Note: This document contains side effect information about ixazomib. Some dosage forms listed on this page may not apply to the brand name Ninlaro.

Summary

Common side effects of Ninlaro include: constipation, diarrhea, macular eruption, maculopapular rash, nausea, peripheral edema, peripheral neuropathy, peripheral sensory neuropathy, skin rash, and vomiting. Other side effects include: hepatic insufficiency. Continue reading for a comprehensive list of adverse effects.

Applies to ixazomib: oral capsule.

Serious side effects of Ninlaro

Along with its needed effects, ixazomib (the active ingredient contained in Ninlaro) 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 while taking ixazomib:

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

Other side effects of Ninlaro

Some side effects of ixazomib 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

For Healthcare Professionals

Applies to ixazomib: oral capsule.

General

The most common adverse reactions were thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, upper respiratory tract infection, back pain, and bronchitis. Serious adverse reactions included diarrhea, thrombocytopenia, and bronchitis.

Because this drug is used in combination with lenalidomide and dexamethasone, the manufacturer product information for these agents should be consulted.^[Ref]

Cardiovascular

Very common (10% or more): Arrhythmia (up to 17%)

Common (1% to 10%): Hypotension, heart failure

Dermatologic

Very common (10% or more): Rash (up to 27%)

Rare (0.01% to 0.1%): Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet's syndrome)

Postmarketing reports: Stevens-Johnson syndrome

Rash was reported in up to 27% of patients receiving this drug regimen. Most rash adverse reactions were Grade 1 (15%) and Grade 2 (9%); Grade 3 rash was reported in 3% of patients. Serious adverse reactions of rash were reported in less than 1% of patients. The most common type of rash reported included maculopapular and macular rash.

Stevens-Johnson syndrome (including a fatal case) has been reported with this drug.

Gastrointestinal

Very common (10% or more): Diarrhea (up to 52%), constipation (up to 35%), nausea (up to 32%), vomiting (up to 26%)

Hematologic

Very common (10% or more): Thrombocytopenia (includes thrombocytopenia, decreased platelet count; up to 85%), neutropenia (up to 74%)

Rare (0.01% to 0.1%): Thrombotic microangiopathy, thrombotic thrombocytopenic purpura

Frequency not reported: Hemolytic uremic syndrome

Postmarketing reports: Thrombotic microangiopathy

Thrombocytopenia (Grade 3: 17%; Grade 4: 13%) has been reported in patients receiving this drug regimen.

Hepatic

Very common (10% or more): Liver impairment (including enzyme changes; up to 11%), hepatotoxicity

Frequency not reported: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, cholestatic hepatitis

Metabolic

Very common (10% or more): Decreased appetite (up to 13%)

Common (1% to 10%): Hypokalemia (Grade 3 to 4)

Rare (0.01% to 0.1%): Tumor lysis syndrome

Musculoskeletal

Very common (10% or more): Back pain (up to 27%)

Nervous system

Peripheral neuropathy adverse reactions (Grade 1: 18%; Grade 2: 11%; Grade 3: 2%) have been reported in patients receiving this drug regimen. The most commonly reported reaction was peripheral sensory neuropathy (24%); peripheral motor neuropathy was not commonly reported (less than 1%).

Very common (10% or more): Peripheral neuropathies (includes peripheral neuropathy, peripheral sensory neuropathy, peripheral motor neuropathy, peripheral sensorimotor neuropathy; up to 32%), peripheral sensory neuropathy (up to 24%)

Rare (0.01% to 0.1%): Posterior reversible encephalopathy disorders, transverse myelitis

Frequency not reported: Peripheral motor neuropathy

Ocular

Very common (10% or more): Eye disorders (up to 38%), cataract (up to 15%)

Common (1% to 10%): Conjunctivitis, blurred vision, dry eye

Other

Very common (10% or more): Fatigue (up to 28%), peripheral edema (up to 28%)

Common (1% to 10%): Herpes zoster, deaths

Peripheral edema was reported in 28% of patients receiving this drug regimen. Most peripheral edema adverse reactions were Grade 1 (18%) and Grade 2 (7%); Grade 3 peripheral edema was reported in 2% of patients.

Herpes zoster was reported in 6% of patients receiving this drug regimen. Antiviral prophylaxis was allowed at the health care provider's discretion. Patients treated with this drug regimen who received antiviral prophylaxis had a lower incidence (1%) of herpes zoster infection compared to those who did not receive prophylaxis (10%).

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 28%), bronchitis (up to 22%)

Frequency not reported: Fungal pneumonia, viral pneumonia

Fungal and viral pneumonia resulting in fatal outcome were rarely reported in patients receiving this drug regimen.