Filgrastim Solution for injection

What is this medicine?

FILGRASTIM, G-CSF (fil GRA stim) is a granulocyte colony-stimulating factor that stimulates the growth of neutrophils, a type of white blood cell (WBC) important in the body’s fight against infection. It is used to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow, to stimulate blood cell production for removal of WBCs from the body prior to a bone marrow transplantation, to reduce the incidence of fever and infection in patients who have severe chronic neutropenia, and to improve survival outcomes following high-dose radiation exposure that is toxic to the bone marrow.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease

• latex allergy

• ongoing radiation therapy

• sickle cell disease

• an unusual or allergic reaction to filgrastim, pegfilgrastim, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin or infusion into a vein. As an infusion into a vein, it is usually given by a health care professional in a hospital or clinic setting. If you get this medicine at home, you will be taught how to prepare and give this medicine. Refer to the Instructions for Use that come with your medication packaging. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 7 months for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you miss a dose.

What may interact with this medicine?

This medicine may interact with the following medications:

• medicines that may cause a release of neutrophils, such as lithium

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dizziness or feeling faint

• fever

• pain, redness, or irritation at site where injected

• pinpoint red spots on the skin

• shortness of breath or breathing problems

• signs and symptoms of kidney injury like trouble passing urine, change in the amount of urine, or red or dark-brown urine

• stomach or side pain, or pain at the shoulder

• swelling

• tiredness

• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone pain

• headache

• muscle pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Keep in carton to protect from light. Throw away this medicine if vials or syringes are left out of the refrigerator for more than 24 hours. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.