Nivestym Drug Information: How It Works, Who Needs It, and What To Expect

In the U.S., about 2 million new cancer cases are diagnosed each year. Chemotherapy is the most common and effective treatment for cancer, but it comes with many side effects. One such side effect is that it causes a condition known as neutropenia, in which the level of neutrophils (a type of white blood cell) becomes very low. When this happens, you become more likely to develop infections, which can be fatal if not managed well. 

Fortunately, drugs such as Nivestym (filgrastim-aafi) can help restore white blood cells after chemotherapy. In this article, we’ll talk about everything you need to know about Nivestym in a clear and easy-to-understand way.

What Is Nivestym?

Nivestym (filgrastim-aafi) is an FDA-approved medicine used to treat neutropenia (low levels of neutrophils, a type of white blood cell) caused by chemotherapy, bone marrow transplant, or some other condition. It is a synthetic version of the naturally occurring protein called granulocyte colony-stimulating factor (G-CSF), which promotes white blood cell production. 

The FDA first approved Nivestym on July 20, 2018, as a biosimilar to Neupogen [1]. This means that there is no clinical difference between Nivestym and Neupogen, but Nivestym is less expensive.  

What Is Nivestym Used To Treat?

Nivestym (filgrastim-aafi) is a medicine that helps your body make more white blood cells, which help fight infections. It is FDA-approved for the following purposes [2][3]:

Chemotherapy-Induced Neutropenia: This medication can reduce the risk of infection in cancer patients receiving intensive chemotherapy that can lower white blood cell counts and cause fever.

Acute Myeloid Leukemia: Nivestym can help white blood cells recover faster and shorten the duration of fever in patients with acute myeloid leukemia (AML) after extensive chemotherapy.

Bone Marrow Transplant: After a bone marrow transplant, Nivestym can speed up white blood cell recovery and reduce the duration of severe neutropenia. 

Peripheral Blood Progenitor Cell Collection: Nivestym is used to move blood-forming stem cells into the bloodstream so they can be collected and used later for treatment.

Severe Chronic Neutropenia: Nivestym can help patients with long-term neutropenia, including congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. It can reduce infections and related problems, such as fever and mouth sores.

How Does Nivestym Work?

Neutrophils are a kind of white blood cell that fight bacterial and fungal infections. They are produced in your bone marrow. Unfortunately, chemotherapy and radiation therapy can harm your bone marrow, which can reduce or stop neutrophil production. This increases your chance of having serious infections.

Nivestym is a synthetic version of a naturally occurring protein called granulocyte colony-stimulating factor (G-CSF). It works by encouraging your bone marrow to:

• Produce more neutrophils
• Speed up neutrophil production
• Release neutrophils into the bloodstream

As a result, your neutrophil count increases faster, reducing the time your immune system is weakened after chemotherapy. 

Side Effects

Like any other medication, Nivestym can also cause some side effects. Most are mild to moderate, but some can be severe. Here are some of the side effects of Nivestym [2][3]:

Common Side Effects

• Bone Pain
• Muscle Pain
• Headache
• Fatigue
• Nausea
• Injection site reaction (redness, swelling, or pain)
• Diarrhea and vomiting

Bone pain is the most common side effect because your bone marrow is working harder to produce more white blood cells. It is usually manageable with mild pain medicines. 

Severe Side Effects

Serious side effects from Nivestym are rare but can happen. Here are some serious side effects of Nivestym:

Spleen Rupture: In rare cases, Nivestym can cause rupture in your spleen, which can be fatal. Symptoms include pain in the upper left abdomen or shoulder.

Acute Respiratory Distress Syndrome (ARDS): Nivestym can cause ARDS in some patients. Symptoms include shortness of breath, rapid breathing, and low oxygen levels.

Serious Allergic Reactions: You may experience allergic reactions to Nivestym, particularly with the initial dose. Symptoms include rash, swelling of the face or throat, dizziness, or difficulty breathing. 

Capillary Leak Syndrome: This is a rare but serious condition where fluid leaks from your blood vessels. This leads to low blood pressure and swelling.

Sickle Cell Disorders: Nivestym can cause sickle cell crisis in patients with sickle cell disorder. This can be fatal. Discontinue Nivestym if a sickle cell crisis occurs.

Low Platelet Count: Nivestym can lower your platelet count, which can be severe.

Kidney Problems: Nivestym can cause inflammation in your kidneys. Symptoms include dark-colored urine and swelling in the face, hands, or feet.

Please note that this is not a complete list of all possible side effects. Consult your doctor immediately if you experience any severe side effects of Nivestym.

Dosing Information

The dosage of Nivestym depends on your body weight and medical condition. Your doctor will determine the right dosage for you based on your condition. Here is the usual recommended dosage [3]:

For Cancer Patients Receiving Chemotherapy (including AML treatment): The usual starting dose is 5 micrograms per kilogram of your body weight per day (5 mcg/kg/day). 

For Cancer Patients Undergoing a Bone Marrow Transplant: The recommended dose is 10 mcg/kg/day. It is given as an IV infusion that lasts no longer than 24 hours.

For Patients Undergoing Autologous Stem Cell Therapy: The recommended dose is 10 mcg/kg/day. You will receive it as an injection under the skin. Your doctor will start at least 4 days before the first stem cell collection and continue until the final collection is completed.

For Patients With Congenital Neutropenia: The starting dose is 6 mcg/kg. You will receive it via an injection under your skin twice daily.

Patients with Cyclic or Idiopathic Neutropenia: The recommended starting dose is 5 mcg/kg/day.

Before Starting Nivestym

Before you start your treatment with Nivestym, have a detailed discussion with your doctor to ensure that the medicine is safe and appropriate. Tell your doctor if you:

• Have osteoporosis (a bone disease that causes bones to become weak and prone to fracture)
• Have allergies to filgrastim or pegfilgrastim
• Have sickle cell disease because Nivestym can trigger life-threatening complications.
• Have a history of bone marrow disorders
• Have kidney problems
• Have ever had an enlarged spleen or splenic rupture
• Experience difficulty breathing or cough
• Are pregnant or planning to become pregnant. There is limited data on its safety during pregnancy. You should only use this medication during pregnancy if your doctor thinks the potential benefits outweigh the risks.
• Are breastfeeding
• Are taking other prescription medicines, over-the-counter drugs, or herbal supplements

Cost

Nivestym is available in single-dose vials and prefilled syringes in various strengths. One common option is 300 mcg/ml, where a package of 10 single-dose vials (1 ml each) costs around $2,147 [4]. However, the actual price depends on your insurance plan, location, and the pharmacy you visit. Contact us if you are interested in exploring financial assistance options for Nivestym.