Table of Contents
What is Xalkori?
Xalkori (crizotinib) is an oral kinase inhibitor indicated for various conditions, including:
- Adults with Non-Small Cell Lung Cancer (NSCLC): Specifically, when NSCLC has metastasized and is associated with a defect in the ALK (anaplastic lymphoma kinase) or ROS1 gene.
- Children (Aged 1 Year and Older) and Young Adults with ALK-Positive Anaplastic Large Cell Lymphoma (ALCL): Used in cases where ALCL has recurred or when previous treatments have proven ineffective.
- Adults and Children (Aged 1 Year and Older) with ALK-Positive Inflammatory Myofibroblastic Tumors (IMT): Employed when surgical removal of IMT is not feasible, or if it has relapsed, or when previous treatments are ineffective.
Xalkori acts by inhibiting receptor tyrosine kinases (RTKs), including ALK, hepatocyte growth factor receptor (HGFR, c-Met), ROS1 (c-ros), and Recepteur d’Origine Nantais (RON). RTKs play crucial roles in cell-to-cell communication signaling pathways. In tumors expressing these proteins, defects in RTKs can lead to increased cell proliferation and survival. Laboratory studies indicate that Xalkori induces cell death and tumor regression in ALCL-derived cell lines containing nucleophosmin-ALK or c-Met.
Xalkori Approval and Warnings
Xalkori received FDA approval on August 26, 2011.
Warnings:
- Heart, Lung, or Liver Problems: Xalkori may cause serious issues in these organs. Seek immediate medical attention if you experience symptoms like fast or pounding heartbeats, sudden dizziness, shortness of breath, tiredness, itching, upper stomach pain, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
- Visual Changes: Severe visual loss has been reported with Xalkori. Regular monitoring by a healthcare provider is essential, and any vision changes should be reported promptly.
- Nausea, Vomiting, Diarrhea, and Mouth Ulcers: Xalkori may cause severe gastrointestinal symptoms, especially in children or young adults. Healthcare providers monitor and manage these symptoms, adjusting treatment if necessary.
- Pregnancy and Birth Control: Xalkori can harm an unborn baby. Effective birth control is crucial during Xalkori use and for at least 3 months post-treatment. Both men and women should use contraception. Pregnant individuals should not use Xalkori.
Before Taking Xalkori:
Before starting Xalkori, inform your healthcare provider if you have:
- Liver or kidney problems.
- Lung problems.
- Heart problems, including long QT syndrome or a family history of it.
- Electrolyte imbalances.
- Vision or eye problems.
- Use any heart or blood pressure medicines.
- Are pregnant, plan to become pregnant, or breastfeeding.
Xalkori may affect fertility, so effective birth control is necessary. Pregnant individuals must not use Xalkori.
How to Take Xalkori:
- Take as prescribed by your doctor, with dosage adjustments as needed.
- Typically taken twice daily, with or without food.
- Capsules should be swallowed whole, and oral pellets administered as directed.
- Healthcare providers regularly monitor blood cell counts during the initial month, followed by at least monthly checks.
Dosing Information:
- Usual adult dose for metastatic NSCLC or unresectable IMT: 250 mg orally twice a day.
- Usual pediatric dose for lymphoma or unresectable IMT: 280 mg/m2 orally twice a day.
- Missed Dose and Overdose:
- Take a missed dose as soon as possible. Skip if the next dose is within 6 hours.
- Do not take two doses simultaneously.
- If vomiting occurs after a dose, do not take an extra dose.
What to Avoid:
- Grapefruit interaction with Xalkori can lead to unwanted side effects.
- Xalkori may cause blurred vision; avoid driving or hazardous activities.
- Caregivers handling patient body fluids should wear gloves.
- Prolonged sunlight exposure may cause photosensitivity; use sunscreen and protective clothing.
Xalkori Side Effects:
Seek emergency medical help for signs of an allergic reaction. Serious side effects may include liver or lung problems, abnormal heartbeats, and vision issues. Common side effects encompass gastrointestinal symptoms, headaches, nerve pain, abnormal liver function tests, swelling, numbness or tingling, muscle weakness, cold symptoms, dizziness, tiredness, and vision problems.
This is not an exhaustive list; consult your doctor for guidance. Report side effects to the FDA at 1-800-FDA-1088.
Xalkori Drug Interactions and Storage:
Xalkori may interact with specific medications. Strong CYP3A inhibitors and inducers should be avoided.
Store Xalkori at room temperature (20°C to 25°C); excursions permitted between 15°C to 30°C.
Ingredients:
- Capsules: Active – Crizotinib 200mg, 250mg; Inactive – Various components detailed in the prescription label.
- Oral Pellets: Active – Crizotinib 20mg, 50mg, 150mg; Inactive – Various components detailed in the prescription label.
Manufacturer:
Pfizer.
