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ENSPRYNG is a brand name for Satralizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ENSPRYNG (satralizumab) is indicated: As monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive. ENSPRYNG is not intended for acute treatment of an NMOSD…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations ENSPRYNG should be prescribed by physicians experienced in the management of patients with NMOSD. ENSPRYNG is not intended for the acute treatment of an NMOSD relapse. In order to prevent medication errors, it is important to check the pre -filled syringe label to ensure that the drug being administered is ENSPRYNG.
2 Recommended Dose and Dosage Adjustment Recommended Dosage ENSPRYNG must be administered as a subcutaneous (SC) injection. PrENSPRYNG® (satralizumab injection) Page 6 of 41 ENSPRYNG can be used as a monotherapy or in combination with immunosuppressant therapy (IST).
In a clinical trial, ENSPRYNG was administered with oral corticosteroids (OCs), azathioprine (AZA), mycophenolate mofetil (MMF), or a combination of these (see CLINICAL TRIALS). Please also refer to the Product Monographs for these products.
Withdrawal of ISTs during treatment with ENSPRYNG was not assessed in clinical trials. If background IST is decreased or discontinued, patients should be monitored for signs and symptoms of NMOSD relapse. The recommended loading dose is 120 mg by SC injection at Weeks 0, 2, and 4 for the first three administrations, followed by a maintenance dose of 120 mg every 4 weeks .
Duration of Treatment ENSPRYNG is intended for long-term treatment. Use of ENSPRYNG has been studied only in the setting of chronic administration and the effect of discontinuation has not been characterized. Patients who discontinue ENSPRYNG should be closely monitored for signs and symptoms of NMOSD relapse.
Dose Modifications Liver Enzyme Abnormalities If the alanine aminotransferase (ALT) or aspartate transaminase (AST) elevation is >5x Upper Limit of Normal (ULN) and associated with any bilirubin elevation, treatment with ENSPRYNG must be discontinued, and reinitiation is not recommended.
If the ALT or AST elevation is >5x ULN and not associated with any bilirubin elevation, treatment with ENSPRYNG should be discontinued; it can be restarted (120 mg SC injection every 4 weeks) when the ALT and AST levels have returned to the normal range and based on assessment of benefit-risk of treatment in the patient.
If the decision is taken to restart treatment, the liver parameters must be closely monitored, and if any subsequent increase in ALT/AST and/or bilirubin is observed the drug must be discontinued, and reinitiation is not recommended.
1 Adverse Reaction Overview The safety of ENSPRYNG as monotherapy or in combination with IST was evaluated based on data from two phase III randomized, multicenter, double-blind, placebo-controlled clinical trials (BN40900 and BN40898), which included 63 patients exposed to ENSPRYNG monotherapy and 41 patients exposed to ENSPRYNG in combination with IST (see CLINICAL TRIALS).
In the double-blind controlled period, patient median exposure to satralizumab was approximately 2 years in both studies BN40900 and BN40898 each. The median exposure to placebo was approximately 1 year. The most frequently reported adverse drug reactions (ADRs) were headache, arthralgia and injection related reactions (Table 4).
9% of patients that received ENSPRYNG treatment in the placebo -controlled portion of clinical trials. , infections). These rates were comparable to rates seen in placebo-treated patients. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be PrENSPRYNG® (satralizumab injection) Page 13 of 41 compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 4 summarizes the ADRs that have been reported in association with the use of ENSPRYNG as monotherapy or in combination with IST in clinical trials.
In both trials, patients in the ENSPRYNG group received doses of 120 mg, injected subcutaneously, at Weeks 0, 2, 4, and every 4 weeks thereafter. Because patients in the ENSPRYNG groups in both clinical studies had a longer treatment period than those in the placebo (or placebo in combination with IST) groups, adverse events after adjustment for exposure are also presented.
General In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. Cardiovascular Elevated blood lipids have been observed in clinical trials with ENSPRYNG.
Patients with severe cardiac impairment were excluded from clinical trials with ENSPRYNG. Dependence/Tolerance No studies on drug abuse and dependence have been conducted. Driving and Operating Machinery No studies on the effects on the ability to drive and use of machines have been performed.
In clinical trials, some patients experienced symptoms such as vertigo that may affect ability to drive and use machines. Patients experiencing such symptoms should be advised to avoid operating machinery until symptoms subside. Carcinogenesis and Mutagenesis Carcinogenesis and mutagenesis studies have not been performed (see NON-CLINICAL TOXICOLOGY).
Hepatic/Biliary/Pancreatic Liver Enzymes Mild and moderate elevations of liver transaminases have been observed with ENSPRYNG treatment. Most elevations were below 5x ULN and not treatment-limiting and resolved while ENSPRYNG was given.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous Solution, in single-use, pre-filled syringe, 120 mg/mL L-arginine, L-aspartic Acid, L-histidine, poloxamer 188, and water for injection.
PrENSPRYNG® (satralizumab injection) Page 10 of 41 ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for 1 year, thereafter as clinically indicated. For treatment discontinuation recommendations, please refer to Dosage and Administration, Recommended Dose and Dosage Adjustment.
2 Clinical Trial Adverse Reactions). 2 Recommended Dose and Dosage Adjustment). Vigilance for the timely detection of serious infection is recommended for patients receiving treatment with ENSPRYNG, as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants.
ENSPRYNG is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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(see WARNINGS AND PRECAUTIONS). Table 1 – Recommended Dosage for Restart of Treatment After Liver Transaminase Elevation Last Dose Administered Recommended Dosage for Restart of Treatment Less than 12 weeks Restart at a dosage of 120 mg by subcutaneous injection every 4 weeks.
