Lumoxiti - patient leaflet, side effects, dosage

1. What Lumoxiti is and what it is used forWhat Lumoxiti isLumoxiti contains the active substance moxetumomab pasudotox.

What Lumoxiti is used for

Lumoxiti is used on its own to treat a rare cancer called hairy cell leukaemia (HCL) in which the bone marrow makes abnormal white blood cells. It is intended for use in adults when:

• the cancer has come back or
• previous treatment has not worked.

Lumoxiti is for patients who have received at least 2 other treatments for their HCL, including a type of medicine called purine nucleoside analogue.

How Lumoxiti works

Lumoxiti acts by attaching to cells that have a protein called CD22. HCL cells have this protein. After attaching to the HCL cells, the medicine delivers a substance into the cells that causes the HCL cell to die.

2. What you need to know before you are given LumoxitiDo not use Lumoxiti: if you are allergic to moxetumomab pasudotox or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lumoxiti if you:

• have had a blood vessel and kidney disease called haemolytic uraemic syndrome (HUS). HUS is a serious side effect of Lumoxiti (see section 4).
• have had clots forming in small blood vessels due to a condition called severe thrombotic microangiopat­hy (TMA).
• have had a condition whereby fluid leaks from your small blood vessels into your body called capillary leak syndrome (CLS). CLS is a serious side effect of Lumoxiti (see section 4).
• have kidney problems.

Patients who have previously experienced any of the above conditions may be at greater risk of experiencing them again whilst undergoing treatment with Lumoxiti. If you think any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.

Tests and checks

Before and during treatment with Lumoxiti, your doctor may check your blood pressure and weight and carry out some tests. For example, blood tests and urine samples may be required to check how well your kidneys are working.

Children and adolescents

Lumoxiti should not be used in children and adolescents because it has not been stu with HCL aged less than 18 years due to extreme rareness of HCL in these ag

Other medicines and Lumoxiti

Tell your doctor or pharmacist if you are medicines.

Contraception, pregnancy and breast-feeding

Contraception

You must use effective birth control if you are a woma being treated with Lumoxiti. You must continue using b dose. Discuss with your doctor the most appropriate methods of birth control.

Pregnancy

Tell your doctor if you are pregnant, think because Lumoxiti may harm your unbo

• Do not use Lumoxiti during pre
• If you become pregnant duri

-feeding or plan to breast-feed. It is not known if Lumoxiti passes into

• You and your doctor should decide what is best for you and for your baby.
• This may that you will not breast-feed and receive Lumoxiti or that you will breast-feed and

not receiv oxiti.

Drivi g and using machines

Lumoxiti is unlikely to affect your ability to drive and use machines. However, if you feel you are not able to concentrate well enough and react quickly, be careful when driving or using machines.

Lumoxiti contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.

• 3. How Lumoxiti will be given

This medicine must be reconstituted and diluted by a healthcare professional. Lumoxiti will be given to you in a hospital or clinic by an experienced doctor or nurse.

The doctor will work out the dose that is right for you based on your weight.

Your doctor or nurse will give you Lumoxiti through an infusion (drip) into your vein (intravenous) over 30 minutes on days 1, 3, and 5 of each 28-day treatment cycle. You may receive up to 6 treatment cycles. Your doctor will decide how many treatment cycles you need.

Before each Lumoxiti infusion, you will be given other medicines to help reduce side effects including reactions related to the infusion (see section 4).

You will be given fluids by infusion before and after each Lumoxiti infusion to help prevent HUS.

HUS is a serious side effect of this medicine (see section 4). It is important to drink 2 to 3 litres of fluids every day for the first 8 days of each 28-day treatment cycle as recommended by your doctor.

If you miss an appointment to get Lumoxiti

Call your doctor right away to reschedule your appointment. It is very important that y dose of this medicine.

If you have any further questions on the use of this medicine, ask your doctor,

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Lumoxiti can cause some serious side effects. Tell your d or nurse immediately if you have

any of the following side effects because they may need to be treated and your treatment with

Lumoxiti may need to be delayed or stopped:

Bloody diarrhoea, stomach pain, vomiting, fever, feeling tired, confusion, decrease

amount of urine or dark urine or unusual bleeding or bruising. This may be symptoms of a blood vessel and kidney disease called haemolytic uraemic syndrome (HUS) (common , may affect up to 1 in 10 people).

Fast weight gain, low blood pressure, dizziness or light-headedness, swelling in your arms or legs, shortness of breath, or cough. This may be symptoms of fluid leaking from small blood vessels into your body called capillary leak syndrome (CLS) (common , may affect up to 1 in 10

ion may occur at any time during your infusion and any cycle of may affect more than 1 in 10 people). Symptoms may be headache, pressure, muscle pain, fever, chills, nausea, or vomiting.

