Posology : מינונים

5. DOSAGE AND ADMINISTRATION
5.1 Recommended Dose
Administer SPEVIGO as a single 900 mg dose by intravenous infusion over 90 minutes.
If GPP flare symptoms persist, an additional intravenous 900 mg dose (over 90 minutes) may be administered one week after the initial dose.

5.2 Preparation and Administration Instructions
SPEVIGO must be diluted before use.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits. SPEVIGO is a colorless to slightly brownish-yellow, clear to slightly opalescent solution. The solution is practically free from particles. Discard the vial if the solution is cloudy, discolored, or contains large or colored particulates.

Preparation
• Use aseptic technique to prepare the solution for infusion.
• Draw and discard 15 mL from a 100 mL container of sterile 0.9% Sodium Chloride Injection.
• Slowly replace with 15 mL of SPEVIGO (complete content from two vials of 450 mg/7.5 mL).
• Mix gently before use.
• Use the diluted SPEVIGO solution immediately.

Administration
• Do not mix SPEVIGO with other medicinal products.
• Administer SPEVIGO as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes.
• If the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes [see Warnings and Precautions (8.3)].
Spevigo IV                                                                  Prescribing Information Spesolimab 450mg                                                                         April 2024 • A pre-existing intravenous line may be used for administration of SPEVIGO. The line must be flushed with sterile 0.9% Sodium Chloride Injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.
• No incompatibilities have been observed between SPEVIGO and infusion sets composed of polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).

Storage of Diluted Solution
Use the diluted solution immediately.
Protect from light.

5.3 Testing and Procedures Prior to Treatment Initiation
Evaluate patients for tuberculosis (TB) infection. SPEVIGO initiation is not recommended in patients with active TB infection. Consider initiating treatment of latent TB prior to initiation of SPEVIGO [see Warnings and Precautions (8.2)].

6. DOSAGE FORMS AND STRENGTHS
SPEVIGO is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution. The solution is practically free from particles.
Each vial contains: 450 mg/7.5 mL (60 mg/mL) solution in a single-dose vial