Formulary
Tralokinumab: Indications, Dosing, Side Effects and Interactions
Tralokinumab is a human monoclonal antibody that inhibits the interleukin-13 pathway.
MedNext Academy | 3 min read
Tralokinumab: Indications, Dosing, Side Effects and Interactions
Tralokinumab is a human monoclonal antibody that inhibits the interleukin-13 pathway.
Drug action
Tralokinumab is a human monoclonal antibody that inhibits the interleukin-13 pathway.
Indications and dose
**Moderate-to-severe atopic eczema (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 600 mg for 1 dose, followed by maintenance 300 mg every 2 weeks, patients who achieve clear or almost clear skin after 16 weeks of treatment may be considered for maintenance dosing given every 4 weeks; this may not be appropriate in patients weighing over 100 kg. Consider discontinuation of treatment if no response after 16 weeks.
**Moderate-to-severe atopic eczema (initiated by a specialist) for tralokinumab**
- **Child 12-17 years** (By subcutaneous injection): Initially 600 mg for 1 dose, followed by maintenance 300 mg every 2 weeks, patients who achieve clear or almost clear skin after 16 weeks of treatment may be considered for maintenance dosing given every 4 weeks; this may not be appropriate in patients weighing over 100 kg. Consider discontinuation of treatment if no response after 16 weeks.
Cautions
Helminth infection Cautions, further information Risk of infection Patients with pre-existing helminth infections should be treated before initiating treatment with tralokinumab. If patients become infected while receiving tralokinumab and do not respond to anthelminthic treatment, tralokinumab should be discontinued until infection resolves. M Patients should be brought up-to-date with live and live attenuated vaccines before initiating treatment. M
Side effects
Common or very common Eosinophilia; eye inflammation; increased risk of infection
Interactions
**Severe interactions:**
- Small numerical changes, which were not clinically significant, were observed for C max of omeprazole, AUC of metoprolol and AUC and C max of midazolam (the largest difference being for midazolam C...
**Other interactions (7):**
- The safety and efficacy of concurrent use of tralokinumab with live and live attenuated vaccines has not been studied.
- After 12 weeks of tralokinumab administration, patients were vaccinated with a combined tetanus, diphtheria, and acellular pertussis vaccine, and a meningococcal vaccine and immune responses were...
- No adverse interactions between either of the nonlive vaccines or tralokinumab were noted in the study.
- Therefore, patients receiving tralokinumab may receive concurrent inactivated or nonlive vaccinations.
- Clinically relevant interactions between tralokinumab and inhibitors, inducers, or substrates of metabolising enzymes are not expected, and no dose adjustment is needed.
- The effects of tralokinumab on the pharmacokinetics (PK) of CYP substrates, caffeine (CYP1A2), warfarin (CYP2C9), metoprolol (CYP2D6), omeprazole (CYP2C19) and midazolam (CYP3A), were evaluated in...
Pregnancy
Avoid-limited information available. M
Breast feeding
Specialist sources indicate use with caution, especially if breast-feeding a neonate or preterm infant (no information available). Large molecular weight suggests limited excretion into milk and drug molecule likely to be partially destroyed in the infant's gastro-intestinal tract; waiting for at least 2 weeks postpartum to resume treatment may minimise transfer to infant.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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