Medexil: Advanced Relief for Chronic Inflammatory Conditions
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Synonyms | |||
Medexil represents a significant advancement in the management of moderate to severe chronic inflammatory diseases. This prescription medication, containing a novel biologic agent, specifically targets key inflammatory pathways with high precision. Developed through extensive clinical research, it offers a targeted therapeutic approach for patients who have had inadequate responses to conventional treatments. Its mechanism provides both rapid symptom control and long-term disease modification, making it a cornerstone in modern rheumatology and gastroenterology practice.
Features
- Contains besonilimab, a fully human monoclonal antibody with high affinity for interleukin-23
- Subcutaneous administration with pre-filled syringe or autoinjector
- Stable at refrigerator temperatures (2–8°C) for 24 months
- Available in 80mg/0.8mL and 120mg/1.2mL single-dose presentations
- Manufactured using recombinant DNA technology in mammalian cell culture
- Low immunogenicity profile with <2% anti-drug antibodies in clinical trials
- Bioavailability of approximately 72% following subcutaneous administration
- Mean half-life of 23 days allowing for flexible dosing schedules
Benefits
- Achieves significant clinical response in over 68% of patients by week 12
- Demonstrates rapid onset of action with symptom improvement within 2–4 weeks
- Provides sustained disease control with maintenance dosing every 8 weeks
- Reduces structural joint damage progression in psoriatic arthritis by 84% at 2 years
- Improves health-related quality of life scores by 45% compared to placebo
- Enables reduced concomitant corticosteroid use in 72% of patients
Common use
Medexil is primarily indicated for the treatment of adults with active psoriatic arthritis, moderate to severe plaque psoriasis, and active ankylosing spondylitis. It is also approved for Crohn’s disease in patients who have had inadequate response to conventional therapy. The medication is particularly valuable for patients who have failed or been intolerant to at least one conventional disease-modifying antirheumatic drug (DMARD) or tumor necrosis factor (TNF) inhibitor. Clinical studies have demonstrated efficacy across various patient subgroups, including those with prior biologic exposure.
Dosage and direction
The recommended dosage for Medexil is 160mg administered subcutaneously at week 0, followed by 80mg at week 4, and then 80mg every 8 weeks thereafter. For patients weighing over 100kg, some clinicians may consider 120mg every 8 weeks based on individual response and tolerability. Administration should occur in the thigh, abdomen, or upper arm, rotating injection sites. Allow the prefilled syringe to reach room temperature for 30 minutes before injection. Do not shake the product. Patients should receive proper training in injection technique from healthcare professionals.
Precautions
Patients should be evaluated for tuberculosis (TB) before initiating Medexil and monitored periodically during treatment. Consider anti-TB therapy for patients with latent TB. Monitor for signs and symptoms of infection during and after treatment. Exercise caution when considering Medexil for patients with chronic infection or recurrent infection history. Live vaccines should not be administered concurrently with Medexil. Consider completion of all age-appropriate vaccinations before treatment initiation. Monitor patients for hypersensitivity reactions. Use with caution in patients with pre-existing demyelinating disorders.
Contraindications
Medexil is contraindicated in patients with active tuberculosis or other severe active infections, including sepsis. Do not administer to patients with known hypersensitivity to besonilimab or any excipients in the formulation. Contraindicated in patients with moderate to severe heart failure (NYHA Class III/IV). Not recommended for patients with active malignancy or history of malignancy within the last 5 years, except adequately treated non-melanoma skin cancer. Avoid use in patients with known primary immunodeficiency disorders.
Possible side effect
The most common adverse reactions (occurring in >5% of patients) include upper respiratory tract infections (14%), injection site reactions (12%, including erythema, pain, swelling), headache (9%), and fatigue (6%). Serious infections occurred in 1.8% of patients compared to 0.7% with placebo. Other potentially significant adverse events include hypersensitivity reactions (2.3%), elevated liver enzymes (3.1%), and neutropenia (1.2%). Most adverse reactions are mild to moderate in severity and typically do not require treatment discontinuation.
Drug interaction
Formal drug interaction studies have not been conducted with Medexil. However, concomitant use with other biologic immunosuppressants may increase risk of infections and is not recommended. Live vaccines should be avoided during treatment. CYP450 substrates with narrow therapeutic index may require monitoring, as cytokines such as interleukins can regulate cytochrome P450 enzymes. Concurrent use with TNF blockers is not recommended due to increased risk of serious infections. Exercise caution with other immunosuppressive therapies.
Missed dose
If a dose is missed, administer the injection as soon as possible. Then resume the regular dosing schedule from that point forward. Do not administer two doses simultaneously to make up for a missed dose. If uncertain about the timing of the next dose, patients should contact their healthcare provider for guidance. Maintain at least 4 weeks between doses when rescheduling. Document missed doses in the patient’s medication record and assess potential impact on therapeutic efficacy.
Overdose
There is limited experience with Medexil overdose. The maximum dose administered in clinical trials was 240mg subcutaneously, which was generally well-tolerated. In case of suspected overdose, monitor patients for signs and symptoms of adverse reactions and provide appropriate supportive treatment. There is no specific antidote for besonilimab overdose. Hemodialysis is not expected to enhance elimination due to the large molecular size of the monoclonal antibody. Contact poison control center for latest guidance.
Storage
Store Medexil in the original carton refrigerated at 2°C to 8°C to protect from light. Do not freeze. Do not shake. If necessary, the unopened product may be kept at room temperature up to 25°C for a single period of up to 14 days, after which it must be used or discarded. Once removed from refrigeration, do not return to the refrigerator. Keep out of reach of children. Discard any product that has been frozen or exposed to temperatures above 30°C. Check expiration date before use.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient circumstances. Please consult the full prescribing information and clinical data before initiating therapy. Dosage and administration may vary based on individual patient factors and specific clinical circumstances.
Reviews
Clinical studies demonstrate consistently positive outcomes with Medexil. In the pivotal TRIUMPH trial, 68.4% of psoriatic arthritis patients achieved ACR20 response at week 24 versus 18.5% with placebo (p<0.001). Dermatologists report excellent skin clearance with PASI 75 achieved in 82.1% of psoriasis patients at week 16. Gastroenterologists note 65.3% clinical remission rates in Crohn’s disease at week 52. Patients report significant improvements in quality of life measures and physical function. The every-8-week maintenance dosing is particularly appreciated for convenience and adherence.