Administration
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
Reconstitution:
Calculate the dose (mg), total volume (ml) of reconstituted siltuximab required and the number of vials needed.
Allow the vial(s) to come to room temperature over approximately 30 minutes. Siltuximab should remain at room temperature for the duration of the preparation.
Reconstitute vials as listed below to obtain a concentration of 20 mg/ml. A 21 gauge 1 1/2 inch needle is recommended for preparation.
Reconstitute 100 mg vials with 5.2 ml of sterile water.
Reconstitute 400 mg vials with 20 ml of sterile water.
Gently swirl the the reconstituted vials to aid dissolution of the lyophilized powder. DO NOT SHAKE OR SWIRL VIGOROUSLY. Do not remove the contents until there is complete dissolution which should take place in less than 60 minutes.
Further dilution is necessary.
Storage following reconstitution: The reconstituted vials should be kept for no more than 2 hours prior to the addition to the infusion bag. Do not store an unused portion of the reconstituted product.
Dilution:
Infusion bags (250 ml) must contain D5W and must be made of polyvinyl chloride (PVC) with di-{2-ethylhexyl}phthalate (DEHP) or polyolefin (PO).
Dilute the reconstituted solution to 250 ml by withdrawing a volume equal to the total calculated volume of reconstituted siltuximab from the D5W 250 ml bag.
Slowly add the total calculated volume (ml) of reconstituted solution to the D5W bag and gently invert the bag to mix the solution.
Intravenous injection:
Infuse over 1 hour using administration sets lined with polyvinyl chloride (PVC) with di-{2-ethylhexyl}phthalate (DEHP) or polyurethane (PU), containing a 0.2 micron inline polyethersulfone (PES) filter.
The infusion should be completed within 4 hours of the dilution of the reconstituted solution to the infusion bag.
Do not infuse concomitantly in the same IV line with other agents.
Do not store any unused portion of the infusion solution.
STORAGE
Sylvant:
- Do not freeze
- Protect from light
- Refrigerate (between 36 and 46 degrees F)
CONTRAINDICATIONS / PRECAUTIONS
Infection
Do not administer siltuximab to patients with a severe infection until the infection resolves as use may mask signs and symptoms of acute inflammation, including suppression of fever and acute phase reactants such as C-reactive protein (CRP). Babies born to pregnant women treated with siltuximab may be at increased risk of infection and caution is advised in the administration of live vaccines to these babies.
Infusion-related reactions
Discontinue siltuximab in patients with severe infusion-related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndrome. Do not reinstitute treatment in these patients. If a patient develops mild to moderate infusion reactions, stop the infusion. The siltuximab infusion may be restarted a a lower infusion rate. Consider medicating with antihistamines, acetaminophen, and corticosteroids. Discontinue siltuximab if the patient does not tolerate the infusion after these interventions.
Vaccination
Avoid vaccination with live vaccines in patients receiving siltuximab as IL-6 inhibition may interfere with the normal immune response to new antigens.
GI perforation
Gastrointestinal (GI) perforation has been reported in siltuximab clinical tr |
