Nypozi Prefilled Syringe

Uses of Nypozi Prefilled Syringe

Filgrastim belongs to the family of medications known as granulocyte colony stimulating factors (G-CSF). It helps the bone marrow produce white blood cells which help the body fight infection.

Filgrastim is used to prevent infections caused by febrile neutropenia (a condition of low blood counts of a certain type of white blood cell known as neutrophils, accompanied by fever) or to reduce the duration of neutropenia for people who:

• are receiving a type of chemotherapy that slows down white blood cell production,
• are receiving bone marrow or stem cell transplants,
• have acute myeloid leukemia, or
• have severe chronic neutropenia

This medication is also used by people with HIV infection (the virus that causes AIDS), to keep the number of white blood cells within the normal range.

Precautions and Warnings

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Filgrastim may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Some people with breast or lung cancer who received filgrastim may have an increased risk of myelodysplasia (bone marrow disorders) and certain types of leukemia. When used for long periods of time, filgrastim may increase the risk of bone marrow disorders and certain types of leukemia. If you experience symptoms of fever, bone pain, bruising, difficulty breathing, or bleeding, contact your doctor as soon as possible.

Filgrastim has been reported to cause CLS, a condition where blood leaks out of the small blood vessels into the tissues of the body. If you experience symptoms of CLS, such as swelling or puffiness, decreased need to urinate, trouble breathing, swelling in the abdominal area, or a general feeling of tiredness, contact your doctor immediately. The symptoms often develop quickly and the severity of each episode is different. In severe episodes, CLS can be fatal.

The safety of using filgrastim at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Filgrastim should not be used within 24 hours before or 24 hours after chemotherapy is administered.

Filgrastim can cause an enlarged spleen, and there have been reports of the spleen rupturing. Pain in the left upper part of the stomach and extending to the shoulder may indicate that the spleen has become enlarged. A ruptured spleen is a medical emergency. If you experience any unusual abdominal pain, contact your doctor immediately.

Heart-related conditions such as heart attacks and abnormal heart rhythms have been observed in rare cases with filgrastim. If you have had a heart condition before starting filgrastim, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Filgrastim may cause acute respiratory distress syndrome (ARDS), a serious lung condition, when people with neutropenia have a bacterial infection in the blood. If you experience difficulty breathing, fever, or coughing blood while using filgrastim, contact your doctor immediately.

Long-term use of filgrastim may increase the risk of osteoporosis for some people. If you have chronic neutropenia or have osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor may want to check your bone density regularly while you are receiving this medication.

Filgrastim may cause sickle cell crisis when used by people who have sickle cell disease. You and your doctor should carefully consider the benefits and risks of using filgrastim if you have sickle cell disease.

this medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

It is not known whether filgrastim passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

The safety and effectiveness of filgrastim have not been established for newborn babies.

Dosage

The recommended starting dose of Nypozi for patients with cancer receiving myelosuppressive chemotherapy for induction and/or consolidation chemotherapy for AML is 5 mcg/kg/day by subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

The recommended dose of Nypozi for patients with cancer undergoing bone marrow transplantation is 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours.

The recommended dose of Nypozi for patients undergoing autologous peripheral blood progenitor cell collection and therapy is 10 mcg/kg/day by subcutaneous injection administered for at least 4 days before first leukapheresis procedure and continued until last leukapheresis.

The recommended starting dose of Nypozi for patients with congenital neutropenia is 6 mcg/kg by subcutaneous injection twice daily.

The recommended starting dose of Nypozi for patients with cyclic or idiopathic neutropenia is 5 mcg/kg by subcutaneous injection daily.

The recommended dose of Nypozi for patients acutely exposed to myelosuppressive doses of radiation is 10 mcg/kg/day by subcutaneous injection.

Side Effects

Common Side Effects:

• fever,
• pain,
• rash,
• cough,
• shortness of breath,
• nosebleed,
• bone pain,
• headache,
• anemia,
• diarrhea,
• numbness and tingling, and
• hair loss.