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MIEBO is a brand name for Perfluorohexyloctane, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MIEBO (perfluorohexyloctane ophthalmic solution, 100% w/w) is indicated for the treatment of the signs and symptoms of dry eye disease (DED). 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • For topical ophthalmic use only • MIEBO should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the solution. Contact lenses may be reinserted 30 minutes after the administration of MIEBO.
2 Recommended Dose and Dosage Adjustment Instill one drop of MIEBO four times daily into each affected eye. This recommended dose is the maximum recommended dose and should be used both as the starting dose and throughout long term treatment.
No dosage adjustment is required in any comorbid conditions. The effect of MIEBO has not been studied in patients with hepatic or renal impairment, and no dosage adjustment is recommended as the potential for systemic exposure is low.
Limited data from clinical studies exists for long term administration of MIEBO (up to 12 months). It is expected that use of the product will continue long term. Health Canada has not authorized an indication for pediatric use. 4 Administration Patients should be counselled on the proper administration to ensure proper dosage is administered: 1.
Remove the cap from eye drop bottle. 2. Holding the bottle upright, gently squeeze the bottle. PRMIEBOTM (perfluorohexyloctane ophthalmic solution, 100%) Page 5 of 19 Unclassified / Non classifié Patients should be advised to wash their hands before each use and not to touch the tip of the bottle to the eye or any other surface, in order to avoid eye injury or contamination of the solution.
5 Missed Dose If a dose of this medication is missed, it should be applied as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Do not try to catch up on missed drops by applying more than one dose at a time.
1%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. SEECASE, GOBI and MOJAVE Pooled Safety Data The safety data presented are the pooled dataset from two multi-center, randomized, double-masked, saline-controlled Phase 3 clinical studies (GOBI and MOJAVE), and one multi-center, randomized, double-masked, saline-controlled Phase 2 study (SEECASE).
A total of 1,442 subjects with a history of DED and clinical signs of meibomian gland dysfunction received MIEBO (four times a day) or saline for 57 days. Overall, the mean age of the 728 subjects who received MIEBO was 56 years (range, 19-87 years) and the majority of subjects were female (75%).
0%) were similar between MIEBO and the saline group. Most of the TEAEs were mild or moderate in severity. 1%) (Table 2). There were no non-ocular AEs that occurred at ≥1% at a higher incidence in the MIEBO group compared to saline control.
See 14 CLINICAL TRIALS. 1) There were no ocular serious adverse events or deaths, and no treatment related non ocular adverse events occurred with MIEBO treatment. KALAHARI Extension Study Safety Data Long-term safety data are provided by a 52-week open label extension (OLE) study KALAHARI.
All 208 subjects had completed the pivotal Phase 3 GOBI study and received MIEBO four times daily in both eyes for 52 weeks. Overall, subjects in the KALAHARI study had a mean age of 61 years (range, 19-88 years); most (70%) were female subjects.
General For topical ophthalmic use only. MIEBO should not be administered while wearing contact lenses. Contact lenses should be removed 3. While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle).
4. Keeping the bottle upside down, place the bottle above your eye and squeeze it again to release a drop into your eye. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Ophthalmic Solution containing perfluorohexyloctane 100% w/w None PRMIEBOTM (perfluorohexyloctane ophthalmic solution, 100%) Page 6 of 19 Unclassified / Non classifié prior to and for at least 30 minutes after administration of MIEBO.
MIEBO has not been studied in patients with active ocular or systemic infection. If an infection occurs during treatment, MIEBO should be temporarily withheld until the infection has been resolved. Perfluorohexyloctane is a member of the class of semi-fluorinated alkanes.
Notwithstanding the low systemic exposure with ophthalmic use, there is no information regarding the bioaccumulative potential of perfluorohexyloctane through long-term MIEBO use. Carcinogenesis and Mutagenesis Refer to 16 NON-CLINICAL TOXICOLOGY.
Driving and Operating Machinery Transient blurred vision has been reported in patients treated with MIEBO. If patients experience blurred vision, they should be advised not to drive or operate machinery until vision has cleared. Immune MIEBO has not been studied in patients with ocular allergies and hypersensitivity reactions.
There is the potential to experience hypersensitivity to MIEBO. If a hypersensitivity reaction occurs, patients should be advised to discontinue MIEBO treatment. Ophthalmologic Caution is advised in patients with history of other ophthalmologic conditions and trauma, as well as in patients with dry eye disease secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells as with vitamin A deficiency, as MIEBO has not been studied in these patient groups.
Perfluorohexyloctan is contraindicated in patients with: • known hypersensitivity to perfluorohexyloctane
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3% of subjects reporting ≥1 drug-related ocular TEAE. 4%). Chalazion, dry eye, hordeolum and instillation site pain all occurred in 1% of subjects. Increased frequency of TEAEs compared with the 57-day studies is attributed to the longer duration of study.
4%). Sinusitis, urinary tract infection, arthralgia, neuralgia, and insomnia all occurred in 1% of subjects. None of the ocular TEAEs were considered drug-related. Most ocular and non-ocular TEAEs were mild to moderate in severity. 8% of subjects and none were considered drug-related.
3 Less Common Clinical Trial Adverse Reactions The observed adverse drug reactions are provided below for those events reported by <1% of patients who received MIEBO four times daily in the three pooled 8-week saline-controlled clinical trials.
5 Post-market adverse reactions Other ophthalmic formulations containing perfluorohexyloctane captured the following post-market adverse reactions: PRMIEBOTM (perfluorohexyloctane ophthalmic solution, 100%) Page 9 of 19 Unclassified / Non classifié Eye disorders: Eye allergy, eye swelling, ocular discomfort, ocular hyperemia, periorbital disorder, periorbital swelling, photophobia, vision blurred, visual impairment General disorders and administration site conditions: Device intolerance, drug intolerance Skin and subcutaneous tissue disorders: Dry skin, erythema
Potential for Eye Injury and Contamination Advise patients not to touch the tip of the vial to their eye or any other surface, in order to avoid eye injury or contamination of the solution. 1 Pregnant Women Studies in pregnant rabbits have shown maternal toxicity of decreased body weight and loss of appetite at high oral doses of perfluorohexyloctane, but no fetal toxicity was observed.
See 16 NON-CLINICAL TOXICOLOGY. Perfluorohexyloctane is a member of the class of semi-fluorinated alkanes. The use of these substances during pregnancy is unknown. MIEBO should be used with caution during pregnancy. 2 Breast-feeding There are no data on the presence of perfluorohexyloctane in human milk, the effects on the breastfed infant, or the effects on milk production.
No studies were conducted to investigate the potential excretion of perfluorohexyloctane in the milk of animals. Furthermore, the potential effects for the class of semi-fluorinated alkanes used during breast-feeding is unknown. PRMIEBOTM (perfluorohexyloctane ophthalmic solution, 100%) Page 7 of 19 Unclassified / Non classifié The lack of clinical data during lactation precludes a clear determination of the risk of MIEBO to an infant during lactation; however, the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for MIEBO and any potential adverse effects on the breast-fed child from MIEBO.
Because many drugs are excreted in human breast milk, precaution should be exercised when MIEBO is administered to a nursing woman. 3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics Geriatrics (≥ 65 years of age): No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.