your guide to treatment with lumoxiti...please see accompanying full prescribing information,...

Please see accompanying full Prescribing Information, including Boxed WARNING, and Patient Information (Medication Guide).

YOUR GUIDE TOTREATMENT

WITH LUMOXITILUMOXITI is a prescription

medicine used to treat hairy cell leukemia that has come back or has not responded to previous treatment in adults who have

received at least 2 other therapies, including a type of medicine called a purine nucleoside analog (PNA).

SELECT SAFETY INFORMATION LUMOXITI can cause serious side effects, including:• Capillary Leak Syndrome (CLS). LUMOXITI can cause fluid to leak from small blood vessels into your body’s tissues.

This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening if not treated right away. Get emergency medical help right away if you develop any of the following symptoms of CLS:» swelling of your face, arms, or legs» fast weight gain (increase in 5.5 pounds from Day 1 of

your current cycle)» weakness or dizziness

» shortness of breath or trouble breathing» cough» low blood pressure

Your healthcare provider will check your weight and blood pressure before you receive each dose of LUMOXITI and as needed during treatment.

Please see inside for other serious side effects.

2


WHAT IS LUMOXITI?LUMOXITI is a prescription medicine used to treat adults with hairy cell leukemia (HCL)1:

• That has come back or has not responded to previous treatment, and

• Have received at least 2 other treatments, including a type of medicine called a purine nucleoside analog (PNA)

It is not known if LUMOXITI is safe and effective in children.

LUMOXITI is not chemotherapy.

How does LUMOXITI work?

LUMOXITI attaches to CD22, a type of protein found on HCL cells.1

STOP

LUMOXITI enters the cell

LUMOXITI stops the cell from making proteins and leads to cell death

LUMOXITI attaches to CD22 on the cell surface

HCL cell

HCL cellCD22

LUMOXITI

LUMOXITI

HCL cellCellDeath

Adapted from Schneider AK, et al. J Immunol Methods. 2016;435:68-76.2

3

HOW HAS LUMOXITI BEEN STUDIED?LUMOXITI has been evaluated in the largest clinical study to date of adults with HCL whose disease had returned following at least 2 previous treatments1:

80 adults with HCL received treatment with LUMOXITI All received at least 2 other types of treatment before receiving LUMOXITI, including a PNA

How effective was LUMOXITI in the clinical study?

Throughout the study, doctors checked to see how well each person responded to treatment with LUMOXITI1:

• If by the end of treatment no evidence of HCL was seen in the bone marrow or blood, this was called a “complete response”

• People who had a complete response were then followed for more than 180 days to see if the response lasted

SELECT SAFETY INFORMATIONLUMOXITI can cause serious side effects, including:• Hemolytic Uremic Syndrome (HUS). Hemolytic uremic syndrome is a condition that affects your blood cells

and kidneys and may be life-threatening if not treated right away. Get emergency medical help right away if you develop any of the following symptoms of HUS:» decrease in the amount

of urine or dark urine (tea-colored)

» unusual bleeding or bruising of your skin

» stomach pain » vomiting» fever » feeling tired» changes in mood

or behavior

» confusion» seizures» shortness

of breath» fast heartbeat

36%30%Final Analysis3

Initial Analysis1

Other study results

75% of people in the study (60 of 80) responded to treatment with LUMOXITI. Of these1:

• 41% (33 of 80) had a complete response during treatment

• 34% (27 of 80) had a partial response, meaning that the amount of HCL cells in their bodies decreased during treatment

of people in the study (24 of 80) had a complete response that lasted more than 180 days.

of people in the study (29 of 80) had a complete response that lasted more than 180 days.

4


OF EACH TREATMENT CYCLE

Administered as a 30-minute infusion

Given as a single

40µg/kg dose

DAY

5DAY

3DAY

1

3 infusions over a 28-day cycle; maximum 6 cycles

HOW DO I RECEIVE LUMOXITI?

Your doctor will give you medicines and intravenous (IV) fluids before and after your infusion.

Your doctor will determine cycle length based on disease progression.

