Data from FDA (Food and Drug Administration, USA) - Curated by Toby Galbraith - Last updated 01 September 2017

Indication(s)

1 INDICATIONS AND USAGE Lo Minastrin Fe is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies (14) ]. The efficacy of Lo Minastrin Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. Lo Minastrin Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy (1) The efficacy in women with a body mass index of more than 35 kg/m2 has not been evaluated (1, 8.8)

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Advisory information

contraindications
4 CONTRAINDICATIONS Do not prescribe Lo Minastrin Fe to women who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] • Have cerebrovascular disease [see Warnings and Precautions (5.1) ] • Have coronary artery disease [see Warnings and Precautions (5.1) ] • 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) ] • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] • Have uncontrolled hypertension [see Warnings and Precautions (5.4) ] • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] • Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ] ○ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11) ] Hypersensitivity to any ingredients in Lo Minastrin Fe 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 (5.3) ] A high risk of arterial or venous thrombotic diseases (4) Breast cancer or other estrogen- or progestin-sensitive cancer (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Hypersensitivity to any ingredients in Lo Minastrin Fe (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4)
Adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥ 2%) in clinical trials were nausea/vomiting, headache, bleeding irregularities, dysmenorrhea, weight change, breast tenderness, acne, abdominal pain, anxiety and depression (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data presented in Section 6.1 are from a clinical trial conducted with a 28-day regimen consisting of norethindrone acetate 1 mg/ethinyl estradiol 10 mcg tablets for 24 days followed with ethinyl estradiol 10 mcg tablets for 2 days and ferrous fumarate tablets for 2 days. Lo Minastrin Fe is bioequivalent to this 28-day regimen. A multicenter phase 3 clinical trial evaluated the safety and efficacy of the 28-day regimen for pregnancy prevention. The study was a one year, open-label, single-arm, uncontrolled study. A total of 1,660 women aged 18 to 45 were enrolled and took at least one dose of the 28-day regimen and 1,582 had at least one post-treatment evaluation [ s ee Clinical Studies (14) ] . Common Adverse Reactions ( Greater Than or Equal to 2 % of all Treated Subjects ): The most common adverse reactions reported by at least 2% of the 1,660 women using the 28-day regimen were the following in order of decreasing incidence: nausea/vomiting (7%), headache (7%), bleeding irregularities (including metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage and dysfunctional uterine bleeding) (5%), dysmenorrhea (4%), weight fluctuation (4%), breast tenderness (4%), acne (3%), abdominal pain (3%), anxiety (2%), and depression (2%). Adverse Reactions Leading to Study Discontinuation: 10.7% of the women discontinued from the clinical trial due to an adverse reaction. Adverse reactions occurring in greater than or equal to 1% of subjects leading to discontinuation of treatment were in decreasing order: menstrual irregularities (including metrorrhagia, irregular menstruation, menorrhagia and vaginal hemorrhage) (4%), headache/migraine (1%), mood disorder (including mood swings, depression, anxiety) (1%), and weight fluctuation (1%). Serious Adverse Reactions: deep vein thrombosis, ovarian vein thrombosis, cholecystitis. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of a 28-day regimen consisting of norethindrone acetate 1 mg/ethinyl estradiol 10 mcg tablets for 24 days followed with ethinyl estradiol 10 mcg tablets for 2 days and ferrous fumarate tablets for 2 days. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or evaluate a causal relationship to drug exposure. Adverse reactions are grouped into System Organ Classes. Vascular disorders: thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein) Immune system disorders: hypersensitivity reaction Skin and subcutaneous tissues: urticaria, rash, pruritis Gastrointestinal disorders: nausea, vomiting, abdominal pain/discomfort, diarrhea Nervous system disorders: headache, dizziness, migraine headache Psychiatric disorders: mood swings, depression, anxiety Respiratory, thoracic and mediastinal disorders: pulmonary embolism, dyspnea Reproductive system and breast disorders: breast enlargement, breast tenderness, dysmenorrhea, hypomenorrhea, menorrhagia, menstrual disorder, irregular menstruation, metrorrhagia

