Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE TriNessa ® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

TriNessa® is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.

TriNessa® should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Oral contraceptives are highly effective for pregnancy prevention.

Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.

The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant® System, depends upon the reliability with which they are used.

Correct and consistent use of methods can result in lower failure rates.

Table II: Percentage of Women Experiencing an Unintended Pregnancy During the First

Year of

Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year.

United States.

% of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Method Typical Use Perfect Use (1) (2) (3) (4) Hatcher et al, 1998, Ref. #1.

Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75 %.The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose.

The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).

Lactational Amenorrhea Method:

LAM is a highly effective, temporary method of contraception.

However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.

Source: Trussell J, Contraceptive efficacy.

In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition.

New York NY: Irvington Publishers, 1998.

Chance 85 85 Spermicides 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 2 Post-Ovulation 1 CapWith spermicidal cream or jelly.

Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Withdrawal 19 4 Condom Female (Reality®) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81

Depo-Provera® 0.3 0.3 70 Norplant® and Norplant-2® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 TriNessa® has not been studied for and is not indicated for use in emergency contraception.

In four clinical trials with TriNessa®, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years.

TriNessa® was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies.

221 patients received TriNessa® and 234 patients received placebo.

Mean age at enrollment for both groups was 28 years.

At the end of 6 months, the mean total lesion count changes from 55 to 31 (42 % reduction) in patients treated with TriNessa® and from 54 to 38 (27 % reduction) in patients similarly treated with placebo.

Table III summarizes the changes in lesion count for each type of lesion in the ITT population.

Based on the investigator 's global assessment conducted at the final visit, patients treated with TriNessa® showed a statistically significant improvement in total lesions compared to those treated with placebo.

Table III: Acne Vulgaris Indication.

Combined Results: Two Multicenter, Placebo-Controlled Trials.

Observed Means at Six Months (LOCF)LOCF: Last Observation Carried Forward and at Baseline.

Intent-to-Treat Population.

TriNessa® (N=221) Placebo (N=234) Difference in Counts between TriNessa® and Placebo at 6 Months # of Lesions Counts % Reduction Counts % Reduction INFLAMMATORY LESIONS Baseline Mean 19 19 Sixth Month Mean 10 48 % 13 30 % 3 (95 % CI: - 1.2, 5.1) NON-INFLAMMATORY LESIONS Baseline Mean 36 35 Sixth Month Mean 22 34 % 25 21 % 3 (95 % CI: - 0.2, 7.8) TOTAL LESIONS Baseline Mean 55 54 Sixth Month Mean 31 42 % 38 27 % 7 (95 % CI: 2.0, 11.9)

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Advisory information

contraindications

CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular or coronary artery disease (current or past history) Valvular heart disease with complications Severe hypertension Diabetes with vascular involvement Headaches with focal neurological symptoms Major surgery with prolonged immobilization Known or suspected carcinoma of the breast or personal history of breast cancer Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Acute or chronic hepatocellular disease with abnormal liver function

Hepatic adenomas or carcinomas Known or suspected pregnancy Hypersensitivity to any component of this product

Special warnings and precautions

PRECAUTIONS 1.

General Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

2.

Physical Examination and Follow-up It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives.

The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.

The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests.

In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy.

Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

3.

Lipid Disorders Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives.

Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

4.

Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued.

Steroid hormones may be poorly metabolized in patients with impaired liver function.

5.

Fluid Retention Oral contraceptives may cause some degree of fluid retention.

They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

6.

Emotional Disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

7.

Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

8.

Drug Interactions Changes in contraceptive effectiveness associated with co-administration of other products Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids.

This could result in unintended pregnancy or breakthrough bleeding.

Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin and bosentan.

Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases.

The safety and efficacy of oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors.

Healthcare professionals should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

Herbal products containing

St. John 's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

This may also result in breakthrough bleeding.

Concurrent use of bosentan and ethinyl estradiol-containing products may result in decreased concentrations of these contraceptive hormones, thereby increasing the risk of unintended pregnancy and unscheduled bleeding.

Increase in plasma levels associated with co-administered drugs Co-administration of atorvastatin and certain 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.

CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

Changes in plasma levels of co-administered drugs Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds.

Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives.

Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation, have been noted when these drugs were administered with oral contraceptives.

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered due to induction of lamotrigine glucuronidation.

This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.101 Healthcare professionals are advised to also refer to prescribing information of co-administered drugs for recommendations regarding management of concomitant therapy.

9.

Interactions with Laboratory Tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.

Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay.

Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.

Other binding proteins may be elevated in serum.

Sex hormone binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged.

Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.

Glucose tolerance may be decreased.

Serum folate levels may be depressed by oral contraceptive therapy.