EACH TREATMENT CYCLE IS MADE UP OF

CONTINUE LUMOXITI TREATMENT FOR A MAXIMUM OF 6 CYCLES

Each dose of LUMOXITI is infused into a vein (intravenously) over 30 minutes.1

DAYS

1 3 52 4 6

5

OF EACH TREATMENT CYCLE

BE SURE TO STAY HYDRATED! Please speak to your healthcare provider about the amount of fluids appropriate for you. It is important for you to stay hydrated throughout your treatment and to drink the additional recommended amount of fluids during the first 8 days of each cycle when you receive infusions. This may help reduce the risk of serious side effects, including hemolytic uremic syndrome (HUS).1

IF YOU WEIGH 110 LB OR MORE LESS THAN 110 LB

YOU SHOULD DRINK

Up to 3 LITERS OF FLUIDS on Days 1 through 8 of each

28-day cycle

Up to 2 LITERS OF FLUIDS on Days 1 through 8 of each

28-day cycle

DAY

1DAY

2DAY

3DAY

4DAY

5DAY

6DAY

7DAY

8

= hydration day = infusion day

= one 8-oz glass

Your doctor will determine cycle length based on disease progression.

3 LITERS IS THE SAME ASdrinking approximately

twelve 8-oz glasses of water every 24 hours

2 LITERS IS THE SAME ASdrinking approximately

eight 8-oz glasses of water every 24 hours

SELECT SAFETY INFORMATIONYour healthcare provider will do blood tests to check your blood cells and kidneys before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider. If you develop any of these symptoms of CLS or HUS, your healthcare provider may monitor you in the hospital.

6


HOW DO I RECEIVE LUMOXITI? (CONT’D)

What will be checked before each dose of LUMOXITI?

Before you receive each dose of LUMOXITI, tests will be performed to check your health and check for any side effects. These tests may include1:

Measuring your weight Measuring your

blood pressure Taking blood to count blood

cells and check how well your kidneys are working

What should I tell my doctor?

Before you receive LUMOXITI, tell your healthcare provider about all your medical conditions, including if you:

• Have blood or urine problems (hemolytic uremic syndrome or severe thrombotic microangiopathy)

• Have kidney problems

• Are currently or plan to become pregnant

• Are currently breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.

SELECT SAFETY INFORMATION Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LUMOXITI. Your healthcare provider may delay or completely stop treatment with LUMOXITI if you have severe side effects.

LUMOXITI can cause other serious side effects, including:• Kidney problems. LUMOXITI may cause kidney problems. People who have HUS, are 65 years of age or older, or

those who have kidney problems before starting treatment with LUMOXITI may have an increased risk of worse kidney problems after treatment with LUMOXITI. Tell your healthcare provider right away if you have any changes in the amount you urinate. Your healthcare provider will do tests to check your kidneys before you receive each dose of LUMOXITI and as needed during treatment. Your healthcare provider may delay your treatment with LUMOXITI if you have severe kidney problems.

7

What will I receive before each dose of LUMOXITI?

Before each dose of LUMOXITI, you will receive1:

IV fluids to help you Medications to help prevent side stay hydrated effects, such as allergic reactions, fever, or infusion reactions

What will I receive after each dose of LUMOXITI?

After each dose of LUMOXITI, your doctor will prescribe the following:

• IV fluids to help you stay hydrated

• Certain medications may be prescribed as required to help prevent side effects, such as allergic reactions, fevers, or nausea and vomiting

Only use medications as directed by your doctor.

Remember, it’s also important to drink the recommended amount of fluids on Days 1 through 8 of each treatment cycle. Please see page 5 for more details.

SELECT SAFETY INFORMATION LUMOXITI can cause other serious side effects, including:• Infusion reactions. LUMOXITI can cause infusion reactions that are common but can also be serious. Infusion

reactions may happen on the day you receive your LUMOXITI infusion. Signs and symptoms of infusion reactions may include:

» chills » cough » dizziness » shortness of breath

or wheezing

» feeling hot or flushing» fast heartbeat » headache» changes in blood pressure » muscle pain

» nausea» fever» vomiting

Your healthcare provider may give you medicines to take before and after each LUMOXITI infusion.

8


WHAT ARE THE POSSIBLE SIDE EFFECTS?LUMOXITI can cause serious side effects, including1: • Kidney problems. LUMOXITI may cause kidney problems. People who have HUS, are 65 years of age

or older, or those who have kidney problems before starting treatment with LUMOXITI may have an increased risk of worse kidney problems after treatment with LUMOXITI. Tell your healthcare provider right away if you have any changes in the amount you urinate. Your healthcare provider will do tests to check your kidneys before you receive each dose of LUMOXITI and as needed during treatment. Your healthcare provider may delay your treatment with LUMOXITI if you have severe kidney problems.

