NINLARO in combination with lenalidomide and dexamethasone (Rd) is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy1

NINLARO has received a conditional marketing authorisation in Europe

Visit NINLARO.co.uk for more information

Dosing and adverse event management

NINLARO® (ixazomib)PRACTICAL GUIDE FOR

HEALTHCARE PROFESSIONALS

®

Prescribing information can be found inside the back cover UK/IXA/1611/0077a(1) Date of preparation: February 2019

2

Practical guide for healthcare professionals

NINLARO

Contents Page

Before prescribing NINLARO 3-5

Initiating treatment 6-7

Practical administration considerations 8-9

Adverse event management 10-15

Special populations 16-17

References 18

Prescribing information and adverse event reporting 19

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NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy1

Before prescribing NINLARO

Contraindications As NINLARO is administered in combination with lenalidomide and dexamethasone, refer to the individual SmPCs for these medicinal products for additional contraindications1

Hypersensitivity to the active substance or to any of the excipients listed below:1

Microcrystalline cellulose Magnesium stearate Talc Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172) Gelatin Titanium dioxide (E171)

NINLARO 4 mg hard capsules1

Yellow iron oxide (E172)

Red iron oxide (E172)

NINLARO 2.3 mg hard capsules1

Red iron oxide (E172)

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As NINLARO is administered in combination with lenalidomide and dexamethasone, refer to the individual SmPCs for these medicinal products for additional special warnings and precautions for use.1

Special warnings and precautions for use

Thrombocytopenia1

Thrombocytopenia has been reported with NINLARO with platelet nadirs typically occurring between days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle (see page 11 for guidance).

Gastrointestinal toxicities1

Diarrhoea, constipation, nausea and vomiting have been reported with NINLARO, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care (see page 14 for guidance).

Peripheral neuropathy1

Peripheral neuropathy has been reported with NINLARO. Patients should be monitored for symptoms of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification (see page 12 for guidance).

Peripheral oedema1

Peripheral oedema has been reported with NINLARO. Patients should be evaluated for underlying causes and provided with supportive care, as necessary. The dose of dexamethasone should be adjusted per its prescribing information or NINLARO for Grade 3 or 4 symptoms (see page 15 for guidance on “other non-haematological toxicities”).

Cutaneous reactions / rash1

Rash has been reported with NINLARO. Rash should be managed with supportive care or with dose modification (see page 13 for guidance).

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Hepatotoxicity1

Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with NINLARO. Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms (see page 15 for guidance on “other non-haematological toxicities”).

Pregnancy1

Women should avoid becoming pregnant while being treated with NINLARO. Women of childbearing potential must use highly effective contraception while taking NINLARO and for 90 days after stopping treatment. Women using hormonal contraceptives should additionally use a barrier method of contraception.

NINLARO is given in combination with lenalidomide. Lenalidomide is structurally related to thalidomide. The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential. Please refer to the current lenalidomide SmPC.1

Posterior reversible encephalopathy syndrome1 Posterior reversible encephalopathy syndrome (PRES) has occurred in patients receiving NINLARO. PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, altered consciousness, and visual disturbances. Brain imaging, preferably magnetic resonance imaging, is used to confirm the diagnosis. In patients developing PRES, discontinue NINLARO.

Strong CYP3A inducers1

Strong inducers may reduce the efficacy of NINLARO, therefore the concomitant use of strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin and St. John’s Wort (Hypericum perforatum), should be avoided. Closely monitor patients for disease control if co-administration with a strong CYP3A inducer cannot be avoided.

6

The usual recommended starting dose of NINLARO is one 4 mg capsule taken once a week based on the following schedule1

Oral NINLARO is administered once a week for 3 weeks of a 4-week cycle

*The recommended starting dose of dexamethasone is 40 mg – each tablet contains 2 mg dexamethasone. Treatment with NINLARO in combination with Rd for longer than 24 cycles should be based on an individual benefit risk assessment.1

DAY

1

NINLARO

DAY

8DAY

15

Treat to progression or unacceptable toxicity

DAY

22DAY

28

NO DOSE

lenalidomide

dexamethasone*

NO DOSE

NINLARO + Rd 28-day dosing schedule1

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*Treatment with NINLARO in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit-risk assessment.1For additional information regarding lenalidomide or dexamethasone, please refer to each respective Summary of Product Characteristics.

