Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Dermatologic
Adverse Reactions
Additions and/or
revisions underlined:
…
When
initiating treatment with RYBREVANT, prophylactic and concomitant
medications are recommended to reduce the risk and severity of dermatologic adverse
reactions [see Dosage and Administration
(2.6)]. Instruct patients to limit sun exposure during and for 2 months
after treatment with RYBREVANT. Advise patients to wear protective clothing and use broad-spectrum
UVA/UVB sunscreen.
If skin reactions
develop, administer supportive care including topical corticosteroids
and topical and/or oral antibiotics. For Grade
3 reactions, add oral steroids and consider dermatologic consultation.
Promptly refer patients presenting with severe rash, atypical appearance or
distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold,
reduce the dose, or permanently discontinue RYBREVANT
based on severity [see Dosage and
Administration (2.8)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Dermatologic Adverse
Reactions
Advise patients
of the risk of dermatologic adverse reactions. Advise patients that
prophylactic oral antibiotics are recommended starting on Day 1 for the
first 12 weeks of treatment and, after completion of oral antibiotic treatment, topical
antibiotic lotion to the scalp for the next 9 months
of treatment. Advise patients to use a non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying
components) on the face
and whole body (except scalp) and 4% chlorhexidine solution to wash hands and
feet, while on treatment. Advise patients
to limit direct sun exposure during and for 2 months after treatment, to wear protective clothing, and to use
broad-spectrum UVA/UVB sunscreen to reduce the risk and severity of
dermatologic adverse reactions [see
Warnings and Precautions (5.4)].
…
PATIENT INFORMATION
Additions and/or
revisions underlined:
…
How will I receive
RYBREVANT?
…
…
What
are the possible side effects of RYBREVANT?
RYBREVANT may cause serious
side effects, including:
…
blood
clot problems. Blood clots are a serious, but common side effect of RYBREVANT, when given together
with another drug called lazertinib, may cause blood clots in the veins of your legs (deep vein thrombosis) or lungs
(pulmonary embolism) that may lead to death. Your healthcare provider will
start you on medicine to reduce the risk of blood clots for the first 4
months of treatment. Tell your
healthcare provider right away if
you have any signs and symptoms of blood
clots, including swelling, pain or tenderness in the leg, sudden unexplained
chest pain, or shortness of breath.
skin
problems. RYBREVANT can cause severe rash; including blisters,
peeling, skin pain and sores, redness, raised acne-like bumps, itching, and dry
skin. Tell your healthcare provider right away if you get any skin reactions. Your
healthcare provider may start you on an antibiotic for the first 3 months of
treatment followed by an antibiotic lotion for your scalp for the next 9
months. During treatment with RYBREVANT, you should apply a non-comedogenic
(does not clog pores) skin moisturizer (ceramide-based or other types of
moisturizers that provide long-lasting skin hydration and does not include drying
ingredients) on your face and whole body (except scalp) and
wash your hands and feet every day with 4% chlorhexidine solution. Your healthcare provider may treat you with a medicine(s) or send
you to see a skin specialist (dermatologist) if you get skin reactions during
treatment with RYBREVANT. See “What
should I avoid while receiving RYBREVANT?”
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infusion-Related
Reactions
Additions and/or revisions
underlined:
RYBREVANT can cause infusion-related reactions (IRR)
including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing,
fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median
time to IRR onset is approximately 1 hour.
. . .
Monitor patients for signs and symptoms of infusion
reactions during RYBREVANT infusion in a setting where cardiopulmonary
resuscitation medication and equipment are available. Interrupt infusion if IRR
is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT
based on severity [see Dosage and
Administration (2.6)]. If an anaphylactic reaction occurs, permanently
discontinue RYBREVANT.
6
Adverse Reactions
6.2 Postmarketing Experience
Newly Added Subsection
The following adverse reactions associated with the
use of RYBREVANT were identified in clinical studies or postmarketing reports.
Because some of these reactions were 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.
Immune
System disorders: Infusion-related reactions, including
anaphylaxis/anaphylactic reactions
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions
underlined:
. . .
Infusion-Related Reactions
Advise patients that RYBREVANT can cause
infusion-related reactions, including anaphylaxis. The majority of infusion-related
reactions occurred with the first infusion. Advise patients to alert their healthcare
provider immediately for any signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.1)].
. . .
PATIENT INFORMATION
Additions and/or
revisions underlined:
. . .
What are the possible side effects of RYBREVANT?
RYBREVANT may cause serious side effects, including:
- infusion-related reactions. Infusion-related
reactions are common but can be severe or serious and can include life-threatening
(anaphylaxis) allergic reaction. Tell your healthcare provider right away
if you get any of the following symptoms during your infusion of RYBREVANT:
- shortness
of breath, difficulty breathing, or wheezing
- chest
discomfort
- swelling
of your eyes, lips, or tongue
- fever
- chills
- numbness
of the tongue, lips, cheeks, or gums
- flushing
- skin
rash, hives, or itching
- nausea
or vomiting
- stomach
cramps
- lightheadedness,
dizziness, or fainting
- headache
. . .
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infusion-Related Reactions
Additions and revisions
underlined:
Based on the pooled
safety population [see Adverse
Reactions (6.1)], IRR occurred in 50% of patients treated with
RYBREVANT in combination with carboplatin and pemetrexed, including Grade 3 (3.2%)
adverse reactions. The incidence of infusion modifications due to IRR was 46%,
and 2.8% of patients permanently discontinued RYBREVANT due to IRR.
5.2 Interstitial Lung Disease/Pneumonitis
Additions and revisions
underlined:
Based on
the pooled safety population [see Adverse
Reactions (6.1)], ILD/pneumonitis occurred in 2.1% treated with
RYBREVANT in combination with carboplatin and pemetrexed with 1.8% of
patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due
to ILD/pneumonitis.
RYBREVANT as a Single Agent
In CHRYSALIS, [see Adverse Reactions (6.1)],
ILD/pneumonitis occurred in 3.3% of patients
treated with RYBREVANT as a single agent, with 0.7 % of patients
experiencing Grade 3
ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT
due to ILD/pneumonitis.
5.4 Dermatologic Adverse Reactions
Additions and revisions
underlined:
Based on the pooled
safety population [see Adverse
Reactions (6.1)], rash occurred in 82%
of patients treated with RYBREVANT in combination with carboplatin and pemetrexed,
including Grade 3 (15%) adverse reactions. Rash leading to dose
reductions occurred in 14% of patients, and 2.5% permanently
discontinued RYBREVANT and 3.1% discontinued pemetrexed.
5.5 Ocular Toxicity
Additions and revisions
underlined:
Based on
the pooled safety population [see Adverse
Reactions (6.1)], ocular toxicity occurred in 16% of patients treated
with RYBREVANT in combination with carboplatin and pemetrexed. All events
were Grade 1 or 2.
6
Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label
8
Use in Specific Populations
8.5 Geriatric Use
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Information
Additions and revisions
underlined:
What is RYBREVANT?
RYBREVANT is a prescription medicine used to treat adults
with non-small cell lung cancer
(NSCLC) that has spread to other parts of the body (metastatic) or
cannot be removed by surgery, and has certain abnormal epidermal growth factor
receptor (EGFR) gene(s):
in combination with lazertinib as a first-line treatment for non-small cell lung cancer
(NSCLC)
in combination with carboplatin and pemetrexed as a second-line treatment for NSCLC in patients whose disease has worsened on or
after treatment with an EGFR tyrosine kinase inhibitor (TKI)
The most common side effects
of RYBREVANT when given in combination with lazertinib
include:
sores in the mouth · bleeding
swelling of hands, ankles, feet, face, or all of your
body · decreased
appetite
itchy skin
unusual feeling in the skin (such as · nausea
tingling or a crawling
feeling) · changes in certain blood tests
feeling very tired
The most common side effects
of RYBREVANT when
given in combination with carboplatin and pemetrexed include:
rash · decreased appetite
infected skin around
the nail · muscle and joint pain
feeling very tired · vomiting
nausea · COVID-19
sores in the mouth · changes in certain blood tests
constipation
- swelling of hands, ankles,
feet, face, or all of your body
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infusion-Related Reactions
Additions and revisions underlined:
RYBREVANT can cause
infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea,
flushing, fever, chills, nausea,
chest discomfort, hypotension and vomiting. The median time to IRR onset is
approximately 1 hour.
