Gelsyn-3 16.8/2ml Inj, 2ml
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 (minimal systemic absorption, generally considered low risk)
FDA Approved
Mar 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gelsyn-3 is a gel-like substance injected directly into your knee joint. It contains a natural substance called hyaluronate, which is similar to the fluid already in your healthy joints. In osteoarthritis, this natural fluid can become thin. Gelsyn-3 helps to restore the cushioning and lubricating properties of your knee joint fluid, which can reduce pain and improve movement.
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 follow all instructions provided. 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 method.
If you miss a dose, contact your doctor immediately 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 method.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid strenuous activities or prolonged weight-bearing for 48 hours after each injection.
- Follow your doctor's recommendations for physical therapy or exercise programs.
- Maintain a healthy weight to reduce stress on your knee joints.
- Use ice packs if you experience swelling or pain after the injection.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
16.8 mg (2 mL) intra-articularly into the knee joint, once weekly for three weeks (total of 3 injections).
Dose Range:
16.8 - 16.8 mg
Condition-Specific Dosing:
osteoarthritis_knee:
16.8 mg (2 mL) intra-articularly into the knee joint, once weekly for three weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Hyaluronate is a natural polysaccharide found in the synovial fluid, cartilage, and other connective tissues. In osteoarthritis, the concentration and molecular weight of hyaluronate in the synovial fluid are reduced, leading to decreased viscoelasticity. Gelsyn-3, an exogenous hyaluronate, is injected into the knee joint to restore the viscoelastic properties of the synovial fluid, thereby improving lubrication, shock absorption, and joint function. It is believed to exert its therapeutic effects by acting as a viscosupplement, reducing pain, and improving mobility.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local intra-articular administration); minimal systemic absorption
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Primarily confined to the synovial joint space
ProteinBinding:
Not applicable (local action)
CnssPenetration:
No
Elimination:
HalfLife:
Intra-articular half-life varies by product, generally hours to days (e.g., 1-2 days in synovial fluid for similar products); systemic half-life is very short if absorbed.
Clearance:
Local enzymatic degradation and lymphatic drainage.
ExcretionRoute:
Metabolites are primarily excreted via urine and feces after systemic clearance.
Unchanged:
Minimal systemic excretion of unchanged drug.
Pharmacodynamics
OnsetOfAction:
Variable, typically within a few days to weeks after the first injection, with maximal effect often observed after the full series of injections.
PeakEffect:
Weeks to months after the completion of the injection series.
DurationOfAction:
Up to 6 months or longer for symptomatic relief.
Confidence:
Medium
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 emergency 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
+ Swelling of the mouth, face, lips, tongue, or throat
Change in skin color at the injection site
Other Possible Side Effects
While most people may not experience side effects or may only have mild ones, it's essential to be aware of the following potential side effects. If you experience any of these or any other side effects that bother you or do not go away, contact your doctor:
Irritation at the injection site
Mild pain, stiffness, or warmth in or around the knee
Swelling at the injection site
Bruising
Back pain
Muscle pain
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 emergency 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
+ Swelling of the mouth, face, lips, tongue, or throat
Change in skin color at the injection site
Other Possible Side Effects
While most people may not experience side effects or may only have mild ones, it's essential to be aware of the following potential side effects. If you experience any of these or any other side effects that bother you or do not go away, contact your doctor:
Irritation at the injection site
Mild pain, stiffness, or warmth in or around the knee
Swelling at the injection site
Bruising
Back pain
Muscle pain
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 or worsening pain in the injected knee
- Significant swelling, redness, or warmth around the knee that does not subside
- Fever or chills (signs of infection)
- Any signs of allergic reaction (e.g., rash, itching, difficulty breathing)
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 allergy to hyaluronic acid or any component of this medication. If you have experienced an allergic reaction, provide details about the symptoms you encountered.
Allergies to other medications, foods, or substances, as these may interact with this drug.
Use of products containing ammonium salts or chlorhexidine for cleaning the area where the injection will be administered.
Presence of bleeding disorders or difficulties with blood clotting.
* Any active infection or skin condition at the intended injection site.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine the safety of taking 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 safe and effective treatment.
It is essential to inform your doctor about the following:
Any allergy to hyaluronic acid or any component of this medication. If you have experienced an allergic reaction, provide details about the symptoms you encountered.
Allergies to other medications, foods, or substances, as these may interact with this drug.
Use of products containing ammonium salts or chlorhexidine for cleaning the area where the injection will be administered.
Presence of bleeding disorders or difficulties with blood clotting.
* Any active infection or skin condition at the intended injection site.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine the safety of taking 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 safe and effective treatment.
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. Additionally, during the first 48 hours after receiving this drug, limit your time 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 overdose in the traditional sense due to local administration. Excessive injection volume could potentially cause increased intra-articular pressure and pain.
What to Do:
If symptoms of severe local reaction or suspected infection occur, contact your healthcare provider immediately. For general overdose concerns, call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of knee pain and function (e.g., WOMAC score)
Rationale: To establish baseline severity of osteoarthritis symptoms and track treatment efficacy.
Timing: Prior to first injection
Inspection of injection site
Rationale: To rule out active skin infection or disease at the injection site, which is a contraindication.
Timing: Prior to each injection
Routine Monitoring
Assessment of knee pain and function
Frequency: Periodically after the injection series (e.g., at 1, 3, and 6 months)
Target: Reduction in pain, improvement in function
Action Threshold: Lack of improvement or worsening symptoms may indicate need for alternative therapies.
Monitoring for local adverse reactions (pain, swelling, effusion, warmth)
Frequency: After each injection and during follow-up visits
Target: Absence or resolution of symptoms
Action Threshold: Persistent or severe reactions may require medical evaluation to rule out infection or other complications.
Symptom Monitoring
- Knee pain (intensity, frequency)
- Knee stiffness
- Knee swelling or effusion
- Warmth or redness at injection site
- Difficulty with ambulation or daily activities
Special Patient Groups
Pregnancy
Gelsyn-3 has not been studied in pregnant women. Due to minimal systemic absorption, the risk to the fetus is considered low. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low theoretical risk due to minimal systemic exposure.
Second Trimester:
Low theoretical risk due to minimal systemic exposure.
Third Trimester:
Low theoretical risk due to minimal systemic exposure.
Lactation
It is unknown if hyaluronate is excreted in human milk. Given the minimal systemic absorption and high molecular weight, transfer into breast milk is unlikely to be significant. Considered probably compatible with breastfeeding.
Infant Risk:
Low risk to infant due to minimal systemic exposure and high molecular weight.
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 adjustments are required for elderly patients. Clinical studies included patients over 65 years of age, and no overall differences in safety or effectiveness were observed compared to younger adults.
Clinical Information
Clinical Pearls
- Ensure proper aseptic technique during injection to minimize the risk of joint infection.
- Prior to injection, remove any joint effusion to maximize the effectiveness of the viscosupplement.
- Do not inject intravascularly or extra-articularly, as this can lead to adverse events.
- Avoid using disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride) for skin preparation, as they can cause hyaluronate to precipitate.
- Patients should be advised to avoid strenuous activities or prolonged weight-bearing for at least 48 hours after each injection.
- Pain relief is often gradual and may not be immediate after the first injection; the full series of three injections is typically required for optimal benefit.
Alternative Therapies
- Oral analgesics (e.g., acetaminophen)
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Topical analgesics (e.g., NSAID gels, capsaicin cream)
- Corticosteroid injections (intra-articular)
- Physical therapy and exercise
- Weight management
- Assistive devices (e.g., knee braces, canes)
- Surgical interventions (e.g., arthroscopy, osteotomy, total knee arthroplasty)
Cost & Coverage
Average Cost:
Varies, typically $800 - $1500 per 3-injection series per 3-injection series
Insurance Coverage:
Often covered by Medicare Part B and commercial insurance plans for approved indications, typically as a medical benefit (buy and bill). Coverage may vary by plan and prior authorization requirements.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to 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 emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to 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 emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.