Initia

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The recommended starting dose of oral NINLARO is 3 mg for patients with moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease requiring dialysis1

NINLARO should be taken with lenalidomide and dexamethasone at standard dosing1

The recommended starting dose of lenalidomide is 25 mg administered daily on days 1 to 21 of a 28-day treatment cycle

The recommended starting dose of dexamethasone is 40 mg administered on days 1, 8, 15, and 22 of a 28-day treatment cycle

Prior to initiating a new cycle of therapy:1

Absolute neutrophil count should be ≥1000/mm3

Platelet count should be ≥75,000/mm3

Non-haematological toxicities should, at the physician’s discretion, generally be recovered to patient’s baseline condition or Grade ≤1

Antiviral prophylaxis should be considered to reduce the risk of herpes zoster reactivation1

Thromboprophylaxis is recommended in patients being treated with NINLARO in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient’s underlying risk and clinical status.1

Treatment should be continued until disease progression or unacceptable toxicity.*1

8

How to administer NINLARO1

Each dose of NINLARO should be taken at approximately the same time each day and on an empty stomach (at least 1 hour before or at least 2 hours after food).*1

Because dexamethasone should be taken with food, NINLARO and dexamethasone should not be taken at the same time

NINLARO should be swallowed whole with a glass of water. The capsule should not be crushed, chewed, or opened.1

If a patient vomits after taking a dose, the patient should not repeat the dose but should resume dosing at the time of the next scheduled dose†

If a dose of NINLARO is delayed or missed, the dose should be taken only if the next scheduled dose is ≥72 hours away.1

A missed dose should not be taken within 72 hours of the next scheduled dose

A double dose should not be taken to make up for a missed dose

NINLARO should be stored in the original packaging in order to protect from moisture‡ and the capsules should be removed just prior to dosing.1 This means they cannot be transferred to a pill box.

Do not store above 30˚C. Do not freeze.1

NINLARO is cytotoxic. Direct contact with the capsule contents should be avoided.1

For additional information regarding lenalidomide or dexamethasone, please refer to each respective Summary of Product Characteristics. *Administration with a high-fat meal decreased ixazomib AUC by 28% compared with administration after an overnight fast. †After oral administration, peak plasma concentrations of ixazomib were achieved at approximately one hour after dosing. ‡Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib.

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Oral NINLARO is available in several strengths to allow for dose modification1

*NINLARO is not dialysable and, therefore, can be administered without regard to the timing of dialysis†Creatinine clearance ≥30 mL/min. ‡Total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN or total bilirubin >1 to 1.5 x ULN and any AST. For additional information regarding lenalidomide or dexamethasone, please refer to each respective Summary of Product Characteristics.

Discontinuation

Recommended starting dose

First dose reduction

Second dose reduction

3 mg

2.3 mg

4 mg

NINLARO dose reduction steps1

Practical ad

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Use the recommended starting dose of 3 mg in patients with:1

moderate (total bilirubin >1.5-3 x ULN) or severe (total bilirubin >3 x ULN) hepatic impairment

Severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease requiring dialysis*

No dose adjustment is required for:1

Body surface area or weight

Elderly patients older than 65 years

Patients with mild or moderate renal impairment†

Patients with mild hepatic impairment‡

10

Antiviral prophylaxis should be considered in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation.1

Patients included in studies with NINLARO who received antiviral prophylaxis had a lower incidence of herpes zoster infection compared to patients who did not receive prophylaxis.1

Thromboprophylaxis is recommended in patients being treated with NINLARO in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient’s underlying risks and clinical status.1

Concomitant medicinal products/general guidance1

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Dose modification guidelines

Monitor platelet counts at least monthly during treatment with NINLARO – consider more frequent monitoring during the first three cycles1,2

Manage thrombocytopenia and neutropenia with dose modification and platelet transfusions or G-CSF, respectively, as per standard medical guidelines1

An alternating dose modification approach is recommended for NINLARO and lenalidomide for overlapping toxicities of thrombocytopenia and neutropenia

Adverse event management: myelosuppression1

For the overlapping toxicities of thrombocytopenia and neutropenia, the first dose reduction step is to reduce lenalidomide1

Adverse event Recommended action1

Thrombocytopenia(platelet count <30,000/mm3)

AND/ORNeutropenia(absolute neutrophil count <500/mm3)

• Withhold NINLARO and lenalidomide until platelet or absolute neutrophil counts are ≥30,000/mm3 or ≥500/mm3, respectively

• Following recovery, resume lenalidomide at the next lower dose according to its SmPC, and resume NINLARO at the most recent dose

• If platelet or absolute neutrophil counts drop again to <30,000/mm3 or <500/mm3, respectively, withhold NINLARO and lenalidomide until recovery

• Following recovery, resume NINLARO at the next lower dose, and resume lenalidomide at the most recent dose*

*For additional occurrences, alternate dose modification of lenalidomide and NINLARO.

