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What is the most important information I should know about Indayo?
Hypersensitivity to any of the components of Indayo; current or history of deep vein thrombosis and thromboembolism; hepatic adenomas or carcinomas, active liver disease, as long as liver function has not returned to normal; known or suspected carcinoma of the breast or other known or suspected estrogen-dependent neoplasia; disorders of lipometabolism; thrombogenic rhythm disorders and thrombogenic valvulopathies; sickle-cell anemia; diabetes with vascular involvement; undiagnosed vaginal bleeding; known or suspected pregnancy; cerebrovascular or coronary artery disease; uncontrolled hypertension; hereditary or acquired thrombophilias; headache with focal neurological symptoms such as aura; pancreatitis associated with severe hypertriglyceridemia (current or history).
Reasons for the Immediate Discontinuation of Indayo: Occurrence for the first time of migrainous headaches or the more frequent occurrence of unusually severe headaches; acute disturbances of vision, hearing or speech; first symptoms of thrombophlebitis or thromboembolism (eg, unusual pain in or swelling of the legs, stabbing pain on breathing or coughing for no apparent reason); feeling of pain or tightness in the chest; six weeks before planned operations or during prolonged periods of immobilization; development of jaundice (cholestasis), hepatitis or generalized pruritus; increase in epileptic seizures; significant rise in blood pressure; onset of severe clinical depression; severe upper abdominal pain or liver enlargement.
Use in Pregnancy: If pregnancy occurs during treatment with combined oral contraceptives (COCs), further intake should be discontinued. There is no conclusive evidence that the estrogen and progestin contained in the COC will damage the developing child if conception accidentally occurs during COC use.
Use in Lactation: Small amounts of contraceptive steroids and/or metabolites 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. Lactation may be affected by COCs, as COCs may reduce the quantity and change the composition of breast milk.
The use of COCs is generally not recommended until the nursing mother has completely weaned her child.
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What are the possible side effects of Indayo?
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical trial that evaluated the safety and efficacy of Indayo was a 12-month, multicenter, non-comparative open-label study, which enrolled women aged 18 to 41, of whom 2,185 took at least one dose of Indayo.
Adverse Reactions Leading to Study Discontinuation: 11% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions leading to discontinuation were irregular and/or heavy uterine bleeding, headache, mood changes, nausea, acne, and weight gain.
Common Treatment-Emergent Adverse Reactions (≥ 5% of women): headaches (33%); irregular and/or heavy uterine bleeding (13%), dysmenorrhea (11%), nausea and/or vomiting (11%), back pain (8%).
Indayo is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or Levonorgestrel (Indayo) are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.
The efficacy and safety of Indayo were studied in 2 one-year clinical trials of subjects age 18-49. There were no exclusions for body mass index (BMI), weight, or bleeding history.
The primary efficacy and safety study (313-NA) was a one-year open-label clinical trial that treated 2,134 subjects in North America. Of these subjects 1,213 (56.8%) discontinued prematurely, including 102 (4.8%) discontinued by the Sponsor for early study closure. The mean weight of subjects in this study was 70.38 kg. The efficacy of Indayo was assessed by the number of pregnancies that occurred after the onset of treatment and within 14 days of the last dose. Among subjects 35 years or less, there were 23 pregnancies (4 of these occurred during the interval 1 to 14 days after the last day of pill use) during 12,572 28-day pill packs of use. The resulting total Pearl Index was 2.38 (95% CI: 1.51, 3.57) and the one-year life table pregnancy rate was 2.39 (95% CI: 1.57, 3.62). Pill pack cycles during which subjects used back-up contraception or were not sexually active were not included in these calculations. Among women 35 years or less who took the pills completely as directed, there were 15 pregnancies (method failures) resulting in a Pearl Index of 1.55 (95% CI: 0.87, 2.56) and the one-year life table pregnancy rate was 1.59 (95% CI: 0.95-2.67).
