Resources for Patients Starting or Continuing NINLARO^® (ixazomib)

A variety of resources are available for both healthcare providers and patients.

Resources for your patients

NINLARO Treatment Calendar

Have your patients track their individual treatment schedule by filling out this calendar.

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Patient Experience Guide

Provide your patients with information they need when starting the NINLARO regimen.

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Packaging
Instructions

Provide these simple steps to your patients for opening the NINLARO packaging.

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SLiM CRAB Tear Sheets for Patient Lab Test Education

The SLiM CRAB Tear Sheets help educate patients on the signs and symptoms of multiple myeloma and identify some of the lab tests that are used.

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Takeda Oncology Here2Assist^® Brochure

Information about access, financial assistance, and available support services.

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NINLARO Patient Support Community

Fingers typing on a laptop keyboard to join the Patient Support Community.

Encourage patients to sign up and join the NINLARO community to extend their support network.

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Resources for healthcare professionals

NINLARO Regimen Dosing Guide for Healthcare Professionals

A comprehensive look at NINLARO dosing, including dosage modifications, instructions for safe handling, and adverse events data.

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Takeda Oncology Here2Assist^® Enrollment Form

An interactive PDF to help your patients get started with Takeda Oncology Here2Assist^®.

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Lab Test Booklet for Healthcare Professionals

Understanding your multiple myeloma lab tests.

Helps you explain common lab test results to patients and provides a space for recording test results.

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NINLARO Access Guide

Read about NINLARO distribution.

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Convenient NINLARO Packaging

Learn about the NINLARO packaging and its positive impact.

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Instructions for patients taking NINLARO on the go

Share this helpful video with your patients so they can better understand how to take NINLARO at home or on the go.

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Looking for more patient resources?

Find additional resources and support that could benefit your patients.

VISIT NINLARO PATIENT WEBSITE

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO. Platelet nadirs typically occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle. Grade 3 thrombocytopenia was reported in 17% of patients in the NINLARO regimen and Grade 4 thrombocytopenia was reported in 13% in the NINLARO regimen. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 3% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.

Peripheral Neuropathy was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (24% and 17% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (<1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 4% of patients in the NINLARO regimen and <1% of patients in the placebo regimen. During treatment, monitor patients for symptoms of neuropathy and consider adjusting dosing for new or worsening peripheral neuropathy.

Peripheral Edema was reported with NINLARO. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of NINLARO for Grade 3 or 4 symptoms or dexamethasone per its prescribing information.

Cutaneous Reactions. Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported with NINLARO. If Stevens-Johnson syndrome or toxic epidermal necrolysis occurs, discontinue NINLARO and manage as clinically indicated. Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in <1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.

Thrombotic Microangiopathy has been reported with NINLARO. Fatal cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been reported in patients who received NINLARO. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop NINLARO and evaluate. If the diagnosis of TTP/HUS is excluded, consider restarting NINLARO. The safety of reinitiating NINLARO therapy in patients previously experiencing TTP/HUS is not known.

Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in <1% of patients treated with NINLARO. Hepatotoxicity has been reported (10% in the NINLARO regimen and 9% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.

Embryo-fetal Toxicity: NINLARO can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with NINLARO and for 90 days following the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with NINLARO and for 90 days following the last dose.

Increased Mortality in Patients Treated with NINLARO in the Maintenance Setting: In two prospective randomized clinical trials in multiple myeloma in the maintenance setting, treatment with NINLARO resulted in increased deaths. Treatment of patients with NINLARO for multiple myeloma in the maintenance setting is not recommended outside of controlled trials.

ADVERSE REACTIONS

The most common adverse reactions (≥ 20%) in the NINLARO regimen compared to placebo in combination with lenalidomide plus dexamethasone, respectively were thrombocytopenia (85%, 67%; pooled from adverse event and laboratory data), neutropenia (74%, 70%; pooled from adverse event and laboratory data), diarrhea (52%, 43%), constipation (35%, 28%), peripheral neuropathy (32%, 24%), nausea (32%, 23%), edema peripheral (27%, 21%), rash (27%, 16%), vomiting (26%, 13%), and bronchitis (22%, 17%). Serious adverse reactions reported in ≥ 2% of patients in the NINLARO regimen included diarrhea (3%), thrombocytopenia (2%), and bronchitis (2%).

DRUG INTERACTIONS:

Avoid concomitant administration of NINLARO with strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Resources for Patients Starting or Continuing NINLARO^® (ixazomib)

Resources for your patients

NINLARO Treatment Calendar

Patient Experience Guide

Packaging
Instructions

SLiM CRAB Tear Sheets for Patient Lab Test Education

Takeda Oncology Here2Assist^® Brochure

NINLARO Patient Support Community

Resources for healthcare professionals

NINLARO Regimen Dosing Guide for Healthcare Professionals

Takeda Oncology Here2Assist^® Enrollment Form

Lab Test Booklet for Healthcare Professionals

NINLARO Access Guide

Convenient NINLARO Packaging

Instructions for patients taking NINLARO on the go

Looking for more patient resources?

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS

INDICATION AND USAGE

Resources for your patients

NINLARO Treatment Calendar

Patient Experience Guide

PackagingInstructions

SLiM CRAB Tear Sheets for Patient Lab Test Education

Takeda Oncology Here2Assist® Brochure

NINLARO Patient Support Community

Resources for healthcare professionals

NINLARO Regimen Dosing Guide for Healthcare Professionals

Takeda Oncology Here2Assist® Enrollment Form

Lab Test Booklet for Healthcare Professionals

NINLARO Access Guide

Convenient NINLARO Packaging

Instructions for patients taking NINLARO on the go

Looking for more patient resources?

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

Packaging
Instructions

Takeda Oncology Here2Assist^® Brochure

Takeda Oncology Here2Assist^® Enrollment Form