Approved Drug Label (PDF)
4
Contraindications
Additions and/or
revisions underlined:
NYVEPRIA is contraindicated in patients with a history
of a serious
hypersensitivity reaction to pegfilgrastim
products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
5
Warnings and Precautions
5.3 Serious
Hypersensitivity reactions
Subsection title
revised
Additions and/or
revisions underlined:
Serious hypersensitivity
reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim
products. The majority of reported
events occurred upon initial exposure.
Hypersensitivity reactions, including anaphylaxis, can recur within
days after the discontinuation of initial therapies to manage the
reaction.
Permanently discontinue NYVEPRIA
in patients with serious hypersensitivity reactions. NYVEPRIA is
contraindicated in patients
with a history of a serious hypersensitivity reaction to pegfilgrastim products or
filgrastim products.
5.7
Thrombocytopenia
Additions and/or
revisions underlined:
Pegfilgrastim products can
cause thrombocytopenia. Monitor
platelet counts during NYVEPRIA therapy.
5.12
Nuclear Imagining
Additions and/or
revisions underlined:
Increased hematopoietic activity of
the bone marrow in response to growth factor therapy, including
pegfilgrastim products, has been associated with transient positive
bone imaging changes.
This should be considered when interpreting bone
imaging results.
6
Adverse Reactions
Additions and/or
revisions underlined:
…
…
6.1 Clinical
Trials Experience
Additions and/or
revisions underlined:
Because clinical trials are conducted
under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared
with rates in the clinical trials of another
drug and may not
reflect the rates observed in clinical practice.
…
The following adverse reaction
data in Table
1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or
non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21
days (Study 3). A total of 928 patients were randomized to receive either 6 mg
pegfilgrastim (n = 467) or placebo (n = 461). The patients were 21 to 88 years
of age and 99% female. The ethnicity was 66% Caucasian,
31% Hispanic, 2% Black, and <1% Asian, Native American, or other.
…
Table 1. Adverse Reactions with greater than or equal to 5% Higher Incidence in Pegfilgrastim Patients
Compared to Placebo
in Study 3
…
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
The safety and effectiveness of NYVEPRIA for chemotherapy-induced neutropenia have been established in pediatric patients aged newborn and older.
Use of NYVEPRIA in
pediatric patients weighing at least 45 kg for chemotherapy-induced
neutropenia is supported by evidence from adequate and well-controlled
studies of pegfilgrastim in adults with additional
pharmacokinetic and safety
data of pegfilgrastim in pediatric patients
aged 8 months
and older with sarcoma
[see Clinical Pharmacology (12.3) and
Clinical Studies (14)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Advise the patient to read the FDA-approved patient
labeling (Patient Information and Instructions for Use).
Advise patients of the following risks and potential risks with NYVEPRIA:
Splenic rupture
and splenomegaly
Acute Respiratory Distress Syndrome
Serious hypersensitivity reactions
Sickle cell crisis
Glomerulonephritis
Increased risk of Myelodysplastic Syndrome and/or Acute
Myeloid Leukemia in patients with breast and lung cancer who receive NYVEPRIA
in conjunction with chemotherapy and/or radiation therapy
Capillary
Leak Syndrome
Aortitis
…
PATIENT INFORMATION
Additions and/or
revisions underlined:
What
is NYVEPRIA?
NYVEPRIA is a prescription medicine that is used in adults and children aged newborn and older to help reduce
the chance of infection due to a low white blood cell count,
in people with certain types of cancer (non-myeloid), who
receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.
…
How will I receive NYVEPRIA?
NYVEPRIA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your
caregiver, follow the detailed “Instructions for Use” that comes with your
NYVEPRIA for information on how to prepare and inject a dose of NYVEPRIA using
the single-dose prefilled syringe.
You and your caregiver will be shown
how to prepare and inject
NYVEPRIA using the single-dose prefilled syringe before you use it.
You should
not inject a dose of NYVEPRIA to children weighing
less than 99 pounds (45 kg) from a NYVEPRIA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured
using the NYVEPRIA
prefilled syringe.
If you are receiving NYVEPRIA because you are also receiving chemotherapy, the last dose of NYVEPRIA
should be injected at least 14 days before and 24 hours after your dose
of chemotherapy.
