Additions and/or revisions underlined:
…
6.Depression
Monitor females with
a history of depression and discontinue ALESSE if depression recurs to a
serious degree. Data on the association of CHCs with onset of depression or
exacerbation of existing depression are limited.
…
8.Gastrointestinal
Diarrhea and/or vomiting may reduce hormone absorption
resulting in decreased serum concentrations. If a patient vomits or has
diarrhea after taking an active tablet, instruct the patient to not take an
additional active tablet on that day and to continue the regimen the next day
as prescribed. In case of vomiting or diarrhea that continues for 48 hours or
greater, instruct the patient to contact the health care provider and use
back-up or alternative contraception until active tablets have been taken for 7
consecutive days after vomiting and diarrhea have resolved.
9.Drug Interactions
…
Changes in Plasma Levels of Co-Administered Drugs:
… Concomitant use of ALESSE may decrease
lamotrigine exposure, which may reduce efficacy of lamotrigine. Adjust
lamotrigine dosage as recommended in its Prescribing Information based on
ALESSE initiation or discontinuation.
Concomitant use of ALESSE may increase
thyroid-binding globulin concentration. Monitor thyroid-stimulating hormone
(TSH) level and follow the recommendation for the thyroid hormone in accordance
with its Prescribing Information.
The prescribing information of concomitant medications
should be consulted to identify potential interactions.
…
12.Pregnancy
Risk Summary
There is no use for contraception in
pregnancy; therefore, ALESSE should be discontinued during pregnancy.
Epidemiologic studies and meta-analyses have not found an increased risk of
genital or nongenital birth defects (including cardiac anomalies and
limb-reduction defects) following exposure to COCs before conception or during
early pregnancy.
In the U.S. general population, the
estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Data
Human Data
Epidemiologic studies and meta-analyses
have not found an increased risk of genital or nongenital birth defects
(including cardiac anomalies and limb-reduction defects) following exposure to
COCs before conception or during early pregnancy.
13.Lactation
Contraceptive hormones and metabolites are
present in human milk. CHCs can reduce milk production in breast-feeding
females. This reduction can occur at any time but is less likely to occur once
breast-feeding is well-established. The developmental and health benefits of
breast-feeding should be considered along with the mother’s clinical need for
ALESSE and any potential adverse effects on the breast-fed child from ALESSE or
from the underlying maternal condition.
…
16.Body Mass Index
The safety and effectiveness of ALESSE in
females with a BMI > 35 kg/m2 have not been adequately evaluated.
Additions and/or revisions underlined:
1. Thromboembolic Disorders and Other
Vascular Problems
Cardiovascular and Cerebrovascular Events
Use of CHCs increases the risk of
cardiovascular events and cerebrovascular events, such as myocardial infarction
and stroke. The risk of these events with CHC use is greater in females with
concomitant risk factors: age 35 years and older, smoking, hypertension,
dyslipidemia, diabetes, or obesity. The risk increases with increasing age and
with increasing number of cigarettes smoked.
Venous Thromboembolism
Use of CHCs also increases the risk of
VTE, such as deep vein thrombosis and pulmonary embolism.
The rate of VTE in females using COCs has
been estimated to be 3 to 9 cases per 10,000 woman-years.
The VTE risk should be considered in the
context of relevant subpopulations of females of reproductive potential who are
not taking CHCs (ADVERSE REACTIONS).
Risk factors for VTE with CHC use include
smoking, obesity, family history of VTE, and prolonged immobilization, in
addition to other factors that contraindicate use of CHCs (see
CONTRAINDICATIONS). The presence of multiple risk factors for VTE with CHC use may
further increase the risk. The risk of VTE is highest during the first year of
CHC use and when restarting hormonal contraception after a break of four weeks
or longer. The risk of VTE returns to baseline approximately 3 months after CHC
use is discontinued.
