Filgrastim-aafi (Intravenous, Subcutaneous)

Filgrastim-aafi 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. Filgrastim-aafi helps the bone marrow produce new white blood cells.

When some cancer medicines fight cancer cells, they can also affect the white blood cells that protect against infections. Filgrastim-aafi is used to prevent or lower the risk of infections while you are receiving cancer treatment. This medicine is also used to help the bone marrow recover after a bone marrow transplant, 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 that your doctor check your or your child's progress at regular visits to make sure 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, such as fever, chills, cough, sore throat, or unusual tiredness or weakness.

Check with your doctor right away if you or your child are having 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 with 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 requires immediate medical attention. Tell your doctor right away if you or your child has a rash, itching skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive 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 decrease in how much or how often you urinate.

This medicine may cause bleeding in the lungs. Check with your doctor right away if you or your child cough up blood or have blood in your sputum (spit).

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 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 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.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, the following points should be thought about:

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 types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research conducted so far has not shown any specific problems in children that would limit the usefulness of filgrastim-aafi injection. Its safety and effectiveness have been established in children with severe chronic neutropenia.

Geriatric

Research conducted so far has not shown any specific problems in the elderly that would limit the usefulness of filgrastim-aafi injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking 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 despite potential interactions. In these situations, your doctor might adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

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

• Vincristine
• Vincristine Sulfate Liposome

Interactions with Food/Tobacco/Alcohol

Certain 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 result in 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 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. 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
• Bladder pain
• Bleeding gums
• Blood in the urine or stools
• Blurred vision
• Body aches or pain
• Bone pain
• Chest pain or tightness
• Chills
• Cloudy urine
• Confusion
• Cough
• Cough producing mucus
• Difficult, burning, or painful urination
• Difficulty or trouble breathing
• Difficulty in moving
• Dizziness
• Ear congestion
• Fainting
• Fast heartbeat
• Fever
• Frequent urge to urinate
• Headache
• Hives, itching, skin rash
• Hoarseness
• Irritation
• Joint pain, stiffness or swelling
• Lightheadedness
• Loss of voice
• Lower back or side pain
• Muscle pain or stiffness
• Nervousness
• Pain in the arms or legs
• Painful or difficult urination
• Pale skin
• Pinpoint red spots on the skin
• Pounding in the ears
• Rapid, shallow breathing
• Redness of the skin
• Runny or stuffy nose
• Slow or fast heartbeat
• Sneezing
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swelling of the eyelids, face, lips, hands, or feet
• Trouble swallowing
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Nausea
• Nosebleed
• Vomiting

Incidence not known

• Blisters on the skin
• Blue lips, fingernails, or skin
• Coughing up blood
• Decrease in height
• Decrease or increase in the amount of urine
• Eye pain
• Fast breathing
• Feeling of fullness
• Fever sores on the skin
• General feeling of illness
• Pain in the ribs
• Pain spreading to the left shoulder
• Stomach pain
• Swollen glands
• Weight gain

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

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Constipation
• Decreased appetite
• Diarrhea
• General feeling of discomfort or illness
• Hair loss or thinning of hair
• Lack or loss of strength
• Mouth or throat pain
• Trouble sleeping

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 has 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 your chemotherapy. However, do not use it within 24 hours before you begin another chemotherapy.

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

Do not shake the prefilled syringe. Use the syringe or vial 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 or vial of medicine is good for only one dose. Throw the syringe or vial 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):For neutropenia: 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.

Do not leave this medicine in direct sunlight. 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 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.

• What biosimilars have been approved in the United States?
• What is the difference between Nivestym and Neupogen?