Approved Drug Label (PDF)
4
Contraindications
5
Warnings and Precautions
WARNINGS
Additions
underlined
…
11.Malignant Neoplasms
Breast
Cancer
NORDETTE-21 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 ADVERSE
REACTIONS, Postmarketing Experience).
…
6
Adverse Reactions
Additions underlined
…
Post
Marketing 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
Additions
underlined
…
Do birth control
pills cause cancer?
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.
…
Approved Drug Label (PDF)
4
Contraindications
(Additions and/or
revisions underlined)
NORDETTE-21
is contraindicated in females who are known to have the following
conditions:
A high risk of arterial or venous thrombotic diseases.
Examples include women who are known to:
Smoke, if over age 35 [see BOXED WARNING and WARNINGS
(1)].
Have current or history of deep vein thrombosis
or pulmonary embolism [see WARNINGS (1)].
Have cerebrovascular disease [see WARNINGS
(1)].
Have
coronary artery disease [see WARNINGS (1)].
Have thrombogenic valvular or thrombogenic
rhythm diseases of the heart (for example, subacute bacterial endocarditis
with valvular disease, or atrial fibrillation) [see WARNINGS (1)].
Have inherited or acquired hypercoagulopathies [see WARNINGS
(1)].
Have uncontrolled hypertension or
hypertension with vascular disease [see WARNINGS (1)].
Have diabetes mellitus and are over age 35, diabetes
mellitus with hypertension or
vascular disease or other end-organ
damage, or diabetes mellitus of >20 years duration [see WARNINGS
(7)].
Have headaches with focal neurological symptoms,
migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8)].
Current or history of breast cancer
or other estrogen- or progestin-sensitive cancer.
Liver tumors, acute viral hepatitis, or severe
(decompensated) cirrhosis [see WARNINGS (2)].
Use of Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the
potential for ALT elevations [see WARNINGS (5)].
Undiagnosed abnormal uterine bleeding [see WARNINGS
(9)].
5
Warnings and Precautions
(Extensive
changes; please refer to label)
6
Adverse Reactions
(Extensive
changes; please refer to label)
Approved Drug Label (PDF)
4
Contraindications
(Additions and/or revisions are underlined)
Combination oral
contraceptives should not be used in women with any of 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 Nordette-21
prior to starting therapy with the combination drug regimen
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Nordette-21 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
Nordette-21 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
LABELING
WHO SHOULD NOT
TAKE ORAL CONTRACEPTIVES
Or, if you have any
of the following:
- 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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