Overview:
Satralizumab is a monoclonal antibody drug used for the treatment of neuromyelitis optica spectrum disorder (NMOSD). This disorder is a rare autoimmune disease that affects the central nervous system, specifically the optic nerves and spinal cord. Satralizumab works by binding to the interleukin-6 (IL-6) receptor, which is involved in the immune system's response to infection and inflammation. By blocking IL-6, Satralizumab helps to reduce inflammation and damage to the nerves in NMOSD patients. Satralizumab is administered through injection and is currently approved for use in several countries.
Dosage and Administration:
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Satralizumab is typically prescribed for patients who have experienced at least one relapse of NMOSD or whose chance of relapse is high based on their medical history.
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Satralizumab is available as a subcutaneous solution for injection in the dose of 120 mg (milligrams)/ 1 ml (milliliter).
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The medication is injected subcutaneously. Follow the instructions given by the healthcare provider for the administration of Satralizumab.
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Satralizumab is administered via injection, usually once every four weeks. It is frequently used with other treatments.
Satralizumab is a prescription medication, so it should only be taken under the guidance and supervision of a healthcare professional. Patients should talk to their doctor to determine if Satralizumab is an appropriate treatment option for their specific case of NMOSD.
Warnings and Precautions:
The general warnings and precautions of Satralizumab are as listed:
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Co-administration: Avoid getting vaccinated while on Satralizumab therapy. The patient should inform the doctor regarding the details of previous immunizations to the healthcare provider.
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Liver Diseases: Satralizumab may cause an elevation in the liver enzymes. Patients with pre-existing liver diseases should hence inform the doctor before the start of therapy with Satralizumab.
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Infections: Patients on Satralizumab therapy are at a higher risk of developing infections. If an active infection is present, Satralizumab therapy may be delayed until it resolves. Patients are advised to report any signs of infections if observed to the healthcare provider immediately.
For Patients
What Is Neuromyelitis Optica Spectrum Disorder?
Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune disease that primarily affects the spinal cord and the optic nerves of the central nervous system. In NMOSD, the immune system mistakenly attacks and damages the myelin sheath that surrounds nerve cells, leading to inflammation and disability. Symptoms of NMOSD can include vision loss, muscle weakness or paralysis, sensory disturbances, and bladder or bowel dysfunction. NMOSD is typically diagnosed through a combination of clinical evaluation, MRI (magnetic resonance imaging) scans, and blood tests to detect specific antibodies that are present in the blood of most patients with this condition. While there is no cure for NMOSD, treatments such as immunosuppressive drugs and monoclonal antibodies like Satralizumab can help to manage symptoms and prevent relapses.
How Does Satralizumab Work?
Satralizumab is a monoclonal antibody drug that works by binding to the interleukin-6 (IL-6) receptor, which is involved in the immune system's response to infection and inflammation. In NMOSD, the immune system mistakenly attacks and damages the myelin sheath that surrounds nerve cells, leading to inflammation and disability. IL-6 is a cytokine that plays a key role in the inflammatory response, and its levels are often elevated in NMOSD patients. By blocking the IL-6 receptor, Satralizumab helps to reduce inflammation and damage to the nerves in NMOSD patients. This can help to prevent relapses and slow the progression of the disease. Satralizumab is administered through injection and is typically used in conjunction with other therapies, such as immunosuppressive drugs, to manage symptoms and prevent relapses in patients with NMOSD.
Learn More About Satralizumab:
Before Starting Satralizumab:
When and Why to Take Satralizumab?
Satralizumab is typically recommended for patients with active NMOSD who have experienced at least two relapses in the past year or who have not responded adequately to other therapies. Follow the instructions given by the healthcare provider during Satralizumab therapy.
How Effective Is Satralizumab?
Satralizumab has been shown to be effective in reducing the frequency and severity of neuromyelitis optica spectrum disorder (NMOSD) attacks in clinical trials. Satralizumab has been shown to be effective in reducing the use of corticosteroids and other immunosuppressant medications commonly used to treat NMOSD. In clinical trials, patients treated with Satralizumab had a lower risk of requiring these additional medications compared to those treated with a placebo.
Things to Inform the Doctor Before Taking Satralizumab:
Before taking Satralizumab, patients should inform their doctor of any medical conditions they have, as well as any medications, supplements, or herbal remedies they are taking. Specifically, patients should inform their doctor if they:
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Have an active infection or a history of chronic infection.
