Pronunciation:

peg-fil-GRA-stim - apgf

Brand Names:

• Nyvepria

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Pegfilgrastim

Uses of This Medicine:

Pegfilgrastim-apgf 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-apgf 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-apgf is used to 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegfilgrastim-apgf 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-apgf 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 problems (eg, bone marrow cancer, myelodysplasia) 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)—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 outer arm, upper outer buttock, stomach, or thigh.

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 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 this medicine to warm to room temperature for 30 minutes before using it.

Check the liquid in the prefilled syringe. Do not use the medicine if the liquid is cloudy, discolored, or has flakes or particles in it. Do not shake.

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

Do not use this medicine between 14 days before and 24 hours after receiving cancer 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 (solution):
  • To increase white blood cell count:
    • Adults—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 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.

Keep this medicine in its original carton. Throw away any medicine stored at room temperature for more than 15 days. If frozen, thaw it in the refrigerator before using. Throw away any medicine if it has been frozen more than once.

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 and urine tests may be needed to check for unwanted effects.

If you or your child have left upper stomach pain or shoulder 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, including 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, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may increase the risk of having sickle cell crises, especially in patients with sickle cell disease. Check with your doctor right away if you have pain in the arms, legs, chest, or lower back, extreme tiredness or weakness, yellow skin, or difficulty breathing.

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 a 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 imaging 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

Bone pain

pain in the arms or legs

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

blue lips, fingernails, or skin

chest pain or tightness

chills

cloudy urine

cough

decrease or increase in the amount of urine

difficult or fast breathing

difficulty swallowing

dizziness

eye pain

fainting

fast heartbeat

fever

fever sores or blisters on the skin

general feeling of illness

headache

hives, itching, skin rash

lightheadedness

lower back or side pain

nausea

pain spreading to the left shoulder

painful or difficult urination

pinpoint red spots on the skin

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

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

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

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

yellow skin

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.