Vyzulta 0.024% Ophth Solution 2.5ml
It is used to treat glaucoma.It is used to lower high eye pressure.
Drug Class
Antiglaucoma agent
Pharmacologic Class
Prostaglandin F2Ξ± analog; Nitric oxide donor
Pregnancy Category
Category C
FDA Approved
Nov 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vyzulta is an eye drop used to lower high pressure inside the eye, which can be caused by conditions like glaucoma. It works by helping fluid drain better from your eye.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for eye use only and should be applied in the evening. Before and after use, wash your hands thoroughly. If you wear contact lenses, remove them before using this medication and wait at least 15 minutes before putting them back in. However, do not reinsert your contact lenses if your eyes are irritated or infected.
When applying the medication, avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss. To apply the medication, tilt your head back and gently drop the medication into your eye. Use a clean tissue or cloth to blot any excess solution from your eyelid.
If you are using multiple medications in the same eye, allow at least a 5-minute interval between each application.
Storage and Disposal
If you receive this medication through mail order, it can be stored at temperatures up to 104Β°F (40Β°C) for up to 14 days during shipping. Once you receive the medication, store it in the refrigerator. Unopened bottles should be kept in the refrigerator, but do not freeze. Opened bottles can be stored in the refrigerator or at room temperature. Discard any unused medication after 8 weeks.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for eye use only and should be applied in the evening. Before and after use, wash your hands thoroughly. If you wear contact lenses, remove them before using this medication and wait at least 15 minutes before putting them back in. However, do not reinsert your contact lenses if your eyes are irritated or infected.
When applying the medication, avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss. To apply the medication, tilt your head back and gently drop the medication into your eye. Use a clean tissue or cloth to blot any excess solution from your eyelid.
If you are using multiple medications in the same eye, allow at least a 5-minute interval between each application.
Storage and Disposal
If you receive this medication through mail order, it can be stored at temperatures up to 104Β°F (40Β°C) for up to 14 days during shipping. Once you receive the medication, store it in the refrigerator. Unopened bottles should be kept in the refrigerator, but do not freeze. Opened bottles can be stored in the refrigerator or at room temperature. Discard any unused medication after 8 weeks.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Remove contact lenses before applying Vyzulta and wait at least 15 minutes after administration before reinserting them.
- If using other ophthalmic medications, administer Vyzulta at least 5 minutes apart from other drops.
- Avoid touching the dropper tip to the eye or any other surface to prevent contamination.
- Use once daily in the evening, as directed by your doctor. Using more often may decrease its effectiveness.
- Be aware of potential changes in eye color (iris), eyelid skin darkening, and increased eyelash growth, which may be permanent.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) once daily in the evening
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment recommended
Moderate:
No adjustment recommended
Severe:
No adjustment recommended
Dialysis:
No specific considerations; systemic exposure is minimal
Hepatic Impairment:
Mild:
No adjustment recommended
Moderate:
No adjustment recommended
Severe:
No adjustment recommended
Pharmacology
Mechanism of Action
Latanoprostene bunod is a nitric oxide-donating prostaglandin F2Ξ± analog. It is metabolized in the eye to latanoprost acid and butanediol mononitrate. Latanoprost acid is a prostaglandin F2Ξ± analog that works by increasing uveoscleral outflow of aqueous humor. Butanediol mononitrate releases nitric oxide, which is believed to increase outflow of aqueous humor through the trabecular meshwork via relaxation of the trabecular meshwork and ciliary muscle.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly applicable (ophthalmic); rapidly hydrolyzed in the cornea
Tmax:
Latanoprost acid: Approximately 3-4 hours in aqueous humor
FoodEffect:
Not applicable (ophthalmic)
Distribution:
Vd:
Not available (ophthalmic)
ProteinBinding:
Latanoprost acid: Approximately 87% in human plasma
CnssPenetration:
Limited
Elimination:
HalfLife:
Latanoprost acid: Approximately 17 minutes (systemic)
Clearance:
Not available (ophthalmic)
ExcretionRoute:
Primarily renal (metabolites of latanoprost acid)
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
Approximately 11-13 hours after administration
DurationOfAction:
At least 24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Eye color changes, which may turn brown and potentially be permanent. If you notice any changes in your eye color, contact your doctor. These changes can occur months to years after starting treatment.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Eye redness
Eye irritation
Darkening of the eyelid skin
* Eyelash growth, including changes such as darker, thicker, or more eyelashes. In most cases, these changes will reverse after stopping the medication.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Eye color changes, which may turn brown and potentially be permanent. If you notice any changes in your eye color, contact your doctor. These changes can occur months to years after starting treatment.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Eye redness
Eye irritation
Darkening of the eyelid skin
* Eyelash growth, including changes such as darker, thicker, or more eyelashes. In most cases, these changes will reverse after stopping the medication.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe eye pain or discomfort
- Sudden vision changes or loss
- Signs of eye infection (e.g., redness, swelling, discharge)
- Increased sensitivity to light
- Any new or worsening eye symptoms
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have an eye infection or swelling in the eye.
