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Overview

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This medicine contains an important and useful components, as it consists of
Bosutinibis available in the market in concentration

Name

Coagulation Factor IX Human USP

Precaution

Before using **Coagulation Factor IX Human USP** (recombinant human factor IX), patients must consult their healthcare provider to ensure appropriate treatment and minimize risks. Key precautions include: - **Allergic Reactions**: Patients should be monitored for any signs of an allergic reaction to factor IX, such as rash, hives, or difficulty breathing. In rare cases, serious allergic reactions, including anaphylaxis, may occur. - **Inhibitors to Factor IX**: Some patients may develop inhibitors (antibodies) to factor IX, which can make the treatment less effective. The presence of inhibitors can be monitored through blood tests, and if inhibitors are detected, alternative treatments may be considered. - **Pre-existing Cardiovascular Conditions**: Factor IX infusion may cause increased blood viscosity and potentially strain the cardiovascular system. Patients with pre-existing heart disease should use caution and be closely monitored. - **Renal and Hepatic Function**: Coagulation Factor IX is metabolized by the liver and cleared by the kidneys. Patients with severe liver or renal impairment may require adjustments in treatment or additional monitoring during therapy. - **Pregnancy and Breastfeeding**: There is limited data on the use of Coagulation Factor IX during pregnancy and breastfeeding. It should only be used if the benefits outweigh the risks, and under the supervision of a healthcare provider. - **Injection Site Reactions**: Patients should be monitored for local reactions at the injection site, including redness, pain, or swelling. If reactions are severe, they may need to be managed or modified.

Indication

Coagulation Factor IX Human USP is primarily indicated for the treatment and prevention of bleeding episodes in individuals with **Hemophilia B** (also known as **Factor IX deficiency**). Other key indications include: - **Prevention of Bleeding**: It is used to prevent bleeding in patients with Hemophilia B during surgeries, dental procedures, or injuries. It helps restore normal blood clotting by replenishing the missing or deficient factor IX. - **Treatment of Acute Bleeding Episodes**: It is used to treat or manage acute bleeding episodes in patients with Hemophilia B. It helps control bleeding by promoting clot formation. - **Prophylactic Treatment**: Regular administration of Factor IX can be used for prophylaxis in patients with Hemophilia B to reduce the frequency of spontaneous bleeding episodes. - **Management of Surgical Bleeding**: In patients with Hemophilia B undergoing surgery, Coagulation Factor IX may be used to ensure appropriate clotting during and after surgery to minimize the risk of bleeding. - **Trauma**: It may also be used in cases of trauma or injury to ensure proper blood clotting and prevent excessive bleeding.

Contra indication

Coagulation Factor IX Human USP should not be used in certain circumstances, including: - **Hypersensitivity to Factor IX**: Patients who are allergic to coagulation Factor IX or any of its components (such as stabilizers or preservatives) should not use this product. - **Known Inhibitors to Factor IX**: In patients with known inhibitors to Factor IX, treatment with this product may be ineffective. Alternative therapies may be considered for such patients. - **Uncontrolled Bleeding or Thrombotic Disorders**: In patients with active thromboembolic disease or uncontrolled bleeding that is not related to hemophilia, Factor IX replacement therapy should not be administered. - **Severe Liver Disease**: Since Factor IX is metabolized in the liver, it should be avoided in patients with severe hepatic insufficiency or active liver disease unless the benefits clearly outweigh the risks. - **Severe Renal Impairment**: In cases of severe renal failure or dialysis-dependent patients, there may be a need for dose adjustments or close monitoring, although contraindication in these cases is not absolute. - **Pregnancy**: There is insufficient evidence on the safety of Coagulation Factor IX during pregnancy, so it should only be used if absolutely necessary and under a healthcare provider’s supervision.

Side Effect

Coagulation Factor IX therapy can cause various side effects, some of which require immediate attention: - **Common Side Effects**: - Pain or swelling at the injection site - Headache or dizziness - Fever or chills - Fatigue or weakness - Nausea - **Severe Side Effects**: - **Allergic Reactions**: Severe allergic reactions such as anaphylaxis, with symptoms like difficulty breathing, swelling, or rash, may occur and require immediate medical attention. - **Inhibitor Development**: Some patients may develop inhibitors to Factor IX, which can lead to reduced effectiveness of the treatment. Regular blood tests are needed to monitor for the development of inhibitors. - **Thromboembolic Events**: The formation of blood clots (e.g., deep vein thrombosis, pulmonary embolism) is a potential risk, particularly when Factor IX is used excessively or inappropriately. - **Arthropathy**: Long-term treatment can lead to joint issues in patients who experience frequent bleeds in joints. - **Renal Complications**: In rare cases, kidney dysfunction may occur, particularly in patients with pre-existing renal conditions or those on long-term treatment. Patients should immediately report any unusual symptoms to their healthcare provider, especially if they experience difficulty breathing, swelling of the face or throat, or signs of bleeding or clotting complications.

