Grastofil

The recommended starting dose of Grastofil (Filgrastim) is based on body weight and varies depending on the condition being treated. For people who are being treated with chemotherapy, treatment should start no sooner than 24 hours after the chemotherapy has been given.

Grastofil (Filgrastim) is given by subcutaneous (under the skin) or intravenous (into a vein) injection once daily. Your dose may be adjusted depending on your response to Grastofil (Filgrastim), and therapy is usually continued until neutrophil counts reach an acceptable level. For some conditions, Grastofil (Filgrastim) will be needed indefinitely.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Grastofil (Filgrastim) is usually given under medical supervision. If you are giving Grastofil (Filgrastim) to yourself, your doctor or health care professional will instruct you on how to use Grastofil (Filgrastim) properly. It is important that Grastofil (Filgrastim) be used exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you are receiving Grastofil (Filgrastim) in a clinic or at your doctor’s office and you miss an appointment to receive Grastofil (Filgrastim), contact your doctor as soon as possible to reschedule your appointment.

Store Grastofil (Filgrastim) in the refrigerator, but do not allow it to freeze. Avoid shaking Grastofil (Filgrastim). Store it in the carton it is packaged in to protect it from light. Grastofil (Filgrastim) may be stored out of the refrigerator, at room temperature, for a single period of up to 7 days. Keep Grastofil (Filgrastim) out of the reach of children. Do not use Grastofil (Filgrastim) if it is cloudy or there are particles in it.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause joint pain; it may cause bone pain; it may cause redness and swelling at the injection site; it may cause nosebleeds. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

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.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Generally, a treatment with this medication lasts several days. Use it for the entire time prescribed in order to achieve the medication's full benefit. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.