ADYNOVATE (antihemophilic factor- recombinant pegylated kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - UNII:P89DR4NY54)

Tilgjengelig fra:

Takeda Pharmaceuticals Amercia, Inc.

INN (International Name):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Sammensetning:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 250 [iU] in 2 mL

Indikasjoner:

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for: - On-demand treatment and control of bleeding episodes - Perioperative management - Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease. ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80). Risk Summary There are no data with ADYNOVATE use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ADYNOVATE. It is unknown whether ADYNOVATE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of ADYNOVATE in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ADYNOVATE and any potential adverse effects on the breastfed infant from ADYNOVATE or from the underlying maternal condition. Safety and efficacy studies have been performed in 91 previously treated, pediatric patients age 1 year to <18 years who received at least one dose of ADYNOVATE as part of routine prophylaxis, on-demand treatment of bleeding episodes, or perioperative management. Adolescent subjects age 12 to <18 (n=25) were enrolled in the adult and adolescent safety and efficacy trial, and subjects <12 years of age (n=66) were enrolled in a pediatric trial. The safety and efficacy of ADYNOVATE in routine prophylaxis and the treatment of bleeding episodes were comparable between children and adults. [see Clinical Studies (14) ] Pharmacokinetic studies in children (<12 years) have demonstrated higher clearance, a shorter half-life and lower incremental recovery of factor VIII compared to adults. Because clearance (based on per kg body weight) has been demonstrated to be higher in children (<12 years), dose adjustment or more frequent dosing based on per kg body weight may be needed in this population. [see Clinical Pharmacology (12.3) ] Clinical studies of ADYNOVATE did not include subjects aged 65 and over. ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] (For intravenous use only) Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center. Step-by-step instructions for reconstituting ADYNOVATE are found at the end of this leaflet. Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using ADYNOVATE. If you are unsure of the procedures, please call your healthcare provider before using. Call your healthcare provider right away if bleeding is not controlled after using ADYNOVATE. Your healthcare provider will prescribe the dose that you should take. Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Your healthcare provider may need to take blood tests from time to time. Talk to your healthcare provider before traveling. Plan to bring enough ADYNOVATE for your treatment during this time. Dispose of all materials, including any leftover reconstituted ADYNOVATE product, in an appropriate container. - Prepare a clean flat surface and gather all the materials you will need for the infusion. Check the expiration date, and let the ADYNOVATE warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional. - Check the expiration date, and let the ADYNOVATE warm up to room temperature. - Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional. - Open the ADYNOVATE package by peeling away the lid. Remove the ADYNOVATE from the package and visually inspect the contents of the product and diluent vial. The ADYNOVATE powder should be white to off-white in color and the diluent should not contain particles. Do not use if discoloration or particles are seen. - Place on a flat surface with the diluent vial on top. The diluent vial has a blue stripe. - With one hand holding the ADYNOVATE housing, press down firmly on the diluent vial with the other hand until the system is fully collapsed and the diluent flows down into the ADYNOVATE vial. Both vials will move into the housing when pressed. If you don't see the diluent transfer to the product vial, press the vials again to assure they are completely inserted. Do not remove the blue cap until instructed in a later step. - Swirl the ADYNOVATE gently and continuously until the ADYNOVATE is completely dissolved. Do not shake . Do not refrigerate after reconstitution . Inspect the ADYNOVATE solution for particulate matter and discoloration prior to administration. The solution should be clear and colorless in appearance. If not, do not use the solution and notify your healthcare provider immediately. - Take off the blue cap from the housing and connect the syringe. Be careful to not inject air into the ADYNOVATE. - Turn over the ADYNOVATE so that the vial containing the ADYNOVATE solution is on top. Draw the ADYNOVATE solution into the syringe by pulling back the plunger slowly. If the solution does not draw into the syringe, be sure that both vials are pressed firmly together. The contents of more than one vial may be drawn into a single, appropriately sized syringe if you are using more than one vial of ADYNOVATE. - Disconnect the syringe from the system. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle. - Apply a tourniquet and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your healthcare provider or hemophilia center). - Insert the needle into the vein and remove the tourniquet. Slowly infuse the ADYNOVATE. Do not infuse any faster than 10 mL per minute. - Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes. - Remove the peel-off label from blister lid and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution. - Do not recap the needle. Place needle, syringe and ADYNOVATE system in a hard-walled Sharps container for proper disposal. Do not dispose of these supplies in ordinary household trash. Important: Contact your healthcare provider or local hemophilia treatment center if you experience any problems. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA 02421 U.S. License No. 1898 ADYNOVATE® , ADVATE® and BAXJECT® are registered trademarks of Baxalta Incorporated. ADYNOVATE® is a registered trademark of Baxalta Incorporated. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited. Patented: see www.takeda.com/en-us/patents Revised: 3/2023

Produkt oppsummering:

How Supplied ADYNOVATE in a BAXJECT III system is packaged with 2 mL or 5 mL of Sterile Water for Injection, one Terumo Microbore Infusion set (2 mL only), one full prescribing physician insert and one patient insert. Components not made with natural rubber latex. ADYNOVATE is available in single-dose vials that contain the following nominal product strengths: Actual factor VIII activity in IU is stated on the label of each ADYNOVATE carton and housing. Storage and Handling

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

ADYNOVATE- ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED
TAKEDA PHARMACEUTICALS AMERCIA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADYNOVATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADYNOVATE.
ADYNOVATE, (ANTIHEMOPHILIC FACTOR, RECOMBINANT, PEGYLATED) LYOPHILIZED
POWDER FOR
SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)
8/2023
INDICATIONS AND USAGE
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human
antihemophilic factor indicated
in children and adults with hemophilia A (congenital factor VIII
deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use
ADYNOVATE is not indicated for the treatment of von Willebrand
disease. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
One unit per kilogram body weight will raise the factor VIII level by
2% international units per deciliter (IU
per dL). Each vial of ADYNOVATE is labeled with the actual amount of
recombinant factor VIII present in
IU. (2.1)
On-demand treatment and control of bleeding episodes and perioperative
management:
Estimated Increment of factor VIII (IU/dL or % of normal) = [Total
Dose (IU)/body weight (kg)] × 2
(IU/dL per IU/kg)
Dose (IU) = Body Weight (kg) × Desired factor VIII Rise (IU/dL or %
of Normal) × 0.5 (IU/kg per IU/dL)
Routine prophylaxis:
Administer 40-50 IU/kg body weight twice weekly in adults and
adolescents (12 years and older).
Administer 55 IU/kg twice weekly in children (<12 years) with a
maximum of 70 IU/kg
Adjust the dose and dosing intervals based on the patient's clinical
response.
Inject intravenously over a period of less than or equal to 5 minutes
(maximum infusion rate 10 mL per
min). (2.3)
DOSAGE FORMS AND STRENGTHS
ADYNOVATE is available as a lyophilized powder in single-dose vials
containing nomin