Antihemophilic Factor (Recombinant), Fc Fusion Protein

What is Antihemophilic Factor (Recombinant), Fc Fusion Protein?

• Antihemophilic Factor (Recombinant), Fc Fusion Protein (ELOCTATE) is a recombinant DNA derived, antihemophilic factor used is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency).

What are the uses of this medicine?

This medicine is in adults and children with Hemophilia A (congenital Factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes,
• Perioperative management of bleeding,
• Routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of Use

• ELOCTATE is not indicated for the treatment of von Willebrand disease.

How does this medicine work?

• ELOCTATE is a recombinant fusion protein that temporarily replaces the missing Coagulation Factor VIII needed for effective hemostasis.
• ELOCTATE contains the Fc region of human immunoglobulin G1 (IgG1), which binds to the neonatal Fc receptor (FcRn).
• FcRn is part of a naturally occurring pathway that delays lysosomal degradation of immunoglobulins by cycling them back into circulation and prolonging their plasma half-life.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• life-threatening hypersensitivity reactions to ELOCTATE or its excipients (sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20).

What drug interactions can this medicine cause?

• No drug interaction studies where performed for ELOCTATE.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Each vial of ELOCTATE is labeled with the amount of recombinant Factor VIII in international units (IU or unit).
• One unit per kilogram body weight will raise the Factor VIII level by 2% (IU/dL).

For on-demand treatment and control of bleeding episodes and perioperative management, calculate dose using the following formulas: Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg) OR Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)

Recommended Dosage:

• For routine prophylaxis: 50 IU/kg every 4 days. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals.
• For routine prophylaxis in children less than 6 years of age: 50 IU/kg twice weekly. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required.

Administration

• You get ELOCTATE as an infusion into your vein.
• Your healthcare provider will instruct you on how to do infusions on your own, and may watch you give yourself the first dose of ELOCTATE.
• Inspect the reconstituted ELOCTATE solution visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed.
• Do not administer reconstituted ELOCTATE in the same tubing or container with other medications.

Administration Steps:

• 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 ELOCTATE has reached the end of the infusion set tubing. Do not push ELOCTATE solution 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 ELOCTATE, remove and properly discard the infusion set.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: nominally 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000, or 6000 IU, lyophilized powder in single-dose vials for reconstitution.

This medicine is available in fallowing brand namesː

• ELOCTATE

What side effects can this medication cause?

The most common side effects of this medicine include:

• arthralgia
• malaise
• myalgia
• headache
• rash
• Factor VIII inhibition
• device-related thrombosis
• rash papular

What special precautions should I follow?

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, immediately discontinue ELOCTATE and initiate appropriate treatment.
• Neutralizing antibodies (inhibitors) to Factor VIII have been reported. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no studies of ELOCTATE use in pregnant women to inform a drug-associated risk.
• It is not known whether ELOCTATE can cause fetal harm when administered to a pregnant woman, or whether it can affect reproduction capacity.

Can this medicine be used in children?

• Safety and efficacy studies have been performed in 82 previously treated, pediatric patients (PTPs) <18 years of age who received at least one dose of ELOCTATE as part of routine prophylaxis, on-demand treatment of bleeding episodes, or perioperative management.
• Safety and efficacy of ELOCTATE have been evaluated in 103 previously untreated pediatric patients (PUPs) <6 years of age (median 0.58 year; range: 0.02–4 years) in one study (PUPs Study).

What are the active and inactive ingredients in this medicine?

Active ingredient:

• EFMOROCTOCOG ALFA

Inactive ingredients:

• Histidine
• sodium chloride
• calcium chloride
• sucrose
• polysorbate 20

Who manufactures and distributes this medicine?

Manufactured by:

• Bioverativ Therapeutics Inc.
• Waltham, MA 02451 USA

What should I know about storage and disposal of this medication?

• Keep ELOCTATE in its original package.
• Protect it from light.
• Do not freeze.
• Store refrigerated (2°C to 8°C or 36°F to 46°F) or at room temperature [not to exceed 30°C (86°F)], for up to six months.
• When storing at room temperature:
• Note on the carton the date on which the product is removed from refrigeration.
• Use the product before the end of this 6-month period or discard it.
• Do not return the product to the refrigerator.
• Do not use ELOCTATE after the expiration date printed on the vial or, if you removed it from the refrigerator, after the date that was noted on the carton, whichever is earlier.

After reconstitution (mixing with the diluent):

• Do not use ELOCTATE if the reconstituted solution is not clear to slightly opalescent and colorless.
• Use reconstituted product as soon as possible.
• You may store reconstituted solution at room temperature, not to exceed 30°C (86°F), for up to three hours. Protect the reconstituted product from direct sunlight. Discard any product not used within three hours.

• Dailymed label info on Antihemophilic Factor (Recombinant), Fc Fusion Protein
• FDA Antihemophilic Factor (Recombinant), Fc Fusion Protein

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