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Have or have had hepatitis B or C, or any other liver disease.
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Have previously experienced adverse reactions to any medication, including Satralizumab.
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Are pregnant, planning to become pregnant, or breastfeeding.
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Have received a live vaccine recently or are scheduled to receive one in the near future.
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Have a history of malignancy or are currently undergoing cancer treatment.
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Have a history of cardiovascular disease or other heart conditions.
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Have a history of autoimmune disorders or other immune-related conditions.
What Are the Side Effects of Satralizumab?
The FDA-approved label for Satralizumab lists the following potential side effects:
The common side effects are as listed:
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Headache.
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Fatigue.
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Diarrhea.
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Elevated blood pressure.
The more severe side effects of the drug include
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Infections: Satralizumab may increase the risk of infections, including serious infections such as sepsis and meningitis.
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Hypersensitivity Reactions: Some patients may experience hypersensitivity reactions to Satralizumab, including rash, hives, and difficulty breathing.
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Liver Damage: Satralizumab can cause liver damage, including inflammation of the liver and hepatitis.
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Joint Pain: Joint pain and other musculoskeletal symptoms are possible side effects of Satralizumab.
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Infusion-Related Reactions: Some patients may experience infusion-related reactions, such as fever, chills, and nausea, during or after receiving Satralizumab.
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Reduced White Blood Cell Count: Satralizumab can reduce the body's total number of white blood cells, which can increase the risk of infection.
If any of these effects are experienced, contact the healthcare provider immediately.
What Should Be Done if a Dose Is Missed?
If a patient misses a dose of Satralizumab, they should contact their healthcare provider as soon as possible to determine the appropriate course of action. In general, if the missed dose is discovered within a few days of the scheduled administration, the patient will likely receive the missed dose as soon as possible and resume their regular dosing schedule thereafter.
If the missed dose is discovered more than a few days after the scheduled administration, the patient may need to receive additional doses to ensure that they continue to receive the appropriate amount of medication. It is important to follow the healthcare provider's instructions closely to avoid any potential complications or adverse effects.
Patients should not attempt to administer an extra dose of Satralizumab to make up for a missed dose without first consulting their healthcare provider. Overdosing on Satralizumab can lead to serious side effects and complications.
What Should Be Done to Treat Satralizumab Overdose?
Overdosing on Satralizumab can lead to serious complications and adverse effects, and patients should seek immediate medical attention if they suspect an overdose has occurred.
For Doctors:
Indication
Satralizumab is indicated to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who test positive for anti-aquaporin-4 (AQP4) antibodies.
Dosing:
Neuromyelitis Optica Spectrum Disorder:
The treatment plan involves administering 120 mg subcutaneously at weeks zero, two, and four as a maintenance dose after the initial dose of 120 mg subcutaneously every four weeks.
Dosing Considerations:
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There have been no formal studies conducted on the effects of the treatment on patients with renal or hepatic impairment.
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If the patient experiences an elevation in their AST/ALT levels of five times the upper limit of normal (ULN) or above, along with an elevation in bilirubin above the ULN, the therapy should be discontinued, and reinitiation is not recommended.
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However, if the AST/ALT levels are five times the ULN or above, but there is no associated bilirubin elevation above the ULN, the therapy may be restarted once the AST/ALT levels have returned to the normal range. The decision to restart the therapy should be made after a benefit/risk assessment has been performed, taking into account the length of time since the therapy was last administered. If less than 12 weeks have passed, the therapy may be restarted at 120 mg subcutaneously every four weeks. If 12 weeks or more have passed, the therapy may be restarted at 120 mg subcutaneously at week zero, followed by doses at weeks two and four, and then a dosage of 120 mg subcutaneously every four weeks.
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If there is a subsequent increase in the patient's ALT/AST levels or bilirubin above the ULN after the therapy has been restarted, it should be discontinued, and reinitiation should not be attempted.
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If the patient's neutrophil count falls below 1 X 10(9)/L and is confirmed by repeat testing, the therapy should be interrupted until the neutrophil count has returned to above 1 X 10(9)/L.