RYBREVANT with Lazertinib
RYBREVANT in combination with
lazertinib can cause infusion-related reactions. In MARIPOSA, [see Adverse
Reactions (6.1)], IRRs occurred in 63% of patients treated
with RYBREVANT in combination with lazertinib, including
Grade 3 in 5% and Grade 4 in 1% of patients. The incidence of infusion modifications due to IRR was 54%, and IRRs leading
to dose reduction of RYBREVANT occurred in 0.7% of patients. Infusion-related reactions
leading to permanent discontinuation of RYBREVANT occurred in 4.5% of patients
receiving RYBREVANT in combination with lazertinib.
RYBREVANT with Carboplatin and Pemetrexed
In PAPILLON, [see Adverse Reactions (6.1)], infusion-related reactions occurred in 42% of patients treated with RYBREVANT in combination with
carboplatin and pemetrexed, including Grade 3 (1.3%) adverse reactions. The incidence
of infusion modifications due to IRR was 40%, and 0.7% of patients permanently
discontinued RYBREVANT.
RYBREVANT as a Single Agent
In CHRYSALIS, [see Adverse Reactions (6.1)], IRR
occurred in 66% of patients treated with RYBREVANT as a single
agent. Among patients
receiving treatment on Week 1 Day
1, 65% experienced an IRR, while the incidence of IRR was 3.4%with the Day 2 infusion,
0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1-2, 2.2%
were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range
0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62%, and 1.3% of patients
permanently discontinued RYBREVANT due to IRR.
Premedicate with
antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as
recommended [see Dosage and Administration (2.4)]. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of infusion-related reactions [see Dosage and Administration (2.7)].
5.2 Interstitial Lung Disease/Pneumonitis
Additions and revisions underlined:
RYBREVANT can cause severe
and fatal interstitial lung disease (ILD)/pneumonitis.
RYBREVANT with Lazertinib
In MARIPOSA, [see Adverse Reactions (6.1)], ILD/pneumonitis
occurred in 3.1% of patients treated with RYBREVANT in combination with
lazertinib, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There
was one fatal case of ILD/pneumonitis and 2.9% of patients permanently
discontinued RYBREVANT and lazertinib due to ILD/pneumonitis [see Adverse Reactions (6.1)].
RYBREVANT with Carboplatin and Pemetrexed
In PAPILLON, [see Adverse Reactions (6.1)], Grade 3 ILD/pneumonitis occurred
in 2.6% of patients treated
with RYBREVANT in combination with carboplatin and pemetrexed, all patients
required permanent discontinuation.
RYBREVANT as a Single Agent
In CHRYSALIS [see Adverse Reactions (6.1)],
ILD/pneumonitis occurred in 3.3% of patients
treated with RYBREVANT as a single
agent, with 0.7 % of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) discontinued RYBREVANT
due to ILD/pneumonitis.
. . .
5.3 Venous Thromboembolic (VTE) Events with Concomitant Use of RYBREVANT and Lazertinib
Newly added subsection:
RYBREVANT in combination with lazertinib can cause serious
and fatal venous
thromboembolic (VTEs) events, including deep vein thrombosis and
pulmonary embolism. The majority of these events occurred during the first four
months of therapy [see Adverse Reaction
(6.1)].
