Nypozi

Pronunciation: ni-poz-ee
Generic name: filgrastim-txid
Dosage form: injection for subcutaneous or intravenous use

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 2, 2024.

What is Nypozi?

Nypozi (filgrastim-txid) is a man-made form of granulocyte colony-stimulating factor (G-CSF) which may be used to stimulate the growth of neutrophils, a type of white blood cell. Nypozi may be used to:

• Decrease the chance of infection in people who have non-myeloid cancer (cancer that does not involve the bone marrow) and are receiving chemotherapy medications that may decrease the number of neutrophils
• Help increase the number of white blood cells, and decrease the length of time with fever in people with acute myeloid leukemia (AML; a type of cancer of the white blood cells) who are receiving treatment with chemotherapy medications
• Treat neutropenia in people who are undergoing bone marrow transplants and in people who have severe chronic neutropenia (a condition in which there are a low number of neutrophils in the blood)
• Prepare the blood for leukapheresis (a treatment in which certain blood cells are removed from the body)
• Increase the chance of survival in people exposed to harmful amounts of radiation. The effectiveness of filgrastim for this use was only studied in animals because it could not be studied in people.

Nypozi works by binding to specific cell surface receptors on the surface of hematopoietic stem and progenitor cells initiating intracellular signaling pathways that stimulate increased production and differentiation, helping the body to make more neutrophils.

Nypozi was FDA-approved on 28 June 2024.

Nypozi side effects

The most common side effects of Nypozi reported include: 

• fever, pain, rash, cough, and shortness of breath in patients with cancer receiving chemotherapy
• pain, nose bleeds, and rash in patients with acute myeloid leukemia receiving chemotherapy
• rash in patients with cancer receiving chemotherapy followed by bone marrow transplant
• bone pain, fever, and headache in patients who are having their blood cells collected
• pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss in patients with severe chronic neutropenia.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Nypozi, such as hives, sweating, rash, dizziness, fast heart rate, wheezing, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Nypozi may cause serious side effects, including:

Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider 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 healthcare provider 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.

Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Nypozi. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). Nypozi can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:

• swelling of your face or ankles
• blood in your urine or dark-colored urine
• you urinate less than usual.

Capillary leak syndrome. Nypozi 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 urinating less than usual
• trouble breathing
• swelling of your stomach area (abdomen) and feeling of fullness
• dizziness or feeling faint
• a general feeling of tiredness.

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Nypozi may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when Nypozi is used with chemotherapy and radiation therapy or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with Nypozi.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Nypozi. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Nypozi. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Nypozi.

Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.

Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received filgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

fluconazole, Diflucan, cisplatin, Zarxio, filgrastim, Neulasta, Neupogen

Before taking this medicine

You should not use Nypozi if you are allergic to filgrastim or other granulocyte colony stimulating factor such as pegfilgrastim, tbo-filgrastim, sargramostim, or eflapegrastim.

Before you take Nypozi, tell your healthcare provider about all of your medical conditions, including if you:

• have a sickle cell disorder.
• have kidney problems.
• are receiving radiation therapy.
• are pregnant or plan to become pregnant. 
• are breastfeeding or plan to breastfeed. 

Pregnancy

It is not known if Nypozi will harm an unborn baby.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using this medicine.

How is Nypozi administered?

Nypozi injections can be:

• given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection)
• self-administered at home by you or your caregiver if your healthcare provider thinks you can manage these at home.

Nypozi self-administration at home

You and your caregiver should be shown how to prepare and inject Nypozi before you use it, by your healthcare provider. Your healthcare provider will tell you how much Nypozi to inject and when to inject it. Do not change your dose or stop it unless your healthcare provider tells you to.

• Read the detailed instructions for use before administering.
• Remove the prefilled syringe from the refrigerator and warm up for 30 minutes to room temperature before administering. Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave. Keep the prefilled syringe in the blister pack until you are ready to use it. Do not leave the prefilled syringe in direct sunlight.
• Do not use the prefilled syringe if the carton is damaged. Do not shake the prefilled syringe.
• You can administer your dose into the upper thigh, your stomach area (excluding a 2-inch area around your navel [belly-button], or a caregiver can give it to you in the outer area of your upper arm.
• Your healthcare provider will prescribe either a full dose or a partial dose for you. Doses of Nypozi are based on weight. Your dose may change if you gain or lose weight.
• Do not inject a dose of Nypozi less than 0.3 mL (180 mcg) from a prefilled syringe because it cannot be accurately measured using the Nypozi prefilled syringe.

If you are receiving Nypozi because you are also receiving chemotherapy, your dose of Nypozi should be injected at least 24 hours before or 24 hours after your chemotherapy dose. Your healthcare provider will do blood tests to monitor your white blood cell counts, and if necessary, adjust your Nypozi dose.

If you are receiving Nypozi because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests every 3 days during treatment with NYPOZI to check your white blood cell count.

Other information

Do not:

• inject into the same place two times in a row.
• inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into skin that has scars or stretch marks.
• change your dose or stop using a medicine without your doctor's advice.
• reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes. Do not switch brand forms without your doctor's advice.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

What happens if I miss a dose?

If you miss a dose of Nypozi, talk to your healthcare provider about when you should give your next dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Nypozi?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What other drugs will affect Nypozi?

Do not use Nypozi within 24 hours before or after you receive chemotherapy, or within 24 hours after a bone marrow transplant.

Other drugs may interact with filgrastim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Nypozi.

Storage

Store Nypozi in the original container in a refrigerator, away from light. Do not freeze and do not shake.

Do not warm the medicine with hot water, sunlight, or a microwave.

Take Nypozi out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not leave the medicine out for longer than 24 hours.

If not used right away, a Nypozi prefilled syringe may be kept at room temperature between 68°F to 77°F (20°C to 25°C) for up to 24 hours. Throw away (dispose of) if it has been left at room temperature for more than 24 hours. 

Throw away a prefilled syringe or vial (bottle) after one use, even if there is still medicine left inside.

Keep out of the reach of children.

Ingredients

Active ingredient: filgrastim-txid
Inactive ingredients: glacial acetic acid, polysorbate 80, sodium acetate, sorbitol, and water for injection.

Who makes Nypozi?

Tanvex BioPharma USA Inc. makes Nypozi.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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