LUMOXITI- moxetumomab pasudotox injection, powder, lyophilized, for solution 
IV SOLUTION STABILIZER- iv solution stabilizer solution 
AstraZeneca Pharmaceuticals LP

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MEDICATION GUIDE

LUMOXITI™ (loo-MOCKS-eh-tee)

(moxetumomab pasudotox-tdfk)

for injection

What is the most important information I should know about LUMOXITI?

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:
o
swelling of your face, arms, or legs
o
fast weight gain (increase in 5.5 pounds from Day 1 of your current cycle)
o
weakness or dizziness
o
shortness of breath or trouble breathing
o
cough
o
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:
o
decrease in the amount of urine or dark urine (tea-colored)
o
unusual bleeding or bruising of your skin
o
stomach pain
o
vomiting
o
fever
o
feeling tired
o
changes in mood or behavior
o
confusion
o
seizures
o
shortness of breath
o
fast heartbeat
 
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.

See “What are the possible side effects of LUMOXITI?” below for other side effects of LUMOXITI.

 
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 purine nucleoside analog (PNA).

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

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

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.

How will I receive LUMOXITI?

Your healthcare provider will give you LUMOXITI into your vein through an intravenous (IV) line over 30 minutes.
LUMOXITI is usually given on Day 1, Day 3, and Day 5 of a 28-day treatment cycle. This is 1 treatment cycle. You may receive up to 6 treatment cycles.
Your healthcare provider will give you medicines and IV fluids before and after your infusions.
It is important for you to drink the additional prescribed amount of fluids (water, milk, or juice) of up to twelve 8‑oz glasses every 24 hours on Days 1 through 8 of each 28-day treatment cycle when you receive LUMOXITI infusions.
Your healthcare provider will decide how many treatment cycles you need.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of LUMOXITI?

LUMOXITI can cause serious side effects, including:

See “What is the most important information I should know about LUMOXITI?”
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:
o
chills
o
cough
o
dizziness
o
shortness of breath or wheezing
o
feeling hot or flushing
o
fast heartbeat
o
headache
o
changes in blood pressure
o
muscle pain
o
nausea
o
fever
o
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:
o
muscle cramps
o
numbness or tingling
o
abnormal or fast heartbeat
o
nausea
o
seizures
 
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 FDA at 1-800-FDA-1088.

General information about the safe and effective use of LUMOXITI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about LUMOXITI that is written for health professionals.

What are the ingredients in LUMOXITI?

Active ingredient: moxetumomab pasudotox-tdfk

Inactive ingredients: glycine, polysorbate 80, sodium phosphate monobasic monohydrate, sucrose, and sodium hydroxide

Inactive ingredients of IV Solution Stabilizer: citric acid monohydrate, polysorbate 80, sodium citrate dihydrate, Water for Injection, USP

LUMOXITI is a trademark of the AstraZeneca group of companies. ©AstraZeneca 2018

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-151 85; U.S. License No. 2059

For more information, go to www.LUMOXITI.com or call 1-800-236-9933.

This Medication Guide has been approved by the U.S. Food and Drug Administration.               Issued: September 2018

LUMOXITI™ (moxetumomab pasudotox-tdfk)

for injection

Healthcare Provider Instructions for Use

 

Important Information

Read the following instructions before reconstitution, dilution, and administration of LUMOXITI.

LUMOXITI must be prepared by a healthcare professional using proper aseptic technique.
Do not freeze or shake LUMOXITI or IV Solution Stabilizer.
Provide each patient the Medication Guide packaged with LUMOXITI prior to each treatment cycle to inform them of the risks and benefits of LUMOXITI.
See Full Prescribing Information for more information on LUMOXITI.

For questions, call AstraZeneca at 1-800-236-9933.

How Supplied

LUMOXITI and IV Solution Stabilizer are packaged separately.
Prior to preparation, LUMOXITI and IV Solution Stabilizer should be stored at 2°C to 8°C (36°F to 46°F) in original cartons to protect from light.

LUMOXITI (moxetumomab pasudotox-tdfk)

Each single-dose vial supplies LUMOXITI 1 mg/vial (moxetumomab pasudotox-tdfk) for injection as a lyophilized cake or powder for reconstitution and dilution prior to intravenous infusion.
Multiple vials of LUMOXITI may be required to administer a single dose (See Step 1: Calculate Dose).
Reconstitute LUMOXITI vials with Sterile Water for Injection, USP only (not supplied).
How_Supplied_Lumoxiti_single_dose_vial_1_mg

IV Solution Stabilizer

Each single-dose vial contains 1 mL IV Solution Stabilizer.
Only one vial of IV Solution Stabilizer is needed per administration of LUMOXITI, regardless of the number of vials of LUMOXITI used to prepare the infusion.
Do not use IV Solution Stabilizer to reconstitute LUMOXITI.
Do not flush IV lines with IV Solution Stabilizer.
IV_Solution_Stabilizer

Storage and Handling of Reconstituted and Diluted LUMOXITI

Table 1. Storage Times and Conditions for Reconstituted and Diluted LUMOXITI Solution

Reconstituted Solution

Diluted LUMOXITI Solution in Infusion Bag

After Dilution

Administration

LUMOXITI does not contain bacteriostatic preservatives.

Use reconstituted solution immediately.

DO NOT STORE reconstituted LUMOXITI vials.

Use diluted solution immediately or after storage at room temperature (20°C to 25°C; 68°F to 77°F) for up to 4 hours or store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.

PROTECT FROM LIGHT.

DO NOT FREEZE.

DO NOT SHAKE.

If the diluted solution is refrigerated (2°C to 8°C; 36°F to 46°F), allow it to equilibrate at room temperature (20°C to 25°C; 68°F to 77°F) for no more than 4 hours prior to administration.

Administer diluted solution within 24 hours of reconstitution as a 30-minute infusion.

PROTECT FROM LIGHT.

Step 1: Calculate Dose

Calculate the dose (mg) and the number of LUMOXITI vials (1 mg/vial) to be reconstituted. The final concentration of the reconstituted LUMOXITI solution is 1 mg/mL.

Individualize dosing based on the patient's actual body weight prior to the first dose of the first treatment cycle.
o
A change in dose should only be made between cycles when a change in weight of greater than 10% is observed from the weight used to calculate the first dose of the first treatment cycle. No change in dose should be made during a particular cycle.
Do not round down the dose for partial vials.

Step 2: Gather Supplies

LUMOXITI 1 mg/vial (number of vials to be reconstituted are based on Step 1)
1 vial of IV Solution Stabilizer (packaged separately)
alcohol swabs
1 infusion bag containing 50 mL of 0.9% Sodium Chloride Injection, USP
Sterile Water for Injection, USP
syringes and needles

Step 3: Reconstitution

Reconstitute each LUMOXITI vial with 1.1 mL Sterile Water for Injection, USP using aseptic technique.

Step_3_Lumoxiti_moxetumomab_vial_blue_capStep 3: Reconstitution 1.1 mL Sterile Water for Injection
Direct the Sterile Water for Injection, USP slowly along the walls of the LUMOXITI vial and not directly at the lyophilized cake or powder (see figure below).
Step3: Lumoxiti vial bottle and syringe
Do not reconstitute LUMOXITI vials with the IV Solution Stabilizer.
Gently swirl the vial until completely dissolved. Invert the vial to ensure all cake or powder in the vial is dissolved. Do not shake.

Visually inspect that the reconstituted solution is clear to slightly opalescent, colorless to slightly yellow, and free from visible particles.

Do not use if solution is cloudy, discolored, or contains any particles.

The resulting 1 mg/mL solution allows a withdrawal volume of 1 mL.

Use reconstituted solution immediately. Do not store reconstituted LUMOXITI vials. See Table 1 for storage times and conditions for the reconstituted solution.

Step 4: Preparation of Infusion Bag with IV Solution Stabilizer

Step 4: IV Solution Stabilizer for LUMOXITI VialStep 4: Sodium Chloride infusion bag

Obtain a 50 mL 0.9% Sodium Chloride Injection, USP infusion bag.

Only one vial of IV Solution Stabilizer is needed per administration of LUMOXITI, regardless of the number of vials of LUMOXITI used to prepare the infusion.

Add 1 mL IV Solution Stabilizer to the infusion bag containing 50 mL 0.9% Sodium Chloride Injection, USP.
Gently invert the bag to mix the solution. Do not shake.

Step 5: Dilution

Slowly withdraw the required volume of reconstituted LUMOXITI solution needed from each vial, per the calculated dose based on the patient’s actual body weight (kg).

Inject LUMOXITI into the infusion bag containing 50 mL 0.9% Sodium Chloride Injection, USP and 1 mL IV Solution Stabilizer.
Gently invert the bag to mix the solution. Do not shake.
Discard any partially used or empty vials of LUMOXITI and IV Solution Stabilizer.
See Table 1 for storage times and conditions for the diluted solution.

Step 6: Intravenous Hydration and Pre-infusion Medications

Administer intravenous hydration and premedication to the patient.

Intravenously administer 1 L of isotonic solution (e.g. 5% Dextrose Injection, USP and 0.45% or 0.9% Sodium Chloride Injection, USP) over 2 to 4 hours before each LUMOXITI infusion. Administer 0.5 L to patients under 50 kg.
Premedicate 30 to 90 minutes prior to each LUMOXITI infusion with an antihistamine (e.g. hydroxyzine or diphenhydramine), acetaminophen, and a histamine-2 receptor antagonist (e.g. ranitidine, famotidine, or cimetidine).

Step 7: Administration

Infuse the diluted LUMOXITI solution intravenously over 30 minutes.

Do not mix LUMOXITI, or administer as an infusion with other medicinal products.
After the infusion, flush the intravenous administration line with of 0.9% Sodium Chloride Injection, USP at the same rate as the infusion. This ensures that the full LUMOXITI dose is delivered.

Step 8: Post-infusion Medications

Administer post-infusion medications.

Intravenously administer 1 L of isotonic solution (e.g. 5% Dextrose Injection, USP and 0.45% or 0.9% Sodium Chloride Injection, USP) over 2 to 4 hours after each LUMOXITI infusion. Administer 0.5 L to patients under 50 kg.
Consider oral antihistamines and acetaminophen for up to 24 hours following LUMOXITI infusions.
Consider oral corticosteroid (e.g. 4 mg dexamethasone) to manage nausea and vomiting.

Maintain adequate oral fluid intake.

Advise all patients to adequately hydrate with up to 3 L (twelve 8-oz glasses) of oral fluids (e.g. water, milk, or juice) per 24 hours on Days 1 through 8 of each 28-day treatment cycle. In patients under 50 kg, up to 2 L (eight 8-oz glasses) per 24-hour period is recommended.

Consider low-dose aspirin on Days 1 through 8 of each 28-day treatment cycle.

This Healthcare Provider Instructions for Use has been approved by the U.S. Food and Drug Administration.

LUMOXITI is a trademark of the AstraZeneca group of companies. © AstraZeneca 2018

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-151 85; U.S. License No. 2059

For more information, go to www.LUMOXITI.com or call 1-800-236-9933.

Issued: 1/2019

Revised: 1/2019
AstraZeneca Pharmaceuticals LP