Latanoprostene Bunod Ophthalmic

Latanoprostene Bunod Ophthalmic is a prescription medication used for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

• Latanoprostene Bunod Ophthalmic is available under the following different brand names: Vyzulta

Common side effects of Latanoprostene Bunod Ophthalmic include:

• eye redness and discharge
• eye irritation
• eye pain
• eyelash changes
• pain on instilling the drops

Serious side effects of Latanoprostene Bunod Ophthalmic include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• eye swelling
• eye redness
• severe discomfort
• crusting or drainage from the eye
• red, swollen, or itchy eyelids
• sudden vision changes
• severe pain, burning, stinging, or irritation after using the medicine

Rare side effects of Latanoprostene Bunod Ophthalmic include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Ophthalmic solution

• 0.024%

Elevated intraocular pressure

Adult dosage

• Instill 1 drop in the affected eye(s) once a day in the evening

Pediatric dosage

• Children aged 16 years and younger: Not recommended owing to potential safety concerns related to increased pigmentation following long-term chronic use
• Children older than 16 years: Instill 1 drop in affected eye(s) once a day in the evening

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Latanoprostene Bunod Ophthalmic has no noted severe interactions with any other drugs
• Latanoprostene Bunod Ophthalmic has no noted serious interactions with any other drugs
• Latanoprostene Bunod Ophthalmic has no noted moderate interactions with any other drugs
• Latanoprostene Bunod Ophthalmic has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Latanoprostene Bunod Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Latanoprostene Bunod Ophthalmic?”

Cautions

• Increased pigmentation to tissues may occur; most frequently reported changes with prostaglandin analogs have been of the iris and periorbital tissue (eyelid) and are expected to increase for the duration of treatment; regularly examine patients who develop noticeably increased iris pigmentation
• Gradual increases in the length, thickness, and number of lashes have been reported
• Exercise caution in patients with a history of intraocular inflammation (iritis/uveitis); avoid if active intraocular inflammation exists, as it may exacerbate this condition
• Macular edema, including cystoid macular edema, reported; use with caution in patients with aphakia pseudophakia with a torn posterior lens capsule or with known risk factors for macular edema
• Bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products has been reported; containers may be inadvertently contaminated by patients who typically had a concurrent corneal disease or an ocular epithelial surface disruption
• Remove contact lenses before administration because the product contains benzalkonium chloride; lenses may be reinserted 15 minutes after administration

Pregnancy and Lactation

• There are no available human data on the use of latanoprostene bunod during pregnancy to inform any drug-associated risks
• Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits; when administered IV to pregnant rabbits at exposures of more than 0.28 times the clinical dose, the drug was shown to be abortifacient and teratogenic
• Doses of 20 mcg/kg/day and more (23 times the clinical dose) produced 100% embryofetal lethality; structural abnormalities (eg, anomalies of the great vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, limb hyperextension and malrotation, abdominal distension, and edema) were observed in rabbit fetuses
• Latanoprostene bunod was not teratogenic in rats when administered IV at 150 mcg/kg/day (87 times the clinical dosLactation
• There are no data on the presence of latanoprostene bunod in human milk and its effects on the breastfed infant or milk production
• Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for latanoprostene bunod, and any potential adverse effects on the breastfed infant from the drug