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Bimatoprost: Drug information

Bimatoprost: Drug information
(For additional information see "Bimatoprost: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Durysta;
  • Latisse;
  • Lumigan
Brand Names: Canada
  • Latisse;
  • Lumigan;
  • Lumigan RC;
  • Vistitan
Pharmacologic Category
  • Ophthalmic Agent, Antiglaucoma;
  • Prostaglandin, Ophthalmic
Dosing: Adult

Elevated intraocular pressure:

Implant (Durysta): Intracameral: Insert 1 implant (10 mcg) in anterior chamber of affected eye. Limit to a single implant per eye; do not readminister to an eye that has received a prior implant.

Solution (Lumigan; Vistitan [Canadian product]): Ophthalmic, topical: Instill 1 drop into affected eye(s) once daily in the evening; do not exceed once-daily dosing (may decrease IOP-lowering effect). If used with other topical ophthalmic agents, separate administration by at least 5 minutes.

Hypotrichosis of the eyelashes (Latisse): Ophthalmic, topical: Place one drop on applicator and apply evenly along the skin of the upper eyelid at base of eyelashes once daily at bedtime; repeat procedure for second eye (use a clean applicator). Note: Onset of effect is gradual but is not significant in the majority of patients until 2 months.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Elevated intraocular pressure (Lumigan): Adolescents ≥16 years: Refer to adult dosing.

Hypotrichosis of the eyelashes (Latisse): Children ≥5 years and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Implant, Intraocular:

Durysta: 10 mcg (1 ea) [contains polyethylene glycol]

Solution, External:

Latisse: 0.03% (3 mL, 5 mL) [contains benzalkonium chloride]

Generic: 0.03% (3 mL, 5 mL)

Solution, Ophthalmic:

Lumigan: 0.01% (2.5 mL, 5 mL, 7.5 mL) [contains benzalkonium chloride]

Generic: 0.03% (2.5 mL, 5 mL, 7.5 mL)

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, External:

Latisse: 0.03% (3 mL) [contains benzalkonium chloride]

Solution, Ophthalmic:

Lumigan: 0.03% (3 mL, 5 mL, 7.5 mL) [contains benzalkonium chloride]

Lumigan RC: 0.01% (2.5 mL, 3 mL, 5 mL, 7.5 mL) [contains benzalkonium chloride]

Vistitan: 0.03% (3 mL, 5 mL) [contains benzalkonium chloride]

Administration: Adult

Intracameral (Durysta): Insert implant under aseptic conditions. Use immediately after foil pouch is opened. Affected eye should not be dilated prior to procedure. Patient should remain upright for ≥1 hour after procedure. Refer to manufacturer's labeling for detailed administration instructions.

Ophthalmic, topical:

Latisse: Remove make-up and contact lenses prior to application; ensure face is clean. Apply with the sterile applicator provided only; do not use other brushes or applicators. Use a tissue or cloth to blot any excess solution on the outside of the upper eyelid margin; do not apply to lower eyelash line. Do not reuse applicators; use new applicator for second eye. Applying more than once nightly will not increase eyelash growth; eyelash growth is expected to return to baseline when therapy is discontinued. May reinsert contacts 15 minutes after application.

Lumigan; Vistitan [Canadian product]: May be used with other eye drops to lower intraocular pressure. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Remove contact lenses prior to administration and wait 15 minutes before reinserting.

Administration: Pediatric

Ophthalmic:

Latisse: Children ≥5 years and Adolescents: Remove make-up and contact lenses prior to application; ensure face is clean. Apply only with the sterile applicator provided; do not use other brushes or applicators. Use a tissue or cloth to blot any excess solution on the outside of the upper eyelid margin; do not apply to lower eyelash line. Do not reuse applicators; use new applicator for second eye. Applying more than once nightly will not increase eyelash growth; eyelash growth is expected to return to baseline when therapy is discontinued. May reinsert contacts 15 minutes after application.

Lumigan: Adolescents ≥16 years: May be used with other eye drops to lower intraocular pressure. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Remove contact lenses prior to administration and wait 15 minutes before reinserting.

Use: Labeled Indications

Elevated intraocular pressure (Durysta; Lumigan; Vistitan [Canadian product]): Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Hypotrichosis of the eyelashes (Latisse): Treatment of hypotrichosis of the eyelashes.

