Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Central Nervous System Effects
(additions and/or
revisions are underlined)
Psychiatric Adverse
Reactions
Fluoroquinolones,
including BAXDELA, have been associated with an increased risk of psychiatric
adverse reactions, including: toxic psychosis; hallucinations, or paranoia; depression,
or suicidal thoughts or acts; delirium, disorientation, confusion, or disturbances
in attention; anxiety, agitation, or nervousness; insomnia or nightmares;
memory impairment. These adverse reactions may occur following the first dose. If
these reactions occur in patients receiving BAXDELA, discontinue BAXDELA
immediately and institute appropriate measures.
Central Nervous System
Adverse Reactions
Fluoroquinolones
have been associated with an increased risk of seizures (convulsions), increased
intracranial pressure (including pseudotumor cerebri), dizziness, and tremors.
As with all fluoroquinolones, use BAXDELA when the benefits of treatment exceed
the risks in patients with known or suspected CNS disorders (e.g., severe cerebral
arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose
to seizures or lower the seizure threshold.
If these reactions occur in patients receiving BAXDELA, discontinue BAXDELA
immediately and institute appropriate measures.
5.9 Development of Drug-Resistant Bacteria
(additions and/or
revisions are underlined)
Prescribing
BAXDELA in the absence of a proven or strongly suspected bacterial infection or
a prophylactic indication is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant bacteria.
6
Adverse Reactions
6.1 Clinical Trials Experience
(extensive additions
and/or revisions; please refer to labeling for complete information)
8
Use in Specific Populations
8.5 Geriatric Use
(additions and/or
revisions are underlined)
Of
the 754 adult ABSSSI patients treated with BAXDELA, in Trials 1 and 2,
111/754 (15%) were 65 years of age and older. The clinical response
rates at 48-72 hours for the BAXDELA-treated and comparator-treated
patients were 84/111 (75.7%) and 72/101 (71.3%), respectively
in ABSSSI patients aged 65 years and older compared to patients aged
less than 65 years of age 529/643 (82.3%) and 538/655 (82.1%),
respectively. In the safety population, of the 741 adult patients treated with
BAXDELA, 18/110 (16.4%) patients aged 65 years and older and 146/631
(23.1%) patients aged less than 65 years had at least one adverse drug reaction.
Of
the 431 adult CABP patients treated with BAXDELA, in Trial 3, 203/431 (47.1%) were
65 years of age and older, while 85/431 (19.7%) were 75 and over. The clinical
response rates at 72-120 hours for the BAXDELA- treated and moxifloxacin-treated
patients were 177/203 (87.2%) and 161/179 (89.9%), respectively in the CABP patients
aged 65 years and older compared to patients aged less than 65 years old
(206/228 (90.4%) and 220/249 (88.4%), respectively). In the safety population,
of the 429 adult patients treated with BAXDELA, 10/84 (11.9%) patients aged 75 and older, 27/202 (13.4%)
patients aged 65 years and older and 38/227 (16.7%) patients aged less than 65 years
old had at least one adverse drug reaction.
Geriatric
patients are at increased risk for developing severe tendon disorders including
tendon rupture when being treated with a fluoroquinolone. This risk is further increased
in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture
can involve the Achilles, hand, shoulder, or other tendon sites and can occur
during or after completion of therapy; cases occurring up to several months after
fluoroquinolone treatment have been reported. Caution should be used when prescribing
BAXDELA to elderly patients especially those on corticosteroids. Patients
should be informed of this potential adverse reaction and advised to discontinue
BAXDELA and contact their healthcare provider if any symptoms of tendinitis or tendon
rupture occur.
Epidemiologic
studies report an increased rate of aortic aneurysm and dissection within two
months following use of fluoroquinolones, particularly in elderly patients.
In
elderly subjects (? 65 years), the mean Cmax and AUC? of delafloxacin were about
35% higher compared with young adults, which is not considered clinically significant.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions and/or
revisions are underlined)
…
3. Central Nervous System
(CNS) effects. Seizures have been reported in people
who take fluoroquinolone antibacterial medicines. Tell your healthcare provider
if you have a history of seizures before you start taking BAXDELA. CNS side
effects may happen as soon as after taking the first dose of BAXDELA. Stop taking
BAXDELA immediately and talk to your healthcare provider right away if you get any
of these side effects, or other changes in mood or behavior:
seizures
hear voices, see things, or sense
things that are not there (hallucinations)
feel restless
tremors
feel anxious or nervous
confusion
depression
trouble sleeping
nightmares
feel lightheaded or dizzy
feel more suspicious (paranoia)
suicidal thoughts or acts
headaches that will not go away, with or without
blurred vision
memory problems
false or strange
thoughts or beliefs (delusions)
difficulty paying attention
reduced awareness of
surroundings
…
What is BAXDELA?
BAXDELA
is a fluoroquinolone antibacterial medicine used to treat certain types of infections
caused by certain germs called bacteria in adults 18 years or older. These bacterial
infections include:
- community-acquired bacterial pneumonia
It
is not known if BAXDELA is safe and effective in people under 18 years of age, and
use in people under 18 years of age is not recommended. Children younger than 18
years of age may have a higher chance of getting bone, joint, and tendon (musculoskeletal)
problems while taking fluoroquinolone antibacterial medicines.
Sometimes
infections are caused by viruses rather than by bacteria. Examples include viral
infections in the sinuses and lungs, such as the common cold or flu. Antibacterial
medicines, including BAXDELA, do not kill viruses. Call your healthcare provider
if you think your condition is not getting
better while you are taking BAXDELA.
…
The most common side
effects of BAXDELA include:
nausea
diarrhea
headache
changes in liver tests
vomiting
PATIENT COUNSELING INFORMATION
(additions and/or
revisions are underlined)
Advise
the patient to read the FDA-approved
patient labeling (Medication Guide).
Serious
Adverse Reactions
Advise
patients to stop taking BAXDELA if they experience an adverse reaction and to call
their healthcare provider for advice on completing the full course of treatment
with another antibacterial drug.
Inform
patients of the following serious adverse reactions that have been associated
with BAXDELA or other fluoroquinolone use:
- Disabling and Potentially Irreversible Serious Adverse
Reactions that may occur together: Inform patients that disabling and
potentially irreversible serious adverse reactions, including tendinitis and
tendon rupture, peripheral neuropathies, and central nervous system effects,
have been associated with use of fluoroquinolones and may occur together in the
same patient. Inform patients to stop taking BAXDELA immediately if they experience
an adverse reaction and to call their healthcare provider.
- Tendinitis and Tendon Rupture: Instruct patients to
contact their healthcare provider if they experience pain, swelling, or
inflammation of a tendon, or weakness or inability to use one of their joints;
rest and refrain from exercise; and discontinue BAXDELA treatment. Symptoms may
be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher
in older patients usually over 60 years of age, in patients taking corticosteroid
drugs, and in patients with kidney, heart or lung transplants.
- Peripheral Neuropathy: Inform patients that
peripheral neuropathies have been associated with BAXDELA use, symptoms may occur
soon after initiation of therapy and may be irreversible. If symptoms of
peripheral neuropathy including pain, burning, tingling, numbness and/or
weakness develop, immediately discontinue BAXDELA and tell them to contact their
physician.
- Central Nervous System Effects: (for example,
convulsions, dizziness, lightheadedness, increased intracranial pressure):
Inform patients that convulsions have been reported in patients receiving fluoroquinolones.
Instruct patients to notify their physician before taking this drug if they have
a history of convulsions. Inform patients that they should know how they react
to BAXDELA before they operate an automobile or machinery or engage in other activities
requiring mental alertness and coordination. Instruct patients to notify their
physician if persistent headache with or without blurred vision occurs.
- Exacerbation of Myasthenia Gravis: Instruct patients
to inform their physician of any history of myasthenia gravis. Instruct
patients to notify their physician if they experience any symptoms of muscle weakness,
including respiratory difficulties.
- Hypersensitivity Reactions: Inform patients that
BAXDELA can cause hypersensitivity reactions, even following a single dose, and
to discontinue BAXDELA at the first sign of a skin rash, hives or other skin reactions,
a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting
angioedema (for example, swelling of the lips, tongue, face, tightness of the throat,
hoarseness), or other symptoms of an allergic reaction.
- Diarrhea: Diarrhea is a common problem caused by antibiotics
which usually ends when the antibiotic is discontinued. Sometimes after
starting treatment with antibiotics, patients can develop watery and bloody stools (with or without
stomach cramps and fever) even as late as two or more months after having taken
the last dose of the antibiotic. If this occurs, instruct patients to contact their
physician as soon as possible.
- Aortic Aneurysm and Dissection: Inform patients to
seek emergency medical care if they experience sudden chest, stomach, or back
pain.
