What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/19/1371/001.


Ultomiris

Package leaflet: Information for the user

Ultomiris 300 mg concentrate for solution for infusion

ravulizumab

▼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.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • 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

1. What Ultomiris is and what it is used for
2. What you need to know before you use Ultomiris
3. How to use Ultomiris
4. Possible side effects
5. How to store Ultomiris
6. Contents of the pack and other information

1. What Ultomiris is and what it is used for

What is Ultomiris

Ultomiris is a medicine that contains the active substance ravulizumab and it belongs to a class of medicines called monoclonal antibodies, that attach to a specific target in the body. Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called the ‘complement system’.

What is Ultomiris used for

Ultomiris is used to treat adult patients with a disease called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, the complement system is overactive and attacks their red blood cells, which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing, erectile dysfunction and blood clots. By attaching to and blocking the C5 protein, this medicine can stop complement proteins from attacking red blood cells and so control symptoms of the disease.

2. What you need to know before you use Ultomiris

Do not use Ultomiris:

  • If you are allergic to ravulizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
  • If you have not been vaccinated against meningococcal infection.
  • If you have meningococcal infection.

Warnings and precautions

Talk to your doctor before using Ultomiris.

Meningococcal and other Neisseria infections symptoms

Because the medicine blocks the complement system, which is part of the body’s defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis. These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis).

Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy. If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. Ensure that your current meningococcal vaccination is up to date. You should also be aware that vaccination may not always prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.

Meningococcal infection symptoms

Because of the importance of rapidly identifying and treating meningococcal infection in patients who receive Ultomiris, you will be provided a ‘patient safety card’ to carry with you at all times, listing relevant signs and symptoms of meningococcal infection/sepsis.

If you experience any of the following symptoms, you should immediately inform your doctor:

  • headache with nausea or vomiting
  • headache and fever
  • headache with a stiff neck or stiff back
  • fever
  • fever and rash
  • confusion
  • muscle aches with flu-like symptoms
  • eyes sensitive to light

Treatment for meningococcal infection while travelling

If you are travelling in a region where you are unable to contact your doctor or will be temporarily unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis to bring with you. If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed. You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics.

Infections

Before starting Ultomiris, inform your doctor if you have any infections.

Infusion reactions

When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain.

Children and adolescents

Do not give this medicine to children under 18 years of age as no data are available on its safety and effectiveness in this group.

Other medicines and Ultomiris

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Pregnancy, breast-feeding, and fertility

Women of childbearing potential

The effects of the medicine on an unborn child are not known. Therefore, effective contraception during treatment and up to 8 months after treatment should be used in women who are able to get pregnant.

Pregnancy/ Breast-feeding

Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

Ultomiris contains sodium

This medicine when diluted with sodium chloride 9 mg/mL (0.9%) solution for injection for IV administration contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose. This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult.

You should take this into consideration if you are on a controlled sodium diet.

3. How to use Ultomiris

At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections if you have not previously had one or if your vaccination is outdated. If you cannot be vaccinated at least 2 weeks before you start treatment with Ultomiris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.

Instructions for proper use

Ultomiris is given by infusion (drip) into a vein. The infusion will take approximately 2 hours.

Your dose will be worked out by your doctor, based on your body weight, as shown in Table 1. Your first dose is called the loading dose. Two weeks after receiving your loading dose, you will be given a maintenance dose of Ultomiris, and this will then be repeated once every 8 weeks.

If you were previously receiving another medicine for PNH called Soliris, the loading dose should be given 2 weeks after the last Soliris infusion.

For individuals with body weight 40 to < 60kg the loading dose is 2400mg. The maintenance dose is 3000mg, starting 2 weeks after loading dose administration.

For individuals with body weight 60 to < 100kg the loading dose is 2700mg. The maintenance dose is 3300mg, starting 2 weeks after loading dose administration.

For individuals with body weight greater than 100kg the loading dose is 3000mg. The maintenance dose is 3600mg, starting 2 weeks after loading dose administration.

If you receive more Ultomiris than you should

If you suspect that you have been accidentally given a higher dose of Ultomiris than prescribed, please contact your doctor for advice.

If you forget an appointment to receive Ultomiris

If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Ultomiris”.

If you stop using Ultomiris

Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely for at least 16 weeks.

The risks of stopping Ultomiris include an increase in the destruction of your red blood cells, which may cause:

  • A significant fall in your red blood cell counts (anaemia),
  • Confusion or change in how alert you are,
  • Chest pain, or angina,
  • An increase in your serum creatinine level (problems with your kidneys), or
  • Thrombosis (blood clotting).

If you have any of these symptoms, contact your doctor.

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.

Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment.

The most serious side effect was meningococcal infection/sepsis.

If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor.

If you are not sure what the side effects below are, ask your doctor to explain them to you.

Very common (may affect more than 1 in 10 people):

  • Headache
  • Upper respiratory tract infection
  • Common cold (nasopharyngitis)

Common (may affect up to 1 in 10 people):

  • dizziness
  • vomiting, nausea, diarrhoea, abdominal pain, dyspepsia
  • rash, itchy skin (pruritus)
  • back pain, joint pain (arthralgia), muscle pain (myalgia) and muscle spasms
  • fever (pyrexia), influenza like illness, chills, feeling tired (fatigue, asthenia)
  • meningococcal infection, meningococcal sepsis

Reporting of side effects

If you get any side effects, talk to your doctor or 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 below:

United Kingdom:

via the

Yellow Card Scheme
Website: https://yellowcard.mhra.gov.uk/

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

5. How to store Ultomiris

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 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 package in order to protect from light.

After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the medicine should be used immediately, or within 24 hours if refrigerated or within 6 hours at room temperature.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ultomiris contains

  • The active substance is ravulizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL).
  • The other ingredients are:
    • sodium dihydrogen phosphate dihydrate
    • disodium phosphate dihydrate
    • sodium chloride
    • polysorbate 80
      Solvent: water for injections

This medicine contains sodium (see section 2 “Ultomiris contains sodium”).

What Ultomiris looks like and contents of the pack

Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial – pack size of 1).

Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution.

Marketing Authorisation Holder

Alexion Europe SAS
103-105 rue Anatole France
92300 Levallois-Perret
France

Manufacturer

Alexion Pharma International Operations
Unlimited Company
Alexion Dublin Manufacturing Facility
College Business and Technology Park
Blanchardstown Rd North
Dublin 15 R925
Ireland

This leaflet was last revised in July 2019

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.