Pregnancy Category ID

3

Mode of Action

Coagulation Factor IX Human USP works by replenishing the deficient or absent Factor IX in individuals with Hemophilia B. Factor IX is a key enzyme in the coagulation cascade, responsible for activating Factor X, which is essential for the formation of a stable blood clot. When Factor IX is missing or dysfunctional in patients with Hemophilia B, their blood cannot clot properly, leading to excessive bleeding. - **Mechanism**: Factor IX activates Factor X in the presence of Factor VIII, leading to the conversion of prothrombin to thrombin, which ultimately forms fibrin and stabilizes the clot. - **Therapeutic Effect**: By replacing the missing Factor IX, Coagulation Factor IX restores the clotting process, allowing for normal hemostasis and preventing or controlling bleeding episodes.

Interaction

Coagulation Factor IX may interact with other drugs and substances, potentially affecting its safety and efficacy: - **Factor IX Inhibitors**: The development of antibodies (inhibitors) against Factor IX can significantly reduce the effectiveness of the therapy. In these cases, alternative treatment strategies may be required. - **Anticoagulants**: The concurrent use of anticoagulants (e.g., warfarin) with Factor IX therapy could affect clotting function and increase the risk of bleeding or thrombosis. Patients receiving both therapies should be closely monitored. - **Vaccines**: Some vaccines, especially live vaccines, may affect immune responses when Factor IX is administered concurrently. It's essential to consult healthcare providers regarding the timing of vaccinations and Factor IX therapy. - **Other Hemostatic Agents**: When used alongside other hemostatic agents, including fibrinogen or desmopressin, Factor IX therapy may cause excessive clotting, increasing the risk of thrombotic complications. - **Corticosteroids**: Long-term use of corticosteroids may increase the risk of bleeding, as they can interfere with coagulation pathways. Monitoring is necessary if corticosteroids are used alongside Factor IX.

Pregnancy Category Note

Information not available

Adult Dose

The dosing of **Coagulation Factor IX Human USP** is individualized based on the severity of Factor IX deficiency, the type of bleeding episode, and the patient's weight: - **Bleeding Episodes**: The typical dose is **30-50 IU/kg body weight**, depending on the severity of the bleeding episode. Repeat doses may be necessary based on the clinical response and blood levels. - **Prophylaxis**: For routine prophylaxis to prevent bleeding, patients may receive **20-40 IU/kg** every 3-4 days, depending on the frequency of bleeds and individual needs. - **Surgical Bleeding**: During surgeries, Factor IX may be given at higher doses, typically **50-100 IU/kg**, to ensure sufficient clotting during the procedure and to manage post-operative bleeding. Dosing is adjusted based on monitoring coagulation parameters and clinical response.

Child Dose

For pediatric patients, **Coagulation Factor IX Human USP** is dosed based on age, weight, and the specific clinical indication: - **Pediatric Hemophilia B**: The typical dose is **30-50 IU/kg** for acute bleeding episodes, with repeat doses as needed. Prophylactic treatment may involve **20-40 IU/kg** every 3-4 days. - **Surgical Procedures in Children**: A higher dose of **50-100 IU/kg** may be required during surgery to prevent excessive bleeding and ensure proper clotting. - **Long-term Prophylaxis**: For long-term prophylactic therapy, children generally receive doses similar to those in adults, adjusted for weight and bleeding history. Regular blood tests are essential in pediatric patients to monitor Factor IX activity and adjust dosing for optimal bleeding control. Always consult a healthcare provider before initiating or adjusting treatment. Before starting **Coagulation Factor IX Human USP**, it is important to consult with a healthcare provider to ensure the right dosage, avoid complications, and monitor for side effects.

Renal Dose

Patients with **renal impairment** may require dose adjustments for **Coagulation Factor IX Human USP**: - **Mild to Moderate Renal Impairment**: No significant dose adjustment is usually necessary in patients with mild to moderate renal dysfunction. Regular monitoring of kidney function is recommended. - **Severe Renal Impairment**: In patients with severe renal impairment or those on dialysis, the pharmacokinetics of Factor IX may be altered. Dosing may need to be adjusted, and careful monitoring is required to prevent overdosage and bleeding complications. Patients with renal issues should be carefully monitored for any side effects related to drug metabolism and excretion.

Administration

Information not available