Pegfilgrastim Solution for injection

What is this medicine?

PEGFILGRASTIM (PEG fil gra stim) is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, a type of white blood cell 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, and to increase survival after being exposed to high doses of radiation.

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

• skin reactions to acrylic adhesives (On-Body Injector only)

• an unusual or allergic reaction to pegfilgrastim, filgrastim, 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. If you get this medicine at home, you will be taught how to prepare and give the pre-filled syringe or how to use the On-body Injector. Refer to the patient Instructions for Use for detailed instructions. 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 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 your dose. If you miss a dose due to an On-body Injector failure or leakage, a new dose should be administered as soon as possible using a single prefilled syringe for manual use.

What may interact with this medicine?

Interactions have not been studied.

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.

If you are going to need a MRI, CT scan, or other procedure, tell your doctor that you are using this medicine (On-Body Injector only).

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

• fever

• pain, redness, or irritation at site where injected

• pinpoint red spots on the skin

• red or dark-brown urine

• shortness of breath or breathing problems

• stomach or side pain, or pain at the shoulder

• swelling

• tiredness

• trouble passing urine or change in the amount of urine

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

• 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 pre-filled syringes 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 it is left out of the refrigerator for more than 48 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.