Ninlaro Side Effects

Generic name: ixazomib

Medically reviewed by Drugs.com. Last updated on Jul 26, 2024.

Note: This document provides detailed information about Ninlaro.

Applies to ixazomib: oral capsule Side Effects associated with ixazomib. Some dosage forms listed on this page may not apply specifically to the brand name Ninlaro.

Applies to ixazomib: oral capsule.

Precautions

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.

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:

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:

For healthcare professionals

Applies to ixazomib: oral capsule.

General adverse events

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

• 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

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%).

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.

See also:

Frequently asked questions

• What is Ninlaro used for?
• Ninlaro vs Velcade, which is better?
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• Is Ninlaro (ixazomib) a chemotherapy drug? How does it work?
• Does Ninlaro cause shingles (herpes zoster)?
• How effective is Ninlaro (ixazomib)?

Further information

Ninlaro side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer