Nurses Compass
Drug Guide
Tralokinumab
Classification
Therapeutic: Immunosuppressant/Anti-inflammatory
Pharmacological: Monoclonal antibody (IgG4) Interleukin-13 inhibitor
FDA Approved Indications
- Atopic dermatitis in adults
Mechanism of Action
Tralokinumab is a monoclonal antibody that binds specifically to interleukin-13 (IL-13), a cytokine involved in the inflammatory process of atopic dermatitis. By inhibiting IL-13, it reduces inflammation and helps improve skin lesions associated with the condition.
Dosage and Administration
Adult: Typically 600 mg (two 300 mg injections) initially, then 300 mg every other week. Dosing may be adjusted based on response and clinical judgment.
Pediatric: Not approved for pediatric use; safety and efficacy not established.
Geriatric: No specific dosage adjustments are generally necessary; however, caution is advised in the elderly due to potential comorbidities.
Renal Impairment: No specific adjustment needed; limited data available.
Hepatic Impairment: No specific adjustment recommended.
Pharmacokinetics
Absorption: Subcutaneous administration with a median time to maximum concentration (Tmax) of approximately 7 days.
Distribution: Limited data; monoclonal antibodies are generally distributed mainly in the vascular and interstitial spaces.
Metabolism: Catabolized by proteolytic pathways similar to other IgG4 antibodies.
Excretion: Not significantly eliminated via renal or hepatic routes; broken down into amino acids through proteolysis.
Half Life: Approximately 17-19 days.
Contraindications
- Hypersensitivity to tralokinumab or any component of the formulation.
Precautions
- Increased risk of infections due to immunosuppression. Patients should be monitored for signs of infection. Use with caution in patients with a history of chronic infections or immunodeficiency. Considerations during pregnancy and lactation should involve a risk-benefit assessment.
Adverse Reactions - Common
- Infusion-related reactions (e.g., headache, fatigue, nausea) (Less common)
- Respiratory infections (e.g., nasopharyngitis) (Common)
- Conjunctivitis, eyelid edema (Common)
Adverse Reactions - Serious
- Anaphylaxis (Rare)
- Serious infections (e.g., cellulitis, herpes zoster) (Uncommon)
Drug-Drug Interactions
- No significant interactions reported; however, caution with other immunosuppressants.
Drug-Food Interactions
- No known interactions.
Drug-Herb Interactions
- Limited data; consult current literature.
Nursing Implications
Assessment: Monitor for signs of infection, allergic reactions, and skin improvement.
Diagnoses:
- Risk for infection related to immunosuppression.
- Impaired skin integrity related to atopic dermatitis.
Implementation: Administer as per dosing schedule. Educate patients about infection signs.
Evaluation: Assess skin lesion improvement and monitor for adverse reactions.
Patient/Family Teaching
- Report any signs of infection or allergic reaction promptly.
- Do not discontinue medication without consulting healthcare provider.
- Maintain follow-up appointments for injection and assessment.
Special Considerations
Black Box Warnings:
- Serious infections and hypersensitivity reactions, including anaphylaxis.
Genetic Factors: No specific genetic testing recommended.
Lab Test Interference: No significant interference expected.
Overdose Management
Signs/Symptoms: Potential for severe allergic or infusion reactions.
Treatment: Supportive care. No specific antidote; manage symptoms and provide emergency treatment as needed.
Storage and Handling
Storage: Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F).
Stability: Stable until the expiration date when stored properly. Do not freeze.