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The following safety information outlines critical warnings and precautions associated with using Neulasta (pegfilgrastim). Please read carefully and discuss any concerns with your healthcare provider.

• Enlarged Spleen: Rare cases of spleen enlargement have been reported, with severe instances leading to spleen rupture, which can be life-threatening. Contact your healthcare provider immediately if you experience pain in the upper left abdomen or shoulder.

• Respiratory Issues: Neulasta may cause acute respiratory distress syndrome (ARDS), a severe condition where fluid leaks into the lungs, impairing oxygen flow. Seek urgent medical attention if you experience shortness of breath, rapid breathing, or fever.

• Allergic Reactions: Serious allergic reactions, including life-threatening ones, can occur. Avoid using Neulasta if you have a history of allergic reactions to it or similar medications, such as Neupogen (filgrastim). Notify your provider if you have allergies to acrylics or latex, as these materials are present in the medication's delivery system. Seek immediate medical help if you notice a rash, breathing difficulties, or swelling of the lips, tongue, or throat.

• Sickle Cell Crisis: Patients with sickle cell anemia may experience a sickle cell crisis while using Neulasta. If this occurs, the medication will be discontinued by your healthcare provider.

• Kidney Damage: Neulasta may cause kidney damage in some individuals. If suspected, your provider may request blood tests to assess kidney function and may adjust your dosage as necessary.

• Capillary Leak Syndrome: This serious condition involves fluid leakage from small blood vessels, leading to symptoms like low blood pressure, dizziness, fatigue, stomach pain, extreme thirst, and sudden weight gain. Contact your provider if you notice these symptoms.

• Cancer Risk: As a growth factor, Neulasta might increase the risk of certain cancers, particularly blood-related ones. Close monitoring of your blood tests is essential, and the medication may be discontinued if the risks outweigh the benefits.

• Blood Vessel Inflammation: Aortitis, an inflammation of blood vessels, can occur within the first week of treatment. Report symptoms like fever, stomach or back pain, or general malaise to your healthcare provider promptly.

Contraindications:

• Do not use Neulasta if you have an allergy to filgrastim products like Neupogen, as it may pose serious health risks. Always consult with your healthcare provider before starting this medication if you have concerns.

When taking this medication, some individuals may experience mild side effects such as aching or pain in the bones and muscles, which can often be alleviated with non-aspirin pain relievers like acetaminophen. Reactions at the injection site, including redness, swelling, itching, or bruising, are also common but typically manageable. If any of these effects persist or worsen, it's important to consult a healthcare provider for guidance.

On rare occasions, more serious side effects may occur. These include pink or bloody urine, unusual bleeding or bruising, fever, a rapid heartbeat, and purple or red spots on the skin. Additionally, some individuals might experience severe back pain or symptoms suggesting a reduction in urination and unusual tiredness. If you notice any of these symptoms, it's crucial to seek medical attention promptly.

In very rare cases, this medication may cause potentially life-threatening conditions, such as damage to the spleen, which can manifest as stomach or shoulder pain. There is also a risk, albeit small, of developing bone marrow disorders like myelodysplastic syndrome or blood cancers such as acute myeloid leukemia, particularly in patients with breast or lung cancer undergoing chemotherapy or radiation therapy.

Furthermore, a severe allergic reaction is possible, though rare. Symptoms may include a rash, itching or swelling, particularly of the face, tongue, or throat, severe dizziness, and difficulty breathing. These signs warrant immediate medical intervention. Always inform your healthcare provider of any unusual effects not listed here, as monitoring and timely intervention can help manage side effects effectively.