Tildrakizumab

Tildrakizumab is a prescription medication used for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

• Tildrakizumab is available under the following different brand names: Ilumya, tildrakizumab-asmn

Common side effects of Tildrakizumab include:

• upper respiratory infections
• injection site reactions (hives, itching, pain, redness, inflammation, swelling, bruising, hematoma, and bleeding)
• diarrhea

Serious side effects of Tildrakizumab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• chills
• sweating
• skin sores
• muscle pain
• increased urination
• pain or burning when you urinate
• stomach pain
• diarrhea
• weight loss
• cough
• shortness of breath
• coughing up pink or red mucus

Rare side effects of Tildrakizumab 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, coordination loss, 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 because 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

Injection, solution

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

Plaque psoriasis

Adult dosage

• 100 mg SC at weeks 0, 4, and every 12 weeks thereafter

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, healthcare provider, or pharmacist first.

• Tildrakizumab has severe interactions with no other drugs
• Tildrakizumab has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • cholera vaccine
  • influenza virus vaccine quadrivalent, intranasal
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella, and varicella vaccine, live
  • rotavirus oral vaccine, live
  • smallpox (vaccinia) vaccine, live
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Tildrakizumab has moderate interactions with the following drug:
  • dengue vaccine
• Tildrakizumab 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, health questions, or concerns.

Contraindications

• Hypersensitivity reaction to tildrakizumab or any of the excipients

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• In clinical trials, cases of angioedema and urticaria occurred; if a serious hypersensitivity reaction occurs, discontinue treatment immediately and initiate appropriate therapy
• There is a slightly increased risk of infection in patients treated with Tildrakizumab in clinical trials; patients with active infections or a history of recurrent infections were not included in clinical trials; consider the risks and benefits before prescribing
• Immunizations
  • Before initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines
  • No data are available on the response to live or inactive vaccines
  • Avoid the use of live vaccines
• Pretreatment evaluation for tuberculosis
  • Evaluate patients for TB infection before initiating treatment
  • Initiate treatment of latent TB before administering Tildrakizumab; monitor for signs and symptoms of active TB during and after Tildrakizumab
  • Consider anti-TB therapy before initiating treatment in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed; do not administer it to patients with active TB infection

Pregnancy and Lactation

• Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of adverse developmental outcomes
• Human IgG is known to cross the placental barrier; therefore, tildrakizumab may be transferred from the mother to the fetus
• Lactation
  • No data are available on the presence of tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production
  • Human IgG is known to be present in human milk
  • Tildrakizumab was detected in the milk of monkeys