300 mg concentrate for infusion solution
eculizumab
What Soliris is and what it is used for
What is Soliris?
Soliris contains the active ingredient eculizumab and it belongs to a class of medicines called monoclonal antibodies. Eculizumab binds to and inhibits a certain protein in the body that causes inflammation and thus prevents the body from attacking and destroying sensitive blood cells, kidneys, muscle, and optic nerves as well as the spinal cord.
What Soliris is used for
Paroxysmal nocturnal hemoglobinuria
Soliris is used to treat adults and children with a certain type of disease affecting the blood system called paroxysmal nocturnal hemoglobinuria (PNH). In patients with PNH, the red blood cells can be destroyed, which can lead to low blood counts ( anemia ), fatigue, functional difficulties, pain, dark-colored urine, shortness of breath, and blood clots. Eculizumab can block the body’s inflammatory response, and thus the body’s ability to attack and destroy its own sensitive PNH blood cells.
Atypical hemolytic uremic syndrome
Soliris is also used to treat adults and children with a certain type of disease that affects the blood system and kidneys, called atypical Haemolytic Uremic Syndrome (aHUS). In patients with aHUS, the kidneys and blood cells, including platelets, can become inflamed, which can lead to low blood values ( thrombocytopenia and anemia ), reduced or lost kidney function, blood clots, fatigue, and functional difficulties. Eculizumab can block the body’s inflammatory response and its ability to attack and destroy its sensitive blood cells and kidney cells.
Refractory generalized myasthenia gravis
Soliris is also used in adult patients with a certain type of disease that affects the muscles and is called generalized myasthenia gravis (gMG). In patients with gMG, the muscles are attacked and damaged by the immune system, which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk of aspiration, and marked impairment of activities of daily living. Soliris can block the body’s inflammatory response and its ability to attack and destroy the muscle’s ability to improve muscle contraction, reducing the symptoms of the disease and the impact of the disease on activities of daily living. Soliris is specifically intended for patients who still have symptoms despite treatment with other existing MG treatments.
Neuromyelitis Optica spectrum condition
Soliris is also used to treat adults with a certain type of disease that primarily affects the optic nerves and spinal cord and is called neuromyelitis optica spectrum disorder (NMOSD). In patients with NMOSD, the optic nerve and spinal cord are attacked and damaged by the immune system, which can lead to blindness in one or both eyes, weakness or paralysis in the arms or legs, painful seizures, loss of sensation, and marked impairment in the ability to perform activities in the daily life. Soliris can block the body’s inflammatory response and its ability to attack and destroy its optic nerves and spinal cord, reducing the symptoms of the disease and the disease’s impact on activities of daily living.
What you need to know before using Soliris
Do not use Soliris
- if you are allergic to eculizumab, mouse proteins, other monoclonal antibodies or any other ingredient in this medicine listed in section 6)
- if you have not been vaccinated against meningococcal infection unless you take antibiotics 2 weeks after the vaccination to reduce the risk of infection.
- if you have a meningococcal infection.
Warnings and precautions
Warning regarding meningococcal and other Neisseria infections
Soliris treatment may impair your natural resistance to infection, especially to certain organisms that cause meningococcal infection (severe meningitis and sepsis ) and other Neisseria infections, including disseminated gonorrhea.
Contact your doctor before taking Soliris to make sure you are vaccinated against Neisseria meningitides, an organism that causes meningococcal infection, at least 2 weeks before starting treatment, or that you take antibiotics to reduce the risk of infection until 2 weeks have passed after vaccination. Make sure your recent meningococcal vaccination still protects against infection. You should also be aware that vaccination does not always prevent this type of infection. By national recommendations, your doctor can consider whether in your case additional measures are needed to prevent infection.
If you are at risk of gonorrhea, consult your doctor or pharmacist before using this medicine.
Symptoms of meningococcal infection
As it is important to quickly identify and treat certain types of infection in patients receiving Soliris, you will be given a card to carry with you, with a list of particularly important symptoms. This card is marked “Patient safety card”.
If you experience any of the following symptoms, you should inform your doctor immediately:
- headache with nausea and vomiting
- headache along with neck or back stiffness
- fever
- rash
- confusion
- severe muscle pain combined with flu-like symptoms
- light sensitivity
Treatment of meningococcal infection in connection with travel:
If you are traveling in inaccessible areas where you cannot contact a doctor or where you cannot get prompt medical treatment, as a preventive measure, your doctor can write a prescription for an antibiotic preparation against Neisseria meningitides that you can carry with you. If you experience any of the symptoms listed above, take the antibiotic medication as directed. You should consider contacting a doctor as soon as possible, even if you feel better after taking antibiotics.
Infection you
Before taking Soliris, inform your doctor if you suffer from any infection.
Allergic reactions
Soliris contains a protein, and proteins can cause allergic reactions in some people.
Children and young people
Patients younger than 18 years must be vaccinated against Haemophilus influenza and pneumococcal infections.
Older
No special precautions are needed for the treatment of patients aged 65 years and older.