In MARIPOSA [see Adverse Reactions (6.1)], VTEs occurred in 36% of patients
receiving RYBREVANT in combination with lazertinib,
including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs
occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy.
There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to
dose interruptions of RYBREVANT, 1% of patients had VTE leading to dose
reductions of RYBREVANT, and 3.1% of patients had VTE leading to permanent
discontinuation of RYBREVANT. The median time to onset of VTEs was 84 days
(range: 6 to 777).Administer prophylactic anticoagulation for the first
four months of treatment [see Dosage
and Administration (2.3)]. The
use of Vitamin K antagonists is not recommended. Monitor for signs
and symptoms of VTE events and treat as medically
appropriate.
Withhold RYBREVANT and lazertinib based
on severity
[see Dosage and Administration (2.6)]. Once anticoagulant treatment has been initiated, resume RYBREVANT and lazertinib at the same dose level at the discretion of the
healthcare provider
[see Dosage and
Administration (2.4)]. In the event of VTE recurrence despite therapeutic
anticoagulation, permanently discontinue RYBREVANT. Treatment can continue
with lazertinib at the same
dose level at the discretion of the healthcare provider
[see Dosage and Administration (2.5)]. Refer to the lazertinib prescribing information for recommended lazertinib dosage
modification.
5.4 Dermatologic Adverse Reactions
Additions and revisions underlined:
RYBREVANT can cause severe rash including
toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.
RYBREVANT with Lazertinib
In MARIPOSA, [see Adverse Reactions (6.1)], rash
occurred in 86% of patients treated with RYBREVANT in combination with lazertinib, including Grade 3 in 26% of patients.
The median time to onset
of rash was 14 days (range: 1 to 556 days). Rash leading to dose
interruptions of RYBREVANT occurred in 37% of patients, rash leading to dose reductions
of RYBREVANT occurred in 23% of patients, and rash leading to permanent
discontinuation of RYBREVANT occurred in 5% of patients.
RYBREVANT with Carboplatin and Pemetrexed
In PAPILLON [see Adverse Reactions (6.1)], rash occurred
in 89% of patients treated
with RYBREVANT in combination with carboplatin and pemetrexed, including Grade 3 (19%) adverse reactions. Rash leading to
dose reductions occurred in 19% of patients, and 2% permanently discontinued RYBREVANT
and 1.3% discontinued pemetrexed.
RYBREVANT as a Single Agent
In CHRYSALIS [see Adverse Reactions (6.1)], rash
occurred in 74% of patients treated with RYBREVANT as a single agent, including
Grade 3 rash in 3.3% of patients. The
median time to onset of rash was 14 days
(range: 1 to 276 days). Rash leading
to dose reduction occurred in 5% of patients, and RYBREVANT was permanently
discontinued due to rash in 0.7% of patients [see Adverse Reactions (6.1)].
Toxic epidermal necrolysis (TEN)
occurred in one patient (0.3%) treated with RYBREVANT as a single agent.
Instruct patients to limit
sun exposure during
and for 2 months after
treatment with RYBREVANT. Advise patients to wear
protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g.,
isopropanol-free, ethanol-free) emollient cream is recommended for dry
skin.
When initiating treatment with RYBREVANT,
administer alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream
to reduce the risk of dermatologic adverse reactions. Consider prophylactic
measures (e.g., use of oral antibiotics) to reduce the risk of dermatologic
adverse reactions.
5.5 Ocular Toxicity
RYBREVANT can cause ocular
toxicity including keratitis, blepharitis, dry eye symptoms,
conjunctival redness, blurred vision, visual impairment, ocular itching, eye
pruritus and uveitis.
RYBREVANT with Lazertinib
In MARIPOSA [see Adverse Reactions (6.1)], ocular toxicity
occurred in 16% of patients treated with RYBREVANT in
combination with lazertinib, including Grade 3 or 4 ocular toxicity in 0.7%
of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT and continue lazertinib based on severity
[see Dosage and Administration (2.4)].
