"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Limitation Of Use
DOSAGE AND ADMINISTRATION
Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see WARNINGS AND PRECAUTIONS].
Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection [see WARNINGS AND PRECAUTIONS].
Only administer as an intravenous infusion.
Recommended Dosage Regimen -PNH
Soliris Therapy Consists Of:
- 600 mg weekly for the first 4 weeks, followed by
- 900 mg for the fifth dose 1 week later, then
- 900 mg every 2 weeks thereafter.
Administer Soliris at the recommended dosage regimen time points, or within two days of these time points [see WARNINGS AND PRECAUTIONS].
Recommended Dosage Regimen -aHUS
For Patients 18 Years Of Age And Older, Soliris Therapy Consists Of:
- 900 mg weekly for the first 4 weeks, followed by
- 1200 mg for the fifth dose 1 week later, then
- 1200 mg every 2 weeks thereafter.
For patients less than 18 years of age, administer Soliris based upon body weight, according to the following schedule (Table 1):
Table 1: Dosing Recommendations In Patients Less Than 18 Years Of Age
|Patient Body Weight||Induction||Maintenance|
|40 kg and over||900 mg weekly x 4 doses||1200 mg at week 5;
then 1200 mg every 2 weeks
|30 kg to less than 40 kg||600 mg weekly x 2 doses||900 mg at week 3;
then 900 mg every 2 weeks
|20 kg to less than 30 kg||600 mg weekly x 2 doses||600 mg at week 3;
then 600 mg every 2 weeks
|10 kg to less than 20 kg||600 mg weekly x 1 dose||300 mg at week 2;
then 300 mg every 2 weeks
|5 kg to less than 10 kg||300 mg weekly x 1 dose||300 mg at week 2;
then 300 mg every 3 weeks
Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.
Supplemental dosing of Soliris is required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or fresh frozen plasma infusion) (Table 2).
Table 2: Supplemental Dose Of Soliris After PE/PI
|Type of Intervention||Most Recent Soliris Dose||Supplemental Soliris Dose With Each PE/PI Intervention||Timing of Supplemental Soliris Dose|
|Plasmapheresis or plasma exchange||300 mg||300 mg per each plasmapheresis or plasma exchange session||Within 60 minutes after each plasmapheresis or plasma exchange|
|600 mg or more||600 mg per each plasmapheresis or plasma exchange session|
|Fresh frozen plasma infusion||300 mg or more||300 mg per infusion of fresh frozen plasma||60 minutes prior to each infusion of fresh frozen plasma|
Preparation And Administration
Dilute Soliris to a final admixture concentration of 5 mg/mL using the following steps:
- Withdraw the required amount of Soliris from the vial into a sterile syringe.
- Transfer the recommended dose to an infusion bag.
- Dilute Soliris to a final concentration of 5 mg/mL by adding the appropriate amount (equal volume of diluent to drug volume) of 0.9% Sodium Chloride Injection, USP; 0.45% Sodium Chloride Injection, USP; 5% Dextrose in Water Injection, USP; or Ringer’s Injection, USP to the infusion bag.
The final admixed Soliris 5 mg/mL infusion volume is 60 mL for 300 mg doses, 120 mL for 600 mg doses, 180 mL for 900 mg doses or 240 mL for 1200 mg doses (Table 3).
Table 3: Preparation and Reconstitution of Soliris
|Soliris Dose||Diluent Volume||Final Volume|
|300 mg||30 mL||60 mL|
|600 mg||60 mL||120 mL|
|900 mg||90 mL||180 mL|
|1200 mg||120 mL||240 mL|
Gently invert the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the product and diluent. Discard any unused portion left in a vial, as the product contains no preservatives.
Prior to administration, the admixture should be allowed to adjust to room temperature [18°-25° C, 64-77° F]. The admixture must not be heated in a microwave or with any heat source other than ambient air temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do Not Administer As An Intravenous Push Or Bolus Injection
Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Admixed solutions of Soliris are stable for 24 hours at 2-8° C (36-46° F) and at room temperature.
If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed two hours in adults. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion reaction.
Dosage Forms And Sterngths
Soliris is supplied as 300 mg single-dose vials each containing 30 mL of 10 mg/mL sterile, preservative-free eculizumab solution.
Storage And Handling
Soliris (eculizumab) is supplied as 300 mg single-dose vials containing 30 mL of 10 mg/mL sterile, preservative-free Soliris solution per vial.
Store Soliris vials in the original carton until time of use under refrigerated conditions at 2-8° C (36-46° F) and protected from light. Soliris vials may be held in the original carton at controlled room temperature (not more than 25° C/77° F) for only a single period up to 3 days.Do not use beyond the expiration date stamped on the carton. Refer to [DOSAGE AND ADMINISTRATION] for information on the stability and storage of diluted solutions of Soliris.
DO NOT FREEZE. DO NOT SHAKE.
NDC 25682-001-01 Single unit 300 mg carton: Contains one (1) 30 mL vial of Soliris (10 mg/mL).
Manufactured by Alexion Pharmaceuticals, Inc., 100 College Street, New Haven, CT 06510. USA. Revised: Jan 2017This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2017
Additional Soliris Information
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