In a second supportive study conducted in Europe (315-EU), 641 subjects were randomized to Indayo (n=323) or the cyclic comparator of 100 mcg Levonorgestrel (Indayo) and 20 mcg ethinyl estradiol (n=318). The mean weight of subjects in this study was 63.86 kg. The efficacy analysis among women 35 years or less included 2,756 Indayo pill packs and 2,886 cyclic comparator pill packs. There was one pregnancy in the Indayo group that occurred within 14 days following the last dose. There were three pregnancies in the cyclic comparator group.
Inhibition of Menses (Bleeding Profile)
The bleeding profile for subjects in Study 313-NA also was assessed. Women with a history of unscheduled bleeding and/or spotting were not excluded from the study.
In those subjects who provided complete bleeding data, the percentage of patients who were amenorrheic in a given cycle and remained amenorrheic through cycle 13 (cumulative amenorrhea rate) was determined (Figure 2).
Figure 2: Percentage of Subjects with Cumulative Amenorrhea for Each Pill Pack through Pill Pack 13
When prescribing Indayo, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled bleeding and spotting.
Indayo (ethinyl estradiol and Levonorgestrel (Indayo)) contains a combination of female hormones that prevent ovulation (the release of female hormones that prevent ovulation (the release of an egg from an ovary). Indayo also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Indayo is used as contraception to prevent pregnancy.
Indayo may also be used for purposes not listed in this medication guide.
Each tablet contains Levonorgestrel (Indayo) 100 mcg and Ethinylestradiol (Indayo) 20 mcg.
Indayo is a combined oral contraceptive (COC) tablet containing the synthetic progestin, Levonorgestrel (Indayo) and the synthetic estrogen, Ethinylestradiol (Indayo).
Levonorgestrel (Indayo) is (-)-13-ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Its chemical formula is C21H28O2. It has a molecular weight of 312.45 and a melting point of 232-239°C.
Levonorgestrel (Indayo) is a white, odorless crystalline powder. It is practically insoluble in water, slightly soluble in alcohol, acetone, ether and soluble in chloroform.
Ethinylestradiol (Indayo) is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Its chemical formula is C20H24O2. It has a molecular weight of 296.41 and a melting point of 181-185°C.
Ethinylestradiol (Indayo) is a white to creamy white, odorless crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils and aqueous solutions of alkali hydroxides.
Use Indayo as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Indayo.
To achieve maximum contraceptive effectiveness, Indayo (Levonorgestrel (Indayo) and ethinyl estradiol tablets) 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. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of Indayo is one yellow tablet daily without any tablet-free interval.
It is recommended that Indayo tablets be taken at the same time each day.
Initiation of Therapy
Instructions for beginning Indayo are provided in Table 4 below.
If spotting or unscheduled bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her health care professional. The possibility of ovulation increases with each successive day that scheduled yellow tablets are missed. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered. Hormonal contraception must be discontinued if pregnancy is confirmed.
The risk of pregnancy increases with each tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.
Indayo may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism. The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.
In the case of first-trimester abortion, if the patient starts Indayo immediately, additional contraceptive measures are not needed.
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What other drugs will affect Indayo?
Always inform the prescriber which medicines or herbal products that the patient is using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that the patient uses Indayo. The healthcare providers can tell if the patient needs to take additional contraceptive precautions (eg, condoms) and if so, for how long.
Some medicines can make Indayo less effective in preventing pregnancy or can cause unexpected bleeding.
These include medicines used for the treatment of epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine) and tuberculosis (eg, rifampicin) or HIV infections (ritonavir) or other infectious disease (eg, griseofulvin, ampicillin, tetracycline) to increase intestinal motility (eg, metoclopramide) and the herbal remedy St. John's wort.
If the patient wants to use herbal products containing St. John 's wort while she is already using Indayo, consult the doctor first.
Indayo may decrease efficacy of other medicines eg, medicines containing cyclosporine or the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).
Ask the doctor or pharmacist for advice before taking any medicine.
Laboratory Tests: If the patient needs blood test, inform the doctor or the laboratory staff that she is taking Indayo, because oral contraceptives can affect the results of some tests.
