norethindrone acetate/ethinyl estradiol/ferrous fumarate (Rx)

Brand and Other Names:Loestrin 24 Fe, Loestrin Fe 1.5/30, more...Loestrin Fe 1/20, Lo Loestrin Fe, Lomedia 24 Fe, Lo Minastrin Fe, Estrostep Fe, Gildess Fe 1.5/30, Gildess Fe 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Junel Fe 24, Microgestin Fe 1.5/30, Microgestin Fe 1/20, Minastrin 24 FE, Tilia Fe, TriLegest Fe, Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi Fe 1/20, Taytulla, Larin 24 FE, Larin FE 1/20, Larin FE 1.5/30, Melodetta 24 FE, Mibelas 24 FE, Tarina 24 FE, Tarina FE 1/20
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

norethindrone acetate/ethinyl estradiol/ferrous fumarate

tablet, monophasic 24-day

  • 1mg/20mcg (24 tabs) plus 75mg ferrous fumarate (4 tabs) (Larin 24 Fe, Loestrin 24 Fe, Lomedia 24 Fe, Junel Fe 24, Blisovi 24 Fe, Melodetta 24 Fe, Mibelas 24 Fe Tarina 24 Fe)

softgel capsule, monophasic 24-day

  • 1mg/20mcg (24 caps) plus 75mg ferrous fumarate (4 caps) (Minastrin 24 Fe, Taytulla)

tablet, monophasic 21-day

  • 1.5mg/30mcg (21 tabs) plus 75mg ferrous fumarate (7 tabs) (Blisovi Fe 1.5/30, Larin Fe 1.5/30, Loestrin Fe 1.5/30, Junel Fe 1.5/30, Microgestin Fe 1.5/30)
  • 1mg/20mcg (21 tabs) plus 75mg ferrous fumarate (7 tabs) (Blisovi Fe 1/20, Larin Fe 1/20, Loestrin Fe 1/20, Junel Fe 1/20, Microgestin Fe 1/20, Tarina Fe 1/20)

tablet, multiphasic (Lo Loestrin Fe, Lo Minastrin Fe)

  • 1mg/10mcg (24 tabs)ethinyl
  • estradiol 10mcg only (2 tabs)
  • Plus ferrous fumarate 75mg (2 tabs)

tablet, triphasic (Estrostep Fe, Tilia Fe, TriLegest Fe)

  • 1mg/20mcg (5 tabs)
  • 1mg/30mcg (7 tabs)
  • 1mg/35mcg (9 tabs)
  • Plus 75mg ferrous fumarate (7 tabs)

Oral Contraception

Follow Manufacturer's color-coding for sequence

Monophasic

  • 21 days: 1 active tab PO qDay for 21 days, then 1 Fe tab PO qDay on Days 22-28
  • 24 days: 1 active tab/cap PO qDay for 24 days, then 1 Fe tab/cap PO qDay on Days 25-28

tablet, multiphasic

  • 1mg/10 mcg (Days 1-24)
  • ethinyl estradiol alone 10 mcg (Days 25-26)
  • Plus ferrous fumarate 75 mg (Days 27-28)

tablet, triphasic

  • 1 mg/20 mcg (Days 1-5)
  • 1 mg/30 mcg (Days 6-12)
  • 1 mg/35 mcg (Days 13-21)
  • Plus 75 mg ferrous fumarate (Days 22-28)

Initiating after pregnancy

  • Increased risk for venous thromboembolism (VTE) following delivery with combined hormonal contraceptives; risk declines rapidly after 21 days, but does not return to normal until 42 days after delivery
  • CDC guidelines recommend waiting 3-6 weeks in postpartum women without additional VTE risks (MMWR July 7, 2011)
  • Initiating after vaginal birth: Wait at least 3 weeks
  • Initiating after caesarean section birth: Wait at least 6 weeks
  • Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives

Renal Impairment

Use caution; monitor blood pressure

Hepatic Impairment

Do not administer

Not recommended premenarche

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Interactions

Interaction Checker

and norethindrone acetate/ethinyl estradiol/ferrous fumarate

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    Contraindicated

      Serious - Use Alternative

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            Adverse Effects

            >10%

            Edema

            Weakness

            Anorexia

            Amenorrhea

            Breakthrough bleeding

            Change in menstrual flow

            Spotting

            Frequency Not Defined

            Deep vein thrombosis

            Thrombophlebitis

            Depression

            Dizziness

            Headache

            Nervousness

            Somnolence

            Breast tenderness

            Galactorrhea

            Abdominal pain

            Nausea

            Vomiting

            Weight change

            Cholestatic jaundice

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            Warnings

            Black Box Warnings

            Cardiovascular risks

            • Estrogens with or without progestins should not be used to prevent cardiovascular disease
            • Estrogens plus progestins: Women’s Health Initiative (WHI) Estrogen Plus Progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (aged 50-79 yr) during 5.6 yr of treatment with daily PO conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) compared with placebo
            • Estrogens alone: The estrogen alone substudy of the WHI Study reported increased risks of stroke & DVT in postmenopausal women (aged 50-79 yr) during 6.8 yr of treatment with oral conjugated estrogens (0.625 mg/day) alone compared with placebo

            Dementia Risks

            • Estrogens with or without progestins should not be used to prevent dementia
            • Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women aged 65 yr or older during 4 yr of treatment w/ daily CE 0.625 mg combined with MPA 2.5 mg, compared with placebo
            • Estrogens alone: A substudy of the WHIMS reported an increased risk of developing probable dementia in postmenopausal women aged 65 yr or older during 5.2 yr of treatment with conjugated estrogens 0.625 mg alone compared with placebo
            • Unknown whether these findings apply to younger postmenopausal women

            Dose & Duration

            • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations & dosage forms of estrogens and progestins
            • Because of these risks, estrogens with or without progestins should be prescribed at lowest effective dose and for shortest duration consistent with treatment goals and individual risks

            Cigarette smoking & risk of cardiovascular disease

            • Cigarette smoking increases risk of serious cardiovascular adverse effects from combination hormonal contraceptive use
            • This risk increases with age (>35 yr) and with heavy smoking (15 or more cigarettes/day)
            • Advise women who use hormonal oral contraceptives not to smoke

            Contraindications

            A high risk of arterial or venous thrombotic diseases

            Liver tumors or liver disease

            Undiagnosed abnormal uterine bleeding

            Breast cancer or other estrogen-or progestin-sensitive cancer

            Pregnancy

            Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

            Cautions

            Acitretin inhibits contraceptive efficacy of norethindrone preparations

            Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

            Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

            If a thrombotic event occurs, stop at least 4 wk before through 2 wk after major surgery; start no earlier than 4 weeks after delivery, in women who are not breastfeeding

            Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

            Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk; woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity

            Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

            Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

            Steroid hormones may be poorly metabolized in patients with hepatic impairment; acute or chronic disturbances of liver function may necessitate discontinuation of combination oral contraceptive until markers of liver function return to normal and causation by combination oral contraceptive has been excluded

            CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

            Monitor prediabetic and diabetic women taking eithinyl estradiol/ norethindrone; consider alternative contraceptive method for women with uncontrolled dyslipidemia

            Evaluate significant change in headaches and discontinue therapy if indicated

            Evaluate irregular bleeding or amenorrhea

            If used in women with well-controlled hypertension, monitor blood pressure and stop therapy if blood pressure rises significantly

            Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen

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            Pregnancy & Lactation

            Pregnancy: There is little or no increased risk of birth defects in women who inadvertently use combination oral contraceptives (COC) 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 COC prior to conception or during early pregnancy; women who do not breastfeed should not start COC use earlier than 4 weeks postpartum

            Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Ethinyl Estradiol (EE): Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues

            Norethindrone acetate: progestin; inhibits gonadotropin secretion of gonadotropins from pituitary; prevents follicular maturation and ovulation, stimulates growth of mammary tissues

            Ferrous fumarate: Replacement of iron stores

            Pharmacokinetics

            Peak Plasma Time: 8 hr (ethinyl estradiol); 1-2 hr (norethindrone)

            Protein binding: 80% (ethinyl estradiol); 61% (norethindrone)

            Both components are metabolized in the liver; estradiol undergoes extensive first-pass metabolism

            Ethinyl estradiol metabolites: Estriol, estrone

            Norethindrone metabolites: Sulfate and glucuronide metabolites (inactive)

            Half-Life: 4-13 hr (norethindrone PO)

            Excretion

            • Ethinyl estradiol: Urine as conjugates, most estrogens are also excreted in bile and undergo enterohepatic recycling
            • Norethindrone: 33-81% (urine); 35-43% (feces)
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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