Ilumya (tildrakizumab-asmn) Cost, Side Effects, Dosage, And FDA Prescribing Information For Plaque Psoriasis | Han Nguyen, PharmD Intern | RxEconsult
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Ilumya (tildrakizumab-asmn) Cost, Side Effects, Dosage, And FDA Prescribing Information For Plaque Psoriasis Category: Dermatology by - March 30, 2018 | Views: 12956 | Likes: 0 | Comment: 1  

Ilumya prescribing information for plaque psoriasis

Brand Name: Ilumya
Generic Name: tildrakizumab-asmn  
Medication Class: selective interleukin inhibitor
Similar Drugs: Stelara (ustekinumab), Siliq (brodalumab), Cosentyx (secukinumab), Taltz (ixekizumab)
Manufacturer: Sun Pharma, Merck & Co., Inc.  
FDA Approval Date: March 22, 2018

What is Ilumya and its mechanism of action?

Ilumya (tildrazkizumab-asmn) is a humanized antibody that is used to treat moderate to severe plaque psoriasis. Plaque psoriasis is a chronic genetically inherited inflammatory condition that is caused by excessive production of skin cells. Psoriasis causes patches of red skin, covered with silvery scales which are itchy and painful. About 7 million Americans suffer from plaque psoriasis. 

Ilumya binds selectively to a cytokine called interleukin-23 (IL 23). Cytokines are naturally occurring proteins involved in immune reactions. Interleukin-23 causes an activation of T-lymphocytes (white blood cells) that trigger inflammation of the skin which results in psoriasis. Ilumya reduces symptoms of psoriasis such as inflammation and excessive production of skin cells by attaching to IL-23 and preventing it from activating T-lymphocytes.

What is Ilumya approved for treating?

Ilumya is used for the treatment of patients 18 years or older who have moderate to severe plaque psoriasis and are candidates for systemic therapy or phototherapy. 

How effective is Ilumya?

The efficacy of Ilumya for plaque psoriasis was demonstrated in two randomized double-blind, placebo-controlled trials. The trials involved 926 adults with moderate to severe plaque psoriasis. There were 616 patients in the Ilumya group and 310 patients were treated with placebo. The dose of Ilumya was 100 mg at Week 0, Week 4, and every twelve weeks thereafter for up to 64 weeks. 

At week 12, 61 to 64% of patients in the Ilumya group versus 6% of patients in the placebo group achieved a Psoriasis Area and Severity Index (PASI 75) score.  At week 12, 55 to 58% of subjects in the Ilumya group versus 4 to 7% of patients in the placebo group achieved a Physician Global Assessment (PGA) score of cleared or minimal.

Interesting facts about Ilumya?

The half-life of Ilumya is approximately 23 days. This means that it takes 23 days for the body to break down half the concentration of the drug. This is why Ilumya is taken every 12 weeks.

What are the side effects of Ilumya?

Common side effects:

  • Upper respiratory infections (14%)
  • Injection site reaction (3%)
  • Diarrhea (2%)

Serious side effects:

  • Angioedema
  • Urticaria
  • infections

What is the dosage of Ilumya?

The recommended dose is 100 mg injected under the skin at weeks 0, 4, then every 12 weeks thereafter.

Ilumya comes in a prefilled syringes containing 100 mg/l of Ilumya. Only healthcare providers can administer Ilumya.

Storage: Ilumya should be refrigerated at 2 to 8 C (36 to 46 F) and protected from light until use. Ilumya can be stored at room temperature at 25 C for up to 30 days in the original carton. Do not shake or freeze.

What are Ilumya drug interactions?

Ilumya interacts with live vaccines such as MMR vaccine, Varicella vaccines, Rubella vaccine, Zoster vaccine, and Rubella vaccine. 

What are warnings and precautions for Ilumya?

Infections: Ilumya may increase the risk of infection. Patients with chronic infection or recurrent infections should consider risks and benefits before using Ilumya.

Hypersensitivity: Patients on Ilumya may experience serious hypersensitivity reactions such as angioedema or urticaria (hives). Patients must discontinue Ilumya immediately if hypersensitivity reactions occur.

Vaccines: Patients must be up to date on vaccines before initiating Ilumya. Patients must avoid live vaccines while on Ilumya.

Pregnancy and lactation: Use of Ilumya in women who are pregnant or breastfeeding has not been adequately studied. 

What is the cost of Ilumya?

The wholesale cost of Ilumya is about $30,000 per year.

References

Ilumya FDA Prescribing Information (Package Insert)

 


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