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Adverse event management: peripheral neuropathy1

Dose modification guidelines

Dose modification for peripheral neuropathy (PN)1

Adverse event Recommended action1

Grade 1 PN with painGrade 2 PN

• Withhold NINLARO until PN recovers to ≤Grade 1 without pain or patient’s baseline condition

• Following recovery, resume NINLARO at the most recent dose

Grade 2 PN with painGrade 3 PN

• Withhold NINLARO. Toxicities should, at the physician’s discretion, generally recover to patient’s baseline condition or ≤Grade 1 prior to resuming NINLARO

• Following recovery, resume NINLARO at the next lower dose

Grade 4 PN • Discontinue treatment regimen

Patients on NINLARO should be monitored for symptoms of neuropathy, such as a burning sensation, hyperaesthesia, hypoaesthesia, paraesthesia, discomfort, neuropathic pain or weakness4

Patients experiencing new or worsening peripheral neuropathy may require dose modification (see table below)1

Withhold treatment or adjust dosing for Grade 1-3 symptoms1

Discontinue treatment for Grade 4 symptoms1

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Rash has been most commonly characterised as maculo-papular or macular and is most commonly reported within the first 3 cycles of therapy1,3

Symptomatic measures such as antihistamines or corticosteroids (oral or topical) have been used successfully to manage rash and have been used prophylactically in subsequent cycles during NINLARO clinical studies5

The use of a topical, IV or oral steroid (e.g. prednisolone ≤10 mg per day or equivalent) was permitted within the TOURMALINE-MM1 study5

Manage rash with supportive care and/or with dose modification if Grade 2 or 31

Discontinue treatment if Grade 4 symptoms1

Adverse event management: rash1

*Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03. †For additional occurrences, alternate dose modification of lenalidomide and NINLARO.

The first dose modification for overlapping toxicity of rash is to withhold / reduce lenalidomide1

Adverse event Recommended action1

Grade* 2 or 3 rash • Withhold lenalidomide until rash recovers to ≤Grade 1

• Following recovery, resume lenalidomide at the next lower dose according to its SmPC

• If Grade 2 or 3 rash occurs again, withhold NINLARO and lenalidomide until rash recovers to ≤Grade 1

• Following recovery, resume NINLARO at the next lower dose and resume lenalidomide at its most recent dose†

Grade* 4 rash • Discontinue treatment regimen

Dose modification guidelines

14

Dose modification guidelines

Adverse event management: gastrointestinal toxicities1

Reversible diarrhoea, nausea, vomiting, decreased appetite and constipation have been reported in clinical studies1,6

Patients should be monitored for gastrointestinal toxicity and should be given appropriate supportive care1,6

Standard antiemetics including 5-HT3 antagonists are recommended according to clinical practice for emesis if it occurs once treatment is initiated; prophylactic antiemetics may also be considered at the physician’s discretion5

Dexamethasone should not be administered as an antiemetic5

Prophylactic antidiarrhoeals are not recommended; however diarrhoea should be managed according to standard clinical practice, including the administration of antidiarrhoeals once infectious causes are excluded5

Fluid deficits should be corrected before initiation of NINLARO and as needed during treatment to avoid dehydration5

In the case of severe gastrointestinal events, monitoring of serum potassium level is recommended1

For lenalidomide-related toxicity, refer to lenalidomide SmPC for dose adjustments1

Dose modification guidelines for gastrointestinal toxicities1

Adverse event Recommended action1

Grade 3 or 4 gastrointestinal toxicities

• Withhold NINLARO – toxicities should, at the physician’s discretion, generally recover to patient’s baseline condition or ≤Grade 1 prior to resuming NINLARO

• If attributable to NINLARO, resume at the next lower dose following recovery

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Adverse event management: other non-haematological toxicities1

Dose modification guidelines for other non-haematological toxicities1

For lenalidomide and dexamethasone-related toxicity, refer to lenalidomide or dexamethasone SmPCs for dose adjustments1

