Class: Immunomodulatory Agents
Satralizumab-mwge is an interleukin-6 (IL-6) receptor antagonist.
Uses for Satralizumab-mwge
Satralizumab-mwge has the following uses:
Satralizumab-mwge is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Satralizumab-mwge Dosage and Administration
Satralizumab-mwge is available in the following dosage form(s) and strength(s):
Injection: 120 mg/mL in a single-dose prefilled syringe.
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Dosage and Administration
Hepatitis B virus (HBV), tuberculosis, and liver transaminase screening is required before the first dose.
Prior to every use, determine if there is an active infection.
The recommended loading dosage of satralizumab-mwge is 120 mg by subcutaneous injection on weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every 4 weeks.
See the manufacturer's labeling for important preparation and administration instructions.
Cautions for Satralizumab-mwge
Known hypersensitivity to satralizumab or any of the inactive ingredients.
Active HBV infection.
Active or untreated latent tuberculosis.
An increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including satralizumab-mwge.
The most common infections reported in a randomized clinical trial of patients treated with satralizumab-mwge who were not on other chronic immunosuppressant therapies (Study 1), and that occurred more often than in patients receiving placebo, were nasopharyngitis (12%) and cellulitis (10%). The most common infections in patients who were on an additional concurrent immunosuppressant, and that occurred more often than in patients receiving placebo, were nasopharyngitis (31%), upper respiratory infection (19%), and pharyngitis (12%).
Delay satralizumab-mwge administration in patients with an active infection, including localized infections, until the infection is resolved.
Risk of HBV reactivation has been observed with other immunosuppressant therapies. Patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment with satralizumab-mwge. Do not administer satralizumab-mwge to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+] or are negative for HBsAg and positive for HB core antibody [HBcAb+], consult liver disease experts before starting and during treatment with satralizumab-mwge.
Tuberculosis has occurred in patients treated with other interleukin-6 receptor antagonists. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating satralizumab-mwge. Consider anti-tuberculosis therapy prior to initiation of satralizumab-mwge in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. Patients should be monitored for the development of symptoms and signs of tuberculosis with satralizumab-mwge, even if initial tuberculosis testing is negative.
Live or live-attenuated vaccines should not be given concurrently with satralizumab-mwge because clinical safety has not been established. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of satralizumab-mwge for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of satralizumab-mwge for non-live vaccines.
Elevated Liver Enzymes
Mild and moderate elevations of liver enzymes have been observed in patients treated with satralizumab-mwge at a higher incidence than in patients receiving placebo.
ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for one year, and thereafter, as clinically indicated.
Decreased Neutrophil Counts
Decreases in neutrophil counts were observed in patients treated with satralizumab-mwge at a higher incidence than placebo.
Neutrophil counts should be monitored 4 to 8 weeks after initiation of therapy, and thereafter at regular clinically determined intervals.
Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin-6 receptor antagonists.
Risk Summary: There are no adequate data on the developmental risk associated with the use of satralizumab-mwge in pregnant women. In an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring, with administration of satralizumab-mwge at doses up to 50 mg/kg/week.
In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Fetal/Neonatal Adverse Reactions: Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to satralizumab-mwge in utero.
Animal Data: Weekly subcutaneous administration of satralizumab-mwge (0, 2, or 50 mg/kg) to monkeys throughout pregnancy resulted in no adverse effects on postnatal development of the offspring; however, immune function was impaired in offspring at both doses. Plasma exposures (Cave) in dams at the low and high doses were approximately 3 and 100 times, respectively, that in humans at the recommended monthly maintenance dose of 120 mg.
No information is available on the presence of satralizumab-mwge in human milk, the effects of the satralizumab-mwge on the breastfed infant, or the effects of satralizumab-mwge on milk production. Satralizumab-mwge was excreted in the milk of lactating monkeys administered satralizumab-mwge throughout pregnancy. Human IgG is excreted in human milk and the potential for absorption in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for satralizumab-mwge and any potential adverse effects on the breastfed infant from satralizumab-mwge or from the underlying maternal condition.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of satralizumab-mwge did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, population pharmacokinetic analyses in patients with NMOSD did not show that age affected the pharmacokinetics of satralizumab-mwge. In general, caution should be used when dosing the elderly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.
Common Adverse Effects
The most common adverse reactions (incidence at least 15%) are nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, and nausea.
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Please see product labeling for drug interaction information.
The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.
Advice to Patients
Advise the patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Inform patients that an increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including satralizumab-mwge. Instruct patients to contact their healthcare provider immediately when symptoms suggesting infection (e.g., fever, chills, constant cough, or sore throat) appear during treatment.
Advise patients to complete any required vaccinations at least 4 weeks prior to initiation of satralizumab-mwge for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of satralizumab-mwge for non-live vaccines.
Elevated Liver Enzymes
Inform patients about the importance of liver enzyme testing.
Decreased Neutrophil Counts
Inform patients about the importance of neutrophil count testing.
Inform patients about the signs and symptoms of hypersensitivity reactions and anaphylaxis and advise them to contact their healthcare provider immediately if these symptoms occur.
Instruction on Injection Technique
Instruct patients and caregivers to read the instructions for use in the manufacturer's labeling before the patient starts using satralizumab-mwge, and each time the patient gets a refill as there may be new information they need to know.
Perform the first injection under the guidance of a qualified healthcare professional. If a patient or caregiver is to administer subcutaneous satralizumab-mwge, instruct him/her in injection techniques and assess his/her ability to inject subcutaneously to ensure proper administration of subcutaneous satralizumab-mwge and the suitability for home use.
Instruct patients to remove the prefilled syringe from the refrigerator prior to use and allow it to sit at room temperature outside of the carton for 30 minutes. Do not warm satralizumab-mwge in any other way.
Advise patients to consult their healthcare provider if the full dose is not received.
A puncture-resistant container for disposal of syringes should be used and should be kept out of the reach of children. Instruct patients or caregivers in the technique as well as proper prefilled syringe disposal, and caution against reuse of these items.
AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
For injection, for subcutaneous use
AHFS Drug Information. © Copyright 2021, Selected Revisions September 7, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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