Vyzulta 0.024% Ophth Solution 5ml
It is used to treat glaucoma.It is used to lower high eye pressure.
Drug Class
Anti-glaucoma agent
Pharmacologic Class
Nitric oxide-donating prostaglandin F2Ξ± analog
Pregnancy Category
Not available
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 lead to glaucoma. It works by helping fluid drain better from your eye, reducing the pressure and protecting your vision.
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 use in the eyes only and should be applied in the evening.
Administration Instructions
1. Wash your hands before and after using this medication.
2. Remove contact lenses before applying the medication. You can put them back in 15 minutes later, unless your eyes are irritated or infected.
3. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. Gently blot any excess solution from your eyelid.
6. If you are using multiple medications in the same eye, apply each one at least 5 minutes apart.
Storage and Disposal
If you receive this medication by 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 stored in the refrigerator. Do not freeze.
Opened bottles can be stored in the refrigerator or at room temperature.
* Discard any unused medication after 8 weeks.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular 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 use in the eyes only and should be applied in the evening.
Administration Instructions
1. Wash your hands before and after using this medication.
2. Remove contact lenses before applying the medication. You can put them back in 15 minutes later, unless your eyes are irritated or infected.
3. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. Gently blot any excess solution from your eyelid.
6. If you are using multiple medications in the same eye, apply each one at least 5 minutes apart.
Storage and Disposal
If you receive this medication by 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 stored in the refrigerator. Do not freeze.
Opened bottles can be stored in the refrigerator or at room temperature.
* Discard any unused medication after 8 weeks.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Administer one drop in the affected eye(s) once daily in the evening.
- If using other ophthalmic medications, wait at least 5 minutes between applications.
- Remove contact lenses before instilling drops and wait 15 minutes before reinserting them.
- Avoid touching the dropper tip to the eye or any other surface to prevent contamination.
- Store at room temperature (2Β°C to 25Β°C or 36Β°F to 77Β°F). Protect from light.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) once daily in the evening.
Condition-Specific Dosing:
glaucoma:
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 needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Latanoprostene bunod is a prodrug that is metabolized in the eye to latanoprost acid and butanediol mononitrate. Latanoprost acid is a prostaglandin F2Ξ± analog that increases uveoscleral outflow. Butanediol mononitrate releases nitric oxide (NO), which is believed to increase outflow through the trabecular meshwork by relaxing the trabecular meshwork and Schlemm's canal.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability (minimal systemic absorption after ocular administration)
Tmax:
Latanoprost acid: 5-10 minutes (plasma)
FoodEffect:
Not applicable (ophthalmic)
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Latanoprost acid: Approximately 87% (plasma)
CnssPenetration:
Limited
Elimination:
HalfLife:
Latanoprost acid: Approximately 17 minutes (systemic)
Clearance:
Rapid systemic clearance of latanoprost acid
ExcretionRoute:
Primarily renal (metabolites)
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
Approximately 11-13 hours
DurationOfAction:
At least 24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although 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 may not return to normal. This change can occur several months to years after starting the medication. If you notice any changes in your eye color, contact your doctor.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. 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 or changes, such as:
+ Darker eyelashes
+ Thicker eyelashes
+ Increased number of eyelashes
Most of the time, these eyelash changes return to normal after stopping the medication.
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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.
Although 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 may not return to normal. This change can occur several months to years after starting the medication. If you notice any changes in your eye color, contact your doctor.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. 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 or changes, such as:
+ Darker eyelashes
+ Thicker eyelashes
+ Increased number of eyelashes
Most of the time, these eyelash changes return to normal after stopping the medication.
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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:
- Sudden decrease in vision or vision loss
- Severe eye pain or redness
- Signs of eye infection (e.g., discharge, swelling)
- Significant or bothersome changes in iris color (darkening)
- Increased sensitivity to light
- New or worsening blurred vision
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.
Special Considerations for Children:
If the patient is a child, please note that this medication is not recommended for children under 16 years of age.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you are experiencing.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This medication may interact with other drugs or health conditions, so it is vital to verify that it is safe for you to take this medication with your existing medications and health problems.
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.
Special Considerations for Children:
If the patient is a child, please note that this medication is not recommended for children under 16 years of age.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you are experiencing.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This medication may interact with other drugs or health conditions, so it is vital to verify that it is safe for you to take this medication with your existing medications and health problems.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly follow your doctor's instructions to have your eye pressure and vision checked. 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, you must discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Ocular irritation
- Conjunctival hyperemia (redness)
- Eye pain
What to Do:
If an overdose occurs, treatment should be symptomatic. If ingested, contact a poison control center immediately. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Other prostaglandin analogs (may paradoxically increase IOP when used concomitantly)
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess treatment efficacy for glaucoma.
Timing: Prior to initiation of therapy
Ophthalmic examination (slit lamp, fundoscopy)
Rationale: To assess ocular health and rule out other causes of elevated IOP.
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 set by ophthalmologist
Action Threshold: IOP not at target, significant fluctuations, or progression of optic nerve damage/visual field loss
Ocular examination for adverse effects (e.g., conjunctival hyperemia, iris pigmentation changes, eyelash changes)
Frequency: Regularly, as determined by ophthalmologist
Target: Absence of severe or bothersome adverse effects
Action Threshold: Significant or bothersome adverse effects, especially iris color change or inflammation
Symptom Monitoring
- Blurred vision
- Eye pain or discomfort
- Redness or irritation of the eye
- Foreign body sensation in the eye
- Increased sensitivity to light (photophobia)
- Changes in iris color (darkening, especially in mixed-color irides)
- Changes in eyelashes (increased length, thickness, pigmentation, number)
- Eyelid skin darkening
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies in pregnant women. Animal studies with latanoprost (a component of Vyzulta) showed adverse effects on pregnancy and development when administered systemically. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown; animal data suggest potential for adverse effects.
Second Trimester:
Risk unknown; animal data suggest potential for adverse effects.
Third Trimester:
Risk unknown; animal data suggest potential for adverse effects.
Lactation
It is unknown if latanoprostene bunod is excreted in human milk. Latanoprost (a component of Vyzulta) has been detected in human milk. Caution should be exercised when Vyzulta is administered to a nursing woman. 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.
Infant Risk:
Potential for systemic exposure to latanoprost acid in breastfed infant; risk of adverse effects is low due to minimal systemic absorption in mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Vyzulta is a unique prostaglandin analog that also delivers nitric oxide, providing a dual mechanism of action to lower IOP by increasing both uveoscleral and trabecular outflow.
- Patients should be informed about the potential for permanent iris color change (increased brown pigmentation), especially in eyes with mixed-color irides.
- Other common side effects include conjunctival hyperemia (eye redness), eyelash changes (increased length, thickness, number, pigmentation), and eyelid skin darkening.
- Emphasize once-daily dosing in the evening for optimal efficacy and to minimize systemic exposure.
- If a dose is missed, the patient should continue with the next dose as scheduled; do not double the dose.
Alternative Therapies
- Other prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost, tafluprost)
- Beta-blockers (e.g., timolol, betaxolol)
- Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
- Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide)
- Rho kinase inhibitors (e.g., netarsudil)
- Combination products (e.g., timolol/dorzolamide, timolol/brimonidine)
- Surgical interventions (e.g., laser trabeculoplasty, trabeculectomy, minimally invasive glaucoma surgery)
Cost & Coverage
Average Cost:
Varies, typically $200-$300+ per 2.5ml or 5ml bottle
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.