"The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less fre"...
ALPROLIX™, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B (congenital Factor IX deficiency) for:
- Control and prevention of bleeding episodes,
- Perioperative management,
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only
- Initiate treatment with ALPROLIX™ under the supervision of a qualified healthcare professional experienced in the treatment of hemophilia B.
- Dose and duration of treatment depend on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition.
- Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency of ALPROLIX™ on the individual clinical response. Each vial label for ALPROLIX™ states the Factor IX potency in international units (IU). ALPROLIX™ potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates.
- Factor IX activity measurements in the clinical
laboratory may be affected by the type of aPTT reagent or reference standard used.[see WARNINGS AND PRECAUTIONS]
One IU of ALPROLIX™ per kg body weight increases the circulating level of Factor IX by 1% [IU/dL]. Estimate the required dose or the expected in vivo peak increase in Factor IX level expressed as IU/dL (or % of normal) using the following formulas:
IU/dL (or % of normal) = [Total Dose (IU)/Body Weight (kg)] x Recovery (IU/dL per IU/kg)
Dose (IU) = Body Weight (kg) x Desired Factor IX Rise (IU/dL or, % of normal) x Reciprocal of Recovery (IU/kg per IU/dL)
- Dose adjustment may be necessary in pediatric patients under 12 years of age [see Use In Specific Populations]. For patients 12 years of age or older, dose adjustment is not usually required.
Control and Prevention of Bleeding Episodes
ALPROLIX™ dosing for the control and prevention of bleeding episodes is provided in Table 1.
Table 1: Dosing for Control and Prevention of Bleeding
|Type of Bleeding||Circulating Factor IX Level Required (IU/dL or % of normal)||Dosing Interval (hours)|
|Minor and Moderate
For example: Uncomplicated hemarthroses, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucous membranes
|30-60||Repeat every 48 hours if there is further evidence of bleeding|
For example: Iliopsoas and deep muscle with neurovascular injury, or substantial blood loss; Pharyngeal, retropharyngeal, retroperitoneal, CNS
|80-100||Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days.
Due to the long half-life of ALPROLIX™, the dose may be reduced and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.
ALPROLIX™ dosing for perioperative management is provided in Table 2 .
Table 2: Dosing for Perioperative Management
|Type of Surgery||Circulating Factor IX Level Required (IU/dL or % of normal)||Dosing Interval (hours)|
|Minor (including uncomplicated dental extraction)||50 to 80||A single infusion may be sufficient. Repeat as needed after 24-48 hours until bleeding stops and healing is achieved.|
|Major||60 to 100 (initial level)||Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days.
Due to the long half-life of ALPROLIX™, the dose may be reduced and frequency of dosing in the post-surgical setting may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.
- The recommended starting regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days.
- Adjust dose based on individual response.
- Use aseptic technique (clean and germ-free) and a flat work surface during the reconstitution procedure.
- Allow the vial of ALPROLIX™ and the pre-filled diluent syringe to reach room temperature before use.
- Remove the plastic cap from the vial and wipe the rubber stopper of the vial with an alcohol wipe. Allow the rubber stopper to dry.
- Completely remove the backing from the vial adapter package by peeling back the lid. Do not remove the vial adapter from the package or touch the inside of the package of the adapter.
- Keeping the vial on a flat surface, hold the vial adapter package with one hand, and using the other hand, place the vial adapter over the vial. Place the adapter spike directly above the center of the rubber stopper and push the adapter straight down until the spike punctures the center of the vial stopper and is fully inserted.
- Lift the package cover away from the vial adapter and discard the cover.
- Hold the plunger rod at the circular disk. Place the tip of the plunger rod into the end of the syringe. Turn clockwise until it is securely attached. Only use the diluent syringe provided in the ALPROLIX™ package.
- With one hand, hold the diluent syringe by the ridged part directly under the cap, with the cap pointing up. Do not use if the cap has been removed or is not securely attached.
