Tralokinumab

Tralokinumab is a prescription medication used for the treatment of moderate-to-severe atopic dermatitis.

• Tralokinumab is available under the following different brand names: Adbry, tralokinumab-ldrm

Common side effects of Tralokinumab include:

• eye pain, redness, or swelling.
• itching in the eyes
• high white blood cell count
• injection site reactions (pain, redness, swelling, or itching)

Serious side effects of Tralokinumab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• severe dizziness
• itching
• fainting 
• lightheadedness 
• skin rash
• changes in vision

Rare side effects of Tralokinumab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

SC injectable solution

• 150 mg/mL (single-dose prefilled syringe)

Atopic Dermatitis

• 600 mg SC initially, followed by 300 mg every other week
• Patients weighing less than100 kg treated for 16 weeks and who achieve clear or almost clear skin may consider 300 mg SC every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tralokinumab has severe interactions with no other drugs.
• Tralokinumab has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • axicabtagene ciloleucel
  • BCG vaccine live
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • dengue vaccine
  • idecabtagene vicleucel
  • influenza virus vaccine quadrivalent, intranasal
  • lisocabtagene maraleucel
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella, and varicella vaccine, live
  • rotavirus oral vaccine, live
  • smallpox (vaccinia) vaccine, live
  • tisagenlecleucel
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Tralokinumab has moderate interactions with at least 39 drugs.
• Tralokinumab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to tralokinumab or any excipients in drug product

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tralokinumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tralokinumab?”

Cautions

• Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred; discontinue therapy if a hypersensitivity reaction occurs
• Conjunctivitis and keratitis reported; report new onset or worsening eye symptoms to a healthcare provider
• Treat patients with pre-existing helminth infections before initiating; if an infection develops during treatment and is unresponsive to antihelminth therapy, discontinue treatment until the infection resolves
• Drug interaction overview
  • Vaccinations
    • Avoid the use of live vaccines
    • Tralokinumab may alter immunity and increase the risk of infection following the administration of live vaccines
    • Limited data are available regarding coadministration with non-live vaccines

Pregnancy and Lactation

• Limited data are available on use in pregnant females
• Human IgG antibodies are known to cross the placental barrier; therefore, the drug may be transmitted from the mother to the developing fetus
• Lactation
  • There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production
  • Maternal IgG is present in breast milk
  • Effects of local gastrointestinal exposure and limited systemic exposure on breastfed infants are unknown