Pegfilgrastim-pbbk (Subcutaneous)

Pegfilgrastim-pbbk injection is used to treat neutropenia (low white blood cells) caused by cancer medicines. It is a synthetic (man-made) version of a substance that your body naturally produces, called a colony stimulating factor. Pegfilgrastim-pbbk helps the bone marrow produce new white blood cells.

When certain cancer medicines are used to fight cancer cells, they can also lower the number of white blood cells that help fight infections. Pegfilgrastim-pbbk is used to reduce the risk of getting an infection while you are being treated with cancer medicines.

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

It is very important that your doctor checks your or your child's progress during regular visits to ensure 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 experiencing 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 related to 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, itchy skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after receiving 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 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 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 (e.g., 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 (e.g., bone tests) may be affected by this medicine.

In deciding to use a medicine, you and your doctor need to think about the risks of the medicine compared to the benefits it provides. Here are some important points to consider for this medicine:

Allergies

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

Pediatric

Studies to date have not shown any specific problems in children that would limit the use of pegfilgrastim-pbbk injection in the pediatric population. Safety and effectiveness have been confirmed.

Geriatric

Studies to date have not identified any specific problems in older adults that would limit the use of pegfilgrastim-pbbk injection in the elderly.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if interactions might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be required. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, 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 worsen these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor right away 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
• Difficulty 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 happen 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 how 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.

In the U.S.

• Fylnetra

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Pegfilgrastim

Find detailed information on biosimilars for this medication.

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 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. If it is frozen, thaw it in the refrigerator before using it. Throw this medicine away if it has been frozen more than once 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.

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