Ilumya (Tildrakizumab-Asmn)

ILUMYA^® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

• See the full prescribing information for recommended evaluations and immunizations prior to treatment. (
  2 DOSAGE AND ADMINISTRATION

  • See the full prescribing information for recommended evaluations and immunizations prior to treatment. (
    2.1
    )
  • Administer by subcutaneous injection. (
    2.2
    )
  • Recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. (
    2.2
    )

  2.1 Recommended Evaluation and Immunization Prior to Treatment Initiation

  • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA
    [see Warnings and Precautions (
    5.3
    )]
    .
  • Consider completion of all age appropriate immunizations according to current immunization guidelines.
    [see Warnings and Precautions (
    5.4
    )]

  2.2 Dosage

  ILUMYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

  2.3 Important Administration Instructions

  ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each prefilled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

  2.4 Preparation and Administration of ILUMYA

  Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes.

  Follow the instructions on the ILUMYA carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.

  Inspect ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.

  Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Also, do not inject into scars, stretch marks, or blood vessels.

  

  • While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
  • Inject ILUMYA subcutaneously as recommended
    [see
    Dosage and Administration (2.3)
    ]
    .
  • Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
  • Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safety lock will draw the needle inside the needle guard.

  

  • Discard any unused portion. Dispose of used syringe.

  

  

  

  )
• Administer by subcutaneous injection. (
  2 DOSAGE AND ADMINISTRATION

  • See the full prescribing information for recommended evaluations and immunizations prior to treatment. (
    2.1
    )
  • Administer by subcutaneous injection. (
    2.2
    )
  • Recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. (
    2.2
    )

  2.1 Recommended Evaluation and Immunization Prior to Treatment Initiation

  • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA
    [see Warnings and Precautions (
    5.3
    )]
    .
  • Consider completion of all age appropriate immunizations according to current immunization guidelines.
    [see Warnings and Precautions (
    5.4
    )]

  2.2 Dosage

  ILUMYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

  2.3 Important Administration Instructions

  ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each prefilled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

  2.4 Preparation and Administration of ILUMYA

  Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes.

  Follow the instructions on the ILUMYA carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.

  Inspect ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.

  Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Also, do not inject into scars, stretch marks, or blood vessels.

  

  • While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
  • Inject ILUMYA subcutaneously as recommended
    [see
    Dosage and Administration (2.3)
    ]
    .
  • Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
  • Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safety lock will draw the needle inside the needle guard.

  

  • Discard any unused portion. Dispose of used syringe.

  

  

  

  )
• Recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. (
  2 DOSAGE AND ADMINISTRATION

  • See the full prescribing information for recommended evaluations and immunizations prior to treatment. (
    2.1
    )
  • Administer by subcutaneous injection. (
    2.2
    )
  • Recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. (
    2.2
    )

  2.1 Recommended Evaluation and Immunization Prior to Treatment Initiation

  • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA
    [see Warnings and Precautions (
    5.3
    )]
    .
  • Consider completion of all age appropriate immunizations according to current immunization guidelines.
    [see Warnings and Precautions (
    5.4
    )]

  2.2 Dosage

  ILUMYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

  2.3 Important Administration Instructions

  ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each prefilled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

  2.4 Preparation and Administration of ILUMYA

  Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes.

  Follow the instructions on the ILUMYA carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.

  Inspect ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.

  Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Also, do not inject into scars, stretch marks, or blood vessels.

  

  • While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
  • Inject ILUMYA subcutaneously as recommended
    [see
    Dosage and Administration (2.3)
    ]
    .
  • Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
  • Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safety lock will draw the needle inside the needle guard.

  

  • Discard any unused portion. Dispose of used syringe.

  

  

  

  )

Injection: 100 mg/mL solution in a single-dose prefilled syringe. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution.

There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while being treated with or who are exposed to ILUMYA during pregnancy. These patients should be encouraged to enroll in this registry by calling MotherToBaby a service of the Organization of Teratology Information Specialists (OTIS) at 1-866-626-6847 or by visiting the website https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn.

Limited available data with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations).  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, an increase in neonatal death was observed at 59 times the MRHD

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.

Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ILUMYA may be present in infants exposed

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 (22 days from parturition). No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison). 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 (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times the MRHD based on AUC comparison). The clinical significance of these nonclinical findings is unknown. No tildrakizumab-related adverse effects were noted in the remaining infants from birth through 6 months of age.

• Hypersensitivity:
  If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. (
  5.1 Hypersensitivity

  Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy

  [see

  Adverse Reactions (6.1)

  ].
  )
• Infections
  : ILUMYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, consider discontinuing ILUMYA until the infection resolves. (
  5.2 Infections

  ILUMYA may increase the risk of infection. Although infections were more common in the ILUMYA group (23%), the difference in frequency of infections between the ILUMYA group and the placebo group (22%) was less than 1% during the placebo-controlled period. However, subjects with active infections or a history of recurrent infections were not included in clinical trials. Upper respiratory infections occurred more frequently in the ILUMYA group than in the placebo group

  [see

  Adverse Reactions (6.1)

  ]

  .

  The rates of serious infections for the ILUMYA group and the placebo group were ≤0.3%. Treatment with ILUMYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

  In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves

  [see

  Adverse Reactions (6.1)

  ]

  .
  )
• Pretreatment Evaluation for Tuberculosis (TB):
  Evaluate for TB prior to initiating treatment. (
  5.3 Pretreatment Evaluation for Tuberculosis

  Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Initiate treatment of latent TB prior to administering ILUMYA. In clinical trials, of 55 subjects with latent TB who were concurrently treated with ILUMYA and appropriate TB prophylaxis, no subjects developed active TB (during the mean follow-up of 56.5 weeks). One other subject developed TB while receiving ILUMYA. Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Do not administer ILUMYA to patients with active TB infection.
  )
• Immunizations
  : Avoid use of live vaccines. (
  5.4 Immunizations

  Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with ILUMYA. No data are available on the response to live or inactive vaccines.
  )