Adverse event Recommended action1

Other Grade 3 or 4 non-haematological toxicities

• Withhold NINLARO – toxicities should, at the physician’s discretion, generally recover to patient’s baseline condition or ≤Grade 1 prior to resuming NINLARO

• If attributable to NINLARO, resume NINLARO at the next lower dose following recovery

16

Using NINLARO in special patient populations1

Elderly

No dose adjustment of NINLARO is required for patients over 65 years of age1

Discontinuations in patients >75 years of age were reported in 13 patients (28%) in the NINLARO regimen and 10 patients (16%) in the placebo regimen1

Cardiac arrhythmias in patients >75 years of age were observed in 10 patients (21%) in the NINLARO regimen and 9 patients (15%) in the placebo regimen1

Paediatric population

NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy1

The safety and efficacy of NINLARO in children below 18 years of age have not been established – no data are available1

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Hepatic impairment

No dose adjustment of NINLARO is required for patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN or total bilirubin >1 to 1.5 x ULN and any AST)1

A lower starting dose of 3 mg is recommended for patients with moderate (total bilirubin >1.5 to 3 x ULN) or severe (total bilirubin >3 x ULN) hepatic impairment1

Renal impairment

No dose adjustment of NINLARO is required for patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min)1

A lower starting dose of 3 mg is recommended for patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease (ESRD) requiring dialysis1

NINLARO is not dialysable and therefore can be administered without regard to the timing of dialysis1

Refer to the lenalidomide SmPC for dosing recommendations in patients with renal impairment1

Sp

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1. NINLARO (ixazomib capsules) Summary of Product Characteristics.

2. REVLIMID (lenalidomide) 25 mg Summary of Product Characteristics.

3. Takeda Data on File – UK/DF/1611/0018.

4. Takeda Data on File – UK/DF/1701/0001.

5. Protocol for Moreau P, Masszi T, Grzasko N. N Engl J Med 2016; 374:1621-1634.

6. Moreau P, Masszi T, Grzasko N. N Engl J Med 2016; 374:1621-1634.

References

19

Abbreviated Prescribing Information: NINLARO® (ixazomib)Refer to Summary of Product Characteristics (SmPC) before prescribing.Presentation: Ixazomib 2.3 mg, 3 mg and 4 mg hard capsules. Indication: NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Dosage & Administration: Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma. NINLARO should be used in combination with lenalidomide and dexamethasone. For additional information regarding lenalidomide and dexamethasone, refer to their SmPCs. The recommended starting dose of NINLARO is 4 mg (one capsule) administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle at least 1 hour before or at least 2 hours after food. The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle. The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle. Prior to initiating a new cycle of therapy, absolute neutrophil count should be ≥ 1,000/mm3, platelet count should be ≥ 75,000/mm3, non-haematologic toxicities should, at the physician’s discretion, generally be recovered to patient’s baseline condition or ≤ Grade 1. Treatment should be continued until disease progression or unacceptable toxicity. Treatment with NINLARO in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit risk assessment, as the data on the tolerability and toxicity beyond 24 cycles are limited. Antiviral prophylaxis should be considered in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation. Thromboprophylaxis is recommended in patients being treated with NINLARO in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient’s underlying risks and clinical status. Elderly: No dose adjustment is necessary in patients over 65 years of age. Renal impairment: Mild or moderate renal impairment, no dose adjustment is necessary. Reduced 3 mg starting dose recommended in severe renal impairment or end-stage renal disease requiring dialysis. Hepatic impairment: Mild hepatic impairment, no dose adjustment is necessary. Reduced 3 mg starting dose recommended in moderate or severe hepatic impairment. Paediatric population: No data are available. Contraindications: Hypersensitivity to the active substance or to its excipients. Warnings & Precautions: Thrombocytopenia: Thrombocytopenia has been reported with NINLARO with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. Thrombocytopenia did not result in an increase in haemorrhagic events or platelet transfusions. Platelet counts should be monitored at least monthly during NINLARO treatment. Thrombocytopenia can be managed with dose modifications and platelet transfusions as per standard medical guidelines. Gastrointestinal toxicities: Diarrhoea, constipation, nausea and vomiting have been reported with NINLARO, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care. The dose should be adjusted for severe (Grade 3–4) symptoms. Peripheral neuropathy: Peripheral neuropathy has been reported with NINLARO. Patients should be monitored for symptoms of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification. Peripheral

