Approved Drug Label (PDF)
5
Warnings and Precautions
5.12 Potential Device failures
New subsection
added:
Missed or partial doses have been reported in
patients receiving UDENYCA via the on-body injector (OBI) due to the device not
performing as intended. In the event of a missed or partial dose, patients may
be at increased risk of events such as neutropenia, febrile neutropenia and/or
infection than if the dose had been correctly delivered.
Instruct patients using the OBI to notify their
healthcare professional immediately in order to determine the need for a
replacement dose of UDENYCA if they suspect that the device may not have
performed as intended.
5.4 Allergies to Acrylics
New subsection
added:
The on-body injector (OBI) for UDENYCA uses acrylic
adhesive. For patients who have reactions to acrylic adhesives, use of this
product may result in a significant reaction.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
- Allergies to Acrylics [see Warnings and
Precautions (5.4)]
6.2 Immunogenicity
Additions and/or revisions underlined:
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay.
Differences in assay methods preclude meaningful comparisons of the
incidence of anti-drug antibodies in the studies described below with
the incidence of anti-drug antibodies in other studies, including
those of pegfilgrastim or of other pegfilgrastim products.
…
6.3 Postmarketing
Experience
Addition of the
following to the bulleted line listing:
Application
site reactions (including events such as application site hemorrhage,
application site pain, application site discomfort, application site bruise,
and application site erythema) have been reported with the use of the
on-body-injector for UDENYCA.
Contact
dermatitis and local skin reactions such as rash, pruritus, and urticaria have
been reported with the use of the on-body-injector for UDENYCA, possibly
indicating a hypersensitivity reaction to the adhesive.
8
Use in Specific Populations
8.4 Pediatric Use
Additions
and/or revisions underlined:
…
Use
of UDENYCA in pediatric patients for chemotherapy-induced neutropenia is based
on UDENYCA’s approval as a biosimilar to pegfilgrastim and evidence from
adequate and well controlled studies of pegfilgrastim in adults with additional
pharmacokinetic and safety data of pegfilgrastim in pediatric patients with
sarcoma [see Clinical Pharmacology (12.3)
and Clinical Studies (14.1)].
The
use of UDENYCA to increase survival in pediatric patients acutely exposed to
myelosuppressive doses of radiation is based on UDENYCA’s approval as a
biosimilar to pegfilgrastim and evidence from efficacy studies of
pegfilgrastim conducted in animals and clinical data supporting the use of
pegfilgrastim in patients with cancer receiving myelosuppressive chemotherapy.
Efficacy studies of pegfilgrastim products could not be conducted in humans
with acute radiation syndrome for ethical and feasibility reasons. Results from
population modeling and simulation indicate that two doses of pegfilgrastim
(Table 1), administered one week apart provide pediatric patients with
exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.3),
Clinical Pharmacology (12.3) and Clinical Studies (14.2)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Extensive additions and/or revisions, please refer
to label for complete information.
Approved Drug Label (PDF)
6
Adverse Reactions
Additions
and/or revisions underlined:
The following clinically
significant adverse reactions are discussed in greater detail in other sections
of the labeling: …
8
Use in Specific Populations
8.4 Pediatric Use
Newly
added information to bottom of subsection:
The
use of pegfilgrastim to increase survival in pediatric patients acutely exposed
to myelosuppressive doses of radiation is based on efficacy studies conducted
in animals and clinical data supporting the use of pegfilgrastim in patients with
cancer receiving myelosuppressive chemotherapy. Efficacy studies of pegfilgrastim
products could not be conducted in humans with acute radiation syndrome for
ethical and feasibility reasons. Results from population modeling and
simulation indicate that two doses of pegfilgrastim (Table 1), administered one
week apart provide pediatric patients with exposures comparable to that in
adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.3), Clinical Pharmacology (12.3) and
Clinical Studies (14.2)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions
and/or revisions underlined:
…
Advise
patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic
Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim
products for this indication could not be conducted in humans for ethical and
feasibility reasons and that, therefore, approval of this use was based on
efficacy studies conducted in animals [see
Clinical Studies (14.2)].
Instruct
patients who self-administer UDENYCA using the single-dose prefilled syringe of
the: …
PATIENT INFORMATION
Additions
and/or revisions underlined:
What is UDENYCA?
UDENYCA
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.
Acute
Radiation Syndrome: The effectiveness of pegfilgrastim for this use was only studied
in animals, because it could not be studied in people.
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
(Newly added
subsection)
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
(Newly added
subsection)
Thrombocytopenia has been reported in patients
receiving pegfilgrastim products. Monitor platelet counts.