12 weeks or longer Restart at a dose of 120 mg by subcutaneous injection at Weeks 0*, 2, and 4, followed by a dosage of 120 mg every 4 weeks. *“0 weeks” refers to time of the first administration after the missed dose. 0 x109/L. Active Infections Treatment with ENSPRYNG should not be initiated in patients with active infections.
In patients PrENSPRYNG® (satralizumab injection) Page 7 of 41 that develop an active infection while taking ENSPRYNG, dosing should be interrupted until the infection is controlled. Special Dosage Instructions Pediatric use There are limited clinical data in patients aged 12 years and older who have a body weight of 40 kg or more.
1 Special Populations). 1 Special Populations). 3 Pharmacokinetics, Special Populations and Conditions). Renal Impairment The safety and efficacy of ENSPRYNG have not been studied in patients with moderate to severe renal impairment. 3 Pharmacokinetics, Special Populations and Conditions).
3 Pharmacokinetics, Special Populations and Conditions). 3 Reconstitution Not Applicable. 4 Administration The recommended injection sites are the abdomen and thigh. Injection sites should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
Comprehensive instructions for the administration of ENSPRYNG are given in the Patient Medication Information. The first injection must be performed under the supervision of a qualified healthcare professional (HCP) and patients should be monitored for symptoms of hypersensitivity after injection.
An adult patient may self-inject ENSPRYNG or the patient’s caregiver may administer ENSPRYNG at home after receiving instruction on injection technique, if the treating physician determines that it is appropriate and the adult patient/caregiver can perform the injection technique.
PrENSPRYNG® (satralizumab injection) Page 8 of 41 Patients/caregivers should seek immediate medical attention if the patient develops symptoms of serious allergic reactions. 5 Missed Dose If an injection is missed, for any reason other than increases in liver enzymes, it should be administered as described in Table 2.
Table 2 - Recommended Dosage for Delayed or Missed Doses Last Dose Administered Recommended Dosage for Delayed or Missed Doses Less than 8 weeks during the maintenance period or missed a loading […]
ADRs from clinical trials are listed by MedDRA system organ class. 9 1ADRs identified based on medical review of all AEs w hich w ere >2/100PY higher AND >2% higher in the ENSPRYNG group versus the controlled groups ADRs=Adverse Drug Reactions IST=Immunosuppressive Therapy AE=Adverse Events PY= Patient Years Description of Selected Adverse Drug Reactions from Clinical Trials Injection-related Reactions (IRRs) IRRs reported in patients treated with ENSPRYNG as monotherapy or in combination with IST were predominantly mild to moderate, most occurred within 24 hours after injections.
None of the injection related reactions required dose interruption or discontinuation. 1% of patients receiving placebo reported systemic injection related reactions. The most commonly reported systemic symptoms were diarrhea and headache.
Severe symptoms include vertigo and hypertension. 96 events per 100 patient-years. 41 events per 100 patient-years. 8% of patients receiving placebo reported local injection site reactions. The most commonly reported symptoms were flushing, erythema, pruritus, rash and pain.
61 events per 100 patient-years. 41 events per 100 patient-years. 6 events/100 PY]. 2 events/100 PY in […]
A patient who develops a new infection during treatment with ENSPRYNG should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Patients should be instructed to contact a physician immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment. 2 Clinical Trial Adverse Reactions). Advise patients to seek medical attention if they experience serious or severe allergic reactions to ENSPRYNG.
If an anaphylactic or serious hypersensitivity reaction occurs, ENSPRYNG should be discontinued. Vaccinations Live or live attenuated vaccines should not be given concurrently with ENSPRYNG as clinical safety has not been established.
The interval between live vaccinations and initiation of ENSPRYNG therapy should be in accordance with current vaccination guidelines regarding immunomodulatory/immunosuppressive agents. No data are available on the effects of vaccination in patients receiving ENSPRYNG.
It is recommended that all patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating ENSPRYNG therapy. 2 Clinical Trial Adverse Reactions). Neutrophil counts should be monitored 4 to 8 weeks after start of therapy and thereafter as clinically indicated.
2 Recommended Dose and Dosage Adjustment. Peri-Operative Considerations There is no experience with bleeding events in patients taking ENSPRYNG that developed PrENSPRYNG® (satralizumab injection) Page 11 of 41 abnormal clotting factors; assessment of clotting should be performed in patients with severely decreased platelets and/or fibrinogen prior to surgical procedures.
Reproductive Health:
Female and Male Potential Fertility No clinical data are available on the effect of ENSPRYNG on human fertility. Effects on male and female reproductive endpoints have been investigated in monkeys. c. injection, males developed testicular atrophy (see NON- CLINICAL TOXICOLOGY).
1 Pregnant Women There are no data from the use of ENSPRYNG in pregnant women. Human IgG is known to cross the placental barrier; therefore, ENSPRYNG may be transmitted from the mother to the developing fetus. Satralizumab was shown to cross the placenta in pregnant cynomolgus monkeys (see NON-CLINICAL TOXICOLOGY).
In an enhanced pre- and postnatal development study, satralizumab administration to pregnant cynomolgus monkeys resulted in reduced immune function in infants (see NON-CLINICAL TOXICOLOGY). ENSPRYNG is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
2 Breast-feeding Breastfeeding is not recommended during treatment with ENSPRYNG as a risk to the nursing infant cannot be excluded. There are no data on the presence of satralizumab in human milk, the effects on the breastfed infant, or the effects on human milk production.
However, IgGs are excreted in human milk and satralizumab has been shown to be present in the milk of lactating cynomolgus monkeys (see NON-CLINICAL TOXICOLOGY). […]