RYBREVANT with Carboplatin and Pemetrexed
In PAPILLON [see Adverse Reactions (6.1)], ocular toxicity
including blepharitis, dry eye,
conjunctival redness, blurred vision, and eye pruritus occurred in 9%. All
events were Grade 1-2.
RYBREVANT as a Single Agent
In CHRYSALIS [see Adverse Reactions (6.1)], keratitis
occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT.
All events were Grade 1-2.
Promptly refer patients with new
or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or
permanently discontinue RYBREVANT based on severity [see Dosage and Administration (2.6 )].
6
Adverse Reactions
Additions and revisions underlined:
The following adverse reactions are discussed elsewhere in the labeling:
Infusion-Related Reactions [see Warnings
and Precautions (5.1)]
Interstitial Lung Disease/Pneumonitis [see Warnings
and Precautions (5.2)]
Venous Thromboembolic Events
[see Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
Extensive changes; please refer to label
8
Use in Specific Populations
8.5 Geriatric Use
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and revisions underlined:
Venous Thromboembolic Events with Concomitant Use with Lazertinib
When RYBREVANT is used in combination with
lazertinib, advise patients of the risks of serious and life threatening venous
thromboembolic (VTE) events, including deep venous thrombosis and pulmonary
embolism. Advise patients that prophylactic anticoagulants are recommended to be used for the first four months of treatment. Advise
patients to immediately contact their healthcare
provider for signs and symptoms of venous thromboembolism [see Warnings and Precautions (5.3)].
Dermatologic Adverse
Reactions
Advise patients of the risk of dermatologic adverse
reactions. Advise patients
to apply alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream
to reduce the risk of skin reactions. Consider prophylactic measures (e.g., use of oral antibiotics)
to reduce the risk of dermatologic adverse reactions. Advise patients to
limit direct sun exposure during and for 2 months after treatment, to
use broad-spectrum UVA/UVB sunscreen, and to wear protective clothing during
treatment with RYBREVANT [see Warnings
and Precautions (5.4)].
PATIENT INFORMATION
Extensive changes; please refer to label
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infusion-Related Reactions
Additions and/or revisions underlined:
RYBREVANT can cause
infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea,
flushing, fever, chills, nausea, chest discomfort, hypotension and vomiting.
RYBREVANT with Carboplatin and Pemetrexed
RYBREVANT in combination with
carboplatin and pemetrexed can cause infusion-related reactions. Based on the
safety population [see Adverse Reactions (6.1)], infusion-related
reactions occurred in 42% of patients treated with RYBREVANT in combination
with carboplatin and pemetrexed, including Grade 3 (1.3%) adverse reactions. The
incidence of infusion modifications due to IRR was 40%, and 0.7% of patients
permanently discontinued RYBREVANT.
RYBREVANT as a Single Agent
Based on the safety
population [see Adverse Reactions (6.1)], IRR occurred in 66% of
patients treated with RYBREVANT as a single agent.
…
5.2 Interstitial Lung Disease/Pneumonitis
Additions
and/or revisions underlined:
RYBREVANT
can cause interstitial lung disease (ILD)/pneumonitis.
![]()
RYBREVANT
with Carboplatin and Pemetrexed
Based on
the safety population [see Adverse Reactions (6.1)], Grade 3 ILD/pneumonitis
occurred in 2.6% of patients treated with RYBREVANT in combination
with carboplatin and pemetrexed, all patients required permanent
discontinuation.
RYBREVANT
as a Single Agent
Based
on the safety population [see Adverse
Reactions (6.1)], ILD/pneumonitis occurred in 3.3% of patients treated with
RYBREVANT as a single agent, with 0.7 % of patients experiencing Grade 3
ILD/pneumonitis. Three patients (1%) discontinued RYBREVANT due to
ILD/pneumonitis.
![]()
…
5.3 Dermatologic Adverse Reactions
Additions
and/or revisions underlined:
RYBREVANT
can cause rash (including dermatitis acneiform), pruritus and dry skin.