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION One blue tablet daily chewed and swallowed taken at the same time every day for 24 days. Follow with 8 ounces of water (2.1) One white tablet daily swallowed taken at the same time every day for 2 days (2.1) One brown tablet daily swallowed taken at the same time every day for 2 days (2.1) Take tablets in the order directed on the blister pack (2.1) Tablets may be administered without regard to meals (2.1) 2.1 How to Take Lo Minastrin Fe To achieve maximum contraceptive effectiveness, Lo Minastrin Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The blue tablet should be chewed and swallowed. The patient should drink a full glass (8 ounces) of water immediately after chewing and swallowing the blue tablet. The white tablet and the brown tablet are swallowed. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets [ see FDA-approved patient labeling ]. Lo Minastrin Fe may be administered without regard to meals [see Clinical Pharmacology (12.3) ]. 2.2 How to Start Lo Minastrin Fe Instruct the patient to begin taking Lo Minastrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding) [see FDA-approved patient labeling ]. One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Minastrin Fe other than on the first day of her menstrual cycle. For postpartum women who do not breastfeed or after a second trimester abortion, Lo Minastrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1) ]. The possibility of ovulation and conception before starting COCs should also be considered. Lo Minastrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Minastrin Fe immediately, additional contraceptive measures are not needed. 2.3 Switching from another H ormonal M ethod of C ontraception If the patient is switching from a combination hormonal method such as: ° Another pill ° Vaginal ring ° Patch Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Minastrin Fe. If she previously used a vaginal ring or transdermal patch, she should start using Lo Minastrin Fe on the day she would have resumed the previous product. If the patient is switching from a progestin-only method such as a: ° Progestin-only pill ° Implant ° Intrauterine system ° Injection She may switch any day from a progestin-only pill; instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill. If switching from an implant or injection, start the first blue tablet on the day her next injection would have been due or on the day of removal of her implant. If switching from an IUD, depending on the timing of removal, back-up contraception may be needed. 2.4 Advice in Case of Gastrointestinal Disturbances If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling ].
Use in special populations
8 USE IN SPECIFIC POPULATIONS Nursing mothers: Not recommended; can decrease milk production (8.3) 8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion. 8.3 Nursing Mothers When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. 8.4 Pediatric Use Safety and efficacy of Lo Minastrin Fe have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. 8.5 Geriatric Use Lo Minastrin Fe has not been studied in postmenopausal women and is not indicated in this population. 8. 6 Hepatic Impairment The pharmacokinetics of Lo Minastrin Fe has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [ s ee Contraindications (4) and Warnings and Precautions (5.2) ] . 8. 7 Renal Impairment The pharmacokinetics of Lo Minastrin Fe has not been studied in subjects with renal impairment. 8.8 Body Mass Index The safety and efficacy of Lo Minastrin Fe in women with a BMI greater than 35 kg/m2 has not been evaluated [ s ee Clinical Studies (14) ] .
Pregnancy and lactation
8.3 Nursing Mothers When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

Interactions

7 DRUG INTERACTIONS Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Lo Minastrin Fe. 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) 7.1 Effects of Other Drugs on Combined Oral 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 COCs 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 oral 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 COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Colesevelam: Colesevelam, a bile acid sequestrant, given together with a combination oral hormonal contraceptive, has been shown to significantly decrease the AUC of ethinyl estradiol. A drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20-25%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol 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 in the plasma concentrations of the estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [for example, nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [for example, indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [for example, boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [for example, nevirapine] or increase [for example, etravirine]). 7.2 Effects of Combined Oral Contraceptives on Other Drugs COCs containing ethinyl estradiol may inhibit the metabolism of other compounds (for example, 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 and temazepam. A significant decrease in the 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 concentration of thyroid-binding globulin increases with use of COCs [see Warnings and Precautions (5.12) ]. 7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Lo Minastrin Fe with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [s ee Warnings and Precautions (5.3) ]. 7. 4 Interference with Laboratory Tests The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

More information

Category Value
Authorisation number NDA204654
Orphan designation No
Product NDC 0430-0537
Date Last Revised 01-08-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 248310
Marketing authorisation holder Allergan, Inc.
Warnings WARNING : CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age , particularly in women over 35 years of age , and with the number of cigarettes smoked . For this reason, COCs should not be used by w omen who are over 35 years of age and smoke [ see Contraindications (4) ] . WARNING : CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use Lo Minastrin Fe ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use ( 4 )