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Nypozi (filgrastim-txid) is a subcutaneous injection or IV infusion used to prevent complications of low neutrophil levels.

Nypozi is available as a 300 mcg/0.5 mL or 480 mcg/0.8 mL single-dose prefilled syringe.

Nypozi is used to prevent low-neutrophil complications if you are getting chemotherapy, have received bone marrow transplants, or have long-term neutropenia (low neutrophil levels).

Nypozi 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, which helps your body fight infections.

Nypozi is given as a subcutaneous injection or IV infusion. Your dose will be based on your weight and may be given once or twice daily, depending on the condition being treated. Your length of treatment will be based on your neutrophil levels.

Nypozi is a safe and effective treatment when used for FDA approved 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 take 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 Nypozi: Fever ,Nausea Low platelets, Fatigue, Dizziness Cough, Rash, Shortness of breath, Chest pain

Serious side effects are rare with Nypozi. Contact your healthcare provider immediately if you experience any of the following: Enlarged spleen: pain in your upper left stomach area or arm Acute respiratory distress syndrome (ARDS): shortness of breath, fast breathing, fever Kidney damage: changes in how often you urinate, swelling in your face or ankles, or blood in your urine Capillary leak syndrome: swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint Bleeding in your lungs: coughing up blood or have blood in your sputum (spit) Aortitis (inflammation of the aorta, the largest artery in the body): fever, stomach pain, unusual tiredness or weakness, or back pain Sickle cell crisis: stop this medication if this occurs Serious allergic reactions, including anaphylaxis: swelling of your face, tongue, or throat and trouble breathing

There are no drug interactions listed for Nypozi.

Tanvex BioPharma USA, Inc.

It is not known whether Nypozi will harm your unborn baby. Talk with your healthcare provider about the risks of taking this medication if you are pregnant or plan on becoming pregnant.

• Filgrastim-TXID