Pronunciation:

fil-GRA-stim

Brand Names:

• Neupogen
• Nivestym
• Zarxio

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Colony Stimulating Factor

Uses of This Medicine:

Filgrastim injection is used to treat 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 your body called a colony stimulating factor. 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. Filgrastim is used to prevent or reduce the risk of infections while you are being treated with cancer medicines. This medicine is also used to help the bone marrow recover after a bone marrow transplantation, for a process called peripheral blood progenitor cell collection in cancer patients, and to improve survival in cancer patients who have been exposed to radiation.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of filgrastim injection in children. However, safety and efficacy have not been established in infants younger than 1 month of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Vincristine
• Vincristine Sulfate Liposome

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:

• Bleeding problems or
• Cutaneous vasculitis (skin disorder) or
• Glomerulonephritis (kidney disease) or
• Leukocytosis (high white blood cell count) or
• Lung disease or breathing problems or
• Sickle cell disease (red blood cell disease) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional may give you this medicine. It is given as a shot under your skin or into a vein.

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. You will also be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, hard, or has scars or stretch marks.

This medicine comes with 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.

Start using the medicine 24 hours or more after you finish your chemotherapy. However, do not use it within 24 hours before you begin another chemotherapy.

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

Do not shake the prefilled syringe. Use the syringe or vial only once. Do not save leftover medicine.

If you use the prefilled syringe, make sure you know how to use the needle guard. After giving an injection, slide the needle guard forward over the needle until you hear a "click." The needle guard will safely cover the used needle.

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 vial or syringe. Do not shake the medicine.

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—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 10 microgram per kilogram (mcg/kg) of body weight injected under the skin per day. Your doctor may adjust your dose as needed.
    • Infants 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.

Leave the medicine in the carton until you are ready to use it. If you accidentally freeze the medicine, let it thaw out in the refrigerator before you use it. If you accidentally freeze the medicine a second time, do not use it.

You may let the medicine warm up to room temperature before you use it. The medicine can stay out of the refrigerator for up to 24 hours. Discard any medicine that has been out of the refrigerator for more than 24 hours.

Throw away used needles in a hard, closed container where 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.

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 has a rash, itching skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

Check with your doctor right away if you or your child are having pain in the upper left part of your stomach or at the tip of the left shoulder. This could be a symptom of a serious side effect with the spleen.

Check with your doctor right away if you or your child develop 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 bleeding in the lungs. Check with your doctor right away if you or your child cough up blood or have blood in your sputum (spit).

This medicine may cause blood or bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer. Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause kidney problems. Call your doctor right away if you or your child has swelling in your face or ankles, blood in the urine, or 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 have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor right away if you or your child has black or tarry stools, bleeding gums, blood in the urine or stools, pinpoint red spots on the skin, or unusual bleeding or bruising after receiving this medicine.

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.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex). This may cause an allergic reaction in people who are sensitive to latex. Tell your doctor if you or your child has a latex allergy before you start using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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 immediately if any of the following side effects occur:

More common

Bleeding gums

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

blood in the urine or stools

bloody nose

chills

cough

coughing up blood

diarrhea

difficult or labored breathing

difficulty with swallowing

dizziness

facial swelling

feeling of fullness

fever

headache

increased menstrual flow or vaginal bleeding

lower back or side pain

nausea

nosebleeds

pain in the back, ribs, arms, or legs

pain spreading to the left shoulder

painful or difficult urination

pale skin

paralysis

pinpoint red or purple spots on the skin

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

skin rash

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach pain

tightness in the chest

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

Blurred vision

chest pain

nervousness

pounding in the ears

slow or fast heartbeat

Incidence not known

Blisters on the skin

blue lips, fingernails, or skin

difficult or fast breathing

sores on the skin

swollen glands

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

Bone, joint, or muscle pain

hair loss or thinning of the hair

loss of appetite

weight loss

Less common

Cracked lips

difficulty having a bowel movement

swelling or inflammation of the mouth

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.