Filgrastim-sndz (Intravenous, Subcutaneous)

Filgrastim-sndz 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, known as a colony stimulating factor. Filgrastim-sndz helps the bone marrow produce new white blood cells.

When certain cancer medicines are used to kill cancer cells, they can also affect the white blood cells that help fight infections. Filgrastim-sndz is used to prevent or lower the risk of infections during cancer treatment. This medicine is also used to assist the bone marrow in recovering after a bone marrow transplantation and for a process called peripheral blood progenitor cell collection in cancer patients.

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

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

Contact your doctor right away at the first sign of an infection, including fever, chills, cough, sore throat, or unusual tiredness or weakness.

Contact 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 indicate a serious side effect involving the spleen.

Contact your doctor immediately if you or your child develop a fever, chest pain or tightness, or have 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 needs immediate medical attention. Inform 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 lead to kidney problems. Contact your doctor right away if you or your child experiences swelling in the face or ankles, blood in the urine, or a decrease in how much or how often you urinate.

This medicine may cause bleeding in the lungs. Contact your doctor immediately if you or your child coughs up blood or has blood in your sputum (spit).

This medicine may cause a condition called capillary leak syndrome, which can result in fluid leaking from blood vessels into your body’s tissues. Contact 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 born with low white blood cells (congenital neutropenia) or in patients with breast or lung cancer. Contact your doctor immediately 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.

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 aortitis (inflammation of the aorta, the largest artery in the body). Contact your doctor immediately if you have fever, stomach pain, unusual tiredness or weakness, or back pain.

Before you undergo any medical tests, inform the medical doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may trigger allergic reactions in individuals sensitive to latex. Inform your doctor if you have a latex allergy before starting this medicine.

In deciding to use a medicine, it is important to consider the risks of taking it against the benefits it may provide. This decision will be made together with your doctor. For this medicine, you should 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 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 conducted so far have not shown any specific problems in children that would limit the use of filgrastim-sndz injection. Its safety and effectiveness have been confirmed in children with severe chronic neutropenia.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the use of filgrastim-sndz injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a possibility of an interaction. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Vincristine
• Vincristine Sulfate Liposome

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or 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 problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Bleeding problems or
• Cutaneous vasculitis (skin disorder) 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. This may worsen these conditions.

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

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blood in your sputum
• chest pain or tightness
• cloudy urine
• cough
• coughing up blood
• decrease in how much or how often you urinate
• decrease or increase in the amount of urine
• difficulty with swallowing
• dizziness
• fainting or lightheadedness
• fast heartbeat
• fever
• hives, itching, or rash
• nausea
• pain spreading to the left shoulder
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• stomach pain
• swelling in your face, ankles, feet, or lower legs
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Chills
• lower back or side pain
• painful or difficult urination
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands

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

• Back pain
• bone pain
• decreased appetite
• difficulty having a bowel movement (stool)
• difficulty with moving
• dizziness
• hair loss or thinning of the hair
• muscle pain or stiffness
• pain in the joints
• rash

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.

Pharmacologic Class: Filgrastim

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 your skin or into a vein.

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. You will also 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 have scars or stretch marks.

This medicine comes with 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.

Start using the medicine 24 hours or more after you finish chemotherapy. However, do not use it within 24 hours before you begin another chemotherapy session.

Allow the medicine to warm to room temperature for at least 30 minutes before you inject it. If the liquid in the prefilled syringe has changed color, looks cloudy, or if you see particles in it, do not use it.

Check the liquid in the prefilled syringe. It should be clear and colorless to slightly yellowish. Do not use it if it is cloudy, discolored, or has particles in it.

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

If you use the prefilled syringe, make sure you know how to use the needle guard. After giving an injection, slide the needle guard forward over the needle until you hear a "click." The needle guard will safely cover the used needle.

Each syringe of medicine is good for only one dose. Throw the syringe away after your dose. Do not save unused medicine from an opened vial or syringe. Do not shake the 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):
• Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 10 microgram per kilogram (mcg/kg) of body weight injected under the skin per day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.

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 the medicine in the original container to protect it from light. If it is frozen, thaw it in the refrigerator before using it. Throw this medicine away if it has been left at room temperature for longer than 24 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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