Ixazomib

DEA Class; Rx

Common Brand Names; Ninlaro

• Antineoplastics, Proteasome Inhibitors

Multiple Myeloma

Indicated in patients who have received at least 1 prior therapy

Use in combination with lenalidomide and dexamethasone

Continue treatment until disease progression or unacceptable toxicity

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• Thrombocytopenia (78%)
• Neutropenia (67%)
• Diarrhea (42%)
• Constipation (34%)
• Peripheral neuropathies (28%)
• Nausea (26%)
• Thrombocytopenia, grade 3-4 (26%)
• Neutropenia, grade 3-4 (26%)
• Peripheral edema (25%)
• Vomiting (22%)
• Back pain (21%)
• Upper respiratory tract infection (19%)
• Rash (19%)

Cases, sometimes fatal, of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), reported; monitor for signs and symptoms of TTP/HUS; if TTP/HUS is suspected, stop therapy, and evaluate; if TTP/HUS is excluded, consider restarting therapy; safety of reinitiating therapy in patients previously experiencing TTP/HUS not known

Thrombocytopenia reported with platelet nadirs typically occurring between days 14 and 21 of each 28-day cycle and recovery to baseline by the start of the next cycle; monitor platelet counts at least monthly during treatment; consider more frequent monitoring during the first 3 cycles

Diarrhea, constipation, nausea, and vomiting reported, occasionally requiring use of antidiarrheals, antiemetics, and supportive care

Peripheral neuropathy reported; monitor for symptoms; new or worsening peripheral neuropathy may require dose modification

Peripheral edema reported; evaluate for underlying causes and provide supportive care, as necessary; adjust dosing of dexamethasone per its prescribing information or ixazomib for Grade 3 or 4 symptoms

Cutaneous reactions reported, including maculopapular and macular rash; manage with supportive care or with dose modification if Grade ≥2; Stevens-Johnson syndrome, including a fatal case, reported; discontinue therapy if Stevens-Johnson syndrome occurs and manage as clinically indicated

Rare occurrence of drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic, and hepatotoxicity reported; monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms

Herpes zoster infection reported; consider antiviral prophylaxis during therapy to decrease risk of herpes zoster reactivation

Can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals

Maintenance treatment for multiple myeloma in clinical trial resulted in increased deaths; therefore, not recommended for maintenance treatment outside of controlled trials

Can cause fetal harm when administered to a pregnant woman

There are no human data available regarding the potential effect of ixazomib on pregnancy or development of the embryo or fetus

No data are available in human milk; effects of drug on breastfed infant, or effects of drug on milk production

Ixazomib 

capsule

• 2.3mg
• 3mg
• 4mg