- Antibacterial Resistance: Patients should be counseled that antibacterial
drugs including BAXDELA Tablets and Injection should only be used to treat bacterial
infections. They do not treat viral infections (for example, the common cold). When
BAXDELA Tablets and BAXDELA Injection are prescribed to treat a bacterial infection,
patients should be told that although it is common to feel better early in the course
of therapy, the medication should be taken exactly as directed. Skipping doses
or not completing the full course of therapy may (1) decrease the effectiveness
of the immediate treatment and (2) increase the likelihood that bacteria will develop
resistance and will not be treatable by BAXDELA Tablets and BAXDELA Injection
or other antibacterial drugs in the future.
Administration
with Food and Concomitant Medications
- Inform
patients that BAXDELA Tablets may be taken with or without food and without any
dietary restrictions.
- Inform
patients that BAXDELA Tablets should be taken at least 2 hours before or 6 hours
after antacids containing magnesium, or aluminum, with sucralfate, with metal cations
such as iron, or with multivitamin preparations containing zinc or iron, or with
didanosine buffered tablets for oral suspension or the pediatric powder for oral
solution.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.8 Risk of Aortic Aneurysm and Dissection
(new
subsection added)
Epidemiologic
studies report an increased risk of aortic aneurysm and dissection within two
months following use of fluoroquinolones, particularly in elderly patients. The
cause for the increased risk has not been identified. In patients with a known
aortic aneurysm or patients who are at greater risk for aortic aneurysms,
reserve BAXDELA for use only when there are no alternative antibacterial
treatments available.
8
Use in Specific Populations
8.5Geriatric Use
(additions
underlined)
…
Epidemiologic
studies report an increased rate of aortic aneurysm and dissection within two
months following use of fluoroquinolones, particularly in elderly.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions
underlined)
…
What are the
possible side effects of BAXDELA?
…
Aortic aneurysm
and dissection. Tell your healthcare provider if you have ever been
told that you have an aortic aneurysm, a swelling of the large artery that
carries blood from the heart to the body. Get emergency medical help right away
if you have sudden chest, stomach, or back pain.
…
PATIENT COUNSELING INFORMATION
(additions
underlined)
…
Serious
Adverse Reactions
…
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Central Nervous System Effects
(Additions and/or
revisions are underlined)
Psychiatric Adverse
Reactions
Fluoroquinolones have been associated with an
increased risk of psychiatric adverse reactions, including: toxic
psychosis; hallucinations, or paranoia; depression, or suicidal
thoughts or acts; delirium, disorientation, confusion, or disturbances in
attention; anxiety, agitation, or nervousness; insomnia or nightmares; memory
impairment. These adverse reactions may occur following the first dose. If
these reactions occur in patients receiving BAXDELA, discontinue BAXDELA
immediately and institute appropriate measures.
Central Nervous System
Adverse Reactions
Fluoroquinolones have been associated with an
increased risk of seizures (convulsions), increased intracranial pressure
(including pseudotumor cerebri), dizziness, and tremors. As with all
fluoroquinolones, use BAXDELA when the benefits of treatment exceed the risks
in patients with known or suspected CNS disorders (e.g., severe cerebral
arteriosclerosis, epilepsy) or in the presence of other risk factors that may
predispose to seizures or lower the seizure threshold. If these reactions occur in patients receiving BAXDELA,
discontinue BAXDELA immediately and institute appropriate measures.
5.9 Blood Glucose Disturbances
(Additions and/or revisions
are underlined)
Fluoroquinolones have been associated with
disturbances of blood glucose, including symptomatic hyperglycemia and
hypoglycemia, usually in diabetic patients receiving concomitant treatment with
an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these
patients, careful monitoring of blood glucose is recommended. Severe cases of
hypoglycemia resulting in coma or death have been reported with other
fluoroquinolones. If a hypoglycemic reaction occurs in a patient being treated
with BAXDELA, discontinue BAXDELA and initiate appropriate therapy immediately.
6
Adverse Reactions
The following serious and otherwise important
adverse reactions are discussed in greater detail in other sections of
labeling:
(Additions and/or
revisions are underlined)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(Additions
and/or revisions are underlined)
What
are the possible side effects of BAXDELA?
Changes in
blood sugar. People who take
fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can
get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow
your healthcare provider’s instructions for how often to check your blood
sugar. If you have diabetes and you get low blood sugar while taking BAXDELA,
stop taking BAXDELA and call your healthcare provider right away. Your
antibiotic medicine may need to be changed.
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