Postpartum Venous Thromboembolism
The risk of VTE is increased during the
first six weeks postpartum. The risk is highest up to four weeks postpartum but
remains higher than baseline until at least six weeks postpartum. The presence
of multiple risk factors for VTE may further increase the risk. Obstetric
complications may extend the elevated risk up to 12 weeks postpartum.
…
7.Gallbladder Disease
… A past history of COC-related cholestasis
predicts an increased risk with subsequent COC use. Women with a history of
pregnancy-related cholestasis may be at an increased risk for COC related
cholestasis.
8.Carbohydrate and Lipid Metabolic Effects
… Carefully monitor females with prediabetes and
diabetes who are using ALESSE. ALESSE may decrease glucose tolerance.
…
9.Elevated Blood Pressure
ALESSE is contraindicated in women with
uncontrolled hypertension or hypertension with vascular disease (see
CONTRAINDICATIONS). For all females, including those with well- controlled
hypertension, monitor blood pressure at routine visits and stop ALESSE if blood
pressure rises significantly.
An increase in blood pressure has been reported in
females using CHCs, and this increase is more likely in older women with
extended duration of use. The effect of CHCs on blood pressure may
vary according to the progestin in the CHC.
10.Headache
ALESSE is contraindicated in females who
have headaches with focal neurological symptoms or have migraine headaches with
aura, and in women over age 35 years who have migraine head aches with or
without aura.
The onset or exacerbation of migraine or development
of headache with a new pattern that is recurrent, persistent, or severe
requires discontinuation of oral contraceptives and evaluation of the cause. Consider
discontinuation of ALESSE if there is an increased frequency or severity of
migraines during CHC use (which may be prodromal of a cerebrovascular event;
see WARNINGS and CONTRAINDICATIONS.)
11. Bleeding Irregularities
…
In the clinical trial with levonorgestrel
0.1 mg and ethinyl estradiol 0.02 mg tablets, unscheduled bleeding was defined
as bleeding or spotting that occurred:
• During
cycle 1 on pill-pack Days 4 to 21, inclusive of a 28-day cycle.
• In
subsequent cycles, on Days 5 to 21 inclusive or on pill-pack Days 1 to 4
inclusive if preceded by 2 consecutive days without bleeding or spotting.
Based on subject diaries, the proportion
of subjects reporting unscheduled bleeding or spotting per 28-day cycle
decreased over time: 30.5% at Cycle 1 versus 18.2% at Cycle 12.
12.Hereditary Angioedema
In women with hereditary angioedema,
exogenous estrogens may induce or exacerbate symptoms of angioedema.
13.Chloasma
Chloasma may occur, especially in women
with a history of chloasma gravidarum. Advise women with a history of chloasma
to avoid exposure to the sun or ultraviolet radiation while taking ALESSE.
14.Effect on Binding Globulins
The estrogen component of COCs may raise
the serum concentrations of thyroxine-binding globulin, sex hormone-binding
globulin, and cortisol-binding globulin. Monitor thyroid- stimulating hormone
(TSH) levels for females receiving ALESSE and thyroid hormone replacement
therapy concomitantly. Follow the recommendation for the thyroid hormone in
accordance with its Prescribing Information.
Additions and/or
revisions underlined:
…
The
following adverse reactions associated with the use of oral CHCs 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. Common adverse reactions associated with oral
CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and
pain, acne, and vaginitis.
Additional adverse reactions that have been reported
include the following:
Eye disorder: intolerance to contact lenses, steepening of corneal
curvature
Gastrointestinal disorders: Abdominal bloating, vomiting
General disorders and administration site conditions: Edema, fluid
retention
Hepatobiliary disorders: Cholestatic jaundice
Pyschiatric disorders: Change in libido, mood changes
Reproductive system and breast disorders: Amenorrhea, breast tenderness,
breast pain, breast enlargement, increased cervical mucous, change in menstrual
flow, unscheduled bleeding
Skin and subcutaneous tissue disorders: Acne, melasma
Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins
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