Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER)
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). (addition): 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 NEUPOGEN 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 NEUPOGEN or whether the patient would benefit from a different NEUPOGEN presentation.
Addition of the following:
- Instruct patients who self-administer NEUPOGEN 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 NEUPOGEN prefilled syringe. If difficulty occurs, use of the NEUPOGEN vial may be considered.
- Difference in product concentration of the NEUPOGEN prefilled syringe in comparison to the NEUPOGEN vial. When switching patients from the NEUPOGEN prefilled syringe to the NEUPOGEN vial, or vice versa, ensure that patients understand the correct volume to be administered since the concentration of NEUPOGEN differs between the prefilled syringe and the vial.
WARNINGS AND PRECAUTIONS
- Glomerulonephritis has occurred in patients receiving NEUPOGEN. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of NEUPOGEN. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NEUPOGEN
PATIENT COUNSELING INFORMATION
- …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…
- Thrombocytopenia has been reported in patients receiving NEUPOGEN. Platelet counts should be monitored closely
- information on Amgen’s Lactation Surveillance Program
- added ... splenomegaly (enlarged spleen)
- decreased bone density and osteoporosis in pediatric SCN patients
PATIENT PACKAGE INSERT
What about pregnancy or breast-feeding?
- If you become pregnant during NEUPOGEN treatment, you are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. You should call 1-800-77-AMGEN (1-800-772-6436) to enroll
How to Prepare the dose of Neupogen in Vials or Prefilled Syringes ..... section updated
Pregnancy Category C
- Women who become pregnant during Neupogen treatment are encouraged to enroll in Amgren's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.