For Children:
If the patient is under 16 years of age, do not administer this medication. It is not approved for use in children younger than 16 years.
Additional Considerations:
This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Natural products and vitamins you are using
+ Any health problems you have
* Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have an eye infection or swelling in the eye.
For Children:
If the patient is under 16 years of age, do not administer this medication. It is not approved for use in children younger than 16 years.
Additional Considerations:
This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Natural products and vitamins you are using
+ Any health problems you have
* Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly schedule check-ups with your doctor to monitor your eye pressure and eyesight as advised. If you develop an eye infection, suffer an eye injury, or are scheduled to undergo eye surgery, promptly notify your doctor. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Eye irritation
- Ocular hyperemia (redness)
- Excessive tearing
What to Do:
If an overdose occurs, treatment should be symptomatic. If accidentally ingested, contact a poison control center or emergency medical services. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess treatment efficacy for glaucoma/ocular hypertension.
Timing: Prior to initiation of therapy
Ophthalmic examination (e.g., slit lamp, fundoscopy)
Rationale: To assess overall ocular health and rule out other conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, as determined by ophthalmologist (e.g., 2-4 weeks after initiation, then every 3-6 months)
Target: Individualized target IOP based on disease severity and progression
Action Threshold: IOP above target range, or signs of disease progression
Iris color
Frequency: Periodically (e.g., annual eye exam)
Target: Not applicable (monitor for changes)
Action Threshold: Significant or bothersome change in iris pigmentation
Eyelid skin pigmentation and eyelash changes
Frequency: Periodically (e.g., annual eye exam)
Target: Not applicable (monitor for changes)
Action Threshold: Significant or bothersome changes
Symptom Monitoring
- Eye irritation
- Eye pain
- Blurred vision
- Redness of the eye
- Foreign body sensation
- Increased sensitivity to light (photophobia)
- Changes in iris color (e.g., increased brown pigmentation)
- Changes in eyelid skin color
- Changes in eyelash length, thickness, or number
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of Vyzulta in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk not well-established; animal studies showed developmental toxicity at high systemic doses.
Second Trimester:
Risk not well-established; animal studies showed developmental toxicity at high systemic doses.
Third Trimester:
Risk not well-established; animal studies showed developmental toxicity at high systemic doses.
Lactation
L3 - Moderate Risk. It is not known whether latanoprostene bunod or its metabolites are excreted in human milk. Caution should be exercised when Vyzulta is administered to a nursing woman.
Infant Risk:
Potential for serious adverse reactions in breastfed infants. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for Vyzulta and any potential adverse effects on the breastfed infant from Vyzulta or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of Vyzulta in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary in elderly patients.
Clinical Information
Clinical Pearls
- Vyzulta is a unique dual-mechanism agent for IOP reduction, combining prostaglandin F2Ξ± agonism with nitric oxide donation.
- Administer once daily in the evening for optimal efficacy and to minimize potential side effects.
- Patients should be informed about the potential for permanent changes in iris color (especially in mixed-color irides), eyelid skin darkening, and increased eyelash growth.
- Proper instillation technique is crucial to maximize efficacy and minimize systemic absorption and side effects.
- If a dose is missed, the treatment should continue with the next dose as normal. Do not double the dose.
Alternative Therapies
- Latanoprost (Xalatan, Xelpros)
- Travoprost (Travatan Z)
- Bimatoprost (Lumigan, Latisse)
- Tafluprost (Zioptan)
- Timolol (Timoptic)
- Brimonidine (Alphagan P)
- Dorzolamide (Trusopt)
- Brinzolamide (Azopt)
- Netarsudil (Rhopressa)
- Fixed-combination products (e.g., Cosopt, Combigan, Simbrinza)
Cost & Coverage
Average Cost:
Approximately $200-$300 per 2.5ml bottle
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.