6
Adverse Reactions
(Additions and/or
revisions underlined)
The following serious adverse reactions are
discussed in greater detail in other sections of the labeling:
- Splenic
Rupture [see Warnings and Precautions (5.1)]
- Acute
Respiratory Distress Syndrome [see Warnings and Precautions (5.2)]
- Serious
Allergic Reactions [see Warnings and Precautions (5.3)]
- Use
in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.4)]
- Glomerulonephritis
[see Warnings and Precautions (5.5)]
- Leukocytosis
[see Warnings and Precautions (5.6)]
- Thrombocytopenia
[see Warnings and Precautions (5.7)]
- Capillary
Leak Syndrome [see Warnings and Precautions (5.8)]
- Potential
for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings
and Precautions (5.9 )]
- Myelodysplastic
syndrome [see Warnings and Precautions (5.10)]
- Acute
myeloid leukemia [see Warnings and Precautions (5.10)]
- Aortitis
[see Warnings and Precautions (5.11)]
6.3 Postmarketing Experience
(Additions and/or
revisions underlined)
The
following adverse reactions have been identified during post approval use of
pegfilgrastim products. Because these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.
Splenic
rupture and splenomegaly (enlarged spleen) [see
Warnings and Precautions (5.1)]
Acute
respiratory distress syndrome (ARDS) [see
Warnings and Precautions (5.2)]
Allergic
reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria,
generalized erythema and flushing [see
Warnings and Precautions (5.3)]
Sickle
cell crisis [see Warnings and Precautions
(5.4)]
Glomerulonephritis
[see Warnings and Precautions (5.5)]
Leukocytosis
[see Warnings and Precautions (5.6)]
Thrombocytopenia [see
Warnings and Precautions (5.7)]
Capillary
leak syndrome [see Warnings and
Precautions (5.8)]
Injection site reactions
Sweet’s syndrome (acute
febrile neutrophilic dermatosis), cutaneous vasculitis
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)]
Aortitis [see
Warnings and Precautions (5.11)]
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 UDENYCA [See Warnings and Precautions (5)]:
Splenic
rupture and splenomegaly
Acute
Respiratory Distress Syndrome
Serious
allergic reactions
Sickle
cell crisis
Glomerulonephritis
Increased risk of Myelodysplastic Syndrome and/or
Acute Myeloid Leukemia in patients with breast and lung cancer who receive
pegfilgrastim in conjunction with chemotherapy and/or radiation therapy
Capillary
Leak Syndrome
Aortitis
Instruct
patients who self-administer UDENYCA using the single-dose prefilled syringe of
the:
Importance
of following the Instructions for Use (see Instructions for Use)
Dangers
of reusing syringes
Importance
of following local requirements for proper disposal of used syringes.
PATIENT INFORMATION
(Additions and/or
revisions underlined)
…
What are possible
side effects of UDENYCA? UDENYCA may
cause serious side effects, including:
Spleen rupture. Your spleen may
become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare
provider right away if you have pain in the left upper stomach area or your left
shoulder.
A serious lung
problem called Acute Respiratory Distress Syndrome (ARDS). Call your
healthcare provider or get emergency care right away if you have shortness of
breath with or without a fever, trouble breathing, or a fast rate of breathing.
Serious allergic
reactions.
UDENYCA can cause serious allergic reactions. These 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 UDENYCA and call your healthcare provider or get emergency
medical help right away.
Sickle cell crises. You may have a
serious sickle cell crisis if you have a sickle cell disorder and receive
UDENYCA. Serious sickle cell crises have happened in people with sickle cell
disorders receiving pegfilgrastim that has sometimes led to death. Call your
healthcare provider right away if you have symptoms of sickle cell crisis such
as pain or difficulty breathing.
Kidney injury
(glomerulonephritis).
UDENYCA can cause kidney injury. Call your healthcare provider right away if
you develop any of the following symptoms:
swelling of your
face or ankles
blood in your
urine or dark colored urine
you urinate less
than usual
Increased white
blood cell count (leukocytosis). Your healthcare provider will check your
blood during treatment with UDENYCA.
Decreased platelet
count (thrombocytopenia). Your healthcare provider will check your
blood during treatment with UDENYCA. Tell your healthcare provider if you have
unusual bleeding or bruising during treatment with UDENYCA. This could be a sign
of decreased platelet counts, which may reduce the ability of your blood to clot.
Capillary Leak Syndrome. UDENYCA can
cause fluid to leak from blood vessels into your body’s tissues. This condition
is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have
symptoms that may become life-threatening. Get emergency medical help right away
if you develop any of the following symptoms:
swelling or
puffiness and are urinating less than usual
trouble breathing
swelling of your
stomach-area (abdomen) and feeling of fullness
dizziness or
feeling faint
a general feeling
of tiredness
Myelodysplastic syndrome and acute myeloid
leukemia. If
you have breast cancer or lung cancer, when UDENYCA 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 UDENYCA.
- Inflammation of the aorta (aortitis). Inflammation of
the aorta (the large blood vessel that transports blood from the heart to the
body) has been reported in patients who received pegfilgrastim. Symptoms may
include fever, abdominal pain, feeling tired, and back pain. Call your healthcare
provider if you experience these symptoms.
The most common
side effects of UDENYCA are pain in the bones, arms, and legs. These are not
all the possible side effects of UDENYCA.
Call
your doctor for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
…
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