oedema: Peripheral oedema has been reported with NINLARO. Patients should be evaluated for underlying causes and provide supportive care, as necessary. The dose of dexamethasone should be adjusted per its SmPC or NINLARO for Grade 3 or 4 symptoms. Cutaneous reactions: Rash has been reported with NINLARO. Rash should be managed with supportive care or with dose modification if Grade 2 or higher. Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with NINLARO. Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms. Pregnancy: Women should avoid becoming pregnant while being treated with NINLARO. Posterior reversible encephalopathy syndrome (PRES): PRES has occurred in patients receiving NINLARO. In patients developing PRES, discontinue NINLARO. Interactions: Strong cytochrome P450 (CYP) 3A inducers: Co-administration of strong CYP3A inducers with NINLARO is not recommended. Strong CYP3A inhibitors: No dose modification is required for NINLARO with co-administration of strong CYP3A inhibitors. Strong CYP1A2 inhibitors: No dose modification is required for NINLARO with co-administration of strong CYP1A2 inhibitors. Fertility, Pregnancy & Lactation: Women should avoid becoming pregnant while being treated with NINLARO. Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Women using oral hormonal contraceptives should additionally use a barrier method of contraception. No data from use in pregnant women. Avoid use during pregnancy. Unknown whether NINLARO/metabolites are excreted in human milk, a risk to newborns/infants cannot be excluded; therefore breast feeding should be discontinued. The effect of NINLARO on fertility in humans has not been studied. Undesirable Effects: (All grades) Very common (≥1/10): Upper respiratory tract infection, thrombocytopenia, neutropenia, peripheral neuropathies, diarrhoea, nausea, vomiting, constipation, rash, back pain and oedema peripheral. Common (≥1/100, <1/10): Herpes zoster. Outside of the Phase 3 study, the following serious adverse reactions were rarely (≥ 1/10,000 to < 1/1,000) reported: acute febrile neutrophilic dermatosis, Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumour lysis syndrome and thrombotic thrombocytopenic purpura. Refer to the SmPC for details on full side effect profile and interactions. Pharmaceutical Precautions: Do not store above 30°C. Do not freeze. Store in the original package in order to protect from moisture. PI Date of Preparation: Dec 2016 PI approval code: UK/IXA/1611/0096 Legal category: POM Basic NHS Price: £6336 for 3 capsules. Marketing Authorisation: EU/1/16/1094/001, EU/1/16/1094/002, EU/1/16/1094/003 Further information is available from: Takeda UK Ltd. Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Buckinghamshire, HP10 0DF. Tel: 01628 537900 Fax: 01628 526617. NINLARO® is a registered trademark of Takeda Pharmaceutical Company Limited.

NINLARO has received a conditional marketing authorisation in Europe. A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact additional data are still required. The European regulatory agency will review new information on NINLARO at least every year and the summary of product characteristics will be updated as necessary.

Takeda Oncology, and NINLARO are registered trademarks of Takeda Pharmaceutical Company Limited. Other trademarks are the property of their respective owners. Copyright © 2019, Millennium Pharmaceuticals, Inc.

Prescribing information

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Please refer to the Summary of Product Characteristics for details on the full side-effect profile and drug interactions of NINLARO. Adverse events should be reported. Reporting forms and information can be found at

https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Takeda UK Ltd 01628-537900

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Oral NINLARO is administered once a week for 3 weeks of a 4-week cycle

*The recommended starting dose of dexamethasone is 40 mg – each tablet contains 2 mg dexamethasone.Treatment with NINLARO in combination with Rd for longer than 24 cycles should be based on an individual benefit risk assessment.1

NINLARO + Rd 28-day dosing schedule1

The recommended starting dose of oral NINLARO is one 4 mg capsule taken once a week with lenalidomide and dexamethasone at standard dosing†1

Should be taken at least 1 hour before or at least 2 hours after food

Should be swallowed whole with a glass of water

If a dose of NINLARO is delayed or missed, the dose should be taken only if the next scheduled dose is ≥72 hours away1

NINLARO should be stored in the original packaging and the capsules should be removed just prior to dosing1

DAY

1NINLARO

DAY

8DAY

15

Treat to progression or unacceptable toxicity

DAY

22DAY

28NO DOSE

lenalidomide

dexamethasone*

NO DOSE

Treatment should be continued until disease progression or unacceptable toxicity.1

4mg 3mg

†The recommended starting dose of oral NINLARO is 3 mg for patients with moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease requiring dialysis.1

For additional information regarding lenalidomide or dexamethasone, please refer to each respective Summary of Product Characteristics.