Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Ninlaro (Ixazomib). If you are concerned about side effects, discuss the risks and benefits of Ninlaro (Ixazomib) with your doctor.

The following side effects have been reported by at least 1% of people taking Ninlaro (Ixazomib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• arm, leg, back, or joint pain
• Constipation
• cough
• decreased appetite
• Diarrhea
• dizziness
• dry eyes
• fatigue
• headache
• muscle spasms or cramps
• nausea
• redness in whites of the eye
• itchy or red skin rash
• trouble sleeping
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision or vision changes
• changes in mental status
• Fever
• frequent cold or cold-like symptoms
• not able to move legs
• muscle weakness
• numbness, tingling, or burning sensation or pain in arms or legs
• rash with skin peeling and mouth sores
• red to purple bumps on skin
• shortness of breath
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding, black stools)
• signs of fluid build-up in the body or edema (e.g., rapid weight gain, swelling of ankles or feet)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• symptoms of a lung infection (LRTI) (e.g., shortness of breath, cough, chest pain)
• symptoms of Shingles (e.g., painful blisters, rash on a small area of skin on one side of the face or body)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
• symptoms of Blood Clots in small blood vessels (e.g., weakness, nausea, vomiting, fatigue, fever, bruising, bleeding, swelling, confusion, vision loss, seizures)
• symptoms of tumour lysis syndrome (rapid death of cancer cells; e.g., dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, heart rhythm changes)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Ninlaro (Ixazomib).

2.3 mg
Each light pink capsule marked "Takeda" on the cap and "2.3 mg" on the body with black ink, contains 3.3 mg of Ninlaro (Ixazomib) citrate, which is equivalent to 2.3 mg of Ninlaro (Ixazomib). Nonmedicinal ingredients: microcrystalline cellulose, magnesium stearate, and talc; capsule shell: gelatin, titanium dioxide, and red iron oxide; printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide.

3 mg
Each light grey capsule marked "Takeda" on the cap and "3.0 mg" on the body with black ink contains 4.3 mg of Ninlaro (Ixazomib) citrate, which is equivalent to 3 mg of Ninlaro (Ixazomib). Nonmedicinal ingredients: microcrystalline cellulose, magnesium stearate, and talc; capsule shell: gelatin, titanium dioxide, and black iron oxide; printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide.

4 mg
Each light orange capsule marked "Takeda" on the cap and "4.0 mg" on the body with black ink contains 5.7 mg of Ninlaro (Ixazomib) citrate, which is equivalent to 4 mg of Ninlaro (Ixazomib). Nonmedicinal ingredients: microcrystalline cellulose, magnesium stearate, and talc; capsule shell: gelatin, titanium dioxide, red iron oxide and yellow iron oxide; printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide.

Do not take Ninlaro (Ixazomib) if you are allergic to Ninlaro (Ixazomib) or any ingredients of the medication.

There may be an interaction between Ninlaro (Ixazomib) and any of the following:

• 5-ASA medications (e.g.,  Mesalamine, Olsalazine, Sulfasalazine)
• Apalutamide
• bacillus Calmette-Guérin (BCG)
• birth control pills
• Bosentan
• Carbamazepine
• Cladribine
• Clozapine
• Dabrafenib
• Deferiprone
• Deferasirox
• efavirenz
• Enzalutamide
• Eslicarbazepine
• etravirine
• fosphenytoin
• lumacaftor and Ivacaftor
• Mitotane
• Modafinil
• Phenobarbital
• Phenytoin
• primidone
• rifabutin
• rifampin
• St. John's wort
• Sarilumab
• siltuximab
• Tocilizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Ninlaro (Ixazomib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ninlaro (Ixazomib).

Anemia: Ninlaro (Ixazomib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: Ninlaro (Ixazomib) can cause harm to the developing baby if it is taken by the mother while she is pregnant. If you or your partner are taking Ninlaro (Ixazomib) and may become pregnant, it is important to use 2 effective types of birth control. Oral contraceptives (birth control pills) are not enough, as the effectiveness of birth control pills may be decreased by medications in this cancer treatment. Both males and females should use effective birth control during treatment and for at least 90 days after stopping treatment.

Blood clotting: Ninlaro (Ixazomib) can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor about any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including platelets, in your blood.

Infection: As well as killing cancer cells, Ninlaro (Ixazomib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Severe Kidney Disease or reduced kidney function may cause Ninlaro (Ixazomib) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Ninlaro (Ixazomib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ninlaro (Ixazomib), and whether any special monitoring is needed.

Liver function:  Liver disease or reduced liver function may cause Ninlaro (Ixazomib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Ninlaro (Ixazomib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ninlaro (Ixazomib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Ninlaro (Ixazomib).

Ninlaro (Ixazomib) can cause decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Open capsules: The medication contained inside each capsule is very harmful if it is inhaled or touched. It is important to avoid coming into contact with the drug powder. If a capsule is opened accidentally, wear gloves and protective clothing, including a mask, to clean up the spill. Do not crush, chew, or intentionally open any capsules.

Shingles: Shingles is a reactivation of the herpes zoster virus, which is the virus that causes Chickenpox. The virus stays in the nerve cells after chickenpox and can become activated when the body's defense system is not working well. Because Ninlaro (Ixazomib) can reduce the body's ability to fight infection, the risk of developing shingles is increased for people taking Ninlaro (Ixazomib). Talk to your doctor about ways to reduce the chances of developing shingles.

Pregnancy: Ninlaro (Ixazomib) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ninlaro (Ixazomib), contact your doctor immediately.

Breast-feeding: It is not known if Ninlaro (Ixazomib) passes into breast milk. If you are a breast-feeding mother and are taking Ninlaro (Ixazomib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ninlaro (Ixazomib) have not been established for children.