Nyvepria (Subcutaneous)

Pegfilgrastim-apgf 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-apgf helps the bone marrow produce new white blood cells.

Certain cancer medicines can affect the white blood cells that fight infections while they are working to kill cancer cells. Pegfilgrastim-apgf is used to lower the risk of infection during cancer treatment.

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

It is very important for your doctor to check you or your child's progress during regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

If you or your child have pain in the upper left part of the stomach or shoulder pain, contact your doctor immediately. This could be a sign of a serious side effect involving the spleen.

Contact 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 immediately if you or your child develop a fever, chest pain or tightness, fast breathing, or trouble breathing. These could be signs 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. Contact 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 immediately 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. Avoid 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. Contact 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 (for example, myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer. Contact 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). Contact 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 (for example, bone imaging tests).

In deciding to use a medicine, you and your doctor will need to weigh the risks against the benefits of the medicine. For this medicine, consider the following:

Allergies

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

Pediatric

Studies done so far have not shown any pediatric-specific problems that would limit the use of pegfilgrastim-apgf injection in children.

Geriatric

Studies done so far have not shown any geriatric-specific problems that would limit the use of pegfilgrastim-apgf in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential 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 an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Bone marrow problems (e.g., 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 worsen these conditions.

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

• 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.

• Nyvepria

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 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.

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