17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Review the steps for direct patient administration with patients and caregivers. Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of NIVESTYM vial and prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of NIVESTYM or whether the patient would benefit from a different NIVESTYM presentation. Advise patients of the following risks and potential risks with NIVESTYM:
- Rupture or enlargement of the spleen may occur. Symptoms include left upper quadrant abdominal pain or left shoulder pain. Advise patients to report pain in these areas to their physician immediately [see Warnings and Precautions (5.1)].
- Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur.
Advise patients to report dyspnea to their physician immediately [see Warnings and Precautions (5.2)].
- Serious allergic reactions may occur, which may be signaled by rash‚ facial edema‚ wheezing‚ dyspnea‚ hypotension‚ or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur [see Warnings and Precautions (5.3)].
- In patients with sickle cell disease, sickle cell crisis and death have occurred. Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of human granulocyte colony-stimulating factors [see Warnings and Precautions (5.4)].
- Glomerulonephritis may occur. Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately [see Warnings and Precautions (5.5)].
- There may be an increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with congenital neutropenia who receive filgrastim products and in patients with breast and lung cancer who receive filgrastim products in conjunction with chemotherapy and/or radiation therapy. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Advise patients to report to their physician signs and symptoms of MDS/AML [see Warnings and Precautions (5.8)].
- Cutaneous vasculitis may occur, which may be signaled by purpura or erythema. Advise patients to report signs or symptoms of vasculitis to their physician immediately [see Warnings and Precautions (5.11)].
- Aortitis may occur. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Advise patients to report signs and symptoms of aortitis to their physician immediately [see Warnings and Precautions (5.15)].
Instruct patients who self-administer NIVESTYM using the prefilled syringe or single-dose vial of the:
- Importance of following the applicable Instructions for Use.
- Dangers of reusing needles, syringes, or unused portions of single-dose vials.
- Importance of following local requirements for proper disposal of used syringes, needles, and unused vials.
- Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the NIVESTYM prefilled syringe. If difficulty occurs, use of the NIVESTYM vial may be considered.
- Difference in product concentration of the NIVESTYM prefilled syringe in comparison to the NIVESTYM vial. When switching patients from the NIVESTYM prefilled syringe to the NIVESTYM vial, or vice versa, ensure that patients understand the correct volume to be administered since the concentration of NIVESTYM differs between the prefilled syringe and the vial.
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: March 2023
NIVESTYM is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.
Do not take NIVESTYM if you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.
Before you take NIVESTYM, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of NIVESTYM?
NIVESTYM may cause serious side effects, including:
The most common side effects experienced in patients receiving NIVESTYM include:
These are not all the possible side effects of NIVESTYM. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep NIVESTYM out of the reach of children.
General information about the safe and effective use of NIVESTYM.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NIVESTYM for a condition for which it was not prescribed. Do not give NIVESTYM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NIVESTYM that is written for healthcare professionals.
What are the ingredients in NIVESTYM?
Active ingredient: (filgrastim-aafi)
Inactive ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for Injection
Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USA
Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA