ParaGard T 380A
Generic: COPPER
Basic Information
Manufacturer
CooperSurgical, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAUTERINE
FDA Set ID
3c420b53-c95e-46af-aebd-73741be58391
Indications & Usage
1 INDICATIONS AND USAGE Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
( 1 )
Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions ( 5.1 )] Intrauterine pregnancy [see Warnings and Precautions ( 5.2 )] Septic abortion [see Warnings and Precautions ( 5.2 )] Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )] Pelvic Inflammatory Disease and Endometritis [see Warnings and Precautions ( 5.4 )] Embedment [see Warnings and Precautions ( 5.5 )] Perforation [see Warnings and Precautions ( 5.6 )] Expulsion [see Warnings and Precautions ( 5.7 )] Bleeding Pattern Alterations [see Warnings and Precautions ( 5.9 ) ] Adverse reactions reported in clinical trials include: anemia, backache, dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CooperSurgical, Inc.
at 1-877-727-2427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure in two trials [see Clinical Studies ( 14 )].
The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S.
In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old.
The U.S.
Composite Study was a meta-analysis that evaluated randomized, double-blind, comparative studies of copper T IUSs, including Paragard in 3,536 women in the U.S.
In the U.S.
Composite Study, 64% were nulliparous, 49% were nulligravida, 68% were under age 25 at the time of enrollment (median age 23 years old).
Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year.
Table 2: Summary of Rates* (No.
per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation Year 1 2 3 4 5 6 7 8 9 10 Number of Women at Start of Year 4,932 3,149 2,018 1,121 872 621 563 483 423 325 Expulsion 5.7 2.5 1.6 1.2 0.3 0.0 0.6 1.7 0.2 0.4 Bleeding/Pain 11.9 9.8 7.0 3.5 3.7 2.7 3.0 2.5 2.2 3.7 Other Medical Event 2.5 2.1 1.6 1.7 0.1 0.3 1.0 0.4 0.7 0.3 *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S.
Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials.
The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.
Study CSIPD-001 The Paragard inserter that enables single-hand insertion was evaluated in Study CSIPD-001.
A total of 117 females of reproductive potential aged 18 to 49 years, underwent Paragard insertion and were followed for up to 12 weeks of Paragard use.
Subjects were predominantly white (76%), 45% were parous, and 35% were obese.
Successful placement of Paragard with first attempt occurred in 91% of the subjects and 99% with two insertion attempts.
Adverse reactions of special interest occurring during the study were IUS expulsion (2.6%), vasovagal reaction (2.6%), IUS malposition (1.7%), partial uterine perforation (0.9%), and IUS embedment (0.9%).
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Paragard.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: abdominal distension, nausea General Disorders and Administration Site Conditions: device breakage, pyrexia; copper wire breakage Immune System Disorders: allergy to metals, hypersensitivity Infections and Infestations: endometritis/uterine infection Musculoskeletal and Connective Tissue Disorders: muscle spasms Nervous System Disorders: dizziness Reproductive System and Breast Disorders: amenorrhea Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CooperSurgical, Inc.
at 1-877-727-2427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure in two trials [see Clinical Studies ( 14 )].
The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S.
In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old.
The U.S.
Composite Study was a meta-analysis that evaluated randomized, double-blind, comparative studies of copper T IUSs, including Paragard in 3,536 women in the U.S.
In the U.S.
Composite Study, 64% were nulliparous, 49% were nulligravida, 68% were under age 25 at the time of enrollment (median age 23 years old).
Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year.
Table 2: Summary of Rates* (No.
per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation Year 1 2 3 4 5 6 7 8 9 10 Number of Women at Start of Year 4,932 3,149 2,018 1,121 872 621 563 483 423 325 Expulsion 5.7 2.5 1.6 1.2 0.3 0.0 0.6 1.7 0.2 0.4 Bleeding/Pain 11.9 9.8 7.0 3.5 3.7 2.7 3.0 2.5 2.2 3.7 Other Medical Event 2.5 2.1 1.6 1.7 0.1 0.3 1.0 0.4 0.7 0.3 *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S.
Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials.
The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.
Study CSIPD-001 The Paragard inserter that enables single-hand insertion was evaluated in Study CSIPD-001.
A total of 117 females of reproductive potential aged 18 to 49 years, underwent Paragard insertion and were followed for up to 12 weeks of Paragard use.
Subjects were predominantly white (76%), 45% were parous, and 35% were obese.
Successful placement of Paragard with first attempt occurred in 91% of the subjects and 99% with two insertion attempts.
Adverse reactions of special interest occurring during the study were IUS expulsion (2.6%), vasovagal reaction (2.6%), IUS malposition (1.7%), partial uterine perforation (0.9%), and IUS embedment (0.9%).
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Paragard.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: abdominal distension, nausea General Disorders and Administration Site Conditions: device breakage, pyrexia; copper wire breakage Immune System Disorders: allergy to metals, hypersensitivity Infections and Infestations: endometritis/uterine infection Musculoskeletal and Connective Tissue Disorders: muscle spasms Nervous System Disorders: dizziness Reproductive System and Breast Disorders: amenorrhea Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome