{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "levonorgestrel",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• Release rate of levonorgestrel (LNG) is 17.5 mcg/day after 24 days and declines to 7.4 mcg/day after 5 years; Kyleena must be removed or replaced after 5 years.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      },
      {
        "text": "( 2.3 ) 2.1 Dosing Over Time Kyleena contains 19.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 17.5 mcg/day after 24 days.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      },
      {
        "text": "This rate decreases progressively to 9.8 mcg/day after 1 year and to 7.4 mcg/day after 5 years.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for levonorgestrel (Kyleena), retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for levonorgestrel (Kyleena), retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for levonorgestrel (Kyleena), retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The use of Kyleena is contraindicated in pregnancy or with a suspected pregnancy and Kyleena may cause adverse pregnancy outcomes [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.2 )].",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      },
      {
        "text": "If a woman becomes pregnant with Kyleena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery .",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      },
      {
        "text": "Remove Kyleena, if possible, if pregnancy occurs in a woman using Kyleena.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Animal reproduction studies have not been conducted with Kyleena. 8.2 Lactation Risk Summary Published studies report the presence of LNG in human milk.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      },
      {
        "text": "Small amounts of progestins (approximately 0.1% of the total maternal doses) were detected in the breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      },
      {
        "text": "There are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives.",
        "source": "US FDA label for levonorgestrel (Kyleena), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/levonorgestrel.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated in pregnan'."
    }
  }
}