Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
Additions
and/or revisions underlined:
…
Immune System
Disorders: Hypersensitivity.
Skin and
Subcutaneous Tissue Disorders: Erythema multiforme, toxic epidermal
necrolysis (TEN).
Approved Drug Label (PDF)
5
Warnings and Precautions
5.8 Symptom Exacerbation Following Interruption or Discontinuation of Treatment
Newly added subsection:
Following discontinuation of JAK inhibitors, including OJJAARA, signs
and symptoms from myeloproliferative neoplasms may flare. Some patients with MF
have experienced one or more of the following after discontinuing JAK
inhibitors: fever, respiratory distress, hypotension, disseminated
intravascular coagulation, or multi-organ failure.
If one or more of these signs and symptoms occur after discontinuation
of OJJAARA, evaluate for and treat any intercurrent illness and consider
restarting OJJAARA. Instruct patients not to interrupt or discontinue therapy
without consulting their healthcare provider. When discontinuing or
interrupting therapy for reasons other than potentially life-threatening
toxicities, consider tapering the dose of OJJAARA
gradually rather than discontinuing abruptly.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Symptom
Exacerbation Following Interruption or Discontinuation of Treatment
Inform
patients that after discontinuation of OJJAARA, signs and symptoms from
myeloproliferative neoplasms may return. Instruct patients not to interrupt or
discontinue OJJAARA without consulting their healthcare provider [see Warnings and Precautions (5.8)].
…
PATIENT
INFORMATION
Additions
and/or revisions underlined:
…
Before taking
OJJAARA, tell your healthcare provider about all of your medical conditions,
including if you:
…
Females who are
able to become pregnant:
Use highly effective birth control (contraception)
during treatment and for at least 1 week after the last dose of OJJAARA.
Tell
your healthcare provider right away if you think you are pregnant or become
pregnant during treatment with OJJAARA.
are
breastfeeding or plan to breastfeed. It is not known if OJJAARA passes into
your breast milk. You should not breastfeed during treatment and for at
least 1 week after the last dose of OJJAARA. Talk to your healthcare
provider about the best way to feed your baby during this time.
…
What are the
possible side effects of OJJAARA?
OJJAARA may cause
serious side effects, including:
…
Worsening of
symptoms after interruption or stopping treatment. Signs and symptoms
of myelofibrosis may worsen after you stop treatment with OJJAARA. Do not
interrupt or stop treatment with OJJAARA without talking to your healthcare
provider. If you need to stop treatment with OJJAARA, your healthcare provider
may give you instructions for slowly stopping treatment.
Tell
your healthcare provider right away if you get any of the following signs and
symptoms after stopping treatment with OJJAARA:
Your healthcare
provider will do blood tests before you start treatment with OJJAARA and during
treatment to check for side effects.
Your healthcare
provider may change your dose, temporarily stop, or permanently stop treatment
with OJJAARA if you get certain side effects.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Severe Cutaneous Adverse Reactions (SCARs)
New subsection added:
Severe cutaneous adverse reactions,
including toxic epidermal necrolysis (TEN), have been observed in some patients
treated with OJJAARA.
If signs or symptoms of severe
cutaneous reactions occur, interrupt OJJAARA until the etiology of the reaction
has been determined. Consider early consultation with a dermatologist for
evaluation and management.
If etiology is considered
to be associated with OJJAARA, permanently discontinue and do not reintroduce
OJJAARA in patients who have experienced SCARs or other life-threatening
cutaneous reactions during OJJAARA treatment.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
6.1 Clinical
Trials Experience
Additions and/or revisions underlined:
…
Other Adverse Reactions
Clinically relevant adverse reactions occurring in <5%
of anemic patients in the MOMENTUM and SIMPLIFY-1 studies include:
Eye Disorders: Blurred vision.
Infections and Infestations: Fungal infection
(excludes opportunistic infections).
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
Nervous System Disorders: Neuralgia, peripheral
neuropathy, peripheral motor neuropathy, polyneuropathy, syncope.
Vascular Disorders: Flushing.
6.2 Postmarketing
Experience
New
subsection added:
The
following adverse reactions have been identified during postapproval use of OJJAARA.
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.
Skin and Subcutaneous
Tissue Disorders: Toxic
epidermal necrolysis (TEN).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Severe
Cutaneous Adverse Reactions (SCARs)
Inform
patients that SCARs have been reported in some patients treated with OJJAARA
and instruct them to promptly report any signs and symptoms of SCARs to their healthcare
provider [see Warnings and Precautions
(5.4)].
…
PATIENT
INFORMATION
Additions and/or revisions underlined:
…
What are the
possible side effects of OJJAARA?
OJJAARA may cause serious
side effects, including:
…
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