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.
(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 […]