Pronunciation:

peg-fil-GRA-stim

Brand Names:

• Fulphila
• Fylnetra
• Neulasta
• Nyvepria
• Stimufend
• Udenyca
• ZIEXTENZO

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Colony Stimulating Factor

Uses of This Medicine:

Pegfilgrastim 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 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 is used to reduce the risk of infection while you are being treated with cancer medicines. It is also used 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 pegfilgrastim injection in the pediatric population.

Older adults—

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

• Sepsis (serious infection)—There have been reports of acute respiratory distress syndrome (ARDS) in patients who had a serious infection and were receiving a similar medicine called filgrastim.

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.

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine may be given in 2 ways: a single prefilled syringe for manual use or for use with the On-body Injector for Neulasta® use.

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.

If you have any questions about any of these, check with your doctor.

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 treatment.

Allow the medicine to warm to room temperature before you inject it. If the medicine in the prefilled syringe has changed color, looks cloudy, or if you see particles in it, do not use it. Do not shake the syringe. Use the syringe only once. Do not save leftover medicine.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause an allergic reaction in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this 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:
  • To increase white blood cell count:
    • Adults—6 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
    • Children weighing more than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. It is usually 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 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.

Neulasta® single-use prefilled syringe: 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. Keep it away from heat or direct light. The medicine can stay out of the refrigerator for up to 48 hours. Discard any medicine that has been out of the refrigerator for more than 48 hours.

Neulasta® Onpro™ kit: Leave the medicine in the carton until you are ready to use it. You may let the medicine warm up to room temperature before you use it. Keep it away from heat or direct light. The medicine can stay out of the refrigerator for up to 12 hours. Discard any medicine that has been out of the refrigerator for more than 12 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 you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you or your child have left upper stomach pain or shoulder tip pain, contact your doctor right away. This could be a symptom of a serious side effect with the spleen.

Check with your doctor right away at the first sign of any infection such as fever, chills, cough, sore throat, or redness, swelling, or pain around a cut or sore.

Check with your doctor right away if you or your child develop a fever, chest pain or tightness, fast breathing, 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. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

You should not use this medicine for 14 days before and up to 24 hours after you receive cancer medicines.

If you are receiving this medicine via the On-body Injector (OBI) for Neulasta®:

• Tell your doctor if you have an allergy to acrylic adhesives.
• Keep the injector at least 4 inches away from electrical equipment, such as cell or cordless phones, microwaves, and other appliances.
• Do not use hot tubs or saunas while you are wearing the injector. Do not expose the injector to sunlight. Do not sleep on the injector. Call your doctor if the injector comes off before or during a dose.
• Keep the injector dry at least 3 hours before the dose is scheduled to start. This will help you notice any leaks. Call your doctor if the bandage becomes wet or the medicine is dripping.
• The injector is programmed to deliver your dose about 27 hours after it is placed on your skin. It will take about 45 minutes for the dose to be given. Avoid activities, such as driving and traveling, that may interfere with the injector 1 hour before the dose starts, while it is being given, and for at least 1 hour afterward. You must have a caregiver nearby for your first dose.
• You should avoid airport X-ray scans and request a manual pat down instead.
• You should avoid sleeping on the OBI for Neulasta® or applying pressure on the OBI for Neulasta®. Doing so may prevent the OBI from working properly.
• You should avoid getting body lotions, creams, oils, and cleaning agents near the OBI for Neulasta® as these products may loosen the adhesive that holds the OBI into your body.

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

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 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 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 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 tests).

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

Chills

cough

fever

sore throat

ulcers, sores, or white spots in the mouth

Rare

Bluish lips or skin

pain, left upper abdomen or shoulder

tightness in the chest

trouble breathing

Incidence not known

Black, tarry stools

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

blisters in the skin

blood in the urine or stools

chest pain

cloudy urine

decrease in how much or how often you urinate

difficulty with swallowing

dizziness

fainting or lightheadedness

fast heartbeat

flushing or redness of the skin

hives or welts, skin rash

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

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lower back or side pain

nausea

painful or difficult urination

pinpoint red spots on the skin

sores on the skin

stomach pain

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

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

unusually warm skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bone pain

chest pain

difficult or labored breathing

eye pain

general feeling of illness

headache

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

Belching

change in sense of taste

constipation

cracked lips

diarrhea

hair loss or thinning of the hair

heartburn

indigestion

joint pain

lack or loss of strength

loss of appetite

muscle soreness

swelling or inflammation of the mouth

trouble sleeping

vomiting

weakness, generalized

weight loss

Incidence not known

Body produces substance that can bind to drug making it less effective or cause side effects

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.