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 Neupogen (Filgrastim). If you are concerned about side effects, discuss the risks and benefits of Neupogen (Filgrastim) with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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.

• mild-to-moderate bone or muscle pains or aches
• reaction at the injection site (e.g., redness, swelling or itching)

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:

• bone pain or fractures
• enlarged spleen (increased tenderness or swelling in the left upper stomach area)
• signs of kidney injury (puffy face or ankles, blood in the urine or brown-coloured urine, decreased urination)
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• red or purple spots, patches, or lesions on the skin

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

• 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, decreased urine production or need to pass water, difficulty breathing, abdominal swelling, general feeling of tiredness)
• signs of a ruptured spleen (e.g., abdominal pain on the upper left side or pain at the tip of the shoulder)
• signs of a Anaphylaxis (severe allergic reaction) (e.g., Hives, shortness of breath, wheezing, swelling of the face or throat, fast heart rate, dizziness)
• signs of sickle cell crisis (e.g., severe pain in bones, chest, abdomen or joints)

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 Neupogen (Filgrastim).

Single use vials

Each mL of sterile, clear, colourless, preservative-free liquid for parenteral administration contains Neupogen (Filgrastim) 300 µg (3×107 units/mL) formulated in a 10 mM sodium acetate buffer at pH 4.0, containing 5% sorbitol, and 0.004% Tween 80. It is available in single use, preservative-free vials of 1 mL (Neupogen (Filgrastim) 300 µg) and 1.6 mL (Neupogen (Filgrastim) 480 µg).

Pre-filled syringes

Each mL of sterile, clear, colourless, preservative-free liquid for parenteral administration contains Neupogen (Filgrastim) 600 µg (3×107 units/mL) formulated in a 10 mM sodium acetate buffer at pH 4.0, containing 5% sorbitol, and 0.004% Tween 80. It is available in single use, preservative-free pre-filled syringes of 0.5 mL (Neupogen (Filgrastim) 300 µg) and 0.8 mL (Neupogen (Filgrastim) 480 µg). The needle cover on the pre-filled syringe contains dry natural rubber (latex).

Do not take Neupogen (Filgrastim) if you:

• are allergic to Neupogen (Filgrastim) or to any of the ingredients of the medication
• are allergic to products made using the E.coli bacteria
• are allergic to latex (for the pre-filled syringe only)

There may be an interaction between Neupogen (Filgrastim) and any of the following:

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

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 this medication. 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 this medication.

Capillary leak syndrome (CLS): Neupogen (Filgrastim) has been reported to cause CLS, a condition where blood leaks out of the small blood vessels into the tissues of the body. If you experience symptoms of CLS, such as swelling or puffiness, decreased need to urinate, trouble breathing, swelling in the abdominal area, or a general feeling of tiredness, contact your doctor immediately. The symptoms often develop quickly and the severity of each episode is different. In severe episodes, CLS can be fatal.

Chronic use: When used for long periods of time, Neupogen (Filgrastim) may increase the risk of myelodysplasia (bone marrow disorders) and certain types of leukemia. It is not known if this increased risk is directly related to Neupogen (Filgrastim) or to the conditions Neupogen (Filgrastim) is being used to treat. If you are receiving long-term treatment with Neupogen (Filgrastim), your doctor will monitor your blood regularly and check your bone marrow annually.

Cytotoxic chemotherapy: The safety of using Neupogen (Filgrastim) at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Neupogen (Filgrastim) should not be used within 24 hours before or 24 hours after chemotherapy is administered.

Heart conditions: Heart-related conditions such as heart attacks and abnormal heart rhythms have been observed in rare cases with Neupogen (Filgrastim). If you have had a heart condition before starting Neupogen (Filgrastim), discuss with your doctor how Neupogen (Filgrastim) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Neupogen (Filgrastim), and whether any special monitoring is needed.

Lung problems: Neupogen (Filgrastim) may cause adult respiratory distress syndrome (ARDS), a serious lung condition, when people with neutropenia have a bacterial infection in the blood. If you experience difficulty breathing, fever or coughing blood while using Neupogen (Filgrastim), contact your doctor immediately.

Osteoporosis: Long-term use of Neupogen (Filgrastim) may increase the risk of osteoporosis in some people. If you have chronic neutropenia or have osteoporosis, discuss with your doctor how Neupogen (Filgrastim) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Neupogen (Filgrastim), and whether any special monitoring is needed.

Your doctor may want to check your bone density regularly while you are receiving Neupogen (Filgrastim).

Sickle cell disease: Neupogen (Filgrastim) 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 Neupogen (Filgrastim) in these circumstances if you have sickle cell disease.

Pregnancy: Neupogen (Filgrastim) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Neupogen (Filgrastim), contact your doctor immediately.

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

Children: The safety and effectiveness of Neupogen (Filgrastim) have not been established for newborn babies.