Ilumya®(Tildrakizumab-Asmn)

Bimzelx®(Bimekizumab)

Prescription Only

Ilumya is a medication used to reduce inflammation associated with psoriasis. It is administered by subcutaneous injection every 12 weeks after an initial loading dose and must be...

Prescription Only

Bimzelx (bimekizumab) is a medication classified as an interleukin inhibitor, prescribed for the treatment of certain types of plaque psoriasis in adults. It functions by reducing...

Dosage & Administration

Administration

Subcutaneous Injection. Learn more.

Subcutaneous. Learn more.

Dosing

Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.. Learn more.

The recommended dosage of BIMZELX is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16.. Learn more.

Latin Shorthand

100mg Wks 0, 4, then q12w.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

$5 or $15. Learn more.

Annual Cap

$6,000. Learn more.

Learn more.

Assistance Expiration

2 years. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.. Learn more.

The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling: Suicidal Ideation and Behavior [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4)] Inflammatory Bowel Disease [see Warnings and Precautions (5.5)]. Learn more.

Mechanism of Actions (MoA)

Interleukin 23 Antagonist. Learn more.

Interleukin 17A and Interleukin 17F Antagonist. Learn more.

Special Populations

What is the risk of ILUMYA use during pregnancy?

Limited available data on the use of ILUMYA during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes. Human IgG is known to cross the placental barrier; therefore, ILUMYA may be transferred from the mother to the fetus. An embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (MRHD). When dosing was continued until parturition, a small increase in neonatal death was observed at 59 times the MRHD.

What is the background risk of birth defects and miscarriage during pregnancy?

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

What does the animal data on ILUMYA use during pregnancy show?

In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118. No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg. Tildrakizumab crossed the placenta in monkeys. In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 to parturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose, and four monkeys at 100 mg/kg dose. The clinical significance of these nonclinical findings is unknown.

What is the risk of ILUMYA use during lactation?

There are no data 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ILUMYA and any potential adverse effects on the breastfed child from ILUMYA or from the underlying maternal condition.

What is the safety and effectiveness of ILUMYA in pediatric patients?

ILUMYA has not been established as safe and effective in pediatric patients under the age of 18.

What is the geriatric use of ILUMYA?

During Phase 2 and 3 trials, 92 subjects aged 65 or older and 17 subjects aged 75 or older were exposed to ILUMYA 100mg. Although there were no observed differences in safety or efficacy between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.

Ilumya®(Tildrakizumab-Asmn)	Bimzelx®(Bimekizumab)

Prescription Only Ilumya is a medication used to reduce inflammation associated with psoriasis. It is administered by subcutaneous injection every 12 weeks after an initial loading dose and must be...	Prescription Only Bimzelx (bimekizumab) is a medication classified as an interleukin inhibitor, prescribed for the treatment of certain types of plaque psoriasis in adults. It functions by reducing...
Dosage & Administration	Dosage & Administration comparison data
Administration
Subcutaneous Injection. Learn more.	Subcutaneous. Learn more.
Dosing
Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.. Learn more.	The recommended dosage of BIMZELX is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16.. Learn more.
Latin Shorthand
100mg Wks 0, 4, then q12w.. Learn more.	The recommended dosage of BIMZELX is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16.. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$5 or $15. Learn more.
Annual Cap
$6,000. Learn more.	Learn more.
Assistance Expiration
2 years. Learn more.	2 years. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory	Physician Advisory comparison data
Adverse Reactions
Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.. Learn more.	The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling: Suicidal Ideation and Behavior [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4)] Inflammatory Bowel Disease [see Warnings and Precautions (5.5)]. Learn more.
Mechanism of Actions (MoA)
Interleukin 23 Antagonist. Learn more.	Interleukin 17A and Interleukin 17F Antagonist. Learn more.
Special Populations
What is the risk of ILUMYA use during pregnancy? Limited available data on the use of ILUMYA during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes. Human IgG is known to cross the placental barrier; therefore, ILUMYA may be transferred from the mother to the fetus. An embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (MRHD). When dosing was continued until parturition, a small increase in neonatal death was observed at 59 times the MRHD. What is the background risk of birth defects and miscarriage during pregnancy? All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. What does the animal data on ILUMYA use during pregnancy show? In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118. No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg. Tildrakizumab crossed the placenta in monkeys. In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 to parturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose, and four monkeys at 100 mg/kg dose. The clinical significance of these nonclinical findings is unknown. What is the risk of ILUMYA use during lactation? There are no data 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ILUMYA and any potential adverse effects on the breastfed child from ILUMYA or from the underlying maternal condition. What is the safety and effectiveness of ILUMYA in pediatric patients? ILUMYA has not been established as safe and effective in pediatric patients under the age of 18. What is the geriatric use of ILUMYA? During Phase 2 and 3 trials, 92 subjects aged 65 or older and 17 subjects aged 75 or older were exposed to ILUMYA 100mg. Although there were no observed differences in safety or efficacy between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.

Ilumya® Alternatives