Granix contains the active ingredient tbo-filgrastim, a non-glycosylated recombinant methionyl human granulocyte colony-stimulating factor, also known as r-metHuG-CSF. This medication is available as a sterile, preservative-free solution for injection and comes in prefilled syringes or vials with dosages of either 300 mcg or 480 mcg. Key inactive ingredients include glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and water for injection.

How should I use this medication?

This medication is injected under the skin. It is usually given by your care team in a hospital or clinic setting. It may also 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.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 1 month of age 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?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in the refrigerator. Protect from light. Throw away this medication if it is left out of the refrigerator for more than 5 consecutive days. Throw away any unused medication after the expiration date.

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

• Take the medication to a medication 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

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

• Bone pain
• Diarrhea
• Fever
• Headache
• Muscle pain
• Vomiting

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:

• Bone scan or tests planned
• Kidney disease
• Sickle cell anemia
• An unusual or allergic reaction to tbo-filgrastim, filgrastim, pegfilgrastim, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

This medication may interact with the following:

• 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. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while you are 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.

Do not breastfeed while taking this medication and for 2 weeks after the last dose.