Approved Drug Label (PDF)
5
Warnings and Precautions
5.9 Risk of Fatal Adverse Reactions with Medication Error
Subsection title revised
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
…
Risk
of Fatal Adverse Reactions with Medication Error
For
patients who are prescribed a once weekly dosing regimen, advise patients and
caregivers that the recommended dosage is to be taken once weekly as a single
dose and that mistakenly taking the recommended weekly dosage once daily has
led to death [see Warnings and
Precautions (5.9)].
PATIENT
INFORMATION
Additions and/or revisions underlined:
…
Kidney problems.
Kidney problems can happen with JYLAMVO, including kidney failure which can
happen suddenly (acute) and may not go away (irreversible).
Your healthcare
provider will check your kidney function before you start and during treatment
with JYLAMVO.
Tell
your healthcare provider right away if you develop
any signs or symptoms of kidney problems, including:
a big change (either increase or decrease) in the amount
of urine you produce
shortness of breath amount of urine you produce
tiredness
swelling in your legs, ankles or feet
weight gain
- Risk of death from
taking JYLAMVO the wrong way. JYLAMVO is taken
1 time each week for rheumatoid arthritis, polyarticular juvenile idiopathic
arthritis (pJIA), and severe psoriasis. Deaths have happened when JYLMAVO was
taken every day instead of 1 time weekly. See “How should I take JYLAMVO?” for
instructions on taking this medicine correctly.
…
How should I take
JYLAMVO?
…
Taking more
JYLAMVO than prescribed or taking JYLAMVO more often than prescribed, can lead
to severe side effects and cause death. If you are not sure how often to
take JYLAMVO, ask your healthcare provider or pharmacist.
If you take too
much JYLAMVO call your healthcare provider or go to your nearest hospital
emergency room right away. You will need to receive a medicine as soon
as possible to help reduce side effects that could be severe and could cause
death.
- If you miss taking
a dose of JYLAMVO, call your healthcare provider for instructions about when to
take your next dose of JYLAMVO.
If you are taking
JYLAMVO for treatment of severe psoriasis, rheumatoid arthritis or
polyarticular juvenile idiopathic arthritis:
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical
Trials Experience
Additions and/or
revisions underlined:
…
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
The most common adverse
reactions reported in patients 2 to 18 years of age with pJIA treated
with methotrexate 5 mg/m2 to 20 mg/m2 orally once weekly or 0.1 mg/kg to 0.65 mg/kg orally once weekly were as follows: elevated liver tests 14%; gastrointestinal reactions (e.g., nausea,
vomiting, diarrhea) 11%; stomatitis 2%; leukopenia 2%; headache 1.2%; alopecia 0.5%; dizziness 0.2%;
rash 0.2%. Most patients received concomitant NSAIDs
and some also received corticosteroids.
…
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
The
safety and effectiveness of JYLAMVO in pediatric patients have been established
for the treatment of ALL as part of the combination chemotherapy maintenance regimen
and the treatment of pJIA [see Indications and Usage (1), Dosage and Administration
(2), and Adverse Reactions (6.1)].
The safety and effectiveness of JYLAMVO have not been established in pediatric patients
for the other indications [see Indications and Usage (1)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Importance of Proper
Dosage and Administration
Before use, instruct patients
and caregivers on how to measure and administer the recommended dosage,
utilizing the copackaged syringe and bottle adaptor and that a teaspoon is not an appropriate measuring
device. Advise patients
and caregivers to only use the copackaged syringe and that a household
spoon is not an accurate measuring device [see
Dosage and Administration (2)].
…
Ineffective Immunization and Risks Associated with Live Vaccines
Advise patients to avoid receiving vaccines during treatment with JYLAMVO because
they may not be effective and live virus vaccines
may cause infections [see Warnings and
Precautions (5.15)].
…
PATIENT INFORMATION
Additions and/or
revisions underlined:
…
What
is JYLAMVO?
JYLAMVO is a prescription medicine used:
in combination with other chemotherapy medicines in adults
and children, for maintenance treatment of acute
lymphoblastic leukemia (ALL)
to treat adults
with mycosis fungoides (cutaneous T-cell lymphoma)
in combination with other therapies to treat adults with non-Hodgkin lymphoma that has come back (relapsed) or did
not respond to previous treatment (refractory)
to treat adults with rheumatoid arthritis
to treat children
with polyarticular juvenile
idiopathic arthritis (pJIA)
- to treat adults
with severe psoriasis
It is not known
if JYLAMVO is
safe
and effective in
children for the treatment of any
medical condition other than ALL as part of a combination regimen used
for maintenance therapy of their cancer, and pJIA. It is not known
if JYLAMVO is safe in people with liver problems.
Do not take JYLAMVO if you:
are pregnant and are being
treated or will be treated with JYLAMVO for rheumatoid arthritis, pJIA,
severe psoriasis or for any medical condition other than cancer.
