FDA

Kaitlib Fe

Approved 17 Dec 2015OralTablet, chewable

Indications

Kaitlib Fe is a combination of norethindrone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) The efficacy in females of reproductive potential with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Kaitlib™ Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy.

The efficacy of Kaitlib Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

Contraindications

A high risk of arterial or venous thrombotic diseases. ( 4 ) Undiagnosed abnormal uterine bleeding. ( 4 ) Breast cancer. ( 4 ) Liver tumors or liver disease. ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Kaitlib Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases.

Examples include women who are known to: o Smoke, if over age 35 [see BOXED WARNING , and WARNINGS AND PRECAUTIONS ( 5.1 .)] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS ( 5.5 )] o Have diabetes with vascular disease [see WARNINGS AND PRECAUTIONS ( 5.7 )] o Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see WARNINGS AND PRECAUTIONS ( 5.8 )] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see WARNINGS AND PRECAUTIONS ( 5.2 )] Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS ( 5.3 ) , USE IN SPECIFIC POPULATIONS ( 8.7 ) , and CLINICAL PHARMACOLOGY ( 12.3 )] Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS ( 5.9 )] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS AND PRECAUTIONS ( 5.4 )]

At a glance

Brand name: Kaitlib Fe
Active substance: ethinyl estradiol
Route: Oral
Dosage form: Tablet, chewable
Applicant: Lupin
Status: Prescription
FDA approval: 17 Dec 2015
Application: ANDA203448-001

Indications

The efficacy of Kaitlib Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

Contraindications

Interactions

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 ) No drug-drug interaction studies were conducted with Kaitlib Fe.

7.1Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If

a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding.

Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John's wort topiramate HIV Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Antibiotics There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

7.2Increase in Plasma Levels of Ethinyl Estradiol Associated with Co-Administered Drugs Co-administration

of atorvastatin and certain combination oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

7.3Concomitant Use with HCV Combination

Therapy – Liver Enzyme Elevation Do not co-administer Kaitlib Fe with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see WARNINGS AND PRECAUTIONS ( 5.4 )] .

7.4Changes in Plasma Levels of Co-Administered Drugs

COCs containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.

Adverse reactions

The most common adverse reactions (≥ 2%) are nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and smoking [see BOXED WARNING, and WARNINGS AND PRECAUTIONS ( 5.1 )] Vascular events [see WARNINGS AND PRECAUTIONS ( 5.1 )] Liver disease [see WARNINGS AND PRECAUTIONS ( 5.3 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache

6.1Clinical Trial 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. A phase 3 clinical trial evaluated the safety and efficacy of Kaitlib Fe for pregnancy prevention. The study was a multicenter, non-comparative, open-label study with a treatment duration of 12 months (thirteen 28-day cycles).

A total of 1,677 women aged 18 to 46 were enrolled and took at least one dose of Kaitlib Fe. Adverse Reactions Leading to Study Discontinuation 8.5% of the women discontinued from the clinical trial due to an adverse reaction. The most common adverse reactions leading to discontinuation were nausea (1.0%), weight increase (0.8%), acne (0.8%), metrorrhagia (0.7%), altered mood (0.4%), hypertension (0.4%), irritability (0.3%), migraine (0.3%), decreased libido (0.3%) and mood swings (0.3%).

Common Adverse Reactions (≥ 2% of all treated subjects) Nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%). Serious Adverse Reactions Hypertension, depression, cholecystitis, and deep vein thrombosis.

6.2Postmarketing Experience

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. RR = relative risk; OR = odds ratio; HR = hazard ratio. "ever COC" are females with current or past COC use; "never COC use" are females that never used COCs.

Fiq 1

Kaitlib Fe

Indications

Contraindications

At a glance

Two medicines in one question?

Kaitlib Fe

Indications

Contraindications

At a glance

Two medicines in one question?

Warnings and precautions

5.1Thrombotic and Other Vascular Events Stop Kaitlib

5.2Malignant Neoplasms Breast Cancer Kaitlib

5.3Liver Disease Discontinue Kaitlib

5.4Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

5.5High Blood Pressure

5.6Gallbladder Disease

5.7Carbohydrate and Lipid Metabolic Effects

5.8Headache If

5.9Bleeding Irregularities Unscheduled (breakthrough

Interactions

7.1Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If

7.2Increase in Plasma Levels of Ethinyl Estradiol Associated with Co-Administered Drugs Co-administration

7.3Concomitant Use with HCV Combination

7.4Changes in Plasma Levels of Co-Administered Drugs

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trial Experience

6.2Postmarketing Experience

Composition

Official product information