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Nivestym is the brand name for filgrastim-aafi and is available as an injection for subcutaneous or IV use.

Nivestym is available as one of the following:

• 300 mcg/mL in a single-dose vial
• 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial
• 300 mcg/0.5 mL in a single-dose prefilled syringe
• 480 mcg/0.8 mL in a single-dose prefilled syringe

Nivestym is a colony-stimulating factor and is used for the following:

Prevention of low neutrophil-related complications in:

• People getting bone marrow-suppressing chemotherapy
• People with acute myeloid leukemia (AML) after induction or consolidation chemotherapy
• People with cancer who received bone marrow transplants
• People with severe, long-term neutropenia (low neutrophils)
• Preparation for blood collection for your own stem cell transplant (Neupogen, Nivestym, and Zarxio only)
• Increase survival in people exposed to bone marrow-suppressing radiation (Neupogen only)

Nivestym is a granulocyte colony-stimulating factor (G-CSF). It works like the G-CSF protein that you naturally have in your body. G-CSF stimulates (triggers) your bone marrow to make neutrophils, a type of white blood cell that helps your body fight infections.

Your dose depends on your weight, your blood cell counts, and the condition you’re taking the medication for. In general, the typical starting dose is 5 mcg/kg to 10 mcg/kg of body weight per day. It’s given once or twice per day, depending on why you’re taking it. Nivestym is given as an injection under the skin (subcutaneously) or an injection through the veins (intravenously, IV).

Nivestym is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Common side effects of Nivestym:

• Fever
• Nausea
• Low platelets
• Feeling weak or tired
• Dizziness
• Cough
• Rash
• Shortness of breath
• Chest pain

Serious side effects are rare with Nivestym. Contact your healthcare provider immediately if you experience any of the following.

• Shortness of breath or trouble breathing
• Ruptured spleen: pain in your left upper stomach or shoulder
• Kidney damage: swelling of face or ankles, dark colored urine, blood in urine, urinating less
• Low platelet count: easy bruising, longer bleeding time, blood in urine or stools
• Serious allergic reaction: rash, face swelling, shortness of breath, fast heart rate

There are no major drug interactions listed for Nivestym. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking.

Pfizer

It is not known if Nivestym harms your unborn baby. Nivestym should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping INFLECTRA if you
are pregnant or planning to become pregnant.

• Filgrastim-AAFI