Zarxio

The maximum tolerated dose of filgrastim products has not been determined. In filgrastim clinical trials of patients with cancer receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm3 have been reported in less than 5% of patients‚ but were not associated with any reported adverse clinical effects. Patients in the BMT studies received up to 138 mcg/kg/day without toxic effects‚ although there was a flattening of the dose response curve above daily doses of greater than 10 mcg/kg/day.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

• Store Zarxio in the refrigerator. Do not freeze Zarxio.
• Zarxio may be stored at room temperatore for up to 24 hours. Discard Zarxio that has been at room temperature longer than 24 hours.
• Throw away the prefilled syringe after you administer a dose, even if medication is left in the syringe.
• Keep this and all medications out of the reach fo children.

You should not use this medicine if you are allergic to filgrastim or pegfilgrastim, or to other medicines that contain the E. coli bacteria.

To make sure filgrastim is safe for you, tell your doctor if you have:

• a blood cell disorder, such as sickle cell anemia;

• kidney disease;

• latex allergy; or

• if you are receiving chemotherapy or radiation treatment.

It is not known whether filgrastim will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether filgrastim passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use the missed dose as soon as you remember, but not within the 24-hour period before or after you receive chemotherapy treatment. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Filgrastim 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. Filgrastim 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. Filgrastim is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. This medicine is also used to help the bone marrow recover after a bone marrow transplantation, for a process called peripheral blood progenitor cell collection in cancer patients, and to improve survival in cancer patients who have been exposed to radiation.

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

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:

• Abdominal or stomach pain
• 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
• blood in the urine or stools
• bloody nose
• cough
• coughing up blood
• diarrhea
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• facial swelling
• feeling of fullness
• fever or chills
• headache
• increased menstrual flow or vaginal bleeding
• lower back or side pain
• nausea or vomiting
• nosebleeds
• pain in the back, ribs, arms, or legs
• pain spreading to the left shoulder
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red or purple spots on the skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

• Blurred vision
• chest pain
• nervousness
• pounding in the ears
• slow or fast heartbeats

• Blisters on the skin
• blue lips, fingernails, or skin
• difficult or fast breathing
• sores on the skin

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:

• Bone, joint, or muscle pain
• hair loss or thinning of the hair
• loss of appetite
• weight loss

• Cracked lips
• difficulty having a bowel movement (stool)
• swelling or inflammation of the mouth

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.

• It is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo.
• It is used to raise the number of white blood cells in certain patients.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to filgrastim or any other part of Zarxio (filgrastim-sndz injection).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Zarxio. This includes your doctors, nurses, pharmacists, and dentists.
• Do not get this medicine at the same time or within 24 hours before or after chemo or radiation treatment. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Zarxio.
• This medicine may cause a very bad and sometimes deadly problem called capillary leak syndrome (CLS). CLS may lead to low blood pressure and harm to the body. It may also lead to a heartbeat that is not normal, chest pain or pressure, heart attack, lung or breathing problems, bleeding or lower blood flow in the stomach or bowel, kidney problems, swelling, or feeling confused. Talk with the doctor.
• Some people with sickle cell disease have had times where the sickle cell disease has gotten worse when taking this medicine. Sometimes, this has been deadly. Talk with the doctor.
• If you have a latex allergy, talk with your doctor. Some products have latex.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Zarxio while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Zarxio®

(filgrastim-sndz)

Injection

For Subcutaneous Use or

Intravenous Use Only

Single-Dose Only

1 prefilled syringe with a needle guard

300 mcg/0.5 mL

NDC 61314-304-01

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF)

derived from E Coli.

No Preservative.

Refrigerate. Protect from freezing.

Caution: Contains Natural Rubber Latex

Which May Cause Allergic Reaction.

Rx only

SANDOZ

a Novartis company

Zarxio is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. Do not use this medicine if you have had a serious allergic reaction to human G-CSFs such as filgrastim or pegfilgrastim products.

Before you start treatment, tell your doctor about all of your medical conditions, including if you:

• have a sickle cell disorder.
• are receiving radiation therapy.
• are allergic to latex. The needle cap on the prefilled syringe contains natural rubber (derived from latex). Do not handle the prefilled syringe if you are allergic to latex.
• are pregnant or plan to become pregnant. It is not known if this medication will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if this medication passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Zarxio may cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.
• A serious lung problem called acute respiratory distress syndrome (ARDS). Call your doctor or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
• Serious allergic reactions. Zarxio can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Zarxio and call your doctor or get emergency medical help right away.
• Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take Zarxio. Serious sickle cell crises has happened in people with sickle cell disorders receiving filgrastim, that has sometimes led to death. Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Capillary leak syndrome. Zarxio can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening.
  Get emergency medical help right away if you develop any of the following symptoms:
  • swelling or puffiness and are urinating less often
  • trouble breathing
  • swelling of your stomach-area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness
• Decreased platelet count (thrombocytopenia). Your doctor will check your blood during treatment. Tell your doctor if you have unusual bleeding or bruising during treatment. This could mean a decrease of platelets, which reduces the ability of blood to clot.
• Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment.
• Inflammation of your blood vessels (cutaneous vasculitis). Tell your doctor if you develop purple spots or redness of your skin.

The most common side effects include aching in the bones and muscles.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.