If you miss a dose of NYVEPRIA, talk to your healthcare provider
about when you should give your next dose.
If you inject too much NYVEPRIA,
call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the
nearest hospital emergency room right away.
…
What are possible side effects of
NYVEPRIA?
NYVEPRIA may cause serious
side effects, including:
…
Serious allergic reactions. Allergic
reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate,
and sweating. If you have any of these
symptoms, stop using NYVEPRIA and call your healthcare provider or get
emergency medical help right away.
Sickle cell crises in people with sickle
cell disorder. You may have a severe sickle
cell crisis, which could lead to death. Call your healthcare
provider right away if you have symptoms of sickle cell crisis such as pain or
difficulty breathing.
…
Increased white blood
cell count (leukocytosis). Your healthcare provider will check
your blood count during treatment with NYVEPRIA.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood count
during treatment with NYVEPRIA. Tell your healthcare provider if you have unusual
bleeding or bruising
during treatment with
NYVEPRIA.
…
Myelodysplastic Syndrome (MDS)
and Acute Myeloid
Leukemia (AML). If you have breast
cancer or lung
cancer, when NYVEPRIA is used with chemotherapy and radiation therapy, or with
radiation therapy alone, you may have an increased risk of developing a
precancerous blood condition called MDS or a blood cancer called AML. Call
your healthcare provider
if you develop any symptoms of MDS and AML, including tiredness, fever, or easy bruising or bleeding.
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that
carries blood from the heart to the body) has happened in people who receive pegfilgrastim products. Tell your healthcare provider
if you develop fever, stomach
(abdominal) pain, feeling tired, or back pain.
…
How should I store NYVEPRIA
single-dose prefilled syringe?
Store NYVEPRIA
in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze. If NYVEPRIA is accidentally frozen,
allow the prefilled syringe to thaw in the refrigerator before injecting.
Do not use a NYVEPRIA prefilled
syringe that has been frozen more than 1 time. Throw it away and use a new
NYVEPRIA prefilled syringe.
Keep NYVEPRIA in the original
carton to protect
from light or physical damage.
Do not shake NYVEPRIA.
Take NYVEPRIA
out of the refrigerator 30 minutes before
use and allow it to reach room temperature, 68°F to 77°F (20°C to 25°C),
before preparing an injection.
Throw away (dispose of) any NYVEPRIA
that has been left at room temperature, 68°F to 77°F (20°C to 25°C),
for more than 15 days.
Keep NYVEPRIA
and all medicines
out of the reach of children.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.10 Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
New
subsection added
MDS
and AML have been associated with the use of pegfilgrastim products in
conjunction with chemotherapy and/or radiotherapy in patients with breast and
lung cancer. Monitor patients for signs and symptoms of MDS/AML in these
settings.
5.7 Thrombocytopenia
New
subsection added
Thrombocytopenia
has been reported in patients receiving pegfilgrastim products. Monitor
platelet counts.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
Thrombocytopenia [see Warnings and Precautions
(5.7)]
Myelodysplastic
Syndrome [see Warnings and Precautions
(5.10)]
Acute
Myeloid Leukemia [see Warnings and
Precautions (5.10)]
6.3 Postmarketing
Experience
Addition of the
following to the bulleted line listing:
Thrombocytopenia
[see Warnings and Precautions (5.7)]
Myelodysplastic
syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and
lung cancer receiving chemotherapy and/or radiotherapy [see Warnings and Precautions (5.10)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
PATIENT INFORMATION
Additions underlined
…
What
are possible side effects of NYVEPRIA?
NYVEPRIA
may cause serious side effects, including:
…
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with
NYVEPRIA. Tell your healthcare provider if you have unusual bleeding or
bruising during treatment with NYVEPRIA. This could be a sign of decreased
platelet counts, which may reduce the ability of your blood to clot.
…
Myelodysplastic syndrome and
acute myeloid leukemia. If you have breast cancer or lung cancer, when NYVEPRIA
is used with chemotherapy and radiation therapy, or with radiation therapy
alone, you may have an increased risk of developing a precancerous blood
condition called myelodysplastic syndrome (MDS) or a blood cancer called acute
myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever,
and easy bruising or bleeding. Call your healthcare provider if you develop
these symptoms during treatment with NYVEPRIA.
…
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