(may affect more than 1 in 10 people):

ing of the face, eyes, arms and legs (oedema) creased amount of protein called albumin in the blood ncreased levels of liver enzymes

increased levels of creatinine in the blood

• nausea

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lumoxiti

Lumoxiti will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage. The storage details are as follows:

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP. The expiry date refers to the last day of that month.

Unopened vials:

Store and transport refrigerated (2°C – 8°C).

Store in the original carton in order to protect from light.

Do not freeze.

Any unused medicine or waste material should be disposed of in accordance with loca

6. Contents of the pack and other informationWhat Lumoxiti containsThe active substance is moxetumomab pasudotox. Each vial of powder contains 1 mg of moxetumomab pasudotox. After reconstitution with wa         ctions, each vial contains

• 1 mg/mL moxetumomab pasudotox.

The other ingredients in the powder are sodium dihydro glycine, polysorbate 80 and sodium hydroxide (see s The solution (stabiliser) contains citric acid monohy water for injections.

Lumoxiti is a powder for concentrate and solution for solution for infusion.

• The powder is white to off-white.
• The solution (stabiliser) is a colourless-to-slightly yellow, clear solution.

Each Lumoxiti pack contains either:

• 2 vials of powder for concentrate and 1 vial of solution (stabiliser) or
• 3 vials of powderfor concentrate and 1 vial of solution (stabiliser)

The powder for concentrate and the solution (stabiliser) are each provided in separate glass vials each with a stopper and an aluminium seal.

g Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje Sweden

Manufacturer

MedImmune Pharma B.V.

Lagelandseweg 78

Nijmegen

6545CG

Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

Efc^rapufl

AcTpa3eHeKa Etnrapua EOOfl

Ten.: +359 24455000

Luxembourg/Lu­xemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Danmark

AstraZeneca A/S

Tlf: +45 43 66 64 62

Deutschland

AstraZeneca GmbH

Tel: +49 41 03 7080

Nederland

AstraZeneca BV

Tel: +31 79 363 2222

Eesti

AstraZeneca

Tel: +372 6549 600

EXXáóa

AstraZeneca A.E.

TnX: +30 210 6871500

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41

Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35 600

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Kùnpoç

AXéKTop Oap^aKsuTiK^ Ató

TnX: +357 22490305

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100

United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

• Gently swirl the vial until completely dissolved. Invert the vial to ensure all powder in the vial is dissolved. Do not shake.
• Visually inspect that the Lumoxiti concentrate 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.

Following reconstitution, immediately proceed with the dilution process in Steps 3 and 4. Do not store the Lumoxiti concentrate.

Step 3: Prepare infusion bag

The solution (stabiliser) must be added to the infusion bag only. The solution (stabiliser) must be added to the infusion bag before the Lumoxiti concentrate is added.

Only 1 vial of solution (stabiliser) should be used per infusion bag. Any extra vial(s) of solution (stabiliser) should be discarded.

Obtain a 50 mL sodium chloride 9 mg/mL (0.9%) solution for injection infusio Add 1 mL solution (stabiliser) to the infusion bag.

o Gently invert the bag to mix the solution. Do not shake.

Step 4: Add Lumoxiti concentrate to infusion bag

Withdraw the required volume (calculated from Step 1) of Lumoxiti concentrate from the reconstituted vial(s).

Inject Lumoxiti concentrate from the reconstituted vial(s) i

sodium chloride 9 mg/mL (0.9%) solution for injectio Gently invert the bag to mix the solution. Do not s Visually inspect the diluted Lumoxiti concentrate solution is cloudy or contains any particles.

Following this dilution step, infuse the Lumoxiti solution (from the final infusion bag) immediately (step 5).

Immediately administer the Lumoxiti solution intravenously over 30 minutes. Use an infusion set fitted with a sterile, low-protein binding 0.22 micron in-line filter.

Do not mix Lumoxiti, or administer as an infusion with other medicinal products.

After the infusion, flush the intravenous administration line with sodium chloride 9 mg/mL (0.9%) solution for injection at the same rate as the infusion. This ensures the full Lumoxiti dose is deliver

Disp

A ed medicinal product or waste material should be disposed of in accordance with local

requirements.

Storage conditions

Store and transport refrigerated (2°C – 8°C).

Do not freeze.

Store in the original carton in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see below section on shelf life.

Shelf life

Lumoxiti is for single use only.

• Unopened vial: 4 years.

Lumoxiti concentrate (i.e. reconstituted Lumoxiti powder for concentrate):

• The Lumoxiti concentrate should be immediately further diluted.
• From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.