Patient Medication Information: uses, side effects, how to take - Soliris
Serious Warnings and Precautions
Infections
Soliris increases the risk of serious infections including meningococcal infections. There have been reports of serious meningococcal infections including death, in patients treated with Soliris. Meningococcal infections can quickly cause death, deafness, brain damage and/or loss of limbs, especially if not recognized and treated early.
- You must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection; you may be revaccinated according to current medical guidelines for vaccine use.
- You must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.
Vaccination may not prevent all meningococcal infections.
- fever
- fever and a rash
- confusion
- muscle aches with flu-like symptoms
- eyes sensitive to light
What is Soliris used for?
Soliris is used to treat patients with:
- Paroxysmal Nocturnal Hemoglobinuria (PNH) to reduce hemolysis (destruction of red blood cells);
- Chronic atypical Hemolytic Uremic Syndrome (atypical HUS), a very rare disease that affects the blood system, kidney and sometimes other body organs;
- Generalized Myasthenia Gravis (gMG), a disease affecting the muscles
- Neuromyelitis optica spectrum disorder (NMOSD), a disease of the central nervous system that mainly affects the eye nerves and the spinal cord
How does Soliris work?
The active substance in Soliris, eculizumab, is a monoclonal antibody that blocks part of your immune system called the C5 complement protein.
In patients with PNH and atypical HUS, the complement proteins are over-active and damage the patients’ own blood cells. Soliris works by preventing complement proteins from damaging blood cells.
In patients with gMG, over-active complement proteins damage the junction between the nerves and muscles (neuromuscular junction). Soliris is presumed to block the body’s inflammatory response and its ability to attack and destroy its own muscles.
In patients with NMOSD, the eye nerves and spinal cord are attacked and damaged by the immune system. Soliris is presumed to block the body’s inflammatory response, and its ability to attack and destroy its own eye nerves and spinal cord.
Soliris also lowers the ability of your immune system to fight infection.
What are the ingredients in Soliris?
Medicinal ingredients: eculizumab
Non-medicinal ingredients: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, Water for Injection.
Soliris comes in the following dosage forms:
Soliris is supplied as 300 mg of eculizumab in single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free solution.
Do not use Soliris if:
- You have any allergies to this drug or its ingredients
- Your doctor confirms a serious infection, such as an active Neisseria meningitidis infection (in the brain, spinal cord or blood)
- You have not received a meningococcal vaccine prior to or at the time of initiating
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Soliris. Talk about any health conditions or problems you may have, including if you:
- Have a disease that alters your immune system (such as HIV/AIDS) or take medication that alters your immune system (such as prednisone).
Other warnings you should know about:
Fungal infections caused by Aspergillus have occurred in immunocompromised patients with abnormally low white blood cells. Inform your doctor before you take Soliris if you have any infections.
Allergic Reactions:
Serious allergic reactions can happen during your Soliris infusion. Tell your doctor or nurse immediately if you get any of these symptoms during your Soliris infusion:
Chest pain
Trouble breathing or shortness of breath
Swelling of your face, tongue or throat
Feel faint or pass out
Pregnancy and Nursing:
Data in pregnant women treated with Soliris from clinical trials and postmarketing setting, including PNH and atypical HUS registries, indicate SOLIRIS is unlikely to increase the risk of harm to the fetus. There is no clinical data available on the use of SOLIRIS in pregnant gMG patients Soliris may be considered during pregnancy, if clinically needed. Tell your doctor if you are pregnant or nursing.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take Soliris:
- Soliris is given through a vein [“I.V.” or “intravenously”], usually over 35 minutes, and must be administered by a health care professional.
Usual dose:
The usual dose of Soliris for adult patients with PNH is:
- 600 mg of Soliris every 7 days for the first 4 weeks, followed by
- 900 mg of Soliris for the fifth dose 1 week later, then
- 900 mg of Soliris every 2 weeks thereafter
The usual dose of Soliris for adult patients with atypical HUS, gMG or NMOSD is:
- 900 mg of Soliris weekly for the first 4 weeks, followed by
- 1200 mg of Soliris for the fifth dose 1 week later, then
- 1200 mg of Soliris every 2 weeks thereafter
If you are less than 18 years of age and weighting less than 40 kg, the usual dose of Soliris for PNH and atypical HUS will be based on your body weight according to the following schedule:
| Patient Body Weight | Induction | Maintenance |
|---|---|---|
| 30 kg to less than 40 kg | 600 mg weekly x 2 doses | 900 mg at week 3; then 900 mg every 2 weeks |
| 20 kg to less than 30 kg | 600 mg weekly x 2 doses | 600 mg at week 3; then 600 mg every 2 weeks |
| 10 kg to less than 20 kg | 600 mg weekly x 1 dose | 300 mg at week 2; then 300 mg every 2 weeks |
| 5 kg to less than 10 kg | 300 mg weekly x 1 dose | 300 mg at week 2; then 300 mg every 3 weeks |
Soliris should be administered at the recommended dates or within 48 hours of the recommended date. Your doctor should know by blood tests if Soliris is working.
Overdose:
Soliris should be given by a healthcare professional. This minimizes the chance of an overdose. No cases of overdose were seen in clinical studies.
If you think you, or a person you are caring for, have taken too much SOLIRIS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
Tell your doctor right away if you have missed a dose or if you are considering stopping treatment. Stopping treatment with Soliris may cause side effects.
