Patient leaflet - Arzerra
What Arzerra is and what it is used for
Arzerra contains ofatumumab, which belongs to a group o
es called monoclonal antibodies.
Arzerra is used to treat chronic lymphocytic leukaemia (CLL). CLL is a cancer of the blood which affects a type of white blood cell called lymphocytes. The lymphocytes multiply too quickly and live
too long, so there are too many of them c organs in your body. The antibody in Ar and causes the lymphocyte to die.
g in your blood. The disease can also affect other ognises a substance on the surface of lymphocytes
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2. What you need to
you are given Arzerra
You must not be given Arzerra:
- if you are allergic ersensitive) to ofatumumab or any of the other ingredients of this medicine (listed i ction 6).
Check with your if you think this may apply to you.
Warnings
Talk to
precautions
ou have lung disease,
ctor or nurse before you are given Arzerra: have had heart problems,
Check with your doctor if you think any of these may apply to you. You may need extra check-ups while you are being treated with Arzerra.
Your doctor may test the amount of electrolytes, such as magnesium and potassium, in your blood before and during your treatment with Arzerra. Your doctor may treat you if any electrolyte imbalance is detected.
Vaccination and Arzerra
If you are having any vaccinations tell your doctor, or the person giving you the vaccine, that you are being treated with Arzerra. Your response to the vaccine may be weakened and you may not be fully protected.
Hepatitis B
You should be tested for hepatitis B (a liver disease) before starting Arzerra treatment. If you have had hepatitis B, Arzerra could cause it to become active again. Your doctor may treat you with a suitable anti-viral medicine to help prevent this.
If you have or have had hepatitis B, tell your doctor before you are given Arzerra.
Infusion reactions
Medicines of this type (monoclonal antibodies) can cause infusion reactions when they are injected into the body. You will be given medicines such as anti-histamines, steroids or pain relievers to help reduce any reaction. See also section 4, ‘Possible side effects’.
If you think you have had such a reaction before, tell your doctor before you are given Arzerr
Progressive multifocal leukoencephalopathy (PML)
Progressive multifocal leukoencephalopathy (PML), a serious and life-threatening brain condition, has been reported with medicines like Arzerra. Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision. If you had these symptoms prior to treatment with Arzerra, tell your doctor immediately about any changes in these symptoms.
Bowel obstruction
Contact your doctor immediately if you experience constipation, a swollen abdomen or abdominal pain. These could be symptoms of a blockage in the bowel, especially during the early stages of your treatment.
Children and adolescents
It is not known whether Arzerra works in children recommended for use in children and adolescents.
cents. Therefore Arzerra is not
Other medicines and Arzerra
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
This includes herbal medicines and other medicines you can obtain without a prescription.
Pregnancy, breast-feeding and fe Arzerra is not usually recommende
se during pregnancy.
Tell your doctor if you planning to have a baby of taking Ar
you are If yo
Use a reliable with Arzerra,
regnant or breast-feeding, think you may be pregnant, or are
ur doctor will weigh up the benefit to you against the risk to your hile you're pregnant.
f contraception to avoid becoming pregnant while you are being treated
for 12 months after your last dose of Arzerra. Ask your doctor for advice if
ing to become pregnant after this period.
come pregnant during treatment with Arzerra, tell your doctor.
It is n
n whether the ingredients in Arzerra pass into human milk. Breast-feeding is not
recommended during treatment with Arzerra and for 12 months after the last dose.
Driving and using machines
Arzerra is unlikely to affect your ability to drive or use machines.
Arzerra contains sodium
Arzerra contains 34.8 mg sodium in each 300 mg dose, 116 mg sodium in each 1000 mg dose and 232 mg sodium in each 2000 mg dose. You need to take this into account if you are on a controlled sodium diet.
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3. How Arzerra is given
If you have any questions on the use of Arzerra, ask the doctor or nurse who is giving you the infusion.
The usual dose
The usual dose of Arzerra for the first infusion is 300 mg. This dose will be increased, usually to 1000 mg or 2000 mg, for the remaining infusions.
How it is given
Arzerra is given into a vein (intravenously) as an infusion (a drip) over several hours.
If you have not been previously treated for CLL you will have a maximum of 13 infusions. You will be given an initial infusion followed by a second infusion 7 days later. The remaining infusions will then be given once a month for up to 11 months.
♦
If you have been previously treated for CLL but the disease returns you will have a maximum of 7 infusions. You will be given an initial infusion followed by a second infusion 7 days later. The remaining infusions will then be given once a month for up to 6 months.
If you have been previously treated for CLL you will usually have a course of 12 infusions. You will be given an infusion once a week for eight weeks. This is followed by a four- to five-week gap. The remaining infusions will then be given once a month for four months.
Medicines given before each infusion
Before each infusion of Arzerra, you will be given pre-medication – medicines which help to reduce any infusion reactions. These may include anti-histamines, steroids and pain relievers. You will be checked closely and if you do have any reactions these will be treated.
4. Possible side effectsLike all medicines, this medicine canInfusion-related reactions
ide effects, although not everybody gets them.
Infusion-related reactions
Medicines of this type (monoclonal antibodies) can cause infusion-related reactions, which are occasionally severe, and can cause death. They are more likely during the first treatment.