Other medicines and Soliris
Tell your doctor or pharmacist if you are using, have recently used or might be using other medicines.
Pregnancy, breastfeeding, and fertility
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.
Women who can become pregnant
Use of safe contraception during treatment and up to 5 months after treatment should be considered in women of childbearing potential.
Pregnancy/breastfeeding
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 ability and use of machinery
Soliris has no or negligible effect on the ability to drive and use machines.
Soliris contains sodium
Soliris contains 115 mg sodium per vial . This should be taken into account if you have been prescribed a low-salt diet.
How to use Soliris
At least 2 weeks before you start treatment with Soliris, your doctor will vaccinate you against meningococcal infection if you have not been vaccinated before or if the vaccine is no longer protective. If your child is under the age limit for vaccination or if you have not been vaccinated at least 2 weeks before starting treatment with Soliris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Your doctor will vaccinate children under 18 against Haemophilus influenzae and pneumococcus according to national recommendations for each age group.
Instructions for proper use
A doctor or other healthcare professional will treat you with Soliris. Soliris is given as an intravenous infusion (drip). According to the recommendation, the initial phase of the treatment, the so-called initial phase, should last for 4 weeks and then be followed by a maintenance phase.
In the treatment of PNH
For adults:
- Initial phase:
- Every week for the first four weeks, you will receive an intravenous infusion of diluted Soliris. Each infusion consists of a dose of 600 mg (2 bottles of 30 ml) and takes approximately 25-45 minutes (35 minutes ± 10 minutes).
- Maintenance Phase:
- In the fifth week, you will receive an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over 25-45 minutes (35 minutes ± 10 minutes).
- After the fifth week, you will receive 900 mg of diluted Soliris every two weeks as a long-term treatment.
In treatment against aHUS, refractory gMG or NMOSD
For adults:
- Initial phase:
- Every week for the first four weeks, you will receive an intravenous infusion of diluted Soliris. Each infusion consists of a dose of 900 mg (3 bottles of 30 ml) and takes approximately 25-45 minutes (35 minutes ± 10 minutes).
- Maintenance Phase:
- In the fifth week, you will receive an intravenous infusion of diluted Soliris at a dose of 1200 mg (4 bottles of 30 ml) over 25-45 minutes (35 minutes ± 10 minutes).
- After the fifth week, you will receive up to 1,200 mg of diluted Soliris every two weeks as a long-term treatment.
Children and adolescents with PNH or aHUS who weigh 40 kg or more receive the same dose as adults.
Children and adolescents with PNH or aHUS who weigh less than 40 kg need a lower dose based on their body weight. Your doctor will calculate it.
For children and adolescents with PNH or aHUS who are under 18 years of age:
| Body weight | Initial phase | Maintenance phase |
|---|---|---|
| 30 to <40 kg | 600 mg per week x 2 | 900 mg week 3; thereafter 900 mg every two weeks |
| 20 to <30 kg | 600 mg per week x 2 | 600 mg week 3; thereafter 600 mg every two weeks |
| 10 to <20 kg | 600 mg per week x 1 | 300 mg week 2; thereafter 300 mg every two weeks |
| 5 to <10 kg | 300 mg per week x 1 | 300 mg week 2; thereafter 300 mg every three weeks |
People undergoing plasma exchange may receive an additional dose of Soliris.
After each infusion, you will be monitored for about an hour. Follow your doctor’s instructions carefully.
If you have been given too much Soliris
If you suspect that you have accidentally received a higher dose of Soliris than recommended, contact your doctor for advice.
If you forget a time when you should receive Soliris
If you miss an appointment, contact your doctor immediately for advice and read the section below “If you stop using Soliris”.
If you stop using Soliris in the treatment of PNH
If you stop or stop Soliris treatment, your PNH symptoms may come back and be more severe. Your doctor will discuss possible side effects with you and explain the risks. The doctor will want to follow you closely for at least 8 weeks.
The risks of stopping Soliris include an increased breakdown of your red blood cells, which can cause the following:
- A significant decrease in the number of red blood cells ( anemia ).
- Confusion or altered attention
- Chest pain or angina
- An increase in serum creatinine level (kidney problems)
- Thrombosis (blood clot)
If you experience any of these symptoms, contact your doctor.
If you stop using Soliris in the treatment of aHUS
If you stop or stop Soliris treatment, your aHUS symptoms may come back. Your doctor will discuss possible side effects with you and explain the risks. The doctor will want to monitor you closely.
The risks of stopping Soliris include an increased risk of inflammation in your blood platelets, which can cause the following:
- A significant decrease in the number of platelets ( thrombocytopenia )
- A significant increase in the destruction of red blood cells
- Decreased urine output (problems with the kidneys)
- An increase in the serum creatinine level (kidney problems)
- Confusion or altered attention
- Chest pain or angina
- Shortness of breath or
- Thrombosis (blood clot)
If you experience any of these symptoms, contact your doctor.
If you stop using Soliris in the treatment of refractory gMG
If you stop or stop Soliris treatment, your gMG symptoms may come back. Talk to your doctor before you stop using Soliris. Your doctor will discuss possible side effects with you and explain the risks. The doctor will want to monitor you closely.
If you stop using Soliris in the treatment of NMOSD
If you stop or stop Soliris treatment, your NMOSD may get worse and you may relapse. Talk to your doctor before you stop using Soliris. Your doctor will discuss possible side effects with you and explain the risks. The doctor will want to monitor you closely.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Soliris are usually mild or moderate. Your doctor will discuss possible side effects with you and explain the risks and benefits of Soliris before you start treatment.
The most serious side effect was meningococcal sepsis.
Contact a doctor immediately if you experience any symptoms of meningococcal infection (see section 2, Warning regarding meningococcal and other Neisseria infections ).
If you are unsure of what the side effects below mean, ask your doctor to explain.
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people):
- pneumonia ( pneumonia ), cold ( nasopharyngitis ), urinary tract infection
- low white blood cell count ( leukopenia ), decrease in red blood cells which can make the skin pale and cause weakness and shortness of breath
- inability to sleep
- dizziness, taste disturbances, high blood pressure
- upper respiratory tract infection, cough, sore throat, bronchitis, mouth ulcers ( herpes simplex)
- diarrhea, vomiting, nausea, abdominal pain, rash, hair loss, itching
- pain in the joints (arms and legs)
- fever, feeling tired, flu-like illness.
Uncommon (may affect up to 1 in 100 people):
- serious infection (meningococcal infection), sepsis, septic shock, viral infection, lower respiratory tract infection, stomach flu (intestinal infection), cystitis
- infection, fungal infection, accumulation of var (abscess), skin infection ( cellulitis ), flu, sinusitis, tooth infection ( abscess )
- skin cancer ( melanoma ), bone marrow disease
- relatively few platelets in the blood ( thrombocytopenia ), low levels of lymphocytes (a certain type of white blood cells, lymphopenia), palpitations
- severe allergic reaction causing difficulty in breathing or dizziness ( anaphylactic reaction ), hypersensitivity
- loss of appetite
- depression, anxiety, mood swings
- tingling in parts of the body, tremors
- blurred vision
- tinnitus, dizziness
- the sudden and rapid development of extremely high blood pressure, low blood pressure, hot flashes, vascular diseases
- dyspnoea (difficulty breathing), nosebleed, nasal congestion, throat irritation, runny nose ( rhinorrhea )
- peritonitis ( peritonitis ), constipation, discomfort in the stomach after a meal ( dyspepsia ) distended abdomen
- hives, redness, dry skin, red or purple spots under the skin, increased sweating
- muscle cramps, muscle pain, back and neck pain, bone pain, joint swelling, pain in arms and legs
- kidney disease, difficulty or pain when urinating, blood in the urine
- spontaneous erection
- swelling ( edema ), chest discomfort, weakness ( asthenia ), chest pain, infusion site pain, chills
- increase in liver enzyme values, low proportion of red blood cells in the total blood volume, decrease in oxygen-transporting protein in red blood cells
- infusion-related reaction.
Rare (may affect up to 1 in 1,000 people)
- fungal infection (Aspergillus infection ), joint infection (bacterial arthritis ), Haemophilus influenzae infection, gum infection, swine pox, bacterial sexually transmitted disease ( gonorrhea )
- skin tumor ( melanoma ), bone marrow disease
- decrease in the number of red blood cells, cell accumulation, abnormal blood clotting factor, abnormal blood clotting
- disease caused by overproduction of the thyroid gland (Basedow’s disease)
- sleep disturbance, abnormal dreams
- fainting
- eye irritation
- bruises
- acid reflux, pain in the gums
- yellowing of the skin and/or eyes (jaundice)
- skin inflammation, skin discoloration
- spasm in the muscles of the face
- menstrual disorders
- abnormal leakage of infusion medicine from the vein, an abnormal sensation at the infusion site, feeling of warmth
How to store Soliris
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ºC–8 ºC).
Do not freeze.
Bottles of Soliris in original packaging can be taken out of refrigerator storage on a single occasion that lasts a maximum of 3 days. At the end of this period, you can put the product back in the refrigerator.
Store in the original packaging. Light sensitive.
After dilution, the product must be used within 24 hours.
Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
– The active substance is eculizumab 10 mg/ml (300 mg/30 ml in a bottle).
– Other ingredients are
- monobasic sodium phosphate,
- dibasic sodium phosphate,
- sodium chloride,
- polysorbate 80 (vegetable origin)
Appearance and package sizes of the medicine
Soliris is a concentrate solution for injection (30 ml in a bottle – pack size is 1 bottle).
Soliris is a clear and colorless solution.
Marketing Authorisation Holder
Alexion Europe SAS
103-105 rue Anatole France
92300 Levallois-Perret
France
Manufacturer
Almac Pharma Services
22 Seagoe Industrial Estate
Craigavon BT63 5QD
UK
Patheon Italia SpA
Viale GB Stucchi, 110
20900 Monza (MB)
Italy
Alexion Pharma International
Operations Unlimited Company
College Business and Technology Park
Blanchardstown
Dublin 15
Ireland