ADTRALZA 150mg/ml Solution for injection in pre-filled syringe

What is ADTRALZA 150mg/ml

ADTRALZA is a prescription medication containing tralokinumab, a human monoclonal antibody designed to treat moderate-to-severe atopic dermatitis (eczema) in adults and adolescents aged 12 years and older who are candidates for systemic therapy. It is administered via subcutaneous injection and is available in pre-filled syringes containing 150 mg of the active ingredient.

How to use ADTRALZA 150mg/ml

Administration Guidelines: Initial Dose: 600 mg, administered as four 150 mg subcutaneous injections at different sites on the same day. Maintenance Dose: 300 mg every other week, given as two 150 mg injections. Injection Sites: Thigh, abdomen (excluding the 5 cm area around the navel), or upper arm if administered by a caregiver. Preparation: Allow the pre-filled syringe to reach room temperature for 30 minutes before injection. Inspection: Ensure the solution is clear to opalescent and colorless to pale yellow, without visible particles. Rotation: Rotate injection sites with each dose to prevent skin irritation. Missed Dose: If a dose is missed, administer it as soon as possible and then resume the regular dosing schedule.

Mode of Action ADTRALZA 150mg/ml

Tralokinumab, the active component of ADTRALZA, is a monoclonal antibody that specifically targets and neutralizes interleukin-13 (IL-13), a cytokine involved in the inflammatory processes of atopic dermatitis. Mechanism: IL-13 Inhibition: By binding to IL-13, tralokinumab prevents it from interacting with its receptors, thereby reducing inflammation and other symptoms associated with atopic dermatitis. Skin Barrier Improvement: Inhibiting IL-13 helps restore the skin's barrier function, reducing dryness and susceptibility to irritants. Symptom Relief: Patients may experience reduced itching, redness, and skin lesions as the inflammatory response is mitigated.

ADTRALZA 150mg/ml Interactions ADTRALZA 150mg/ml

Vaccinations: Live Vaccines: Avoid concurrent administration with live or live attenuated vaccines due to potential safety concerns. Inactivated Vaccines: May be administered, but monitor for reduced efficacy. Other Medications: No significant interactions have been reported with other systemic immunosuppressants, but caution is advised. Always inform your healthcare provider about all medications and supplements you are taking.

Dosage of ADTRALZA 150mg/ml

The dosage regimen of ADTRALZA 150 mg is designed to provide effective and sustained control of moderate to severe atopic dermatitis symptoms. Dosage should always be individualized by a healthcare professional based on patient response and tolerance.

• Initial Dose: Typically, a 150 mg dose is administered subcutaneously every two weeks.
• Maintenance Dose: After initial doses, the healthcare provider may adjust the interval or continue biweekly injections based on clinical improvement.
• Duration: Treatment duration varies depending on disease severity and response; long-term therapy may be required for chronic management.
• Administration: Given as a single 150 mg injection via the pre-filled syringe, ready for subcutaneous use.
• Missed Dose: If a scheduled dose is missed, it should be administered as soon as possible unless close to the next dose; avoid doubling up doses.

Patients should regularly follow up with their healthcare provider to monitor effectiveness and side effects, and to adjust dosage as needed for optimal disease control.

Possible side effects of ADTRALZA 150mg/ml

Like all medications, ADTRALZA may cause side effects, although not everyone experiences them. Awareness of potential adverse reactions helps with early recognition and management.

• Common Side Effects:
  • Injection site reactions such as redness, swelling, pain, or itching.
  • Upper respiratory tract infections including nasopharyngitis and sinusitis.
  • Headache or mild fatigue.
• Uncommon Side Effects:
  • Allergic reactions including rash or itching.
  • Possible eye symptoms like conjunctivitis or keratitis reported in some cases.
• Serious Side Effects (Rare):
  • Severe hypersensitivity or anaphylaxis requiring immediate medical attention.
  • Signs of infection such as fever, chills, or persistent sore throat.

If you experience any severe or persistent side effects, contact your healthcare provider promptly. Regular monitoring during treatment helps ensure safety.

ADTRALZA 150mg/ml Contraindications ADTRALZA 150mg/ml

There are specific conditions and patient factors that contraindicate the use of ADTRALZA to avoid harm or complications.

• Known Hypersensitivity: History of allergic reactions to tralokinumab or any components of the formulation.
• Active Infections: Patients with severe infections should not initiate therapy until the infection resolves due to potential immune modulation.
• Immunocompromised Patients: Use with caution or avoid in patients with compromised immune systems unless benefits outweigh risks.
• Pediatric Use: Safety and efficacy have not been established in children under 18 years old.
• Pregnancy and Breastfeeding: Limited data available; consult a healthcare provider to weigh risks and benefits.

Always disclose your full medical history to your healthcare provider to determine if ADTRALZA is appropriate for you.

Storage of ADTRALZA 150mg/ml

Proper storage of ADTRALZA is essential to maintain its effectiveness and safety.

• Temperature: Store refrigerated between 2°C and 8°C (36°F to 46°F). Do not freeze.
• Light Protection: Keep the pre-filled syringes in their original packaging to protect from light exposure.
• Handling: Avoid shaking the syringe; handle gently.
• Room Temperature: Before injection, the syringe may be left at room temperature for up to 30 minutes to reduce injection discomfort.
• Disposal: Dispose of used syringes safely in sharps containers according to local regulations.
• Expiry: Do not use beyond the expiration date printed on the package.

Following these storage instructions ensures the medication maintains its potency and reduces risk of contamination or degradation.