- With your other hand, grasp the cap and bend it at a 90° angle until it snaps off. After the cap snaps off, you will see the glass tip of the syringe. Do not touch the glass tip of the syringe or the inside of the cap.
- With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening. Turn the syringe clockwise until it is securely attached to the adapter.
- Slowly depress the plunger rod to inject all of the diluent into the vial. The plunger rod may rise slightly after this process. This is normal.
- With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved. The final solution should be clear to slightly opalescent and colorless. Do not shake. Do not use the reconstituted ALPROLIX™ if it contains visible particles or is cloudy.
- Make sure the plunger rod is completely depressed. Turn the vial upside-down. Slowly pull on the plunger rod to draw the solution into the syringe. Be careful not to pull the plunger rod completely out of the syringe.
- Gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter still attached. Do not touch the syringe tip or the inside of the cap.
- Use the reconstituted ALPROLIX™ as soon as possible, but no later than 3 hours after reconstitution. Protect from direct sunlight. Do not refrigerate after reconstitution.
To combine two or more vials of ALPROLIX™, follow the following pooling steps.
- Leave the vial adapter attached to the vial, as it is needed for attaching a large luer lock syringe. Do not detach the diluent syringe or the large luer lock syringe until ready to attach the large luer lock syringe to the next vial (with vial adapter attached).
- Remove the diluent syringe from the vial adapter by turning it counterclockwise until it is completely detached.
- Attach a separate, large luer lock syringe by turning clockwise until it is securely in place.
- Slowly pull on the plunger rod to draw the solution into the syringe.
- Repeat this pooling procedure with each vial necessary to obtain the required dose. Once you have pooled the required dose, proceed to administration using the large luer lock syringe.
For intravenous injection only
- Inspect the reconstituted ALPROLIX™ solution visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed.
- Do not administer reconstituted ALPROLIX™ in the same tubing or container with other medications.
- Attach the syringe to the connector end of the infusion set tubing by turning clockwise until it is securely in place.
- Depress the plunger until all air is removed from the syringe and ALPROLIX™ has reached the end of the infusion set tubing. Do not push ALPROLIX™ through the needle.
- Remove the protective needle cover from the infusion set tubing.
- Perform intravenous bolus infusion. The rate of administration should be determined by the patient's comfort level, and no faster than 10 ml per minute.
- After infusing ALPROLIX™, remove and properly discard the infusion set.
Dosage Forms And Strengths
ALPROLIX™ is available as a lyophilized powder in single use vials containing nominally 500, 1000, 2000, or 3000 international units (IU) per vial. The actual Factor IX potency is stated on each ALPROLIX™ vial.
ALPROLIX™ is supplied as a kit comprising:
- one single-use rFIXFc vial,
- one pre-filled syringe containing 5 mL diluent and sealed with a plunger stopper and tip-cap, and
- one sterile vial adapter (reconstitution device).
ALPROLIX™ vials are available in 500, 1000, 2000, or 3000 IU nominal dosage strengths. The actual Factor IX potency, expressed in IU is stated on every rFIXFc vial and kit carton label.
|Strength||Kit NDC Number|
Storage And Handling
- Store ALPROLIX™ in the original package in order to protect it from light.
- Store ALPROLIX™ at 2°C to 8°C (36°F to 46°F). ALPROLIX™ may also be stored at room temperature, not to exceed 30°C (86°F) for a single 6 month period. On the carton, record the date when the product was removed from refrigeration. Use the product before the end of this 6 month period or discard it. Do not place the product back into refrigeration after warming to room temperature.
- Do not freeze. Freezing will damage the pre-filled diluent syringe.
- Do not use product or diluent after the expiration date printed on the carton, vial or syringe.
- Reconstituted product may be stored at room temperature, not to exceed 30°C (86°F) for no longer than 3 hours. Protect from direct sunlight. Discard any product not used within 3 hours after reconstitution.
Manufactured by : Biogen Idec, Inc. 14 Cambridge Center, Cambridge, MA 02142
Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Alprolix Information
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