severe—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 side effects.

This medicine should come with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

This medicine should be taken once a week on the same day and at the same time, especially for the first 3 weeks. Take it at least 1 hour before or at least 2 hours after food.

Swallow the capsule whole with water. Do not open, crush, or chew it.

Be careful not to handle crushed or broken capsules. If you have contact with broken or crushed capsules, wash your skin with soap and water. If the medicine gets into your eyes, rinse them with water.

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 multiple myeloma (in combination with lenalidomide and dexamethasone):
    • Adults—At first, 4 milligrams (mg) once a week, taken on Days 1, 8, and 15 of a 28-day cycle. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

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

If you miss a dose or forget to use your medicine, take it if your next regular dose is more than 72 hours away. If your next dose is within 72 hours, wait until then to use the medicine and skip the missed dose. If you vomit after taking a dose, do not repeat the dose. Take your next dose at the regular schedule.

Storage—

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.

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

Keep your medicine in the original package until you are ready to use it.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits while you are using this medicine to make sure that the medicine is working properly. Blood 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 get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control while you are using this medicine and for 90 days after your final dose to keep from getting pregnant. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 90 days after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This can lower the number of your platelets, which are necessary for proper blood clotting. Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, or pinpoint red spots on your skin while receiving this medicine.

Cancer medicines can cause diarrhea, constipation, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of face, arms, hands, lower legs, or feet, tingling of hands or feet, or unusual weight gain or loss.

If you develop a skin rash or redness or discoloration of the skin, check with your doctor as soon as possible.

Thrombotic microangiopathy (damage in the smallest blood vessels) may occur while you are using this medicine. Tell your doctor right away if you have a fever, tiredness, confusion, loss of vision, or seizures.

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

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

Black, tarry stools

bloating or swelling of the face, arms, hands, lower legs, or feet

burning, numbness, tingling, or painful sensations

chills

cough

dark urine

diarrhea

dizziness

fever

headache

itching or rash

light-colored stools

loss of appetite

lower back or side pain

nausea

numbness, tingling, or pain in the hands or feet

painful or difficult urination

pale skin

rapid weight gain

rash with flat lesions or small raised lesions on the skin

redness or discoloration of the skin

sore throat

stomach pain

tingling of the hands or feet

ulcers, sores, or white spots in the mouth

unpleasant breath odor

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting of blood

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Less common

Bleeding gums

blood in the urine or stools

pinpoint red spots on the skin

Rare

Blistering, peeling, or loosening of the skin

bloody nose

heavier menstrual periods

joint or muscle pain

red skin lesions, often with a purple center

red, irritated eyes

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

Back pain

blurred vision

body aches or pain

burning, dry, or itching eyes

difficulty having a bowel movement (stool)

discharge, excessive tearing

ear congestion

loss of voice

nasal congestion

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

sneezing

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.