Xospata 40 mg film-coated tablets

Xospata, with the active ingredient gilteritinib, is an oral medication used primarily for the treatment of acute myeloid leukemia (AML) in adults who have a specific genetic mutation known as FLT3. This medication offers a targeted therapy approach, providing hope for patients who have limited options due to the aggressive nature of AML.

How It Works

Xospata (gilteritinib) is a tyrosine kinase inhibitor that targets specific proteins involved in the growth and survival of cancer cells. Here’s how it works:

1. FLT3 Inhibition:
   • Targeting Mutations: Gilteritinib targets the FMS-like tyrosine kinase 3 (FLT3) receptor, which is often mutated in AML patients. Mutations in FLT3, such as internal tandem duplications (ITD) or tyrosine kinase domain (TKD) mutations, lead to uncontrolled proliferation of leukemic cells.
   • Blocking Signaling Pathways: By inhibiting FLT3, Xospata disrupts key signaling pathways that are essential for cancer cell survival and proliferation. This results in the induction of apoptosis (programmed cell death) in cancerous cells.
2. Multi-Kinase Activity:
   • In addition to FLT3, gilteritinib also inhibits other kinases, including AXL, which can contribute to its anti-cancer activity. This multi-kinase targeting helps prevent the development of drug resistance.
3. Oral Administration:
   • Xospata is administered orally, allowing for convenient outpatient treatment, improving quality of life and compliance in patients.

Clinical Efficacy

Clinical trials have demonstrated that Xospata significantly improves survival rates in patients with relapsed or refractory FLT3-mutated AML. It offers a promising option for those who have limited treatment alternatives, providing a better chance of remission and disease control.

---

Side Effects

While Xospata provides significant benefits, it may also cause side effects. Patients should be closely monitored for any adverse reactions, and healthcare providers should be notified of any concerns.

Common Side Effects

• Fatigue: Tiredness and lack of energy are commonly reported among patients.
• Nausea: Stomach upset and nausea are frequent complaints.
• Diarrhea: Loose stools and gastrointestinal discomfort may occur.
• Muscle and Joint Pain: Patients may experience discomfort in muscles and joints.
• Fever: Elevated body temperature is a possible side effect.
• Cough: Respiratory symptoms like cough can occur.
• Headache: Mild to moderate headaches are reported.

Serious Side Effects

• Differentiation Syndrome: A potentially life-threatening condition that can occur when cancer cells release chemicals into the bloodstream. Symptoms include fever, dyspnea, and weight gain.
• QT Prolongation: Changes in heart rhythm that can lead to serious cardiac events. Monitoring with ECGs is essential.
• Liver Toxicity: Elevated liver enzymes indicating potential liver damage.
• Pancreatitis: Inflammation of the pancreas, presenting as abdominal pain.
• Infections: Increased risk of infections due to suppressed immune function.

Patients experiencing serious side effects should seek immediate medical attention to prevent complications.

Indications

Xospata is specifically indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. It offers a targeted treatment option for those who have failed other therapies or have experienced disease recurrence.

Approved Indications

1. Relapsed AML: Patients whose leukemia has returned after previous treatment.
2. Refractory AML: Patients who have not responded to initial treatment regimens.
3. FLT3-Mutated AML: Specifically for those with confirmed FLT3-ITD or FLT3-TKD mutations, as detected by an FDA-approved test.

Contraindications

While Xospata is effective for treating FLT3-mutated AML, certain contraindications should be considered to ensure patient safety.

Contraindications

1. Hypersensitivity: Patients with known hypersensitivity to gilteritinib or any excipients in Xospata should not receive this medication, as it may cause severe allergic reactions.
2. Cardiac Conditions: Patients with a history of QT prolongation or other significant cardiac arrhythmias should use Xospata cautiously.
3. Severe Hepatic Impairment: Patients with severe liver dysfunction should be closely monitored due to the risk of hepatotoxicity.
4. Concomitant Use with Strong CYP3A Inducers: These medications can reduce the effectiveness of Xospata by increasing its metabolism.
5. Pregnancy and Breastfeeding: Xospata may harm the developing fetus, so it should be avoided during pregnancy unless absolutely necessary. Breastfeeding is also not recommended during treatment.

Price in Different Countries

 

Country	Price (USD) Per 40 mg Tablet	Reference Link
United States	$600 – $700	GoodRx
Canada	$500 – $650	CanadaDrugs
United Kingdom	£500 – £600	NHS
Australia	$700 – $800	PBS
Germany	€550 – €650	Apotheken Umschau