Clasificación: Colony Stimulating Factor Biosimilar
About Pegfilgrastim-jmdb (Fulphila™)
Pegfilgrastim-jmdb is a type of colony stimulating factor, which is a group of medications that stimulate the production and function of blood cells, including white blood cells, red blood cells and platelets. Granulocyte colony-stimulating factor (G-CSF) is a protein produced by the body to increase production of white blood cells. Pegfilgrastim-jmdb is a long-acting, man-made version of G-CSF that stimulates white blood cell production, and in particular, neutrophil production. A neutrophil is a type of white blood cell that is responsible for fighting infection and is often decreased during cancer therapy. When the number of these cells drops below 1000/mm3, it is called neutropenia and puts the patient at significant risk of infection. Pegfilgrastim-jmdb is used to prevent or treat neutropenia related to chemotherapy.
This medication is a biosimilar. A biosimilar is a medication that has been approved by the FDA because it is very similar to an FDA-approved medication (called a reference product, or the medication it is being compared to). There are no meaningful differences between the biosimilar product and the reference product and they work the same.
Pegfilgrastim-jmdb is not a cancer treatment, but a supportive care medicine. This means it is used to lessen the bone marrow suppression (reduced blood counts) secondary to cancer and its cytotoxic treatments.
How to Take Pegfilgrastim-jmdb
Pegfilgrastim-jmdb is given as an injection under the skin. It is typically given as a single dose for each chemotherapy cycle, no sooner than 24 hours after the last dose of chemotherapy, and no more than 14 days before beginning the next chemotherapy cycle.
Storage and Handling
Pegfilgrastim-jmdb should be refrigerated. To lessen the sting of the injection, it should be taken out of the refrigerator 30 minutes ahead of time.
Do not reuse single dose vials, syringes or needles. Do not throw the vials, syringes, or needles in the household trash. Dispose of all used needles and syringes in a puncture-proof disposable container with a lid. The FDA provides further information about the disposal of vials, syringes and needles. Keep the vials out of the reach of children.
Where do I get this medication?
Depending on your insurance coverage, pegfilgrastim-jmdb may be administered in your doctor’s office or provided through home infusion or a specialty pharmacy. Your oncology team will work with your major medical and prescription drug plans to identify where you should receive this medication.
This medication may be covered under your major medical plan or prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.
Possible Side Effects of Pegfilgrastim-jmdb
There are a number of things you can do to manage the side effects of pegfilgrastim-jmdb. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:
Bone or Muscle Pain
Pegfilgrastim-jmdb stimulates the bone marrow to produce many white blood cells, which can lead to pain in the bones. This pain is often felt in the bones or muscles of the thighs, hips and upper arms. Your healthcare team may not want you to take acetaminophen (Tylenol®) because it can "mask" a fever, so talk to them about what pain relievers you can take.
Irritation or Burning at the Injection Site
Some people experience redness, swelling, or itching at the site of injection. This is usually temporary. The injection is known to sting or burn if given when it is cold. Take the medication out of the refrigerator 30 minutes ahead of time to allow it to come up to room temperature before administration.
In some cases, patients can have an allergic reaction to this medication. Signs of a reaction can include: shortness of breath or difficulty breathing, chest pain, rash, flushing or itching or a decrease in blood pressure. If you notice any changes in how you feel during the injection, let your nurse know immediately.
Less common but important side effects can include:
- Rupture of the spleen: Your healthcare team will monitor you for an enlarged spleen or rupture while using this medication. If you have pain in the left side of your abdomen or shoulder pain after receiving pegfilgrastim-jmdb, notify your healthcare team immediately.
- Acute Respiratory Distress Syndrome (ARDS) / Alveolar Hemorrhage: This medication can cause a series lung problems called acute respiratory distress syndrome. If you experience shortness of breath, fever, breathing trouble or a fast rate of breathing, contact your healthcare team or go to the emergency room.
- Capillary Leak Syndrome: Capillary leak syndrome is a condition in which blood, and components of blood, leak out of vessels and into body cavities and muscles. The movement of this fluid out of the vessels can cause hypotension (low blood pressure) and organ failure. Signs and symptoms of capillary leak syndrome include: a sudden drop in blood pressure, weakness, fatigue, sudden swelling of the arms, legs or other parts of the body, nausea, and lightheadedness. If you are having any of these symptoms notify your healthcare provider immediately.
- Kidney Problems: Pegfilgrastim-jmdb can cause a decrease in kidney function or damage to the kidney. For this reason, your healthcare team will monitor your kidney function with blood tests while taking pegfilgrastim-jmdb. Some patients will need to stop the medication due to kidney function changes. Notify your provider if you notice any blood in your urine, decrease in urination or darkening of the urine.
- Sickle Cell Crisis: In patients with sickle cell anemia, pegfilgrastim-jmdb can cause a sickle cell crisis. Contact your healthcare team immediately if you have symptoms of a sickle cell crisis including pain and trouble breathing.
Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this medication.