Very common sy
f an infusion-related reaction (may affect more than 1 in 10 people):
sness, cough
diarrhoea
lack of energy
Common symptoms of an infusion-related reaction (may affect up to 1 in 10 people):
- allergic reactions, sometimes severe where symptoms include raised and itchy rash (hives), swelling of the face or the mouth (angioedema) causing difficulty breathing and collapse
- difficulty in breathing, shortness of breath, chest tightness, cough
- low blood pressure (can cause light-headedness when you stand up)
- flushing
- excessive sweating
- shaking or shivering
- rapid heart beat
- headache
back pain
high blood pressure throat pain or irritation blocked nose.
Uncommon symptoms of an infusion-related reaction (may affect up to 1 in 100
anaphylactic reaction including anaphylactic shock, where symptoms include breathlessness or difficulty breathing, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalised itching, skin reddening, swelling of the face and/or throat, blue discolouration of the lips, tongue or skin
fluid in the lungs (pulmonary oedema) causing breathlessness
slow heart beat
blue discolouration of the lips and extremities (possible symptoms of hypoxia)
Tell your doctor or a nurse immediately if you get any of these symptoms.
Other possible side effects
Very common side effects
These may affect more than 1 in 10 people:
frequent infections, fever, chills, so fever, coughing, difficulty breath
throat or mouth ulcers due to infections
heezing, possible symptoms of infections of the lungs or
airways (respiratory tract) i ing pneumonia
sore throat, feeling of pressur r pain in the cheeks and forehead, infections of the ear, nose or throat.
- Very common side eff low levels of w
- low levels of re
at may show up in your blood tests: od cells (neutropenia)
cells (anaemia).
- Common si These may a fever
de effects
ffect up to 1 in 10 people:
or, alternatively, a very low body temperature, chest pain, shortness of breath or rapid
breathing, shaking, chills, confusion, dizziness, decreased urination and rapid pulse, (possible symptoms of blood infection)
difficulty and pain when passing urine, exaggerated sense of needing to urinate, urinary tract infections
- shingles, cold sores (possible symptoms of herpes viral infection that can potentially be severe).
Common side effects that may show up in your blood tests:
- low levels of platelets in the blood (cells that help blood to clot).
Uncommon side effects
These may affect up to 1 in 100 people:
blockage in the gut (intestine), which may feel like stomach pain.
- If you have persistent stomach pain, see your doctor as soon as possible.
yellow skin and eyes, nausea, loss of appetite, dark urine (possible symptoms of an infection or reactivation of hepatitis B virus)
memory loss, trouble with thinking, and difficulty with walking or loss of vision (possible
symptoms of progressive multifocal leukoencephalopathy)
increase in potassium, phosphate and uric acid in the blood that can cause kidney problems
(tumour lysis syndrome)
The symptoms of this condition include:
- producing less urine than normal
- muscle spasms.
If you notice these symptoms, contact your doctor as soon as possible.
Uncommon side effects that may show up in your blood tests:
- problems with blood clotting
- the bone marrow failing to produce enough red or white blood cells
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes a ssible side effects not
listed in this leaflet. You can also report side effects directly via the nai reporting system listed in
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Arzerra
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry d refers to the last day of that month.
wn on the carton and vial label. The expiry date
Store and transport refrigerated (2 C – 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Store the diluted infusion solution between 2°C and 8 C and use within 24 hours. Any unused infusion
solution should be
ed 24 hours after preparation.
6. Contents of the pack and other informationWhat Arzerra contains- The active substance is ofatumumab. One ml of concentrate contains 20 mg of ofatumumab.
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– The other ingredients are arginine, sodium acetate (E262), sodium chloride, polysorbate 80
(E433), edetate disodium (E386), hydrochloric acid (E507) (for pH-adjustment), water for injections (see “Arzerra contains sodium” under section 2).
What Arzerra looks like and contents of the pack
Arzerra is a colourless to pale yellow concentrate for solution for infusion.
Arzerra 100 mg is available in a pack containing 3 vials. Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 5 ml of concentrate (100 mg of ofatumumab).
Arzerra 1000 mg is available in a pack containing 1 vial. Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 50 ml of concentrate (1000 mg of ofatumumab).
Marketing Authorisation Holder
Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom
Manufacturer
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard
Castle, County Durham, DL12 8DT, United Kingdom
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
eting
For any information about this medicine, please contact the local representative of t Authorisation Holder:
België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50
Efc^rapufl
Novartis Bulgaria EOOD
Ten: +359 2 489 98 28
Česká republika
Novartis s.r.o.
Tel: +420 225 775 111
Eesti
Novartis Pha
Tel: +372 66
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Nederland
Novartis Pharma B.V.
Tel: +31 26 37 82 555
Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
ces Inc.
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0
Luxembou
xemburg
Novarti a N.V.
Tél/Tel: +32 2 246 16 11
Magyarország
Novartis Hungária Kft.
EMáóa
Novartis (Hellas) A.E.B.E.
TnX: +30 210 281 17 12
Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00
Polska
Novartis Poland Sp. z o.o
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00
Portugal
Novartis Farma – Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
| Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 Island Vistor hf. Simi: +354 535 7000 Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Knnpoç Novartis Pharma Services Inc. Tql: +357 22 690 690 Latvija SIA “Novartis Baltics” Tel: +371 67 887 070 This leaflet was last revised in Detailed information on this medicine is site:. | România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50 Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 available on the European Medicines Agency (EMA) web |
The following information is intended for healthcare professionals only:
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1) Before diluting Arzerra
Check the Arzerra concentrate for particulate matter and discolouration prior to dilution. Ofatumumab should be a colourless to pale yellow solution. Do not use the Arzerra concentrate if there is discolouration.
Do not shake the ofatumumab vial for this inspection.
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2) How to dilute the solution for infusion