If you have PNH and miss a dose of Soliris you may experience the following symptoms or problems from red blood cell destruction:
- A sudden or severe drop in your red blood cell count causing anemia
- Confusion or drowsiness
- Chest pain/angina
- Kidney problems including kidney failure
- Blood clots
If you have atypical HUS and miss a dose of SOLIRIS, your blood clotting may be abnormal, causing symptoms including:
- Stroke
- Confusion
- Seizure
- Chest pain
- Trouble breathing
- Kidney problems
- Swelling in arms or legs
- A drop in your platelet count which may cause easy bleeding and easy bruising
If you have PNH and stop treatment of Soliris, your doctor will need to monitor you closely for at least 8 weeks after stopping treatment.
If you have atypical HUS, your doctor will need to monitor you closely during treatment and for at least 12 weeks after stopping Soliris for signs of worsening atypical HUS symptoms or problems related to abnormal clotting.
If you have gMG and stop treatment with Soliris, your doctor will need to monitor you closely for at least 12 weeks after stopping treatment for signs of worsening of gMG symptoms.
If you have NMOSD and stop treatment with Soliris your doctor will need to monitor you closely for signs and symptoms of potential NMOSD relapse.
What are possible side effects from using SOLIRIS?
In all clinical studies, including PNH and atypical HUS clinical trials, the most serious side effect was meningococcal sepsis, which is a common presentation of meningococcal infections in patients treated with Soliris.
- You must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating SOLIRIS, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection; you may be revaccinated according to current medical guidelines for vaccine use.
- You must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.
- Vaccination may not prevent all meningococcal infections.
- You must carry your Safety Card at all time. If you experience any symptoms listed in your safety card immediately seek for medical care.
These are not all the possible side affects you may feel when taking Soliris. If you experience any side effects not listed here, contact your healthcare professional.
The most common side effects in people with PNH treated with Soliris include headache, stuffy nose, sore throat, nausea, fever, joint aches and pains, fatigue, and cold sores.
The most common side effects in people with atypical HUS treated with Soliris include high blood pressure, diarrhea, headache, nausea, vomiting, low white blood cell count, bladder infection, hair loss, cold sore, low lymphocyte count), cough, joint pain, weakness, and viral infection.
The most common side effects in children with atypical HUS treated with Soliris include common viral cold, and rash.
The most common side effects in people with gMG treated with Soliris include headache, upper respiratory infection, nasopharyngitis, myasthenia gravis, nausea, and diarrhea.
The most common side effects in people with NMOSD treated with Soliris include upper respiratory infection, headache, diarrhea, back pain, influenza, pharyngitis, pain or swelling of your nose or throat (nasopharyngitis), dizziness, arthralgia, and contusion.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
VERY COMMON Headache | X | ||
| Flu-like illness | X | ||
COMMON High Blood Pressure | X | ||
| Low white blood cell count | X | ||
| Infection of the lung (pneumonia) | X | ||
| Respiratory Tract infection | X | ||
| Infection of the urinary system (urinary tract infection) | X | ||
| Rash | X | ||
| Abdominal discomfort or pain | X | ||
| Rash | X | ||
| Abdominal discomfort or pain | X | ||
| Agitation | X | ||
| Anemia | X | ||
| Chills | X | ||
| Deafness | X | ||
| Diarrhea | X | ||
| Fever | X | ||
| Light headedness(dizziness) | X | ||
| Low blood pressure | X | ||
| Infection | X | ||
UNCOMMON Meningococcal infection including Meningococcal sepsis | X | X | |
| Fungal infection | X | ||
| Serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction) | X | ||
| Hypersensitivity | X | ||
| Breathing difficulty | X | ||
| Inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen) | X | ||
| Increase of liver enzymes | X | ||
| Relatively few platelets in blood (thrombocytopenia) | X | ||
| Kidney disorder | X | ||
| Muscle Aches | X | ||
| Neck pain | X | ||
| Pain in extremity | X | ||
| Swelling (Face or Leg) | X | ||
RARE Jaundice | X | ||
| Disease with thyroid overactivity (Basedow’s disease) | X | ||
| Menstrual disorder | X | ||
| Infusion related reaction | X | ||
| Blood in urine | X | ||
| Blood clot in vein | X | ||
| Bone marrow disorder | X | ||
| Bacterial sexual transmitted disease | X | ||
| Skin tumor (melanoma) | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Prior to infusions, your healthcare professional will inform you about any signs and symptoms of infusion related reactions and steps to take to seek medical care immediately.
If you have an infusion reaction you may be given additional medicines to treat or help prevent future reactions. If the infusion reaction is severe, your doctor may stop the infusion of Soliris and start giving appropriate medical treatment.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store in original carton in a refrigerator (2°C - 8°C).
Protect from light.
Vial in original carton can stay at room temperature (not more than 25°C) for only one single period up to 3 days.
Do not use past the expiry date stamped on the carton.
DO NOT FREEZE. DO NOT SHAKE.
Keep out of reach and sight of children.
If you want more information about SOLIRIS:
Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.alexion.com, or by calling 1-888-765-4747.
Alexion Pharmaceuticals, Inc. has established Registries for PNH and atypical HUS in order to continue to monitor and evaluate the safety and effectiveness of SOLIRIS. You are encouraged to participate and advised that participation may involve long-term follow-up. Information regarding the PNH Registry can be found at http://www.pnhregistry.com or by contacting the PNH Registry hotline at: 1-800-913-4893; or email: pnhregistry@iconplc.com or by calling 1-888-SOLIRIS (1-888-765-4747). For information regarding the atypical HUS Registry, please email: aHUS-Registry@incresearch.com or call 1-888-SOLIRIS (1-888-765-4747). You can only participate in the Registry through your doctor.
This document plus the full Product Monograph, prepared for health professionals, are available by contacting the sponsor, Alexion Pharma GmbH, at 1-888-765-4747.