Levonorgestrel Oral/Ethinyl Estradiol/Ferrous Bisglycinate

DEA Class; Rx

Common Brand Names; Mirena, Skyla, Liletta, Kyleena

Indicated for use by females of reproductive potential to prevent pregnancy

Liver tumors, benign or malignant, or liver disease (acute viral hepatitis or severe, decompensated, cirrhosis of the liver)

Undiagnosed abnormal uterine bleeding

Pregnancy (no reason to use CHCs during pregnancy)

History or current breast cancer or other estrogen- or progestin-sensitive cancer

Hypersensitivity

Coadministration with ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

• Headache (14%)
• Metrorrhagia (8%)
• Dysmenorrhea (7%)
• Nausea (7%)
• Abdominal pain (4%)
• Breast pain (4%)
• Emotional lability (3%)
• Acne (3%)
• Depression (2%)
• Amenorrhea (2%)
• Vaginal moniliasis (2%)
• Hypertension
• Hypercholesterolemia
• Weight gain
• Dysmenorrhea
• Flatulence
• Cardiac disorder: Chest pain, dyspnea, palpitations
• Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea
• General disorders and administration site conditions: Chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia
• Immune system disorders: Hypersensitivity reactions, including pruritus, rash, urticaria, erythema
• Injury, poisoning, and procedural complications: Injury
• Investigations: Decreased weight
• Musculoskeletal and connective-tissue disorders: Pain in extremity, arthralgia, back pain, muscle spasm
• Nervous system disorders: Headache, migraine, dizziness, hypoesthesia, paresthesia
• Psychiatric disorders: Depression, insomnia, anxiety
• Reproductive system and breast disorders: Metrorrhagia, menorrhagia, hot flush, vaginal hemorrhage
• Respiratory, thoracic, and mediastinal disorders: Nasopharyngitis, cough
• Sleep disorders and disturbances: Somnolence
• Vascular disorders: Deep vein thrombosis, pulmonary embolism

Risk of postpartum VTE decreases after third postpartum week, whereas risk of ovulation increases after third postpartum week; start contraceptive therapy no earlier than 4 weeks after delivery, in women who are not breastfeeding

Acute or chronic disturbances of liver function may necessitate the discontinuation of CHCs use until liver function resolves to normal and CHC causation has been excluded

Hepatic adenomas are associated with CHCs use; studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) combined oral contraceptive (COC) users (see Contraindications)

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users; use of CHCs may worsen existing gallbladder disease; past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use; women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis

CHCs may decrease glucose tolerance; carefully monitor in prediabetes and diabetes

Consider alternative contraception for women with uncontrolled dyslipidemia

Small proportion of women will have adverse lipid changes while on CHCs; women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using CHCs

If new headaches that are recurrent, persistent, or severe develop in women taking the drug, evaluate the cause and discontinue therapy if indicated (see Contraindications)

This product contains FD&C yellow no. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons

Carefully observe women with a history of depression, and discontinue therapy if depression recurs to a serious degree

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum; women with a tendency to chloasma should avoid exposure to the sun or ultraviolet light

Contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy (see Contraindications)

Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breastfed infants