Managing Patients With Relapsed Multiple Myeloma Taking NINLARO^® (ixazomib)

Resources and information on setting expectations and communicating treatment considerations for patients starting the NINLARO regimen*.

*The NINLARO regimen includes NINLARO + lenalidomide + dexamethasone.¹

PATIENT EXPECTATIONS AND TREATMENT CONSIDERATIONS

Sharing the following information about NINLARO at the start of treatment can help ensure that patients and caregivers are well-informed:

Drug indication and usage

Dose and dosing schedule

Handling instructions

Administration and what to do if a dose is missed or too much NINLARO is taken

Food and drug interactions

Side effects and management

LEARN MORE ABOUT DOSING & ADMINISTRATION

Educate patients about potential side effects and how to manage them

Talk to patients about potential adverse reactions of treatment with NINLARO
Ensure patients know to report any side effects they experience so proper management can be set in place
Help manage patients if a side effect occurs with NINLARO treatment
- IDENTIFY AND REPORT: Identify the adverse reaction, determine if it’s a result of the treatment or the disease, and report as required. To report suspected adverse reactions for Oncology products, please call 1-844-662-8532 or email GlobalOncologyMedInfo@takeda.com.
- ASSESS: Use appropriate diagnostic and physical evaluations to monitor the severity of the symptom
- MANAGE: Implement the appropriate pharmacologic or nonpharmacologic intervention

Use the following patient-friendly information to educate your patients about side effects with NINLARO

NINLARO may cause serious side effects, including¹:

Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. Consider platelet transfusions if counts are too low. Speak with patients about the low platelet counts, including bleeding and easy bruisings.
Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Ask patients to call you if they get any of these symptoms and they do not go away during treatment with NINLARO. Tell your patients that you may prescribe medicine to help treat their symptoms.
Nerve problems are common with NINLARO and may also be severe. Ask patients to tell you if they get any new or worsening symptoms including tingling, numbness, pain, a burning feeling in their feet or hands, or weakness in their arms or legs.
Swelling is common with NINLARO and can sometimes be severe. Ask patients to tell you if they develop swelling in their arms, hands, legs, ankles, or feet, or if they gain weight from swelling.
Skin reactions. Rashes are common with NINLARO. NINLARO can cause rashes and other skin reactions that can be serious and can lead to death. Ask patients to tell you right away if they get a new or worsening rash, severe blistering or peeling of the skin, or mouth sores.
Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your patients’ kidneys, brain, and other organs, and may lead to death. Tell your patients to get medical help right away if they get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination.
Liver problems. Ask patients to tell you if they get these signs of a liver problem: yellowing of their skin or the whites of their eyes; pain in their right upper-stomach area (abdomen).

Other common side effects of NINLARO include low white blood cell counts (neutropenia) and bronchitis. Ask your patients to inform you if they get new or worsening signs or symptoms of the following during treatment with NINLARO: skin rash and pain (shingles) due to reactivation of the chicken pox virus (herpes zoster), blurred vision or other changes in vision, dry eye and pink eye (conjunctivitis).

These are not all the possible side effects of NINLARO.
Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at 1-800-FDA-1088.

Get information on dosage modification guidelines for thrombocytopenia, neutropenia, peripheral neuropathy, rash, and other nonhematologic toxicities.

DOWNLOAD DOSING GUIDE

Set up a plan for individualized adherence strategies

Encourage adherence by having patients build a routine and take medication during a certain activity each day.

Explore additional strategies by selecting each card below.

TRACK EACH DOSE

Encourage patients to use a medication diary to keep track of each dose.

SET ALARMS

Encourage patients to set an alarm (e.g., watches, smartphones, text/call reminders) to help them remember to take their medication on time.

DOWNLOAD THE TREATMENT CALENDAR

Encourage patients to download the treatment calendar to track their treatment schedule and know when to take their medication.

Provide patients with a list of Dos and Don’ts for taking the NINLARO regimen¹

Dos

NINLARO should be taken exactly as their healthcare provider has prescribed
NINLARO should be taken at about the same time of day, at least 1 hour before food or at least 2 hours after food
Dexamethasone should be taken with food
Swallow NINLARO capsules whole with water
If a dose of NINLARO is missed, or if a dose is taken late, take the dose as long as the next scheduled dose is more than 3 days (72 hours) away
If a patient vomits after taking a dose of NINLARO, take the next dose of NINLARO on the next scheduled day and time. Do not repeat the dose
Patients taking more NINLARO than instructed by their healthcare provider should call their doctor or go to the hospital right away

Don'ts

Patients should not change their dose or stop taking NINLARO without speaking with their healthcare provider first
Patients should not take NINLARO and dexamethasone at the same time
The capsule should not be crushed, chewed, or opened
Avoid direct contact with the capsule contents
Patients should not take a missed dose of NINLARO if it is within 3 days (72 hours) of their next scheduled dose
Patients should not take more NINLARO than prescribed by their doctor
Make sure patients understand that NINLARO capsules shouldn’t be crushed, chewed, opened, or removed from packaging until the time of administration

Per the clinical trial for NINLARO, talk to your patients about the importance of remaining on therapy until disease progression or unacceptable toxicity¹

Factors that may impact patient adherence include^2,3:

Poor communication between patient and healthcare team

Patient belief that the drugs were not needed or not working

Side effects

NINLARO patient resources

Resources for your practice to help support patients starting or continuing NINLARO.

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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, including a fatal case of Stevens-Johnson syndrome, were reported with NINLARO. If Stevens-Johnson syndrome 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.

Managing Patients With Relapsed Multiple Myeloma Taking NINLARO^® (ixazomib)

PATIENT EXPECTATIONS AND TREATMENT CONSIDERATIONS

Sharing the following information about NINLARO at the start of treatment can help ensure that patients and caregivers are well-informed:

Educate patients about potential side effects and how to manage them

Get information on dosage modification guidelines for thrombocytopenia, neutropenia, peripheral neuropathy, rash, and other nonhematologic toxicities.

Set up a plan for individualized adherence strategies

Provide patients with a list of Dos and Don’ts for taking the NINLARO regimen¹

Dos

Don'ts

Per the clinical trial for NINLARO, talk to your patients about the importance of remaining on therapy until disease progression or unacceptable toxicity¹

Factors that may impact patient adherence include^2,3:

NINLARO patient resources

Takeda Oncology Here2Assist^®

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS

INDICATION AND USAGE

PATIENT EXPECTATIONS AND TREATMENT CONSIDERATIONS​

Sharing the following information about NINLARO at the start of treatment can help ensure that patients and caregivers are well-informed:

Educate patients about potential side effects and how to manage them

Get information on dosage modification guidelines for thrombocytopenia, neutropenia, peripheral neuropathy, rash, and other nonhematologic toxicities.

Set up a plan for individualized adherence strategies

Provide patients with a list of Dos and Don’ts for taking the NINLARO regimen1

Dos

Don'ts

Per the clinical trial for NINLARO, talk to your patients about the importance of remaining on therapy until disease progression or unacceptable toxicity1

Factors that may impact patient adherence include2,3:

NINLARO patient resources

Takeda Oncology Here2Assist®

IMPORTANT SAFETY INFORMATION AND INDICATION

PATIENT EXPECTATIONS AND TREATMENT CONSIDERATIONS

Provide patients with a list of Dos and Don’ts for taking the NINLARO regimen¹

Per the clinical trial for NINLARO, talk to your patients about the importance of remaining on therapy until disease progression or unacceptable toxicity¹

Factors that may impact patient adherence include^2,3:

Takeda Oncology Here2Assist^®