Drug Safety-related Labeling Changes (SrLC)

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ALESSE (NDA-020683)

(ETHINYL ESTRADIOL; LEVONORGESTREL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/29/2022 (SUPPL-16)

Approved Drug Label (PDF)

4 Contraindications

Additions underlined

Combination oral contraceptives should not be used in women with any of the following

conditions:

Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive

5 Warnings and Precautions

WARNINGS

Additions underlined

3.Malignant Neoplasms

Breast Cancer

ALESSE 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].  

6 Adverse Reactions

Additions underlined

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 3).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). 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.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

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 LABELING

Additions underlined

RISKS OF TAKING ORAL CONTRACEPTIVES

5.Risk of 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.

08/09/2017 (SUPPL-11)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

Combination oral contraceptives should not be used in women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (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 ALESSE prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

ALESSE 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 ALESSE 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)

Brief Summary Patient Package Insert

You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

 

DETAILED PATIENT LABELING

You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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