Isibloom Drug Information

Generic name: DESOGESTREL AND ETHINYL ESTRADIOL

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Uses of Isibloom

Combined 0.1

IUD Progesterone T 2 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 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. d Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. e Source: Trussel 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. a Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose.

The FDA 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 4 yellow pills). e However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. f The percents becoming pregnant in columns and are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. g Foams, creams, gels, vaginal suppositories, and vaginal film. h Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. i With spermicidal cream or jelly. j Without spermicides.

Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.

Dosage & Administration of Isibloom

To achieve maximum contraceptive effectiveness, Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) may be initiated using either a Sunday start or a Day 1 start. Day 1 Start The dosage of Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) for the initial cycle of therapy is one orange "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". Tablets are taken without interruption as follows: One orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days.

After 28 tablets have been taken, a new course is started and an orange "active" tablet is taken the next day. The use of Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) 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.) If the patient starts on Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) postpartum, and has not yet had a period, she should be instructed to use another method of contraception until an orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one orange "active" tablet in Weeks 1, 2, or 3, the orange "active" tablet should be taken as soon as she remembers.

If the patient misses two orange "active" tablets in Week 1 or Week 2, the patient should take two orange "active" tablets the day she remembers and two orange "active" tablets the next day; and then continue taking one orange "active" 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 days after missing pills. If the patient misses two orange "active" tablets in the third week or misses three or more orange "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 days after missing pills. Sunday Start When taking Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) the first orange "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first orange "active" tablet is taken on that day.

If switching directly from another oral contraceptive, the first orange "active" tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and an orange "active" tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

The use of Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) for contraception may be initiated 4 weeks postpartum. 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.) If the patient starts on Isibloom TM (desogestrel and ethinyl estradiol tablets, USP) postpartum, and has not yet had a period, she should be instructed to use another method of contraception until an orange "active" tablet has been taken daily for 7 days.

The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one orange “active” tablet in Weeks 1, 2, or 3, the orange "active" tablet should be taken as soon as she remembers. If the patient misses two orange "active" tablets in Week 1 or Week 2, the patient should take two orange "active" tablets the day she remembers and two orange "active" tablets the next day; and then continue taking one orange "active" 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 days after missing pills. If the patient misses two orange "active" tablets in the third week or misses three or more orange "active" tablets in a row, the patient should continue taking one orange "active" 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 days after missing pills.

Side Effects of Isibloom

  • Post Marketing 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 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). 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 2: Risk of Breast Cancer with Combined Oral Contraceptive Use For your reference, below are the studies reviewed by FDA to inform the breast cancer risk: References: 1. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med . 2002;346(26):2025-2032. 2. Dumeaux V, Fournier A, Lund E, Clavel-Chapelon F. Previous oral contraceptive use and breast cancer risk according to hormone replacement therapy use among postmenopausal women. Cancer Causes Control . 2005;16(5):537-544. 3. Dorjgochoo T, Shu XO, Li HL, et al. Use of oral contraceptives, intrauterine devices and tubal sterilization and cancer risk in a large prospective study, from 1996 to 2006. Int J Cancer . 2009;124(10):2442- 2449. 4. Hunter DJ, Colditz GA, Hankinson SE, et al. Oral contraceptive use and breast cancer: a prospective study of young women. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology . 2010;19(10):2496- 2502. 5. Vessey M, Yeates D. Oral contraceptive use and cancer. Final report from the Oxford-Family Planning Association contraceptive study. Contraception. 2013; 88(6): 678-683. 6. Morch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard O. Contemporary Hormonal Contraception and the Risk of Breast Cancer. N Engl J Med . 2017;377(23):2228-2239. 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, and 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

Warnings & Cautions for Isibloom

Oral contraceptives non-smoker b 0.3 0.5 0.9 1.9 13.8 31.6 Oral contraceptives

smoker b 2.2 3.4 6.6 13.5 51.1

IUD b 0.8 0.8 1 1 1.4 1.4 Condom a 1.1 1.6

0.7 0.2 0.3

Diaphragm/ spermicide a 1.9 1.2 1.2 1.3 2.2 2.8 Periodic abstinence a

2.5 1.6 1.6 1.7 2.9

Adapted from H.W. Ory, ref. #35. a) Deaths are birth-related b) Deaths

are method-related 3. Malignant Neoplasms Breast Cancer Isibloom™ is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive. Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer.

