Approved Drug Label (PDF)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined
…
Who
should not take LO/OVRAL?
Do
not take LO/OVRAL if you:
…
…
Do birth control pills cause 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.
Women who use birth control pills may have a slightly
higher chance of getting cervical cancer. However, this may be due to other
reasons such as having more sexual partners.
…
Approved Drug Label (PDF)
4
Contraindications
Additions underlined
LO/OVRAL-28 is contraindicated in females who are
known to have the following conditions to women who are known to have or
develop the following conditions:
…
Current diagnosis of, or history
of, breast cancer, which may be hormone-sensitive [see
Warnings and Precautions (5.10)]
…
5
Warnings and Precautions
The following subsections created to
follow the PLR requirements, please refer to label for complete information.
5.1 Thrombotic
Disorders and Other Vascular Problems
5.2 Liver
Diseas
5.3 Risk
of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment
5.4 High
Blood Pressure
5.5 Gallbladder
Disease
5.6 Carbohydrate
and Lipid Metabolic Effect
5.7 Headache
5.8 Bleeding
Irregularities and Amenorrhea
5.9 Depression
5.10 Malignant
Neoplasms
Additions underlined
Breast Cancer
Lo/Ovral-28 is contraindicated in women
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)].
…
5.11 Effect
on Binding Globulins
5.12 Hereditary
Angioedema
5.13 Chloasma
6
Adverse Reactions
6.1 Clinical
Trials Experience
Newly added
subsection, please refer to label for complete information.
6.2 Postmarketing Experience
Newly added
subsection
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 1).
Three studies compared breast cancer risk between current
or recent COC users (<6 months since last use) and never users of COCs (Figure 1). 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 1: Relevant
Studies of Risk of Breast Cancer with Combined Oral Contraceptives
Please refer to
label to view Figure 1.
…
7
Drug Interactions
The following subsections created to
follow the PLR requirements, please refer to label for complete information.
7.1 Effects
of Other Drugs on Combined Oral Contraceptives
7.2 Concomitant
use with HCV combination therapy – Liver enzyme elevation
7.3 Effects
of Combined Oral Contraceptives on Other Drugs
7.4 Interactions
with Laboratory Tests
8
Use in Specific Populations
8.8 Renal Impairment
New
subsection created
The
pharmacokinetics of LO/OVRAL-28 has not been studied in women with renal impairment.
8.1 Pregnancy
PLLR conversion
Risk Summary
There is little or no increased risk of birth defects
in the children of females who inadvertently use COCs during early pregnancy.
Animal data, along with epidemiologic studies, do not show an increased risk of
birth defects with use of COCs prior to pregnancy or during early pregnancy.
Discontinue LoOvral use if pregnancy is confirmed.
Do not administer COCs to induce withdrawal bleeding
as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.
Animal Data
Several studies were conducted in rodents and
rabbits to evaluate the potential reproductive toxicity of Norgestrel in
combination with Ethinyl Estradiol (Norgestrel/EE) during pregnancy or
lactation at doses approximately up to 25-fold over the clinical dose.
In rats administered Norgestrel/EE from Day 8-21 of
gestation, there were no maternal adverse effects and no effects on embryofetal
development or reproductive potential of the offspring. In rabbits,
Norgestrel/EE administered from
Day 8-18 of gestation showed a decrease in maternal body
weight gain and litter size. There was no indication of teratogenicity in
either rats or rabbits.
Administration of Norgestrel/EE in mice and rats to
suppress fertility was followed by a recovery of reproductive function and
fertility. In lactating female rats administered Norgestrel/EE at doses up to
25-fold the clinical dose from delivery to 21 days post-delivery or weaning,
there were no adverse maternal effects, no effect on the lactation process, and
no effect on offspring growth.
8.2 Lactation
PLLR
conversion
Risk
Summary
Contraceptive
hormones and/or metabolites are present in human milk in small amounts. The effects
of Lo/Ovral-28 on the breastfed child is unknown. COCs can reduce milk
production in lactating women. Advise the nursing mother to use a non-COC contraception,
when possible, until she has weaned her child. This is less likely to occur
once breastfeeding is well-established; however, it can occur at any time in
some women. The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for Lo/Ovral-28 and any
potential adverse effects on the breast-fed child from Lo-Ovral-28 or from the
underlying maternal condition.
8.6
Hepatic Impairment
New
subsection created
The
pharmacokinetics of LO/OVRAL-28 has not been studied in subjects with hepatic impairment.
However, steroid hormones may be poorly metabolized in patients with hepatic
impairment. Acute or chronic disturbances of liver function may necessitate the
discontinuation of COC use until markers of liver function return to normal and
COC causation has been excluded [see
Contraindications (4) and Warnings and
Precautions (5.2)].)].
8.9 Body Mass Index
New
subsection created
The
safety and efficacy of LO/OVRAL-28 in women with a body mass index (BMI) > 35
kg/m2 has not been evaluated
[see Clinical Studies
(14)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions underlined
…
Do
birth control pills cause cancer?
It is not known if hormonal birth control pills
causes 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.
…
Other
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 Lo/Ovral-28
prior to starting therapy with the combination drug regimen
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Lo/Ovral-28 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 HCV combination therapy – Liver
enzyme elevation:
Do not
co-administer Lo/Ovral-28 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
Some women should
not take the pill. You should not take the pill if you have any of the
following conditions:
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