Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Neulasta (Pegfilgrastim). If you are concerned about side effects, discuss the risks and benefits of Neulasta (Pegfilgrastim) with your doctor.

The following side effects have been reported by at least 1% of people taking Neulasta (Pegfilgrastim). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bone and muscle pain
• redness, swelling, or itching at the site of injection

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• rash at the surface of the skin (purple or red spots or bumps, splotches, or Hives)
• signs of an enlarged spleen (e.g., upper left abdominal pain or pain at the tip of the shoulder)
• symptoms of kidney injury (e.g., puffiness in the face or ankles, blood in the urine or brown coloured urine, decreased frequency of urination)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• a Anaphylaxis (severe allergic reaction) (e.g., hives, shortness of breath, wheezing, swelling of the face or throat, fast heart rate, dizziness)
• signs of acute respiratory distress syndrome (e.g., Fever, shortness of breath, cough, or lung congestion)
• symptoms of capillary leak syndrome (e.g., swelling or puffiness, difficulty breathing, abdominal swelling, tiredness, feeling of fullness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Neulasta (Pegfilgrastim).

Each 0.6 mL single-use syringe of sterile, clear, colourless, preservative-free liquid for subcutaneous administration contains 6 mg of Neulasta (Pegfilgrastim) (based on protein mass only). Nonmedicinal ingredients: polysorbate 20, sodium acetate, sorbitol, and water for injection, USP; pH: 4.0. The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex).

Do not take Neulasta (Pegfilgrastim) if you:

• are allergic to Neulasta (Pegfilgrastim), to Filgrastim, or any of the ingredients of the medication
• are allergic to products made using the E. coli bacteria

There may be an interaction between Neulasta (Pegfilgrastim) and any of the following:

• lithium
• Topotecan
• other cytokine medications (e.g., growth factors)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Neulasta (Pegfilgrastim). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Neulasta (Pegfilgrastim).

Capillary leak syndrome (CLS): Capillary leak syndrome been experienced by people using Neulasta (Pegfilgrastim). This is a condition where blood leaks from the small blood vessels, into your body. CLS can cause severely decreased blood pressure and may be life threatening. If you experience symptoms of CLS, such as swelling or puffiness, difficulty breathing, abdominal swelling, tiredness, feeling of fullness, seek immediate medical attention.

Cytotoxic chemotherapy: The safety of using Neulasta (Pegfilgrastim) at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Neulasta (Pegfilgrastim) should not be used within 14 days before or 24 hours after chemotherapy. In addition, it is not known whether it is safe and effective to use Neulasta (Pegfilgrastim) after certain chemotherapy medications (e.g., Mitomycin C, 5-fluorouracil, and nitrosoureas such as carmustine and lomustine).

Ruptured spleen: In rare cases, Neulasta (Pegfilgrastim) has been reported to cause the spleen to rupture, which can be fatal. The spleen is an organ in the body that is involved in the production and removal of blood cells. If you have pain in the left upper stomach or left shoulder tip area, contact your doctor immediately.

Lung problems: Neulasta (Pegfilgrastim) may cause adult respiratory distress syndrome (ARDS), a serious lung condition, when people with neutropenia have sepsis (bacterial infection in the blood). If ARDS occurs, Neulasta (Pegfilgrastim) should be stopped until the ARDS resolves.

Radiation: It is not known whether it is safe and effective to use Neulasta (Pegfilgrastim) with radiation therapy. Neulasta (Pegfilgrastim) should not be used during radiation therapy.

Sickle cell disease: Neulasta (Pegfilgrastim) may cause sickle cell crisis when used by people who have sickle cell disease. You and your doctor should carefully consider the benefits and risks of using Neulasta (Pegfilgrastim) in these circumstances.

Pregnancy: Neulasta (Pegfilgrastim) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Neulasta (Pegfilgrastim), stop taking it immediately and call your doctor.

Breast-feeding: It is not known whether Neulasta (Pegfilgrastim) passes into breast milk. If you are a breast-feeding mother and are taking Neulasta (Pegfilgrastim), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Neulasta (Pegfilgrastim) have not been established for children.