Monovisc 88mg/4ml Inj, 4ml
It is used to treat arthritis of the knee.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Viscosupplement
Pharmacologic Class
Hyaluronic acid derivative
Pregnancy Category
Not assigned
FDA Approved
Feb 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Monovisc is a gel-like substance injected directly into your knee joint to help relieve pain and improve movement caused by osteoarthritis. It works by acting like the natural fluid in your joint, which can become thin in osteoarthritis.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all provided guidelines. This medication is administered via injection.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid strenuous activities or prolonged weight-bearing for 48 hours after the injection.
- Apply ice packs to the injection site if you experience pain or swelling.
- Follow your doctor's recommendations for physical therapy or exercise to maximize benefits.
- Report any severe or persistent pain, swelling, redness, or signs of infection (fever, chills) to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
88 mg (4 mL) administered as a single intra-articular injection into the knee joint
Dose Range:
88 - 88 mg
Condition-Specific Dosing:
Osteoarthritis of the knee:
Single intra-articular injection of 88 mg (4 mL) into the affected knee.
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
Monovisc is a highly purified, high molecular weight sodium hyaluronate. It acts as a viscosupplement, restoring the viscoelasticity of the synovial fluid in osteoarthritic knee joints. This helps to improve lubrication, shock absorption, and reduce pain, thereby improving joint function.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local intra-articular administration, minimal systemic absorption)
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (localized to joint space)
ProteinBinding:
Not applicable (localized to joint space)
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 2-3 days within the joint space (for similar products, specific for Monovisc not precisely quantified systemically due to local action)
Clearance:
Not applicable (local degradation)
ExcretionRoute:
Primarily local degradation products, minimal systemic excretion
Unchanged:
Not applicable (local degradation)
Pharmacodynamics
OnsetOfAction:
Variable, often within a few days to weeks after injection
PeakEffect:
Typically within 4-12 weeks post-injection
DurationOfAction:
Up to 6 months
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
- A change in skin color at the injection site.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects, or if they persist or bother you, contact your doctor for advice:
- Irritation at the site where the drug was administered.
- Mild pain, stiffness, or warmth in or around the knee.
- Swelling at the site of administration.
- Bruising.
- Back pain.
- Muscle pain.
Please note that this list is not exhaustive, and you may experience other side effects. If you have any questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice 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.
If you experience any of the following symptoms, call your doctor immediately or seek medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
- A change in skin color at the injection site.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects, or if they persist or bother you, contact your doctor for advice:
- Irritation at the site where the drug was administered.
- Mild pain, stiffness, or warmth in or around the knee.
- Swelling at the site of administration.
- Bruising.
- Back pain.
- Muscle pain.
Please note that this list is not exhaustive, and you may experience other side effects. If you have any questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice 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:
- Severe pain at the injection site
- Significant swelling or warmth in the knee
- Redness or pus at the injection site
- Fever or chills (possible infection)
- Allergic reaction symptoms (e.g., rash, itching, difficulty breathing, swelling of face/throat)
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:
If you have a known allergy to hyaluronic acid or any component of this medication. Be sure to discuss the specifics of your allergy, including any symptoms you have experienced.
If you are allergic to this medication, any of its ingredients, or other substances, such as foods, drugs, or other products. Share the details of your allergy and the symptoms that occur.
If you are using a cleaning product that contains ammonium salts or chlorhexidine on the area where the injection will be administered.
If you have a history of bleeding problems or disorders.
* If you have an active infection or skin condition at the site where the injection will be given.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
If you have a known allergy to hyaluronic acid or any component of this medication. Be sure to discuss the specifics of your allergy, including any symptoms you have experienced.
If you are allergic to this medication, any of its ingredients, or other substances, such as foods, drugs, or other products. Share the details of your allergy and the symptoms that occur.
If you are using a cleaning product that contains ammonium salts or chlorhexidine on the area where the injection will be administered.
If you have a history of bleeding problems or disorders.
* If you have an active infection or skin condition at the site where the injection will be given.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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. To minimize potential risks, avoid strenuous activity for 48 hours or as advised by your doctor. During the initial 48 hours after receiving this drug, limit standing on your feet to no more than 1 hour at a time. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Not applicable for a single intra-articular injection. Systemic overdose is highly unlikely due to minimal systemic absorption.
What to Do:
Call 1-800-222-1222 (Poison Control) for any concerns, though local reactions would be the primary concern if an excessive volume were injected.
Drug Interactions
Monitoring
Baseline Monitoring
Knee pain and function assessment (e.g., WOMAC score, VAS pain scale)
Rationale: To establish baseline severity of osteoarthritis symptoms and track treatment efficacy.
Timing: Prior to injection
Physical examination of the knee joint
Rationale: To assess range of motion, swelling, tenderness, and rule out other conditions.
Timing: Prior to injection
Inspection of injection site
Rationale: To ensure no active skin infection or inflammation that would contraindicate injection.
Timing: Immediately prior to injection
Routine Monitoring
Knee pain and function assessment
Frequency: Periodically (e.g., 4-12 weeks post-injection, then as needed)
Target: Reduction in pain and improvement in function
Action Threshold: Lack of improvement or worsening of symptoms may indicate need for alternative therapy or re-evaluation.
Local adverse reactions (e.g., pain, swelling, warmth, redness at injection site)
Frequency: Within 72 hours post-injection, then as needed
Target: Minimal or no local reaction
Action Threshold: Severe or persistent local reactions, or signs of infection (fever, purulent discharge) require immediate medical evaluation.
Symptom Monitoring
- Increased knee pain
- Swelling in the knee
- Warmth or redness at the injection site
- Fever or chills (signs of infection)
- Limited range of motion
Special Patient Groups
Pregnancy
Monovisc has not been studied in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Animal reproduction studies are not available.
Trimester-Specific Risks:
First Trimester:
Risk unknown, avoid if possible.
Second Trimester:
Risk unknown, avoid if possible.
Third Trimester:
Risk unknown, avoid if possible.
Lactation
It is not known whether Monovisc is excreted in human milk. Caution should be exercised when Monovisc is administered to a nursing woman. Consider the benefits of breastfeeding and the potential risks.
Infant Risk:
Risk unknown, likely low due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients (under 21 years of age) have not been established. Not indicated for use in this population.
Geriatric Use
No specific dose adjustment is required for elderly patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no overall differences in safety or effectiveness have been observed between these subjects and younger subjects.
Clinical Information
Clinical Pearls
- Monovisc is a single-injection viscosupplement, which can be convenient for patients compared to multi-injection regimens.
- Ensure proper aseptic technique during injection to minimize the risk of joint infection.
- Patients should be advised to avoid strenuous activity for at least 48 hours post-injection to allow the product to settle and minimize local reactions.
- Pain relief is not immediate and may take several weeks to become noticeable, with peak effect often seen around 2-3 months.
- Monovisc is contraindicated in patients with known hypersensitivity to hyaluronate preparations or with infections or skin disease in the area of the injection site.
Alternative Therapies
- Other hyaluronic acid injections (e.g., Synvisc, Euflexxa, Orthovisc, Supartz)
- Corticosteroid injections (e.g., triamcinolone, methylprednisolone)
- Oral NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
- Acetaminophen
- Physical therapy
- Weight management
- Surgical interventions (e.g., arthroscopy, total knee arthroplasty)
Cost & Coverage
Average Cost:
$1000 - $1500 per 4 mL syringe
Insurance Coverage:
Often covered by Medicare and commercial insurance plans for osteoarthritis of the knee when other treatments have failed.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.