Arzerra
ofatumumab
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Arzerra is and what it is used for
What you need to know before you are given Arzerra
How Arzerra is given
Possible side effects
How to store Arzerra
Contents of the pack and other information
Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
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if you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of this medicine (listed in section 6).
Check with your doctor if you think this may apply to you.
Talk to your doctor or nurse before you are given Arzerra:
if you have had heart problems,
if you have lung disease,
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.
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.
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.
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 Arzerra.
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.
pain. These could be symptoms of a blockage in the bowel, especially during the early stages of your treatment.
It is not known whether Arzerra works in children and adolescents. Therefore Arzerra is not
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recommended for use in children and adolescents.
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.
Arzerra is not usually recommended for use during pregnancy.
Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby. Your doctor will weigh up the benefit to you against the risk to your baby of taking Arzerra while you're pregnant.
Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Arzerra, and for 12 months after your last dose of Arzerra. Ask your doctor for advice if you are planning to become pregnant after this period.
If you do become pregnant during treatment with Arzerra, tell your doctor.
It is not known 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.
Arzerra is unlikely to affect your ability to drive or use machines.
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.
If you have any questions on the use of Arzerra, ask the doctor or nurse who is giving you the infusion.
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.
Arzerra is given into a vein (intravenously) as an infusion (a drip) over several hours.
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
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checked closely and if you do have any reactions these will be treated.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
feeling sick (nausea)
high temperature
skin rash
breathlessness, cough
diarrhoea
lack of energy
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.
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
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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
These may affect more than 1 in 10 people:
frequent infections, fever, chills, sore throat or mouth ulcers due to infections
fever, coughing, difficulty breathing, wheezing, possible symptoms of infections of the lungs or airways (respiratory tract) including pneumonia
sore throat, feeling of pressure or pain in the cheeks and forehead, infections of the ear, nose or throat.
Very common side effects that may show up in your blood tests:
low levels of white blood cells (neutropenia)
low levels of red blood cells (anaemia).
These may affect up to 1 in 10 people:
fever 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).
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
If you get any side effects, talk to your doctor 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
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the carton and vial label. The expiry date refers to the last day of that month.
Store and transport refrigerated (2 C – 8C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Store the diluted infusion solution between 2C and 8 C and use within 24 hours. Any unused infusion solution should be discarded 24 hours after preparation.
The active substance is ofatumumab. One ml of concentrate contains 20 mg of ofatumumab.
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).
Arzerra is a colourless to pale yellow concentrate for solution for infusion.
Camberley GU16 7SR United Kingdom
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Novartis Pharma Services Inc. Tel: +370 5 269 16 50
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28
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Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH
Tel: +49 911 273 0
Novartis Pharma B.V.
Tel: +31 26 37 82 555
Novartis Pharma Services Inc. Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12
Novartis Pharma GmbH
Tel: +43 1 86 6570
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690
Novartis Sverige AB
Tel: +46 8 732 32 00
SIA “Novartis Baltics”
Tel: +371 67 887 070
Novartis Pharmaceuticals UK Ltd.
Tel: +44 1276 698370
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The following information is intended for healthcare professionals only:
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.
The Arzerra concentrate must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration, using aseptic technique.
Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Withdraw 5 ml of ofatumumab from each of the three 100 mg vials and inject into the 1000 ml bag;
Do not shake; mix diluted solution by gentle inversion.
Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag
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Do not shake; mix diluted solution by gentle inversion.
Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Withdraw 50 ml of ofatumumab from each of the two 1000 mg vials and inject into the 1000 ml bag;
Do not shake; mix diluted solution by gentle inversion.
Arzerra must not be administered as an intravenous push or bolus. Administer using an intravenous infusion pump.
The infusion must be completed within 24 hours after preparation. Discard any unused solution after this time.
Arzerra must not be mixed with, or administered as an infusion with other medicinal products or intravenous solutions. Flush line before and after ofatumumab administration with sodium chloride 9 mg/ml (0.9%) solution for injection to avoid this.
Previously untreated CLL and relapsed CLL:
For the first infusion, administer over 4.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
If the first infusion was completed without a severe adverse reaction, the remaining infusions of
1000 mg should be administered over 4 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below. If any infusion-related adverse reactions are
observed, infusion should be interrupted and restarted when the patient’s condition is stable (see section 4.2 of the SmPC).
Infusion schedule
Time after start of infusion (minutes) | Infusion 1 | Subsequent infusions* |
Infusion rate (ml/hour) | Infusion rate (ml/hour) | |
0-30 | 12 | 25 |
31-60 | 25 | 50 |
61-90 | 50 | 100 |
91-120 | 100 | 200 |
121-150 | 200 | 400 |
151-180 | 300 | 400 |
180+ | 400 | 400 |
*If the previous infusion was completed without severe infusion-related ADRs. If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient’s condition is stable (see section 4.2 of the SmPC). | ||
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Refractory CLL:
For the first and second infusion, administer over 6.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
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If the second infusion was completed without a severe adverse reaction, the remaining infusions (3-12) should be administered over 4 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below. If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient’s condition is stable (see section 4.2 of the SmPC).
Infusion schedule
Time after start of infusion (minutes) | Infusions 1 and 2 | Infusions 3* to 12 |
Infusion rate (ml/hour) | Infusion rate (ml/hour) | |
0-30 | 12 | 25 |
31- 60 | 25 | 50 |
61-90 | 50 | 100 |
91-120 | 100 | 200 |
121+ | 200 | 400 |
*If the second infusion was completed without severe infusion-related ADRs. If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient’s condition is stable (see section 4.2). | ||
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.