Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

TYBLUME (NDA-209405)


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

Download Data

Expand all

04/29/2022 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

Additions underlined

TYBLUME is contraindicated in females 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

5.10 Malignant Neoplasms

Additions underlined

Breast Cancer

Tyblume 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)].

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 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)


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.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English