RYBREVANT with Carboplatin
and Pemetrexed
RYBREVANT
in combination with carboplatin and pemetrexed can cause dermatologic adverse
reactions. Based on the safety population [see
Adverse Reactions (6.1)], rash occurred in 89% of patients treated with
RYBREVANT in combination with carboplatin and pemetrexed, including Grade 3
(19%) adverse reactions. Rash leading to dose reductions occurred in 19% of patients,
and 2% permanently discontinued RYBREVANT and 1.3% discontinued pemetrexed.
RYBREVANT as a Single
Agent
Based
on the safety population [see Adverse
Reactions (6.1)], rash occurred in 74% of patients treated with RYBREVANT as
a single agent, including Grade 3 rash in 3.3% of patients. The median time
to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose
reduction occurred in 5% of patients, and RYBREVANT was permanently
discontinued due to rash in 0.7% of patients [see Adverse Reactions (6.1)].
Toxic
epidermal necrolysis (TEN) occurred in one patient (0.3%) treated with
RYBREVANT as a single agent.
…
5.4 Ocular Toxicity
Additions
and/or revisions underlined:
RYBREVANT can cause ocular toxicity
including keratitis, dry eye symptoms, conjunctival redness, blurred vision,
visual impairment, ocular itching, and uveitis.
RYBREVANT with Carboplatin
and Pemetrexed
Based
on the safety population [see Adverse
Reactions (6.1)] RYBREVANT in combination with carboplatin and pemetrexed
can cause ocular toxicity including blepharitis, dry eye, conjunctival redness,
blurred vision, and eye pruritus. All events were Grade 1-2.
RYBREVANT as a Single
Agent
Based
on the safety population [see Adverse
Reactions (6.1)], keratitis occurred in 0.7% and uveitis occurred in 0.3% of
patients treated with RYBREVANT. All events were Grade 1-2. Promptly refer
patients presenting with eye symptoms to an ophthalmologist. Withhold, dose
reduce or permanently discontinue RYBREVANT based on severity [see Dosage and Administration (2.6)].
6
Adverse Reactions
6.1 Clinical Trials Experience
Extensive addition
and/or revisions, please refer to label for complete information.
8
Use in Specific Populations
8.5 Geriatric Use
Additions and/or revisions underlined:
Of the 151 patients with locally advanced
or metastatic NSCLC treated with RYBREVANT in combination with
carboplatin and pemetrexed in the PAPILLON study, 37% were greater than or
equal to 65 years of age and 8% were greater than or equal to 75 years
of age.
Of the 302 patients with locally advanced or metastatic NSCLC treated with RYBREVANT as a single agent in the
CHRYSALIS study, 39% were greater than or equal to 65 years of age and 11% were
greater than or equal to 75 years of age.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
…
Paronychia/Nail Toxicity
Advise patients of the risk of paronychia. Advise patients to contact their
healthcare provider for signs or symptoms of paronychia [see Adverse Reactions (6.1)].
…
PATIENT
INFORMATION
Additions
and/or revisions underlined:
What is RYBREVANT?
RYBREVANT
is a prescription medicine used to treat adults:
RYBREVANT may be given in combination with the medicines
carboplatin and pemetrexed. If you have any questions about these medicines,
ask your healthcare provider.
…
The most common side
effects of RYBREVANT in combination with carboplatin and pemetrexed include:
Rash
constipation
infected skin around the nail
decreased appetite
sores in the mouth
nausea
infusion-related reactions
COVID-19
feeling very tired
diarrhea
swelling of hands, ankles, feet, face, or all of your body
vomiting
changes in certain blood tests
The most common side
effects of RYBREVANT when given alone:
rash
swelling of hands, ankles, feet, face, or all of your body
infusion-related reactions
infected skin around the nail
sores in the mouth
muscle and joint pain
cough
shortness of breath
constipation
nausea
vomiting
feeling very tired
changes in certain blood tests
…
Get Email Alerts |
Guide
