ELOCTATE

ELOCTATE is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Type of bleeding episodesMinor‡Major‖Frequency of doses (hrs) for patients 6 and older12-248-24Frequency of doses (hrs) for patients under 68-246-12Duration of therapy (days)Until the bleeding is resolved (approximately 1 to 3 days)Until the bleeding is resolved

*In clinical trials, ADVATE has demonstrated the ability to help patients prevent bleeding episodes using a prophylaxis regimen. For people with hemophilia A, ADVATE has a legacy of treatment experience and provides clinically proven bleed protection.

Hemlibra® (emicizumab-kxwh) is approved by the FDA as a prophylactic (preventative) treatment to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

AHF (antihemophilic factor) is a medication that prevents or manages bleeding if you have hemophilia A. This condition keeps your blood from clotting as it should so you bleed more than expected. A healthcare provider will usually give you this injection in a hospital or clinic setting.

Clinical dataTrade namesElocta, EloctateOther namesAntihemophilic Factor (Recombinant), FcFusion ProteinLicense dataEU EMA: by INN US DailyMed: EloctatePregnancy categoryAU : C

ELOCTATE contains the active ingredient efmoroctocog alfa. Efmoroctocog alfa is a factor VIII protein necessary for forming clots in the blood and helps to control or prevent bleeding. ELOCTATE is used for the management of haemophilia A (congenital factor VIII deficiency). For more information, see Section 1.

ELOCTATE contains the active ingredient efmoroctocog alfa. People with haemophilia A lack sufficient factor VIII to control bleeding. ELOCTATE works by replacing factor VIII to enable blood to clot.

Dr. Wong: The data shows that the half-life of Eloctate is about 19 hours, on average. This compares to other recombinant FVIIIs that are about 12 hours. So this represents a 50 percent extension in half-life, or 1.5 times that of traditional FVIIIs.

Manufacturer: Biogen Idec, Inc.

ADVATE was initially approved by the FDA in July 2003 for control and prevention of bleeding episodes in adults and children with hemophilia A. Â ADVATE (derived from the complete FVIII gene) is a recombinant FVIII therapy that is processed without any blood-based additives.

Classical hemophilia, also known as hemophilia A, is a hereditary hemorrhagic disorder resulting from a congenital deficit of factor VIII that manifests as protracted and excessive bleeding either spontaneously or secondary to trauma.

What is ADVATE? ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.

ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency. Your healthcare provider may give you ALPROLIX when you have surgery.

ADVATE contains nominally 250, 500, 1000, 1500, 2000, 3000 or 4000 IU octocog alfa [recombinant coagulation factor VIII (rFVIII)]. The product contains approximately 40 to 960 IU per mL octocog alfa when reconstituted with either 5 mL or 2 mL sterile water for injections.

HEMLIBRA® (emicizumab-kxwh) | Hemophilia A Treatment.

Hemlibra (emicizumab or emicizumab-kxwh) is used to prevent or reduce the number of bleeding episodes in people with hemophilia A, a genetic disorder that causes the blood to not clot properly due to a missing clotting factor called factor VIII.

Novoeight Generic Name & Formulations Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

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.

ELOCTATE is contraindicated in patients who have had a life-threatening hypersensitivity reaction to ELOCTATE or its excipients. Hypersensitivity reactions, including anaphylaxis, have been reported with ELOCTATE.

ADVATE dosing for routine prophylaxis Use dose of 20 to 40 international units of factor VIII per kg of body weight every other day (3 to 4 times weekly).

You should not self-infuse unless you have been trained by your healthcare provider or HTC. Read the Instructions for Use before you start using ADVATE. Your healthcare provider or HTC should show you how to prepare and infuse ADVATE appropriately.

Administer ADVATE over a period of ≤5 minutes (maximum infusion rate 10 mL/min).

The main treatment for hemophilia is called replacement therapy. Concentrates of clotting factor VIII (for hemophilia A) or clotting factor IX (for hemophilia B) are slowly dripped or injected into a vein. These infusions help replace the clotting factor that’s missing or low.

Manufacturer: Biogen Idec, Inc.

Administration. Factor VIII is generally administered as a slow IV push (bolus injection). Continuous infusion of Factor VIII is indicated for patients requiring admission for severe bleeds or surgical procedures. Factor VIII replacement for such patients should be managed in consultation with Clinical Haematology.

Therefore, correct FVIII dosing is vital. The number of FVIII units required to obtain adequate circulating FVIII levels is calculated using the following formula: [body weight (BW)(kg) × desired FVIII increase(%)]/2.

Take the patient’s present weight in pounds.Divide that weight by 4.4 (a calculator may help).Multiply that number by the factor level to be reached.The result is the required units of factor.

Esperoct is given as an injection into a vein. The dose, frequency and duration of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient’s condition and weight.

Reconstituted ALPHANATE may be stored at room temperature (not to exceed 30°C) prior to administration, but administer intravenously within 3 hours. Discard any unused contents into an appropriate safety container. Do not administer ALPHANATE at a rate exceeding 10 mL/min.

The cost for Eloctate intravenous powder for injection recombinant fc fusion protein is around $12 for a supply of 1 powder for injection, depending on the pharmacy you visit.

How much is Hemgenix? Hemgenix is used to treat hemophilia B, a rare, lifelong bleeding disorder. The single dose therapy is priced at $3.5 million, according to CSL Behring, which made it the most expensive drug at the time of FDA approval in November 2022.

Keep ELOCTATE in the pack until it is time to use it, protected from light. Store in the refrigerator at 2°C to 8°C. Do not freeze ELOCTATE. If necessary, you can keep ELOCTATE out of the refrigerator for a single 6-month period.

Routine Prophylaxis • The recommended starting regimen is 50 IU/kg of ELOCTATE administered every 4 days. Adjust the regimen based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals.

The best way to treat hemophilia is to replace the missing blood clotting factor so that the blood can clot properly. This is typically done by injecting treatment products, called clotting factor concentrates, into a person’s vein.

The average annual cost of medication to treat hemophilia is more than $393,000 per patient. A number of patient-specific variables drive this high cost: Patients with severe disease have more frequent bleeding episodes, and each one requires treatment. These same patients are also eligible for prophylactic therapy.

The cost for NovoSeven RT intravenous powder for injection (1000 mcg (1 mg)) is around $2,835 for a supply of 1000 powder for injection, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans.

After an FDA endorsement Tuesday, CSL Behring and uniQure’s hemophilia B gene therapy Hemgenix debuts not only as the first gene therapy approved for the rare disorder, but as the new most expensive drug in the world. The drug will sport an eye-popping price tag of $3.5 million per dose.

This statistic displays the global average prices of Factor VIII in 2017 in selected countries. In that year, the price of factor VIII averaged 2.53 U.S. dollars in the United States. Factor VIII is a drug used, for example, to treat patients with hemophilia A.