Fulphila (Subcutaneous)

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

Certain cancer medicines target cancer cells but can also impact the white blood cells that fight infections. Pegfilgrastim-jmdb is used to lower the risk of infection while you are receiving cancer treatments.

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

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

If you or your child have pain in the left upper stomach or shoulder, contact your doctor right away. This could be a sign of a serious side effect related to the spleen.

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

Call your doctor right away 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. 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 receiving the medicine.

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

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 get 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 have 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, a feeling of fullness, dizziness, or feeling faint.

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.

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 (e.g., bone tests).

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Current studies have not shown any specific issues in children that would limit the use of pegfilgrastim-jmdb injection in the pediatric population.

Geriatric

Current studies have not shown any specific issues in older adults that would limit the use of pegfilgrastim-jmdb in the elderly.

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 other precautions may be needed. Let your healthcare professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell 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 intended effects, this medicine may 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:

Rare

• Chills
• Cough
• Eye pain
• Fever
• General feeling of illness
• Headache
• Sore throat
• Unusual tiredness

Incidence not known

• Back pain
• 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
• Bloody or cloudy urine
• Blue lips, fingernails, or skin
• Chest pain
• Decrease or increase in the amount of urine
• Difficult or fast breathing
• Dry, red, hot, or irritated skin
• Fainting or lightheadedness
• Fast heartbeat
• Feeling of fullness
• Fever sores or blisters on the skin
• Hives, itching, skin rash
• Hoarseness
• Irritation
• Joint pain, stiffness, or swelling
• Lower back or side pain
• Nausea
• Painful or difficult urination
• Pain spreading to the left shoulder
• Pinpoint red spots on the skin
• Redness of the skin
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach pain
• Swelling of the eyelids, face, lips, hands, or feet
• Swollen glands
• Trouble breathing or swallowing
• Unusual bleeding or bruising
• Weight gain

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

Symptoms of overdose

• Bone pain
• Chest pain or tightness
• Difficult or labored breathing
• Swelling

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 lessen 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

• Bone, arm, or leg pain

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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Fulphila

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 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 the medicine to warm to room temperature for 30 minutes 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.

Use the syringe only once. Do not save leftover 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 72 hours. 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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