Nivestym is a medication that contains the active ingredient filgrastim-aafi, a form of human granulocyte colony-stimulating factor. It is available as a clear, colorless liquid for subcutaneous or intravenous administration, supplied in single-dose vials and prefilled syringes with dosages of either 300 mcg or 480 mcg. The formula is non-glycosylated due to its production in bacteria, and its pH ranges from 3.8 to 4.3.

How should I use this medication?

This medication is injected under the skin or into a vein. It is usually given by your care team in a hospital or clinic setting. It may be given at home. If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

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 care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children 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 any doses. Talk to your care team about what to do if you miss a dose.

Where should I keep my medication?

Keep out of the reach of children and pets.

Keep this medication in the original packaging until you are ready to take it. Protect from light. See product for storage information. Each product may have different instructions. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medications take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
• High white blood cell level—fever, fatigue, trouble breathing, night sweats, change in vision, weight loss
• Inflammation of the aorta—fever, fatigue, back, chest, or stomach pain, severe headache
• Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet
• Shortness of breath or trouble breathing
• Spleen injury—pain in upper left stomach or shoulder
• Unusual bruising or bleeding

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

• Back pain
• Bone pain
• Fatigue
• Fever
• Headache
• Nausea

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.

What should I tell my care team before I take this medication?

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

• History of blood diseases, such as sickle cell anemia
• Kidney disease
• Recent or ongoing radiation
• An unusual or allergic reaction to filgrastim, pegfilgrastim, latex, rubber, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Medications 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 medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need bloodwork while taking this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.