This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

10.

Carcinogenesis See WARNINGS. 11.

Pregnancy Pregnancy Category X See CONTRAINDICATIONS and WARNINGS. 12.

Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement.

In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk.

If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

13.

Pediatric Use Safety and efficacy of TriNessa® has been established in women of reproductive age.

Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older.

There was no significant difference between TriNessa®

Tablets and placebo in mean change in total lumbar spine (L1- L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population.

Use of this product before menarche is not indicated.

14.

Geriatric Use This product has not been studied in women over 65 years of age and is not indicated in this population.

INFORMATION FOR THE PATIENT See Patient Labeling printed below.

Adverse reactions

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS).

Thrombophlebitis and venous thrombosis with or without embolism Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives: Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Temporary infertility after discontinuation of treatment Edema Melasma which may persist Breast changes: tenderness, enlargement

secretion Change in weight (increase or decrease) Change in cervical erosion and secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine Allergic reaction, including rash, urticaria

angioedema Mental depression Reduced tolerance to carbohydrates Vaginal candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Acne Changes in libido Colitis Budd-Chiari Syndrome

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Oral Contraception To achieve maximum contraceptive effectiveness, TriNessa ® must be taken exactly as directed and at intervals not exceeding 24 hours.

The possibility of ovulation and conception prior to initiation of medication should be considered.

TriNessa® is available in a blister card with a tablet dispenser which is preset for a Sunday Start.

Day 1 Start is also provided.

Sunday Start When taking TriNessa ® the first white tablet should be taken on the first Sunday after menstruation begins.

If the period begins on Sunday, the first tablet should be taken that day.

Take one active tablet daily for 21 days followed by one dark green inactive tablet daily for 7 days.

After 28 tablets have been taken, a new course is started the next day (Sunday).

For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers.

If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack.

The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills.

If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday.

On Sunday the patient should throw out the rest of the pack and start a new pack that same day.

The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient

Labeling (" How to Take the Pill " section).

Day 1 Start The dosage of TriNessa ® for the initial cycle of therapy is one active tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as " Day 1 " followed by one dark green inactive tablet daily for 7 days.

Tablets are taken without interruption for 28 days.

After 28 tablets have been taken, a new course is started the next day.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers.

If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack.

The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills.

If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day.

The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill " section).

The use of TriNessa® for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed.

When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.

(See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease.

See also PRECAUTIONS: Nursing Mothers.)

The possibility of ovulation and conception prior to initiation of medication should be considered.

(See Discussion of Dose-Related Risk of

Vascular

Disease from Oral Contraceptives.)

ADDITIONAL INSTRUCTIONS Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives.

In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind.

In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy.

If pathology has been excluded, time or a change to another formulation may solve the problem.

Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period: If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

ACNE The timing of initiation of dosing with TriNessa ® for acne should follow the guidelines for use of TriNessa® as an oral contraceptive.

Consult the DOSAGE AND ADMINISTRATION section for oral contraceptives.

The dosage regimen for TriNessa® for treatment of facial acne, as available in a blister card with a tablet dispenser, utilizes a 21-day active and a 7-day placebo schedule.

Take one active tablet daily for 21 days followed by one dark green inactive tablet for 7 days.

After 28 tablets have been taken, a new course is started the next day.

Pregnancy and lactation

12. Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement.

In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk.

If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Interactions

8. Drug Interactions Changes in contraceptive effectiveness associated with co-administration of other products Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids.

This could result in unintended pregnancy or breakthrough bleeding.

Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin and bosentan.

Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases.

The safety and efficacy of oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors.

Healthcare professionals should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

Herbal products containing St. John 's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

This may also result in breakthrough bleeding.

Concurrent use of bosentan and ethinyl estradiol-containing products may result in decreased concentrations of these contraceptive hormones, thereby increasing the risk of unintended pregnancy and unscheduled bleeding.

Increase in plasma levels associated with co-administered drugs Co-administration of atorvastatin and certain 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.

CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

Changes in plasma levels of co-administered drugs Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds.

Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives.

Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation, have been noted when these drugs were administered with oral contraceptives.

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered due to induction of lamotrigine glucuronidation.

This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.101 Healthcare professionals are advised to also refer to prescribing information of co-administered drugs for recommendations regarding management of concomitant therapy.

More information

Category Value
Authorisation number NDA019697
Orphan designation No
Product NDC 54868-5826
Date Last Revised 23-05-2012
Type HUMAN PRESCRIPTION DRUG
RXCUI 748797
Storage and handling Keep out of reach of children. Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F). Protect from light.
Marketing authorisation holder Physicians Total Care, Inc.
Warnings Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quit