• Infusion reactions. LUMOXITI can cause infusion reactions that are common but can also be serious. Infusion reactions may happen on the day you receive your LUMOXITI infusion. Signs and symptoms of infusion reactions may include:

» chills

» cough

» dizziness

» shortness of breath or wheezing

» feeling hot or flushing

» fast heartbeat

» headache

» changes in blood pressure

» muscle pain

» nausea

» fever

» vomiting

Your healthcare provider may give you medicines to take before and after each LUMOXITI infusion.

• Electrolyte problems. Tell your healthcare provider if you get any of the following symptoms of electrolyte problems:

» muscle cramps » nausea

» numbness or tingling » seizures

» abnormal or fast heartbeat

Your healthcare provider will do blood tests to check your electrolytes before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider.

The most common side effects of LUMOXITI include:

• Swelling in your face, arms, or legs

• Nausea

• Feeling tired

• Headache

• Fever

• Constipation

• Low red blood cells (anemia)

• Diarrhea

These are not all the possible side effects of LUMOXITI.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

9

What is CLS?

Capillary Leak Syndrome (CLS). LUMOXITI can cause fluid to leak from small blood vessels into your body’s tissues. CLS can quickly cause you to have symptoms that may become life-threatening if not treated right away.1

Your healthcare provider will check your weight and blood pressure before you receive each dose of LUMOXITI and as needed during treatment.

What is HUS?

Hemolytic Uremic Syndrome (HUS). Hemolytic uremic syndrome is a condition that affects your blood cells and kidneys and may be life-threatening if not treated right away.

Your healthcare provider will do blood tests to check your blood cells and kidneys before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider.

Get emergency medical help right away if you develop any of the following symptoms of CLS or HUS1:

If you develop any of these symptoms of CLS or HUS, your doctor may monitor you in the hospital. Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment with LUMOXITI. Your doctor may delay or completely stop treatment with LUMOXITI if you have severe side effects.

References: 1.LUMOXITI®(moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Schneider AK, Vainshtein I, Roskos LK, Chavez C, Sun B, Liang M. An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox. J Immunol Methods. 2016;435:68-76. 3. Kreitman RJ, et al. Moxetumomab Pasudotox-Tdfk in Heavily Pretreated Patients with Relapsed/Refractory Hairy Cell Leukemia (HCL): Long-Term Follow-up from the Pivotal Phase 3 Trial. Blood. 2019;134(Suppl_1):2802.

CLS SYMPTOMS MAY INCLUDE:

• Swelling of your face, arms, or legs• Fast weight gain (increase in 5.5 pounds

from Day 1 of your current cycle)• Weakness or dizziness• Shortness of breath or trouble breathing• Cough• Low blood pressure

• Decrease in the amount of urine or dark urine (tea-colored)

• Unusual bleeding or bruising of your skin• Stomach pain• Vomiting• Fever• Feeling tired• Changes in mood or behavior• Confusion• Seizures• Shortness of breath• Fast heartbeat

HUS SYMPTOMS MAY INCLUDE:

10


IMPORTANT SAFETY INFORMATIONLUMOXITI can cause serious side effects, including:• Capillary Leak Syndrome (CLS). LUMOXITI can cause fluid to leak from small blood vessels into your body’s

tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening if not treated right away. Get emergency medical help right away if you develop any of the following symptoms of CLS:» swelling of your face, arms, or legs» fast weight gain (increase in 5.5 pounds from

Day 1 of your current cycle)

» weakness or dizziness» shortness of breath or trouble breathing» cough» low blood pressure

Your healthcare provider will check your weight and blood pressure before you receive each dose of LUMOXITI and as needed during treatment. • Hemolytic Uremic Syndrome (HUS). Hemolytic uremic syndrome is a condition that affects your blood cells

and kidneys and may be life-threatening if not treated right away. Get emergency medical help right away if you develop any of the following symptoms of HUS:

Your healthcare provider will do blood tests to check your blood cells and kidneys before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider. If you develop any of these symptoms of CLS or HUS, your healthcare provider may monitor you in the hospital.Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LUMOXITI. Your healthcare provider may delay or completely stop treatment with LUMOXITI if you have severe side effects.LUMOXITI can cause other serious side effects, including:• Kidney problems. LUMOXITI may cause kidney problems. People who have HUS, are 65 years of age or older, or those

who have kidney problems before starting treatment with LUMOXITI may have an increased risk of worse kidney problems after treatment with LUMOXITI. Tell your healthcare provider right away if you have any changes in the amount you urinate. Your healthcare provider will do tests to check your kidneys before you receive each dose of LUMOXITI and as needed during treatment. Your healthcare provider may delay your treatment with LUMOXITI if you have severe kidney problems.

» decrease in the amount of urine or dark urine (tea-colored)

» unusual bleeding or bruising of your skin

» stomach pain

» vomiting» fever » feeling tired» changes in mood or behavior» confusion

» seizures» shortness of

breath» fast heartbeat

11

• Infusion reactions. LUMOXITI can cause infusion reactions that are common but can also be serious. Infusion reactions may happen on the day you receive your LUMOXITI infusion. Signs and symptoms of infusion reactions may include:

» chills » cough » dizziness » shortness of breath or

wheezing

» feeling hot or flushing » fast heartbeat » headache » changes in blood pressure

» muscle pain » nausea » fever » vomiting

Your healthcare provider may give you medicines to take before and after each LUMOXITI infusion.• Electrolyte problems. Tell your healthcare provider if you get any of the following symptoms of electrolyte

problems: » muscle cramps » abnormal or fast heartbeat » seizures » numbness or tingling » nausea Your healthcare provider will do blood tests to check your electrolytes before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider.Before you receive LUMOXITI, tell your healthcare provider about all your medical conditions, including if you:• have had conditions that affect your blood and blood vessels called HUS or severe thrombotic microangiopathy

(TMA) • have kidney problems• are pregnant or plan to become pregnant. LUMOXITI may harm your unborn baby.

» If you are a female who can become pregnant, you should use effective birth control during treatment with LUMOXITI and for at least 30 days after your last dose of LUMOXITI.

» If you are a female who can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with LUMOXITI.

» Tell your healthcare provider right away if you become pregnant during treatment with LUMOXITI.• are breastfeeding or plan to breastfeed. It is not known if LUMOXITI passes into your breast milk. You and your

healthcare provider should decide if you will receive LUMOXITI or breastfeed. You should not do both.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of LUMOXITI include:• swelling in your face, • feeling tired • constipation • diarrhea

arms, or legs • headache • low red blood• nausea • fever cells (anemia)These are not all the possible side effects of LUMOXITI.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.What is LUMOXITI?LUMOXITI is a prescription medicine used to treat adults with hairy cell leukemia (HCL) • that has come back or has not responded to previous treatment, and • have received at least 2 other treatments, including a type of medicine called a purine nucleoside analog (PNA).It is not known if LUMOXITI is safe and effective in children.

» seizures» shortness of

breath» fast heartbeat

LUMOXITI is a trademark of Innate Pharma S.A. InnateCares is a registered trademark of Innate Pharma S.A. ©2020 Innate Pharma S.A. All rights reserved. US-LX-2000012 Last Updated 2/20


LEARN MORE ABOUT TREATMENT WITH LUMOXITIFor more information about HCL and treatment with LUMOXITI, and to register for support and updates, please visit www.LUMOXITI.com.

Additional web resourcesConsider visiting these additional websites and resources to learn more about HCL, treatment options, support groups, and more! Hairy Cell Leukemia Foundation www.hairycellleukemia.orgLeukemia and Lymphoma Society www.lls.orgAmerican Cancer Society www.cancer.org

National Organization for Rare Disorders www.rarediseases.orgNational Cancer Institute www.cancer.gov

Helping You Access the Care You Need

If your doctor has prescribed LUMOXITI, you may have questions. The InnateCaresTM program can help. We can answer your questions about: • Insurance coverage for your medicine • Your out-of-pocket costs • Financial support

• Pharmacies that stock or deliver your medicine

• Nurse and other educational help

To learn more about the InnateCares™ program, please call 1-844-694-6628 Monday–Friday 8 am–8 pm EST or visit www.innatecares.com.

For more information about LUMOXITI, please visit www.LUMOXITI.com.

your guide to treatment with lumoxiti...please see accompanying full prescribing information,...

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