Pronunciation:

peg-fil-GRA-stim - fpgk

Brand Names:

• Stimufend

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Pegfilgrastim

Uses of This Medicine:

Pegfilgrastim-fpgk 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. Pegfilgrastim-fpgk 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. Pegfilgrastim-fpgk is used to lower the risk of getting an 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegfilgrastim-fpgk injection in the pediatric population. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegfilgrastim-fpgk 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:

• Bone marrow cancer or other bone marrow problems 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 the skin of your upper arm, upper outer buttock, stomach, or thigh. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use it.

If you use this medicine at home, you will 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 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.

Allow the medicine to warm to room temperature for 30 minutes before using it. Do not warm it by using a heat source (eg, hot water or microwave) or in any other way. Do not shake.

Check the liquid in the prefilled syringe. It should be clear and colorless. Do not use it if it is cloudy, discolored, or has flakes or particles in it.

Use the syringe only once. Do not save leftover medicine.

Do not use this medicine between 14 days before and 24 hours after receiving 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 (solution):
  • For neutropenia:
    • Adults and children weighing more than 45 kilograms (kg)—6 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
    • Children weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
      • Weighing 31 kg to 44 kg—4 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
      • Weighing 21 kg to 30 kg—2.5 mg as a single injection under the skin once every cancer treatment cycle.
      • Weighing 10 kg to 20 kg—1.5 mg as a single injection under the skin once every cancer treatment cycle.
      • Weighing less than 10 kg—0.1 mg per kg of body weight as a single injection under the skin once every cancer treatment cycle.

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.

Protect from light. Throw this medicine away if it has been frozen or if it has been left at room temperature for longer than 72 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, including fever, chills, cough, sore throat, or unusual tiredness or weakness.

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 serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.

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 or your child 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.

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.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests (eg, bone 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

Bone pain

pain in the arms or legs

Incidence not known

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

blue lips, fingernails, or skin

blurred vision

change in the amount of urine

chest pain or tightness

chills

cloudy or bloody urine

cough

difficult or fast breathing

difficulty swallowing

dizziness

eye pain

fainting or lightheadedness

fast heartbeat

feeling of fullness

fever

fever sores on the skin

general feeling of discomfort or illness

headache

hives, itching, skin rash

lower back or side pain

nausea

nervousness

pain spreading to the left shoulder

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

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

redness of the skin

slow or fast heartbeat

sore throat

sores, welts, or blisters

stomach pain

swelling of the hands, ankles, feet, or lower legs

trouble breathing

ulcers or white spots on the lips or in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

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:

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

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.