Posted on July 29th, 2015 by
Class: Biological Therapy
Generic Name: Filgrastim-sndz
Trade Name: Zarxio™
For which conditions is this drug approved? Zarxio is approved to decrease the incidence of infection in patients with a low neutrophil (type of white blood cell that helps fight infection) count due to cancer treatment, a condition called neutropenia.
What is the mechanism of action? Zarxio is a man-made form of a substance produced by the body known as granulocyte colony-stimulating factor (G-CSF). G-CSF stimulates the growth of neutrophils, a type of white blood cell that helps the body fight against infection. Man-made forms of naturally occurring substances are known as biosimilars.
How is Zarxio typically given (administered)? Zarxio is given by intravenous (IV) infusion or injection under the skin by a doctor or nurse. Your doctor may also decide that you can give yourself Zarxio injections under the skin at home or your caregiver can give you the injections. If you’re receiving Zarxio at home, see the detailed “Instructions for Use” that comes with your Zarxio for information on how to prepare and inject a dose.
How are patients typically monitored? During treatment with Zarxio, patients will be monitored for an enlarged spleen or ruptured spleen; patients who report left upper abdominal or shoulder pain should have their spleens examined. Patients will also be monitored for acute respiratory distress syndrome (ARDS); signs and symptoms include fever and lung infiltrates (pus, blood, or protein in the lungs) or respiratory distress. Patients will also be watched for serious allergic reactions and have blood tested regularly to check for blood disorders.
What are the common (occur in 30% or more of patients) side effects of treatment with Zarxio?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Zarxio?
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician? Tell your doctor if you have signs or symptoms of:
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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