Fulphila (Pegfilgrastim-jmdb Subcutaneous)

Generic name: Pegfilgrastim-jmdb
Drug class: Colony stimulating factors

Usage of Fulphila (Pegfilgrastim-jmdb Subcutaneous)

Pegfilgrastim-jmdb 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-jmdb 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-jmdb 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.

Fulphila (Pegfilgrastim-jmdb Subcutaneous) side effects

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:

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 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

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

Before taking Fulphila (Pegfilgrastim-jmdb Subcutaneous)

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegfilgrastim-jmdb injection in the pediatric population.

Geriatric

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

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

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How to use Fulphila (Pegfilgrastim-jmdb Subcutaneous)

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.

Warnings

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, 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, 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 you receive 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 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).

Disclaimer

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