Pronunciation:

tee-boe - fil-GRA-stim

Brand Names:

• Granix

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Colony Stimulating Factor

Uses of This Medicine:

Tbo-filgrastim injection is used to treat severe neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in the body called a colony stimulating factor. Tbo-filgrastim helps the bone marrow to make new white blood cells.

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Tbo-filgrastim is used to prevent or reduce the risk of infection while you are being treated with cancer medicines.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tbo-filgrastim injection in children younger than 1 month of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tbo-filgrastim injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glomerulonephritis (kidney disease) or
• Leukocytosis (high white blood cell count) or
• Lung disease or breathing problems or
• Sickle cell disease (red blood cell disease), history—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin (usually in the abdomen, front of the middle thighs, upper outer areas of the buttocks, or upper back portion of the upper arms).

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection can be stored at home.

This medicine is available in two forms: a vial (glass container) or a prefilled syringe. These are the dosage forms that you can use at home.

Allow the medicine to warm to room temperature for 30 minutes before you inject it. If the liquid in the syringe or vial has changed color, looks cloudy, or if you see particles in it, do not use it. Do not shake the syringe or vial.

Each syringe or vial of medicine is good for only one dose. Throw the syringe or vial away after your dose. Do not save unused medicine from an opened syringe or vial.

You should not use this medicine within 24 hours (1 day) before or after receiving cancer medicine or radiation treatments. Also do not use it within 24 hours before you begin another dose of chemotherapy.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form:
  • For neutropenia:
    • Adults and children 1 month of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 microgram per kilogram (mcg/kg) of body weight injected under the skin per day.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep this medicine in its original container until you are ready to use it. You may store it at room temperature for up to 5 days, and if not used can be returned to the refrigerator. Throw away any unused medicine that has been left at room temperature for more than 5 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away at the first sign of an infection, such as fever, chills, cough, sore throat, or unusual tiredness or weakness.

Check with your doctor right away if you or your child have pain in the upper left part of your stomach or at the tip of the left shoulder. These could be symptoms of a serious condition with the spleen.

Check with your doctor right away if you or your child have a fever, chest pain or tightness, or trouble breathing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after using the medicine.

This medicine may cause kidney problems. Call your doctor right away if you or your child have swelling in your face or ankles, blood in the urine, or a decrease in how much or how often you urinate.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you or your child have swelling or puffiness, urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

This medicine may cause aortitis (inflammation of the aorta, the largest artery in the body). Check with your doctor right away if you have fever, stomach pain, unusual tiredness or weakness, or back pain.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, bone-imaging test).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

bone pain

fever

pinpoint red spots on the skin

unusual bleeding or bruising

Rare

Chills

cough

eye pain

general feeling of illness

headache

sore throat

unusual tiredness

Incidence not known

Blisters or fever sores on the skin

bloody or cloudy urine

chest pain or tightness

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

pain in the upper left part of the stomach or at the tip of the left shoulder

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

trouble breathing

unusual weakness

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

pain in the arms or legs

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.