JYLAMVO can cause
harm to an unborn baby, including birth
defects or death of an unborn baby. See “What is the most important information I should know about JYLAMVO?”
- have or had a severe allergic reaction
to JYLAMVO or any other medicine containing methotrexate. See “What is the most important information I should know about JYLAMVO?” See the end of this Patient
Information leaflet for a
complete list of ingredients in JYLAMVO.
Before taking
JYLAMVO tell your healthcare provider
about all of your medical
conditions, including if you:
…
- have recently received or are scheduled
to receive a vaccine. You should not receive live vaccines during treatment
with JYLAMVO. These vaccines may not be safe or may not work as well during
treatment with JYLAMVO.
…
How should I take JYLAMVO?
…
If you are taking JYLAMVO
for treatment of severe psoriasis, rheumatoid arthritis or polyarticular juvenile idiopathic arthritis:
…
General information about the safe and effective use of JYLAMVO.
Medicines
are sometimes prescribed for purposes other than those listed in a Patient
Information leaflet. Do not use JYLAMVO for a condition for which it was not
prescribed. Do not give JYLAMVO to other people, even if they have the same symptoms
that you have. It may harm them. This Patient Information leaflet summarizes the most important
information about JYLAMVO. If you would like more information, talk with
your healthcare provider. You can ask your pharmacist or healthcare provider
for information about JYLAMVO that is written for health professionals.
…
Approved Drug Label (PDF)
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
The
safety and effectiveness of JYLAMVO in pediatric patients have been established
for the treatment of ALL as part of the combination chemotherapy maintenance regimen
and the treatment of pJIA [see Indications and Usage (1), Dosage and Administration
(2), and Adverse Reactions (6.1)].
The safety and effectiveness of JYLAMVO have not been established in pediatric patients
for the other indications [see Indications and Usage (1)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Importance of Proper
Dosage and Administration
Before use, instruct patients
and caregivers on how to measure and administer the recommended dosage,
utilizing the copackaged syringe and bottle adaptor and that a teaspoon is not an appropriate measuring
device. Advise patients
and caregivers to only use the copackaged syringe and that a household
spoon is not an accurate measuring device [see
Dosage and Administration (2)].
…
Ineffective Immunization and Risks Associated with Live Vaccines
Advise patients to avoid receiving vaccines during treatment with JYLAMVO because
they may not be effective and live virus vaccines
may cause infections [see Warnings and
Precautions (5.15)].
…
PATIENT INFORMATION
Additions and/or
revisions underlined:
…
What
is JYLAMVO?
JYLAMVO is a prescription medicine used:
in combination with other chemotherapy medicines in adults
and children, for maintenance treatment of acute
lymphoblastic leukemia (ALL)
to treat adults
with mycosis fungoides (cutaneous T-cell lymphoma)
in combination with other therapies to treat adults with non-Hodgkin lymphoma that has come back (relapsed) or did
not respond to previous treatment (refractory)
to treat adults with rheumatoid arthritis
to treat children
with polyarticular juvenile
idiopathic arthritis (pJIA)
- to treat adults
with severe psoriasis
It is not known
if JYLAMVO is safe
and effective in children for the treatment of any
medical condition other than ALL as part of a combination regimen used
for maintenance therapy of their cancer, and pJIA. It is not known
if JYLAMVO is safe in people with liver problems.
Do not take JYLAMVO if you:
are pregnant and are being
treated or will be treated with JYLAMVO for rheumatoid arthritis, pJIA,
severe psoriasis or for any medical condition other than cancer.
JYLAMVO can cause
harm to an unborn baby, including birth
defects or death of an unborn baby. See “What is the most important information I should know about JYLAMVO?”
- have or had a severe allergic reaction
to JYLAMVO or any other medicine containing methotrexate. See “What is the most important information I should know about JYLAMVO?” See the end of this Patient
Information leaflet for a
complete list of ingredients in JYLAMVO.
Before taking
JYLAMVO tell your healthcare provider
about all of your medical
conditions, including if you:
…
- have recently received or are scheduled
to receive a vaccine. You should not receive live vaccines during treatment
with JYLAMVO. These vaccines may not be safe or may not work as well during
treatment with JYLAMVO.
…
How should I take JYLAMVO?
…
If you are taking JYLAMVO
for treatment of severe psoriasis, rheumatoid arthritis or polyarticular juvenile idiopathic arthritis:
…
General information about the safe and effective use of JYLAMVO.
Medicines
are sometimes prescribed for purposes other than those listed in a Patient
Information leaflet. Do not use JYLAMVO for a condition for which it was not
prescribed. Do not give JYLAMVO to other people, even if they have the same symptoms
that you have. It may harm them. This Patient Information leaflet summarizes the most important
information about JYLAMVO. If you would like more information, talk with
your healthcare provider. You can ask your pharmacist or healthcare provider
for information about JYLAMVO that is written for health professionals.
…
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