5.1 Thromboembolic
Disorders and Other Vascular Conditions
Extensive changes;
please refer to label
5.2 Liver Disease
Additions and/or
revisions underlined:
Elevated
Liver Enzymes
SEASONIQUE
is contraindicated
in women with acute viral hepatitis or severe (decompensated)
cirrhosis of the liver [see
Contraindications (4)]. Acute liver test abnormalities may
necessitate the discontinuation of SEASONIQUE until the liver tests
return to normal and SEASONIQUE causation has been excluded. Discontinue
SEASONIQUE if jaundice develops.
Liver
Tumors
SEASONIQUE
is contraindicated in women with benign or malignant liver tumors [see Contraindications (4)]. COCs
increase the risk of hepatic adenomas. An estimate of the attributable risk is 3.3
cases/100,000 COC users. Rupture of hepatic adenomas may cause death from
abdominal hemorrhage.
Studies
have shown an increased risk of developing hepatocellular carcinoma in long-term
(> 8 years) COC users. The attributable risk of liver cancers in COC users
is less than one case per million users.
5.3
Hypertension
Subsection title
revised; Additions and/or revisions underlined:
SEASONIQUE
is contraindicated in women with uncontrolled hypertension or hypertension with
vascular disease [see Contraindications (4)].
For all women, including those with well- controlled hypertension, monitor
blood pressure at routine visits and stop SEASONIQUE if blood pressure rises
significantly.
An
increase in blood pressure has been reported in women taking COCs, and this increase
is more likely in older women and with extended duration of use. The effect of
COCs on blood pressure may vary according to the progestin in the COC.
5.5
Age-related Considerations
Newly
added subsection
The
risk for cardiovascular disease and prevalence of risk factors for
cardiovascular disease increases with age. Certain conditions, such as smoking
and migraine headache without aura, that do not contraindicate COC use in
younger females, are contraindications to use in women over 35 years of age [see Contraindications (4) and Warnings and Precautions
(5.1)]. Consider the presence of underlying risk factors that may increase
the risk of cardiovascular disease or VTE, particularly before initiating a COC
for women over 35 years, such as:
Hypertension
Diabetes
Dyslipidemia
5.6
Gallbladder Disease
Additions and/or
revisions underlined:
Studies suggest a small increased relative risk of
developing gallbladder disease among COC users. Use of COCs, including SEASONIQUE,
may also worsen existing gallbladder disease.
A past history of COC-related cholestasis predicts an
increased risk with subsequent COC use. Females with a history of
pregnancy-related cholestasis may be at an increased risk for COC- related
cholestasis.
5.7 Adverse Carbohydrate and Lipid Metabolic Effects
Subsection title
revised; Additions and/or revisions underlined:
Hyperglycemia
SEASONIQUE is contraindicated in diabetic women
over age 35, or females who have diabetes with hypertension, nephropathy, retinopathy,
neuropathy, other vascular disease, or females with diabetes of > 20 years
duration [see Contraindications (4)]. SEASONIQUE may decrease glucose
tolerance. Carefully monitor prediabetic and diabetic women
who are taking SEASONIQUE.
Dyslipidemia
Consider alternative contraception for women with uncontrolled
dyslipidemia. SEASONIQUE may cause adverse lipid changes.
Women with hypertriglyceridemia, or a family history
thereof, may have an increase in serum triglyceride concentrations when
using SEASONIQUE, which may increase the risk of pancreatitis.
5.8 Headache
Additions and/or
revisions underlined:
SEASONIQUE is contraindicated in females who have
headaches with focal neurological symptoms or have migraine headaches with aura,
and in women over 35 years of age who have migraine headaches with or without
aura [see Contraindications (4)].
If a woman taking SEASONIQUE develops new headaches
that are recurrent, persistent, or severe, evaluate the cause and discontinue SEASONIQUE
if indicated. Consider discontinuation of SEASONIQUE if there is an
increased frequency or severity of migraine during COC use (which may be
prodromal of a cerebrovascular event).
5.9 Bleeding Irregularities and Amenorrhea
Extensive changes;
please refer to label
5.10 Depression
Subsection title
revised; Additions and/or revisions underlined:
Carefully observe women with a history of depression and discontinue SEASONIQUE if
depression recurs to a serious degree. Data on the association of COCs with
the onset of depression or exacerbation of existing depression are
limited.
5.11 Malignant Neoplasms
Additions and/or
revisions underlined:
Breast
Cancer
SEASONIQUE is contraindicated in females who currently
have or have had breast cancer because breast cancer may be hormonally
sensitive [see Contraindications (4)].
Epidemiology studies have not found a consistent
association between use of combined oral contraceptives (COCs) and breast
cancer risk. Studies do not show an association between ever (current or
past) use of COCs and risk of breast cancer. However, some studies report a
small increase in the risk of breast cancer among current or recent users (<6
months since last use) and current users with longer duration of COC use [see
Postmarketing Experience (6.2)].
