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Only Available By Prescription
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Alprolix (Factor IX Recombinant) is an advanced biotechnologically engineered form of Factor IX, a blood-clotting protein that is naturally present in the blood. This medication is specifically designed to help individuals with Hemophilia B, a genetic disorder that results from insufficient amounts of Factor IX. By providing a recombinant version of Factor IX, Alprolix helps to control and prevent bleeding episodes, or is used in a prophylactic regimen to prevent or reduce the frequency of bleeding episodes.
Alprolix is produced through recombinant DNA technology in a mammalian cell culture, which ensures a high level of purity and safety. It is designed to mimic the naturally occurring protein as closely as possible, thereby providing effective management of bleeding disorders in patients lacking this crucial clotting factor.
Before you buy Alprolix, it is crucial that you talk to your healthcare provider about potential side effects and Alprolix cost.
| Fact Table | |
|---|---|
| Generic Name | Factor IX (Recombinant) |
| Brand Name | Alprolix |
| License | FDA approved |
| Bioavailability | 100% (intravenous administration) |
| Chemical Name | Coagulation Factor IX, recombinant, Fc fusion protein |
| Elimination Half-Life | 82 hours (mean, adults) |
| Dosage (Strength) | 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU |
| Pregnancy Category | C |
| Protein Binding | Not applicable (endogenous protein) |
| Routes of Administration | Intravenous |
| ATC Code | B02BD04 |
| DrugBank | DB09130 (Factor IX recombinant, Fc fusion) |
| KEGG | D10293 (Factor IX recombinant, Fc fusion) |
Alprolix should be administered according to the prescription provided by a healthcare professional. It is generally given as an intravenous injection and can be administered at a hospital, a clinic, or at home if instructed by your healthcare provider. The recommended starting Alprolix dosing is 50 IU/kg once weekly. Adjustments may be made depending on the patient's needs and bleeding episodes.
Active Ingredient: Factor IX (Recombinant), Fc Fusion Protein.
Alprolix should only be used after proper training in the reconstitution and administration of the product.
Do not use if allergic to any of the components of Alprolix.
Inform your doctor of any medical history of heart disease or blood clots.
Pregnant or breastfeeding women should consult their healthcare provider before using Alprolix.
Alprolix may interact with other medications, especially those that affect blood clotting. Before starting Alprolix, inform your healthcare provider about all medications you are taking, including:
It is also important to notify your healthcare provider of any new medications or changes in your treatment regimen.
Common side effects of Alprolix include:
What is ALPROLIX used for?
ALPROLIX is used for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). It is suitable for use in adults and children.
How does ALPROLIX work?
ALPROLIX works by replacing the missing or deficient factor IX in the blood, which is necessary for blood clotting. ALPROLIX is a recombinant coagulation factor IX Fc fusion protein that extends the half-life of factor IX, allowing it to remain in the bloodstream longer and provide prolonged protection against bleeding.
What is the dosing schedule for ALPROLIX?
The dosing schedule for ALPROLIX varies depending on whether it is used for on-demand treatment, routine prophylaxis, or perioperative management. For routine prophylaxis, it is typically administered once weekly or every 10-14 days. The exact dose and frequency depend on individual patient needs and the severity of their condition.
What is the strength of ALPROLIX?
ALPROLIX is available in several strengths, including 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU per vial. The exact strength and dosage are determined by the treating physician based on the patient's weight and clinical condition.
What is the active substance in ALPROLIX?
The active substance in ALPROLIX is recombinant coagulation factor IX Fc fusion protein (rFIXFc).
Is ALPROLIX an orphan drug?
Yes, ALPROLIX has been designated as an orphan drug. Orphan drug status is granted to medications that are intended for the treatment of rare diseases or conditions.
How is ALPROLIX administered?
ALPROLIX is administered via intravenous (IV) injection. The injection should be given by a healthcare professional or by the patient or caregiver after proper training in the administration technique.
What is the half-life of ALPROLIX?
The half-life of ALPROLIX is approximately 82 hours in adults. This extended half-life allows for less frequent dosing compared to standard factor IX products.
When was ALPROLIX approved?
ALPROLIX was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2014.
What is the indication of ALPROLIX?
ALPROLIX is indicated for use in adults and children with hemophilia B for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
