Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
13. Depression
(Newly added
subsection)
Carefully observe women with a history
of depression and discontinue Mircette
if depression recurs
to a serious degree.
14. Hereditary Angioedema
(Newly added subsection)
In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms
of angioedema.
15. Chloasma
(Newly added subsection)
Chloasma
may occur with Mircette
use, especially in females with a history
of chloasma gravidarum. Advise females with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while using Mircette.
PRECAUTIONS
7. Drug interactions
(Additions and/or revisions underlined)
Reduced efficacy and increased incidence
of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked,
has been suggested with
barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with
griseofulvin, ampicillin, and tetracyclines (72).
Combined
hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of
lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage
adjustments of lamotrigine may be necessary.
Concomitant Use with Hepatitis
C Virus (HCV) Combination Therapy
– Liver Enzyme Elevation
Co-administration of Mircette with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
is contraindicated due to potential for ALT elevations (see CONTRAINDICATIONS
and WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS
C TREATMENT). Co-administration of Mircette and glecaprevir/pibrentasvir is not
recommended due to potential for ALT elevations.
Consult
the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the
potential for enzyme alterations.
10. Pregnancy
(Additions and/or revisions underlined)
Discontinue Mircette if pregnancy occurs because there is no reason to use COCs in pregnancy. See
WARNINGS
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT
COUNSELING INFORMATION
(Extensive changes; please refer to label for complete
information)
PATIENT PACKAGE
INSERT BRIEF SUMMARY
WHO SHOULD
NOT TAKE ORAL CONTRACEPTIVES
…
RISKS OF TAKING ORAL CONTRACEPTIVES
…
5. Risk of Cancer
It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in
the risk of breast cancer among current users with longer duration of use.
If you have breast cancer
now, or have had it in the past, do not use hormonal birth control because
some breast cancers are sensitive to hormones.
Some studies have found an increase in
the incidence of cancer of the cervix in women who use oral contraceptives. However,
this finding may be related
to factors other than the use of oral contraceptives. There is insufficient
evidence to rule out the possibility that pills may cause such cancers.
ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL
METHOD OR PREGNANCY
All methods
of birth control
and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number
of deaths associated with different
methods of birth control and pregnancy has been calculated and is shown in the
following table.
ANNUAL NUMBER
OF BIRTH-RELATED OR METHOD-RELATED DEATHS
ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NON-STERILE WOMEN, BY
FERTILITY CONTROL METHOD ACCORDING TO AGE
In the above table, the risk of death
from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if
they do not smoke. It can be seen in the table that for
women aged 15 to 39, the risk of death was highest with
pregnancy (7 to 26 deaths per 100,000 women, depending on age). Among pill
users who do not smoke, the risk of
death is always lower than that associated with pregnancy
for any age group, although over the
age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28
associated with pregnancy at that age. However, for pill users who smoke and
are over the age of 35, the estimated number of deaths exceeds those for other
methods of birth control. If a woman is over the age of 40 and smokes, her
estimated risk of death is four times higher (117/100,000 women) than the
estimated risk associated with pregnancy (28/100,000 women) in that age group.
Approved Drug Label (PDF)
4
Contraindications
Addition of the
following to the bulleted line listing:
5
Warnings and Precautions
WARNINGS
…
3. Malignant Neoplasms
Additions
inderlined
Breast
Cancer
Mircette is contraindicated in females who
currently have or have had breast cancer because breast cancer may be
hormonally sensitive (see CONTRAINDICATIONS).
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 ADVERSE REACTIONS, Postmarketing
Experience).
…
6
Adverse Reactions
Additions
underlined
Postmarketing Experience
Five
studies that compared breast cancer risk between ever-users (current or past
use) of COCs and never-users of COCs reported no association between ever use
of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure
2).
Three
studies compared breast cancer risk between current or recent COC users (<6
months since last use) and never users of COCs (Figure 2) . One of these
studies reported no association between breast cancer risk and COC use. The
other two studies found an increased relative risk of
1.19
- 1.33 with current or recent use. Both of these studies found an increased
risk of breast cancer with current use of longer duration, with relative risks
ranging from 1.03 with less than one year of COC use to approximately 1.4 with
more than 8-10 years of COC use.
FIGURE
2: RELEVANT STUDIES OF RISK OF BREAST CANCER WITH COMBINED ORAL CONTRACEPTIVES
Please
refer to label to view Figure 2.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
PATIENT
PACKAGE INSERT BRIEF SUMMARY
Additions underlined
…
There may be slight increases in the risk of
breast cancer among current users of hormonal birth control pills with
longer. duration of use of 8 years or more. Some studies have found
an increase in the incidence of cancer of the cervix in women who use oral
contraceptives. However, this finding may be related to factors other than
the use of oral contraceptives.
…
DETAILED
PATIENT PACKAGE INSERT
Additions underlined
…
5. Risk of Cancer
It is not known
if hormonal birth control pills cause breast cancer. Some studies, but not
all, suggest that there could be a slight increase in the risk of breast cancer
among current users with longer duration of use.
If you have breast cancer now,
or have had it in the past, do not use hormonal birth control because some
breast cancers are sensitive to hormones.
Some studies have found an increase in the incidence
of cancer of the cervix in women who use oral contraceptives. However, this
finding may be related to factors other than the use of oral contraceptives.
There is insufficient evidence to rule out the possibility that pills may cause
such cancers.
…
Approved Drug Label (PDF)
4
Contraindications
(Additions and/or revisions are underlined)
Oral contraceptives
should not be used in women who currently have the following conditions:
- Are receiving Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the
potential for ALT elevations
5
Warnings and Precautions
WARNINGS
(Additions and/or revisions are underlined)
5. Risk of Liver Enzyme Elevations with
Concomitant Hepatitis C Treatment
During clinical
trials with the Hepatitis C combination drug regimen that contains
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations
greater than 5 times the upper limit of normal (ULN), including some cases
greater than 20 times the ULN, were significantly more frequent in women using
ethinyl estradiol-containing medications such as COCs. Discontinue Mircette® prior to starting therapy with the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir. Mircette® can be
restarted approximately 2 weeks following completion of treatment with the
combination drug regimen.
7
Drug Interactions
(Additions and/or revisions are underlined)
Concomitant
Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation
Do not
co-administer Mircette® with HCV
drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir, due to potential for ALT elevations.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Information
(Additions and/or revisions are underlined)
DETAILED PATIENT
PACKAGE INSERT
WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES
Some women should
not use the pill. For example, you should not take the pill if you are pregnant
or think you may be pregnant. You should also not use the pill if you have any
of the following conditions:
- Hepatitis C and are taking any drug combination containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may
increase levels of the liver enzyme “alanine aminotransferase” (ALT) in
the blood
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