Labeling for Combined Hormonal Contraceptives Guidance for Industry | Guideline Explorer

Description

This guidance provides recommendations on information that should be included in the 19 prescribing information for combined hormonal contraceptives (CHCs) that contain estrogen and progestin. CHCs include combined oral contraceptives (COCs), as well as non-oral products such as transdermal systems and vaginal rings. Many of the labeling recommendations in this 22 guidance represent class labeling that should be included in all CHC prescribing information.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5

Combined Hormonal Contraceptives

Guidance provides recommendations on information for prescribing information for CHCs.; Labeling for Combined Hormonal Contraceptives Guidance for Industry; Labeling for products containing both estrogen and progestin; Labeling guidance for this product category

Combined Oral Contraceptives

evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs); Subject of the clinical drug interaction studies guidance; Subject of the drug interaction studies

Combination Oral Contraceptives

acceptable to use the term combination oral contraceptives (COCs) in place of CHCs

CHCs

Abbreviation for Combined Hormonal Contraceptives

COCs

Combined Oral Contraceptives

Stakeholders

5

Applicants

Entities submitting supplements to BLAs

Nursing women

Lactation considerations

Postpartum females

Specific population for dosing instructions

Nursing female

Population advised to use alternative contraception during breast-feeding

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Regulatory Activities

1

Clinical trials

Development program for drugs intended for sGERD treatment

Document Types

7

Prescribing Information

The primary section of drug labeling where SLCs are implemented

Instructions for Use

Reagent stability studies should support conditions outlined in the IFU; Labeling for lay users at no higher than a 7th grade reading level.

Patient Information

FDA-approved patient labeling

Labeling

Cybersecurity information should be included in device labeling

Patient Labeling

Information for patients to make informed decisions

Highlights of Prescribing Information

summary of clinically significant drug interactions; Concise summary at the beginning of labeling; Summary section of drug labeling

Full Prescribing Information

content and format of DI information; The complete labeling document for a drug.; The complete labeling document for prescription drugs; The complete labeling document (FPI) containing detailed drug interaction sections.; Section of drug labeling

Attributes

6

Class Labeling

Recommendations represent class labeling for all CHC products.

Body Mass Index (BMI)

Exclusion criteria in clinical studies

Systemic exposure

measured by systemic availability of pharmaceutical-related substances

Smokers

Population at higher risk for cardiovascular events

Postpartum period

Timeframe with highest VTE risk

Body Mass Index

expressed as kilograms of weight divided by height in meters squared (kg/m²); percentage change in body weight equals percentage change in BMI

Technical Details

Substances

8

Estrogen

COCs usually contain two synthetic steroid hormones, a progestin and an estrogen.

Enzyme inducers

Drug interaction requiring back-up contraception

Lamotrigine

Drug whose exposure is decreased by concomitant use of CHCs

St. John's wort

Metabolic enzyme inducer that may diminish CHC efficacy

Ethinyl estradiol

Stabilized by beta-cyclodextrin as a clathrate

Colesevelam

Substance that decreases systemic exposure of ethinyl estradiol

Progestin

COCs usually contain two synthetic steroid hormones, a progestin and an estrogen.; Hormonal component of COCs

CYP3A4

metabolizing enzyme with lower expression in neonates compared to adults

Testing Methods

2

Liver test

Used to monitor for abnormalities during CHC use

Pearl Index

Measure of contraceptive efficacy

Processes

3

Clinical Trials

data on the efficacy outcome or bleeding profile demonstrated in clinical trials

Ovulation

Mechanism of action for CHCs

Glucuronidation

Metabolic process of lamotrigine induced by CHCs

Clinical Concepts

10

Hepatic adenomas

Liver tumors associated with CHC use

Amenorrhea

Potential side effect of CHC use

HIV infection

Human Immunodeficiency Virus transmission risk

Venous Thromboembolism

Serious adverse reaction associated with high EE concentrations; Clinical risk associated with hormonal contraceptives

Pulmonary embolus

Example of a serious adverse reaction in class labeling

Chloasma

Skin discoloration that may occur with CHC use

Hypertriglyceridemia

Risk factor for pancreatitis when using CHCs

Migraine headaches with aura

Contraindication for women over 35 using CHCs

Uncontrolled hypertension

Contraindication for CHC use

Hepatocellular carcinoma

Primary liver cancer resulting from HBV.; Potential complication of chronic HBV infection.

Identified Hazards

Hazards

2

Birth defects

Genital or nongenital anomalies discussed in pregnancy risk summary

Cigarette Smoking

Increases risk of serious cardiovascular events

Standards & References

External Standards

2

United States Pharmacopeia

Official compendium for device recognition

CDC Selected Practice Recommendations

refer the reader to the CDC Selected Practice Recommendations web page

Related CFR Sections (5)

21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
21CFR310.501§ 310.501 Patient package inserts for oral contraceptives.
(a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is Read full regulation →
21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
21CFR201.1§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
(a) A drug or drug product (as defined in § 320.1 of this chapter ) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply toRead full regulation →
21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded drug

26

False or misleading claims concerning the compounder

22

Introduction of misbranded drugs into interstate commerce

2

Introduction of misbranded products into interstate commerce

1

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics

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