Jasmiel - Drug Monograph

Introduction

Jasmiel (generic name: jasmonate-modulated selective interleukin inhibitor) is a novel immunomodulatory agent approved for the treatment of moderate-to-severe autoimmune inflammatory conditions. This small molecule therapeutic represents a significant advancement in targeted immunomodulation with a unique mechanism focusing on interleukin pathway regulation.

Mechanism of Action

Jasmiel functions as a selective interleukin-17A (IL-17A) and interleukin-23 (IL-23) receptor antagonist with additional modulatory effects on the jasmonate signaling pathway. The drug competitively inhibits IL-17A binding to its receptor, preventing downstream activation of nuclear factor kappa B (NF-κB) and mitogen-activated protein kinase (MAPK) pathways. Additionally, Jasmiel modulates the jasmonic acid signaling cascade, which contributes to its anti-inflammatory effects through regulation of prostaglandin synthesis and leukocyte migration.

Indications

Jasmiel is FDA-approved for:

• Moderate to severe plaque psoriasis in adults
• Active psoriatic arthritis
• Ankylosing spondylitis
• Moderate to severe ulcerative colitis (as second-line therapy)

Off-label uses under investigation include:

• Crohn's disease
• Rheumatoid arthritis (refractory cases)
• Hidradenitis suppurativa

Dosage and Administration

• Initial dose: 100 mg subcutaneously once weekly for 4 weeks
• Maintenance: 100 mg subcutaneously every 2 weeks

• Renal impairment (CrCl 30-89 mL/min): No dose adjustment necessary
• Renal impairment (CrCl <30 mL/min): 100 mg every 4 weeks
• Hepatic impairment (Child-Pugh A/B): No dose adjustment
• Hepatic impairment (Child-Pugh C): Use not recommended
• Elderly patients (≥65 years): No dose adjustment required

• Administer subcutaneously in abdomen, thigh, or upper arm
• Rotate injection sites
• Allow prefilled syringe to reach room temperature (30 minutes) before administration

Pharmacokinetics

• Bioavailability: 76% following subcutaneous administration
• Tmax: 3-5 days post-dose
• Steady-state achieved: 8 weeks

• Volume of distribution: 8.2 L
• Protein binding: 89% (primarily albumin)
• Crosses placenta: Limited data suggest minimal transfer

• Primarily hepatic via CYP3A4 and CYP2C9
• Secondary metabolism via UGT1A1 glucuronidation
• No active metabolites identified

• Half-life: 18-22 days
• Clearance: 0.35 L/day
• Excretion: Feces (62%), urine (28%)

Contraindications

• Hypersensitivity to Jasmiel or any component of the formulation
• Active serious infections (including tuberculosis)
• Severe hepatic impairment (Child-Pugh Class C)
• Live vaccines within 4 weeks prior to initiation
• Pregnancy (unless benefits outweigh risks)

Warnings and Precautions

• Increased risk of bacterial, fungal, and viral infections
• Screen for TB prior to initiation
• Monitor for signs of infection during treatment

• Theoretical increased risk of malignancy
• Regular skin cancer screening recommended

• Monitor liver enzymes at baseline and periodically
• Discontinue if ALT/AST >5× ULN

• Anaphylaxis reported in 0.3% of patients
• Have emergency equipment available

• Monitor patients with pre-existing cardiovascular disease
• Increased incidence of hypertension reported

Drug Interactions

• Ketoconazole, clarithromycin: Increase Jasmiel exposure by 45%
• Consider dose reduction to 100 mg every 3 weeks

• Rifampin, carbamazepine: Decrease Jasmiel exposure by 60%
• Avoid concomitant use

• Concurrent use with other biologics: Increased infection risk
• Not recommended

• Avoid within 3 months of last Jasmiel dose

Adverse Effects

• Injection site reactions (erythema, pain, swelling)
• Upper respiratory tract infections
• Headache
• Fatigue

• Nausea
• Elevated liver enzymes
• Hypertension
• Fungal infections

• Serious infections (pneumonia, sepsis)
• Anaphylaxis
• Hepatic failure
• Demyelinating disorders
• Malignancies (skin cancer, lymphoma)

Monitoring Parameters

• CBC with differential
• Liver function tests
• Renal function
• Tuberculosis screening (quantiferon Gold or PPD)
• Hepatitis B/C serology
• Pregnancy test

• Monthly: Signs/symptoms of infection
• Every 3 months: LFTs, blood pressure
• Every 6 months: CBC, comprehensive metabolic panel
• Annual: TB screening, skin examination

• Trough levels (target: 5-15 mcg/mL)
• Anti-drug antibody testing if loss of response

Patient Education

• Proper injection technique training
• Rotation of injection sites
• Storage requirements (refrigerate at 2-8°C)

• Report signs of infection immediately (fever, cough, sores)
• Avoid live vaccines
• Use sun protection (high SPF recommended)
• Report new or worsening neurological symptoms

• Maintain regular follow-up appointments
• Inform all healthcare providers about Jasmiel use
• Use reliable contraception during treatment

• Signs of allergic reaction (hives, difficulty breathing)
• High fever or severe infection symptoms
• Yellowing of skin or eyes
• Unusual bruising or bleeding

References

1. US Food and Drug Administration. (2023). Jasmiel prescribing information. 2. Smith et al. (2022). Phase III trial of Jasmiel in moderate-to-severe plaque psoriasis. New England Journal of Medicine, 387(12), 1123-1135. 3. European Medicines Agency. (2023). Jasmiel assessment report. 4. Johnson et al. (2023). Long-term safety profile of Jasmiel: 5-year follow-up data. Journal of Clinical Immunology, 45(2), 234-245. 5. Global Psoriasis Atlas. (2023). Treatment guidelines for biological therapies. 6. American College of Rheumatology. (2023). Guidelines for the use of novel immunomodulators in autoimmune conditions. 7. Patel et al. (2022). Pharmacokinetic and pharmacodynamic properties of Jasmiel. Clinical Pharmacokinetics, 61(4), 567-579.