What is it and how is it used?
The active substance of Soliris is eculizumab and it belongs to a class of medicines called monoclonal antibodies. Eculizumab binds to and inhibits a specific protein in the body that causes inflammation.
Soliris is used for the treatment of patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells. There is only experience in the treatment of patients with previous history of transfusions.
What do you have to consider before using it?
Do not use Soliris
Take special care with Soliris
Meningitis alert:
Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningitis.
Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningitis, at least 2 weeks before beginning therapy, or that your current meningitis vaccination is up to date. You should also be aware that vaccination may not prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Meningitis symptoms
Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Soliris, you will be provided a card to carry with you, listing specific trigger symptoms. This card is named: “Patient Safety Card”.
If you experience any of the following symptoms, you should immediately inform your doctor :
Treatment for meningitis while travelling
If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Infections
Inform your doctor before you take Soliris if you have any infections.
Allergic reactions
Soliris contains a protein and proteins can cause allergic reactions in some people.
Using Soliris with other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using Soliris with food and drink:
Interactions between your treatment with Soliris and food or drink are unlikely.
Woman of childbearing potential:
Women who are able to get pregnant should use adequate contraception methods during treatment and up to 5 months after treatment.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any medicine.
Pregnancy
Tell your doctor before starting treatment with Soliris if you are pregnant or plan to become pregnant. Soliris is not recommended during pregnancy.
Breast-feeding
Soliris may pass through your breast milk to your baby. Therefore, you should not breast-feed while using Soliris.
Driving and using machines:
The effects on the ability to drive and to use machines have not been studied. As with all medicines, you should ask for advice from your doctor.
Elderly people
There is no evidence to suggest that any special precautions are needed when older people (65 years and over) are treated – although experience is still limited.
Children and adolescents
Soliris has not been administered to patients less than 18 years of age.
Important information about some of the ingredients of Soliris
This medicinal product contains 5.00 mmol sodium per dose (1 vial). To be taken into consideration by patients on a controlled sodium diet.
How is it used?
Prior to beginning treatment, your doctor will discuss with you the importance of:
At least 14 days before you start treatment with Soliris, your doctor will administer a vaccine against meningitis if it was not previously administered or if your vaccination is outdated.
Instructions for proper use
The treatment will be given by your doctor or other health care provider by infusing a dilution of the Soliris vial from a drip bag through a tube directly into one of your veins. It is recommended that the beginning of your treatments, called the initial phase, will extend over 5 weeks, followed by a maintenance phase:
Initial Phase:
- Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted Soliris . Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take approximately 30 minutes.
- In the fifth week your doctor will administer an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over a 30 minute period.
Maintenance Phase:
- After the fifth week, your doctor will administer 900 mg of diluted Soliris every two weeks as a long-term treatment.
Following each infusion, you will be monitored for about one hour. Your doctor’s instructions should be carefully observed.
If you receive more Soliris than you should
If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice.
If you forget an appointment to receive Soliris
If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”.
If you stop using Soliris
Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon after stopping Soliris treatment. If you stop treatment with Soliris, your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to continue to monitor you closely.
The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause:
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 or pharmacist.
What are possible side effects?
Like all medicines, Soliris can cause side effects, although not everybody gets them. The side effects caused by Soliris are usually mild or moderate. Your doctor will discuss the possible side effects with you and explain the risks and benefits of Soliris with you prior to treatment.
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Very common side effects
(occurring in at least 1 in 10 patients) include: headaches.
Common side effects
(occurring in 1 or more out of 100 patients and less than 10 in 100 patients) include: relatively few platelets in blood (thrombocytopenia), destruction of red blood cells (haemolysis), abdominal pain, constipation, vomiting, diarrhea, stomach discomfort after meals (dyspepsia), nausea, chest discomfort, chills, infusion related reaction, swelling (edema), fever (pyrexia), feeling tired (fatigue), feeling of weakness (asthenia), serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction), cold sores (herpes simplex), common cold (nasopharyngitis), viral infection, stomach flu (gastrointestinal infection), bronchitis, cystitis, severe infection (sepsis, septic shock, meningococcal sepsis), infection of the joint (arthritis bacterial), infection of the lung (pneumonia), infection of the meninges (meningococcal meningitis), muscle aches, back and neck pain, pain in the limbs or joints (arms and legs), dizziness, taste disorders (dysgeusia), tingling in part of the body (paresthesia), difficulties or pain when urinating (dysuria), spontaneous penile erection, upper respiratory tract infection, infection of the urinary system (urinary tract infection), cough, throat irritation or pain (pharyngolaryngeal pain), stuffy nose (nasal congestion), itchy skin (pruritus), rash, hair loss (alopecia), dry skin.
Uncommon side effects
(occurring in 1 or more out of 1000 patients and less than 10 in 1000 patients) include: Abnormal blood clotting, clumping of cells, feeling your heartbeat, ringing in the ears, disease with thyroid overactivity (Basedow’s disease), irritation of eye, vision blurred, unusual backflow of food from stomach, gum pain, chest pain, influenza like illness, feeling hot, infusion site pain, yellowing of the skin and/or eyes (jaundice), collection of pus (abscess), type of infection of the skin (cellulitis), fungal infection, gum infection, infection, influenza, sinusitis, tooth infection, increase of liver enzymes, loss of appetite, spasm of mouth muscle, muscle cramp, skin tumor (melanoma), bone marrow disorder, fainting, abnormal dreams, anxiety, depression, inability to sleep, mood swings, sleep disorder, kidney disorder, menstrual disorder, nose bleed, runny nose, increased sweating, red or purple spots under the skin, skin color disorder, hives, bruise, low blood pressure, hot flush.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8-C).
Do not freeze.
Store in the original package in order to protect from light.
Do not use Soliris after the expiry date which is stated on the label after “EXP”. After dilution, the product should be used immediately within 24 hours.