Pharmacology:
Mechanism of Action:
IL-6 is a cytokine that promotes inflammation and is believed to contribute to the development of NMOSD. IL-6 signaling triggers an inflammatory response that leads to the production of pro-inflammatory TH17 cells and AQP4 autoantibodies by plasmablasts. IL-6 may also increase the permeability of the blood-brain barrier, allowing autoantibodies and pro-inflammatory substances to enter the central nervous system. Satralizumab is a monoclonal antibody that specifically targets human IL-6 receptors. By binding to both soluble and membrane-bound IL-6 receptors, it inhibits the signaling pathway and reduces the pro-inflammatory effects associated with IL-6 binding.
Pharmacodynamics:
After binding to IL-6 receptors, Satralizumab-IL-6 receptor complexes are internalized into cells and transported to acidic endosomes, where the acidic environment causes Satralizumab to dissociate from the receptor. Satralizumab is then released into the plasma, where it can bind to another IL-6 receptor and repeat the process. Although Satralizumab is an effective treatment for NMOSD, it has been associated with an increased risk of infection, including potentially life-threatening infections. Therefore, it should not be used in patients with active infections, including localized infections, until the infection resolves.
Pharmacokinetics:
Absorption:
Satralizumab is administered via subcutaneous injection and is rapidly absorbed into the systemic circulation. The maximum serum concentration (Cmax) is achieved within four to seven days after administration.
Distribution:
Satralizumab is distributed throughout the body through the blood and extravascular fluid, with a mean volume of distribution of approximately 8.7 liters.
Metabolism:
Satralizumab is primarily metabolized in the liver by proteolytic degradation into small peptides and amino acids, which are then eliminated through normal metabolic pathways. The metabolic process is slow, and the half-life of Satralizumab is approximately 23 days.
Excretion:
Satralizumab is eliminated through both renal and non-renal pathways. Approximately 46 percent of the total clearance of Satralizumab is through renal excretion, with the remaining 54 percent cleared through non-renal routes, likely through proteolytic degradation.
Warnings and Precautions:
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Avoid using live or live-attenuated vaccines at the same time as this treatment. Update immunizations before starting therapy.
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Decreased neutrophil counts have been observed. It is recommended to monitor the patient's blood counts.
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Mild and moderate elevations in liver enzymes have been reported. It is recommended to monitor the patient's liver function.
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Patients using this therapy may be at an elevated risk of infections, especially severe and potentially fatal conditions. If a patient has an active infection, the therapy should be delayed until the infection is resolved.
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Patients with active hepatitis should not use this therapy, as it may cause hepatitis B reactivation.
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Patients should be examined for latent tuberculosis and tested for risk factors for tuberculosis infection before starting therapy. Antituberculosis therapy may be considered prior to initiation, and it is recommended to monitor the patient's condition.
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There have been fatal anaphylactic reactions, rash, urticaria, and other hypersensitivity reactions have been reported.
Contraindications:
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Known hypersensitivity to Satralizumab or any of the inactive ingredients.
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Active hepatitis B infection.
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Active or untreated latent tuberculosis.
Drug Interactions:
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Adenovirus vaccine.
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Bacillus of calmette and gerin vaccine.
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Cholera vaccine.
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Dengue tetravalent vaccine.
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Influenza virus vaccine.
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Measles virus vaccine.
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Mumps virus vaccine.
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Poliovirus vaccine.
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Rotavirus vaccine.
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Rubella virus vaccine.
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Smallpox vaccine.
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Typhoid vaccine.
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Varicella virus vaccine.
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Zoster vaccine.
Other Specifications:
Satralizumab in Pregnant Women:
There are no well-controlled studies on the use of Satralizumab in pregnant women. Animal studies have shown that Satralizumab may cause fetal harm, and it is classified as pregnancy category C. Pregnant women should only use Satralizumab if the potential benefits outweigh the potential risks to the fetus. Women who are pregnant or planning to become pregnant should discuss the risks and benefits of using Satralizumab with their healthcare provider.
It is recommended that women of childbearing age use effective contraception during treatment with Satralizumab and for at least five months after the last dose of the drug. If a woman becomes pregnant during treatment with Satralizumab, she should inform her healthcare provider immediately
Satralizumab in Lactating Women:
Limited information is available regarding the use of Satralizumab in lactating women. It is not known whether Satralizumab is excreted in human milk or if it can harm a nursing infant.
