Additions and/or
revisions underlined:
The following clinically
significant adverse reactions are described elsewhere in the labeling:
- Serious Skin/Hypersensitivity
Reactions [see Warnings and Precautions
(5.1)]
- Clostridioides
difficile-Associated Diarrhea
(Antibiotic-Associated Colitis) [see
Warnings and Precautions (5.4)]
- Hepatotoxicity [see Warnings and Precautions (5.5)]
- Central Nervous System Effects [see Warnings and Precautions (5.6)]
- Idiopathic Intracranial Hypertension [see Warnings and Precautions (5.7)]
6.1 Clinical Trials
Experience
Additions and/or
revisions underlined:
Because clinical trials
are conducted under widely varying conditions, adverse reaction rates observed
in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in
practice.
The following table
summarizes selected adverse reactions reported in clinical trials at a rate of
greater than or equal to 1% for SOLODYN and higher than placebo.
Table
2: Selected Treatment-Emergent Adverse Reactions in at Least 1% of Clinical
Trial Subjects and Higher than Placebo
. . .
8.1 Pregnancy
PLLR conversion:
Risk Summary
Tetracycline class drugs,
including SOLODYN may cause permanent discoloration of deciduous teeth and
reversible inhibition of bone growth when administered during the second and
third trimesters of pregnancy [see
Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.4)]. A
few postmarketing cases of limb reductions have been reported over decades of
use; however, the association is unclear. The limited data from postmarketing
reports are not sufficient to inform a drug-associated risk for birth defects
or miscarriage.
If a patient becomes pregnant
while taking this drug, advise
the patient of the risk to the fetus and to discontinue treatment.
The background risk of
major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse
outcomes. In the U.S. general population, the estimated background risk of
major birth defects and miscarriage in clinically recognized pregnancies is 2
to 4% and 15 to 20%, respectively.
Data
Human
Data
The use of tetracycline
class drugs, including SOLODYN, during tooth development (second and third
trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may
cause permanent discoloration of deciduous teeth (yellow-gray-brown). Permanent
discoloration of the teeth is more common during long-term use of the drug but
has been observed following repeated short-term courses [see Warnings and Precautions (5.2)].
Animal
Data
Results of animal studies
indicate that tetracyclines cross the placenta, are found in fetal tissues, and
can cause delayed skeletal development in the developing fetus. Evidence of
embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3)].
Minocycline induced
skeletal malformations (bent limb bones) in fetuses when administered to
pregnant rats and rabbits during the period of organogenesis at doses of 30
mg/kg/day and 100 mg/kg/day, respectively (3 times the MRHD and 2 times the
MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight
was observed in studies in which minocycline was administered to pregnant rats
at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC
comparison basis).
Minocycline was assessed
for effects on peri- and post-natal development of rats in a study that
involved oral administration to pregnant rats during the period of
organogenesis through lactation at dosages of 5, 10, or 50 mg/kg/day. In this
study, body weight gain was significantly reduced in pregnant females that
received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). No
effects of treatment on the duration of the gestation period or the number of
live pups born per litter were observed. Gross external anomalies observed in
offspring of animals that received minocycline included reduced body size,
improperly rotated forelimbs, and reduced size of extremities. No effects were
observed on the physical development, behavior, learning ability, or
reproduction of the offspring of animals that received minocycline.
8.2 Lactation
PLLR conversion:
Risk Summary
Tetracycline-class
antibiotics, including minocycline, are present in breast milk following oral
administration. There are no data on the effects of minocycline on milk
production. Because of the potential for serious adverse reactions, including
tooth discoloration and inhibition of bone growth, advise patients that
breastfeeding is not recommended during SOLODYN therapy and for 4 days after
the final dose [see Warnings and
Precautions (5.2, 5.3)].
8.4 Pediatric Use
Additions and/or
revisions underlined:
The safety and
effectiveness of SOLODYN have been established in pediatric patients 12 years
of age and older for the treatment of inflammatory lesions of
non-nodular moderate to severe acne vulgaris [see Clinical Studies (14)]. Tooth
discoloration and inhibition of bone growth have been observed in
pediatric patients [see Warnings and Precaution (5.2, 5.3)]. Use of
tetracycline-class antibiotics below the age of 8 is not recommended due to the
potential for tooth discoloration [see Warnings and Precautions (5.2)].