Medication Safety Issues
Sound-alike/look-alike issues:

Lumigan may be confused with lumasiran.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

Ophthalmic implant:

>10%: Ophthalmic: Conjunctival hyperemia (Latisse: <4%; Lumigan: 31%)

1% to 10%:

Nervous system: Headache (5%)

Ophthalmic: Anterior chamber inflammation, blurred vision, conjunctival hemorrhage, corneal edema, corneal erosion (endothelial cell loss), corneal sensitivity, dry eye syndrome, eye discharge (aqueous humor leakage), eye discomfort, eye irritation, eye pain, foreign body sensation of eye, increased intraocular pressure, increased lacrimation, iris hyperpigmentation, iritis, macular edema, photophobia, synechiae of iris

<1%:

Hypersensitivity: Local hypersensitivity reaction

Ophthalmic: Anterior chamber eye hemorrhage (hyphema), corneal decompensation, corneal opacity, cystoid macular edema, iridocyclitis, uveitis

Ophthalmic solution:

>10%: Ophthalmic: Conjunctival hyperemia (Latisse: <4%; Lumigan: 31%)

1% to 10%:

Dermatologic: Erythema of eyelid, erythema of skin (periorbital), hypertrichosis, hypertrichosis of eyelid

Local: Local skin hyperpigmentation

Ophthalmic: Blurred vision, conjunctival edema, conjunctival hemorrhage, decreased visual acuity, dry eye syndrome, eye irritation, eye pain, eye pruritus, eyelid pruritus, punctate keratitis

Frequency not defined: Ophthalmic: Foreign body sensation of eye, hyperpigmentation of eyelashes, hyperpigmentation of eyelid, hypotony of eye, iris hyperpigmentation

Postmarketing:

Cardiovascular: Hypertension

Dermatologic: Allergic dermatitis, erythematous rash, local dryness of skin (periocular), macular eruption, skin discoloration (periorbital), trichorrhexis, xeroderma (eyelid)

Hypersensitivity: Hypersensitivity reaction

Local: Local skin exfoliation (periorbital area)

Nervous system: Dizziness, headache

Ophthalmic: Abnormal eyelash growth (madarosis), blepharoptosis, deepening of the eyelid sulcus, eye discharge, eyelid edema, eyelid entropion, hordeolum, intraocular inflammation, increased lacrimation, macular edema (including cystoid macular edema), misdirected growth of eyelashes, ocular allergy, ocular edema, periorbital swelling, photophobia, scaling of eyelid

Respiratory: Dyspnea, pulmonary signs and symptoms (asthma-like)

Contraindications

Hypersensitivity to bimatoprost or any component of the formulation.

Additional product-specific contraindications: Implant (Durysta): Active or suspected ocular or periocular infection; corneal endothelial cell dystrophy (eg, Fuchs dystrophy); prior corneal transplantation or endothelial cell transplant (eg, Descemet stripping automated endothelial keratoplasty); absent or ruptured posterior lens capsule (Note: Laser posterior capsulotomy in pseudophakic patients is not a contraindication if the intraocular lens fully covers the opening in the posterior capsule).

Warnings/Precautions

Concerns related to adverse effects:

• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.

• Corneal effects: Intracameral implant may cause corneal adverse effects and increased risk of corneal endothelial cell loss; use with caution in patients with limited corneal endothelial cell reserve. Limit administration to a single implant per eye without retreatment.

• Endophthalmitis: Intraocular surgical procedures and injections are associated with endophthalmitis. Use proper aseptic injection technique and monitor patients appropriately.

• Macular edema: Macular edema, including cystoid macular edema, has been reported; use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with risk factors for macular edema.

• Ocular effects: May permanently change/increase brown pigmentation of the iris, the eyelid skin, periorbital tissue, and eyelashes; area(s) affected may vary based on bimatoprost formulation used. In addition, may increase the length, thickness, and/or number of eyelashes (may vary between eyes); changes occur slowly and may not be noticeable for months or years. Pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes may be reversible following discontinuation of therapy. Long-term consequences of increased pigmentation are not known.

• Ocular inflammation: Intraocular inflammation and exacerbation of inflammation may occur; use with caution in patients with active intraocular inflammation (eg, uveitis).

Disease-related concerns:

• Iridocorneal angle: Use intracameral implant with caution in patients with narrow iridocorneal angles (Shaffer grade <3) or anatomical obstruction (eg, scarring) that may prohibit the implant from settling in the inferior angle.

Special populations:

• Contact lens wearers: Topical solution formulations contain benzalkonium chloride which may be adsorbed and cause discoloration of soft contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.

Dosage form specific issues:

• Latisse: Patients receiving medications to reduce intraocular pressure should consult their healthcare provider prior to using; may interfere with desired reduction of intraocular pressure. Unintentional hair growth may occur on skin that has repeated contact with solution; apply to upper eyelid only, blot away excess.

• Lumigan: Safety and efficacy have not been determined for use in patients with angle-closure, inflammatory, or neovascular glaucoma.

Metabolism/Transport Effects

None known.

Drug Interactions

Latanoprost: The concomitant use of Latanoprost and Bimatoprost may result in increased intraocular pressure. Risk C: Monitor therapy

Latanoprostene Bunod: The concomitant use of Bimatoprost and Latanoprostene Bunod may result in increased intraocular pressure. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Reproductive Considerations

Ophthalmic prostaglandins, such as bimatoprost, have a theoretical risk of miscarriage. To decrease this risk, agents other than bimatoprost may be preferred for the treatment of glaucoma in patients planning to become pregnant (Strelow 2020).