However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use. Cervical Cancer Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. 45-48 However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. 4. Hepatic Neoplasia Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose. 49 Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. 50,51 Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users.

However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users. 5. RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue desogestrel and ethinyl estradiol prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Desogestrel and ethinyl estradiol can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen. 6. Ocular Lesions There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives.

Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately. 7. Oral Contraceptive Use Before or During Early Pregnancy Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. 56-57 The majority of recent studies also do not indicate a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, 55,56,58,59 when oral contraceptives are taken inadvertently during early pregnancy. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.

Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. 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.

Oral contraceptive use should be discontinued if pregnancy is confirmed. 8. Gallbladder Disease Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. 60,61 More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. 62-64 The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens. 9. Carbohydrate and Lipid Metabolic Effects Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. 17 This effect has been shown to be directly related to estrogen dose. 65 In general, progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. 17,66 In the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. 67 Because of these demonstrated effects, prediabetic and diabetic women should be carefully monitored while taking oral contraceptives. A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS 1.a. and 1.d.), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users. 10. Elevated Blood Pressure Women with significant hypertension should not be started on hormonal contraception. 98 An increase in blood pressure has been reported in women taking oral contraceptives 68 and this increase is more likely in older oral contraceptive users 69 and with extended duration of use. 61 Data from the Royal College of General Practitioners 12 and subsequent randomized trials have shown that the incidence of hypertension increases with increasing progestational activity and concentrations of progestogens.

Women with a history of hypertension or hypertension-related diseases, or renal disease 70 should be encouraged to use another method of contraception. If these women elect to use oral contraceptives, they should be monitored closely and if a clinically significant persistent elevation of blood pressure (BP) occurs (≥ 160 mm Hg systolic or ≥ 100 mm Hg diastolic) and cannot be adequately controlled, oral contraceptives should be discontinued. In general, women who develop hypertension during hormonal contraceptive therapy should be switched to a non-hormonal contraceptive.

If other contraceptive methods are not suitable, hormonal contraceptive therapy may continue combined with antihypertensive therapy. Regular monitoring of BP throughout hormonal contraceptive therapy is recommended. 102 For most women, elevated blood pressure will return to normal after stopping oral contraceptives, 69 and there is no difference in the occurrence of hypertension among former and never users. 68,70,71 11. Headache The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and evaluation of the cause. 12. Bleeding Irregularities Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding.

If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. 13. Ectopic Pregnancy Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.

Drug Interactions with Isibloom

8. Drug Interactions Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Effects of Other Drugs on Combined Hormonal Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St.

John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of COCs Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease or increase ) /HCV protease inhibitors (decrease ) or with non-nucleoside reverse transcriptase inhibitors (decrease or increase ). Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer desogestrel and ethinyl estradiol with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT). Colesevelam Colesevelam, a bile acid sequestrant, given together with a combination oral hormonal contraceptive, has been shown to significantly decrease the AUC of EE. A drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.

Effects of Combined Hormonal Contraceptives on Other Drugs COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation.

This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.

Pregnancy Safety for Isibloom

11. Pregnancy Pregnancy Category X See CONTRAINDICATIONS and WARNINGS.

Pediatric Use of Isibloom

13. Pediatric Use Safety and efficacy of desogestrel and ethinyl estradiol tablets have 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. Use of this product before menarche is not indicated.

Contraindications for Isibloom

  • Isibloom is contraindicated in females who are known to have or develop the following conditions:
  • Thrombophlebitis or thromboembolic disorders
  • A past history of deep vein thrombophlebitis or thromboembolic disorders
  • Known thrombophilic conditions
  • Cerebral vascular or coronary artery disease (current or history)
  • Valvular heart disease with complications
  • Persistent blood pressure values of ≥ 160 mm Hg systolic or ≥ 100 mg Hg diastolic 102
  • Diabetes with vascular involvement
  • Headaches with focal neurological symptoms
  • Major surgery with prolonged immobilization
  • Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
  • 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
  • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).

Overdosage Information for Isibloom

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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