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

The following side effects have been reported by at least 1% of people taking Grastofil (Filgrastim). 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.

• cough
• Diarrhea
• fatigue
• headache
• joint swelling and pain
• loss of appetite
• a lump, redness, swelling, or bruising at the injection site
• muscle pain
• sore throat

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

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

• acute respiratory distress syndrome (e.g., fever, shortness of breath, cough, lung congestion)
• bone pain
• enlarged spleen (increased tenderness or swelling in the left upper stomach area)
• inflammation of the blood vessels in the skin
• raised, painful, plum-coloured sores on the limbs, face or neck
• signs of bleeding (such as nosebleeds, blood in the urine, black tarry stools, bleeding gums, coughing or throwing up of blood, easy bruising)

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

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• 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)
• symptoms of a ruptured spleen (e.g., pain in the left upper stomach area or left shoulder tip area)

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 Grastofil (Filgrastim).

300 μg/0.5 mL
Each single-use, pre-filled syringe of sterile, clear, colourless, preservative-free liquid for parenteral administration contains 300 μg of Grastofil (Filgrastim). Nonmedicinal ingredients: sodium acetate buffer, sorbitol, polysorbate 80, and water for injection. The syringe system contains latex.

480 μg/0.8 mL
Each single-use, pre-filled syringe of sterile, clear, colourless, preservative-free liquid for parenteral administration contains 480 μg of Grastofil (Filgrastim). Nonmedicinal ingredients: sodium acetate buffer, sorbitol, polysorbate 80, and water for injection. The syringe system contains latex.

Do not take Grastofil (Filgrastim) if you:

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

There may be an interaction between Grastofil (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 Grastofil (Filgrastim). 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 Grastofil (Filgrastim).

Capillary leak syndrome (CLS): Grastofil (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, Grastofil (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 Grastofil (Filgrastim) or to the conditions Grastofil (Filgrastim) is being used to treat. If you are receiving long-term treatment with Grastofil (Filgrastim), your doctor will monitor your blood regularly and check your bone marrow annually.

Cytotoxic chemotherapy: The safety of using Grastofil (Filgrastim) at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Grastofil (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 Grastofil (Filgrastim). If you have a heart condition before starting Grastofil (Filgrastim), discuss with your doctor how Grastofil (Filgrastim) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Grastofil (Filgrastim), and whether any special monitoring is needed.

Lung problems: Grastofil (Filgrastim) may cause acute respiratory distress syndrome (ARDS), a serious lung condition. It is thought that this is caused by the movement of white blood cells to an area of the lung that is inflamed, as a result of infection. If you experience difficulty breathing, fever, or coughing blood while using Grastofil (Filgrastim), contact your doctor immediately.

Osteoporosis: Long-term use of Grastofil (Filgrastim) may increase the risk of osteoporosis in some people. If you have osteoporosis or chronic neutropenia, discuss with your doctor how Grastofil (Filgrastim) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Grastofil (Filgrastim), and whether any special monitoring is needed. Your doctor may want to check your bone density regularly while you are receiving Grastofil (Filgrastim).

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

Splenic rupture: Using Grastofil (Filgrastim) can cause the spleen to enlarge and in some cases rupture, causing internal bleeding. A ruptured spleen is a medical emergency. Symptoms of a ruptured spleen include pain on the left side of the abdomen, under the rib cage, or pain at the tip of your left shoulder. Other symptoms include symptoms of shock, including lightheadedness or fainting, blurred vision, confusion, anxiety, nausea, or paleness. If you experience any of these, seek immediate medical help.

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

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

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