Safety and effectiveness
of SOLODYN have not been established in pediatric patients younger than 12
years of age.
Additions and/or
revisions underlined:
Advise the patient to
read the FDA-approved patient labeling (Patient Information).
Patients taking SOLODYN
extended-release tablets should receive the following information and
instructions: Administration Instructions
- SOLODYN should be taken exactly as
directed.
- Advise patients to swallow SOLODYN
extended-release tablets whole and not to chew, crush, or split the tablets [see Dosage and Administration (2)].
Serious
Skin/Hypersensitivity Reactions
- Inform patients that serious skin
reactions have occurred with the minocycline use in patients with acne. Advise
patients to discontinue use of SOLODYN and contact their healthcare provider
immediately at the first evidence of skin erythema [see Warnings and Precautions (5.1)].
Tooth Discoloration and
Enamel Hypoplasia
- Advise patients that SOLODYN use in
pregnancy may cause permanent tooth discoloration of deciduous teeth. Advise
patients to discontinue SOLODYN during pregnancy and to inform their healthcare
provider right away if they become pregnant during
treatment [see Warnings and Precautions
(5.2), Use in Specific
Populations (8.1)].
- Advise caregivers of pediatric
patients that SOLODYN use may cause permanent discoloration of deciduous and
permanent teeth [see Warnings and
Precautions (5.2), Use in Specific Populations (8.4)].
Inhibition of Bone Growth
- Advise patients that SOLODYN use in
pregnancy may cause inhibition of fetal bone growth. Advise patients to
discontinue SOLODYN during pregnancy and to inform their healthcare provider
right away if they become pregnant during treatment [see Warnings and Precautions (5.3), Use in Specific Populations
(8.1)].
Clostridioides
difficile-Associated Diarrhea (Antibiotic-Associated
Colitis)
- Advise patients that Clostridioides difficile-associated
diarrhea (antibiotic-associated colitis) can occur with
minocycline therapy, including SOLODYN. If patients develop watery or
bloody stools, advise patients to seek medical attention [see Warnings and Precautions (5.4)].
Hepatotoxicity
- Inform patients
about the possibility of hepatotoxicity. Advise patients to seek medical
advice if they experience signs or symptoms of hepatotoxicity,
including loss of appetite, tiredness, diarrhea, jaundice, bleeding
easily, confusion, and sleepiness [see
Warnings and Precautions (5.5)].
Central Nervous System
Effects
- Inform patients that
central nervous system adverse reactions including dizziness or vertigo have
been reported with oral minocycline therapy. Caution patients about
driving vehicles or using hazardous machinery if they experience such
symptoms while on SOLODYN [see
Warnings and Precautions (5.6)].
Idiopathic Intracranial
Hypertension
- Inform patients
that idiopathic intracranial hypertension can occur with minocycline
therapy. Advise patients to seek medical attention if they develop
unusual headache, visual symptoms, such as blurred vision, diplopia, and
vision loss [see Warnings and Precautions
(5.7)].
Autoimmune Syndromes
- Inform patients that autoimmune
syndromes, including drug-induced lupus-like syndrome,
autoimmune hepatitis, vasculitis, and serum sickness have been observed with
tetracycline-class drugs, including minocycline. Symptoms may be manifested by
arthralgia, fever, rash, and malaise. Advise patients who experience
such symptoms to immediately discontinue SOLODYN and seek medical help [see Warnings and Precautions (5.8)].
Photosensitivity
- Inform patients that photosensitivity
manifested by an exaggerated sunburn reaction has been observed in some
individuals taking tetracyclines, including minocycline. Advise patients to
minimize or avoid exposure to natural or artificial sunlight (i.e.,
tanning beds or UVA/B treatment) while using SOLODYN. Instruct patients to
use sunscreen and wear protective clothing (e.g., hat) over treated areas when
exposure to sun cannot be avoided [see
Warnings and Precautions (5.10)].
Tissue Hyperpigmentation
- Inform patients that SOLODYN may
cause discoloration of skin, scars, teeth, or gums [see Warnings and Precautions (5.11)].
Lactation
- Advise patients that SOLODYN therapy
is not recommended during breast feeding for 4 days after the final dose [see Use in Specific Populations (8.2)].
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