Patient leaflet - Obiltoxaximab SFL
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Obiltoxaximab SFL 100 mg/mL concentrate for solution for infusion obiltoxaximab
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Obiltoxaximab SFL is and what it is used for
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2. What you need to know before you receive Obiltoxaximab SFL
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3. How Obiltoxaximab SFL will be given
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4. Possible side effects
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5. How to store Obiltoxaximab SFL
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6. Contents of the pack and other information
1. What Obiltoxaximab SFL is and what it is used for
Obiltoxaximab SFL contains the active substance obiltoxaximab. Obiltoxaximab is a monoclonal antibody, a type of protein that attaches to and inactivates the toxins produced by the bacteria that causes anthrax.
Obiltoxaximab SFL is used with antibiotic medicines to treat adults and children with anthrax caused by breathing in the bacteria (inhalational anthrax).
Obiltoxaximab SFL may also be used if you could have come into contact with anthrax bacteria or spores but do not have any symptoms of the disease, and if there is no other treatment available and appropriate.
2. What you need to know before you receive Obiltoxaximab SFL
You should not be given Obiltoxaximab SFL
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– if you are allergic to obiltoxaximab or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Obiltoxaximab SFL:
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– if you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, or if
your child can no longer take sweet foods or drinks because it feels sick, vomits or gets unpleasant effects such as bloating, stomach cramps or diarrhoea.
Allergic reactions that may occur after treatment with Obiltoxaximab SFL can sometimes be severe. You may be given an antihistamine before you are given Obiltoxaximab SFL to reduce the risk of allergic reactions.
Other medicines and Obiltoxaximab SFL
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
You may be given antibiotics (e.g. ciprofloxacin) to help treat inhalational anthrax.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you.
It is not known if Obiltoxaximab SFL can harm an unborn baby.
It is not known if Obiltoxaximab SFL passes into breast milk. You and your doctor will decide if you should breast-feed after receiving Obiltoxaximab SFL.
Driving and using machines
Obiltoxaximab SFL may cause side effects such as headache, dizziness, fatigue and vomiting. This may affect your ability to drive or operate machinery.
Obiltoxaximab SFL contains sorbitol (E420)
Sorbitol is a source of fructose (a type of sugar). If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, your doctor may decide that you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Obiltoxaximab SFL contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per each 6 mL vial of Obiltoxaximab SFL, that is to say essentially ‘sodium-free’.
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3. How Obiltoxaximab SFL will be given
Obiltoxaximab SFL will be given to you by a doctor or a nurse. Your doctor or nurse will calculate the dose based on your (or your child’s) weight.
Your doctor, nurse or pharmacist will prepare the medicine for infusion.
The Obiltoxaximab SFL solution will be given as an infusion (drip) over 90 minutes into a vein, usually in your arm. You will be monitored while you are given Obiltoxaximab SFL and also for at least one hour after the infusion.
Before you are given Obiltoxaximab SFL, you will usually be given medicines to prevent or reduce allergic reactions.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or the person giving you the infusion straight away if you notice any of the following side effects:
Itching, rash, shortness of breath or wheezing – these may be signs of an allergic reaction (hypersensitivity).
Other side effects of Obiltoxaximab SFL include:
Common (may affect up to 1 in 10 people)
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– Headache
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– Cough
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– Infusion site pain
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– Itching, skin rash, including an itchy raised rash (hives)
Uncommon (may affect up to 1 in 100 people)
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– Allergic reactions
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– Dizziness
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– Numbness
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– Visual sensitivity to light (photophobia)
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– Ear discomfort
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– Throat irritation
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– Hoarse voice
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– Sinus congestion
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– Shortness of breath
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– Lip pain
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– Eczema, pealing skin
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– Muscle twitching, muscle spasms
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– Fatigue
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– Chills (feeling of coldness)
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– Chest discomfort
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– Pain in general, and pain affecting limbs, chest, jaw, muscles, ligaments, tendons, or bones
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– Infusion site swelling, pain, or phlebitis (inflamed veins)
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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Obiltoxaximab SFL
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 carton and on the label after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original packaging in order to protect from light.
After dilution in infusion bag, chemical, physical and microbial in-use stability has been demonstrated for 8 hours at room temperature (20°C – 25°C) or in the refrigerator (2°C – 8°C).
After dilution of Obiltoxaximab SFL in a syringe for infusion, it should be administered immediately and not stored. Any unused product should be discarded.
6. Contents of the pack and other information
What Obiltoxaximab SFL contains
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– The active substance is obiltoxaximab. Each mL of concentrate contains 100 mg of obiltoxaximab. One vial of 6 mL contains 600 mg of obiltoxaximab.
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– The other ingredients are histidine, sorbitol (E420), polysorbate 80 (E433), hydrochloric acid (E507) and sodium hydroxide (E524). See also section 2 “Obiltoxaximab SFL contains sorbitol”.
What Obiltoxaximab SFL looks like and contents of the pack
Obiltoxaximab SFL is a clear to opalescent, colourless to pale yellow to pale brownish-yellow concentrate for solution.
Obiltoxaximab SFL is available in packs containing 1 vial.
Marketing Authorisation Holder
SFL Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lorrach
Germany
Manufacturer
AcertiPharma B.V.
Minervum 7333
Breda, 4817ZD
The Netherlands
This leaflet was last revised in
This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease and for ethical reasons it has been impossible to get complete information on this medicine.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
. There are also links to other websites about rare diseases and treatments.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Further information: QR code to be included
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