Pregnancy Considerations

According to the manufacturer, an increased risk of major birth defects or miscarriages has not been observed following use of bimatoprost ophthalmic drops in pregnant patients. However, ophthalmic prostaglandins, such as bimatoprost, are generally avoided during pregnancy due to a theoretical risk of miscarriage and premature labor. Agents other than bimatoprost may be preferred for the treatment of glaucoma during pregnancy, especially during the first trimester. In general, if ophthalmic agents are needed in pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease exposure to the fetus (Belkin 2020; Prum 2016; Strelow 2020).

Breastfeeding Considerations

It is not known if bimatoprost is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Due to their short half-lives, ophthalmic prostaglandins, such as bimatoprost, are considered compatible with breastfeeding; administering after breastfeeding may help decrease potential exposure to the infant via breast milk (Belkin 2020; Prum 2016; Strelow 2020).

Monitoring Parameters

Intraocular pressure, ocular pigmentation changes.

Mechanism of Action

As a synthetic analog of prostaglandin with ocular hypotensive activity, bimatoprost decreases intraocular pressure by increasing the outflow of aqueous humor. Bimatoprost may increase the percent and duration of hairs in the growth phase, resulting in eyelash growth.

Pharmacokinetics

Ophthalmic solution:

Note: Pharmacokinetic data based on topical solution formulation (unless otherwise noted).

Onset of action: Reduction of IOP: ~4 hours.

Peak effect: Maximum reduction of IOP: ~8 to 12 hours.

Distribution: Vd: 0.67 L/kg.

Protein binding: ~88%.

Metabolism: Undergoes oxidation, N-deethylation, and glucuronidation after reaching systemic circulation; forms metabolites.

Half-life elimination: IV: ~45 minutes.

Time to peak: ≤10 minutes.

Excretion: Urine (≤67%); feces (25%).

Pricing: US

Implant (Durysta Intraocular)

10 mcg (per each): $2,340.00

Solution (Bimatoprost External)

0.03% (per mL): $46.29 - $48.22

Solution (Bimatoprost Ophthalmic)

0.03% (per mL): $36.75 - $53.85

Solution (Latisse External)

0.03% (per mL): $51.43

Solution (Lumigan Ophthalmic)

0.01% (per mL): $109.40

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Bimagan (NL);
  • Bimaprost (BD);
  • Bimaroz (PL);
  • Bimast (BD);
  • Bimat (LK, VN);
  • Bimato Vision (DE);
  • Bimato-Vision (AT);
  • Bimatoswix (EG);
  • Bimican (CZ);
  • Bimifree (PL);
  • Careprost (IN, LK);
  • Glamigan (BR);
  • Glash Vista (JP);
  • Latisse (AR, BR, CL, HK, IL, KR, KW, NZ, RU, SG, TR, UA);
  • Lumigan (AE, AR, AT, AU, BB, BE, BG, BR, CH, CL, CN, CO, CR, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VE, VN, ZA);
  • Lumiprox (EG);
  • Matrocond (EG);
  • Sturiban (CZ, FI);
  • Up-46 (GR);
  • Vizibim (CZ);
  • ViziBim (ES)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Belkin A, Chen T, DeOliveria AR, Johnson SM, Ramulu PY, Buys YM; American Glaucoma Society and the Canadian Glaucoma Society. A practical guide to the pregnant and breastfeeding patient with glaucoma. Ophthalmol Glaucoma. 2020;3(2):79-89. doi:10.1016/j.ogla.2019.12.004 [PubMed 32672600]
  2. Bimatoprost ophthalmic Solution [prescribing information]. Princeton, NJ: Fosun Pharma USA Inc; January 2020.
  3. Durysta (bimatoprost) implant [prescribing information]. Madison, NJ: Allergan; March 2020.
  4. Durysta (bimatoprost) implant [prescribing information]. Madison, NJ: Allergan; November 2020.
  5. Latisse (bimatoprost ophthalmic solution) [prescribing information]. Madison NJ: Allergan USA, Inc; August 2021.
  6. Lumigan (bimatoprost ophthalmic solution) [prescribing information]. Madison NJ: Allergan USA, Inc; September 2020.
  7. Prum BE Jr, Rosenberg LF, Gedde SJ, et al. Primary open-angle glaucoma Preferred Practice Pattern(®) guidelines. Ophthalmology. 2016;123(1):P41-P111. doi:10.1016/j.ophtha.2015.10.053 [PubMed 26581556]
  8. Strelow B, Fleischman D. Glaucoma in pregnancy: an update. Curr Opin Ophthalmol. 2020;31(2):114-122. doi:10.1097/ICU.0000000000000641 [PubMed 31922978]
  9. Vistitan (bimatoprost ophthalmic solution) [product monograph]. Boucherville, Quebec, Canada: Sandoz Canada Inc; January 2019.
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