Perfluorohexyloctane
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From MedlinePlus, U.S. National Library of Medicine
Semifluorinated Alkane
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Administration Instructions Step 1. Remove the cap from eye drop bottle. Step 2. Holding the bottle upright, gently squeeze the bottle. Step 3. While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle). Step 4. Keeping the bottle upside down, place the bottle above your eye and squeeze it again to release a drop into your eye.
Repeat steps 1 - 4 for the second affected eye. Step 2. Step 3. Step 4.
Contraindications
Hypersensitivity. ( 4.1 )
4.1 Hypersensitivity MIEBO is contraindicated in patients with a history of hypersensitivity reaction to perfluorohexyloctane [see Adverse Reactions ( 6.1 )] .
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for perfluorohexyloctane. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well controlled studies with MIEBO in pregnant women. In animal reproduction studies with oral administration of perfluorohexyloctane during the period of organogenesis, no adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD) ( see Data ). Maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the RHOD. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data An embryofetal study was conducted in pregnant rabbits administered perfluorohexyloctane by oral gavage on gestation days 6 to 19, to target the period of organogenesis. Perfluorohexyloctane produced maternal toxicity, characterized by reduced body weight gain and food consumption, and miscarriages at all doses tested, with the lowest dose as ≥ 250 mg/kg/day (41 times the RHOD based on body surface area). Reduced fetal weights were also observed at ≥ 250 mg/kg/day but no fetal mortality or malformations.
A no observed adverse effect level (NOAEL) for maternal toxicity was not established in rabbits. An embryofetal study was conducted in pregnant rats administered perfluorohexyloctane by oral gavage on gestation days 6 to 17, to target the period of organogenesis. There was no evidence of embryofetal toxicity or teratogenicity at doses up to 2,000 mg/kg/day (162 times the RHOD).
Breastfeeding (LactMed)
No information is available on the use of perfluorohexyloctane during breastfeeding. Because perfluorohexyloctane is poorly absorbed, it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. No special precautions are required.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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