Cervical
Cancer
Some studies suggest that COCs are associated with an
increase in the risk of cervical cancer or intraepithelial neoplasia. However, there
is controversy about the extent to which these findings are due to differences
in sexual behavior and other factors.
5.12 Effect on Binding Globulins
Newly
added subsection
The estrogen component of SEASONIQUE may raise the serum
concentrations of thyroxine- binding globulin, sex hormone-binding globulin,
and cortisol-binding globulin. The dose of replacement thyroid hormone or
cortisol therapy may need to be increased.
5.13 Hereditary Angioedema
Subsection title
revised; Additions and/or revisions underlined:
In females with hereditary angioedema, exogenous
estrogens, including SEASONIQUE, may induce or exacerbate symptoms of hereditary
angioedema.
5.14 Chloasma
Subsection title
revised; Additions and/or revisions underlined:
Chloasma may occur
with SEASONIQUE use, 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 using SEASONIQUE.
8.1 Pregnancy
Additions and/or
revisions underlined:
Risk
Summary
There
is no use for contraception in pregnancy; therefore, SEASONIQUE
should be discontinued during pregnancy. Epidemiologic studies and
meta-analyses have not found an increased risk of genital or non-genital 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.
8.2 Lactation
Additions and/or
revisions underlined:
Risk
Summary
Contraceptive
hormones and/or metabolites are present in human milk. COCs can reduce milk
production in breastfeeding females. This reduction can occur at any
time but is less likely to occur once breastfeeding is well-established.
When possible, advise the nursing woman to use other methods of contraception
until she discontinues breastfeeding [See
Dosage and Administration (2.1]. The developmental and health benefits
of breastfeeding should be considered along with the mother’s clinical need for
SEASONIQUE and any potential adverse effects on the breastfed child from
SEASONIQUE or the underlying maternal condition.
8.5
Geriatric Use
Additions and/or
revisions underlined:
SEASONIQUE
has not been studied in postmenopausal women and is not indicated in this
population.
8.6
Hepatic Impairment
Additions and/or
revisions underlined:
No
studies have been conducted to evaluate the effect of hepatic disease on the disposition
of SEASONIQUE. However, steroid hormones may be poorly metabolized in patients
with impaired liver function. SEASONIQUE is contraindicated in females with
acute hepatitis or severe decompensated cirrhosis [see Contraindications (4) and Warnings and Precautions (5.2)].
Additions and/or
revisions underlined:
Advise
the patient to read the FDA-approved Patient Labeling (Patient Information and
Instructions for Use).
Counsel
patients about the following information:
Cigarette
Smoking
Cigarette
smoking increases the risk of serious cardiovascular events from COC use. Women
who are over 35 years old and smoke should not use SEASONIQUE [see Boxed Warning and Warnings and
Precautions (5.1)].
Venous
Thromboembolism
Increased
risk of VTE compared to non-users of COCs is greatest after initially starting
a COC or restarting (following a 4-week or greater interruption in intake) the same
or a different COC [see Warnings and
Precautions (5.1)].
Use
during Pregnancy
Instruct
females to stop further intake of SEASONIQUE if pregnancy is confirmed during treatment.
Sexually
Transmitted Infections
SEASONIQUE does not protect against
HIV-infection (AIDS) and other sexually transmitted infections.
Dosing
and Missed Pill Instructions
Patients
should
take one tablet daily by mouth at the same time every day.
Instruct
patients what to do in the event pills are missed. See, “What to do if you miss pills”
section
of FDA-Approved Instructions for Use [see
Dosage and Administration (2.3)]. Need for Additional Contraception
Postpartum
females who have not yet had a period when they start SEASONIQUE need to use an
additional method of contraception until they have taken a light blue-green
tablet for 7 consecutive days [see Dosage
and Administration (2.1)].
There
is a need
to use a back-up or alternative method of contraception when enzyme inducers
are used with SEASONIQUE [see Drug
Interactions (7.1)].
Lactation
SEASONIQUE may reduce breast
milk production. This is less likely to occur if breastfeeding is well established.
When possible, nursing women should use other methods of contraception until
they have discontinued breastfeeding [see
Use in Specific Populations (8.2)].
Amenorrhea
and Possible Symptoms of Pregnancy
Amenorrhea
may occur. Advise patients to contact a healthcare provider in the event
of amenorrhea with symptoms of pregnancy, such as morning sickness or unusual breast
tenderness [see Warnings and Precautions
(5.9)].
Fertility
Following Discontinuation of SEASONIQUE
Resumption
of pre-treatment ovarian function is expected, generally within 8 weeks after
discontinuation of SEASONIQUE.
Depression
Depressed
mood and depression may occur. Women should contact their healthcare provider if
mood changes and depressive symptoms occur, including shortly after initiating
the treatment [see Warnings and Precautions
(5.10)].
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