losis (TB) infection prior to initiating treatment with SKYRIZI [seeWarnings and Precautions (5.1)].
2.3 Important Administration Instructions
Administer SKYRIZI subcutaneously. Inject two separate 75 mg single-dose prefilled syringesfor the full 150 mg dose. Discard prefilled syringes after use. Do not reuse.
For each dose, administer the injections at different anatomic locations (such as thighs orabdomen), and not into areas where the skin is tender, bruised, erythematous, indurated oraffected by psoriasis. Administration of SKYRIZI in the upper, outer arm may only beperformed by a healthcare professional or caregiver.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the
regular scheduled time.
SKYRIZI is intended for use under the guidance and supervision of a healthcare professional.
Patients may self-inject SKYRIZI after training in subcutaneous injection technique. Provideproper training to patients and/or caregivers on the subcutaneous injection technique ofSKYRIZI. Instruct the patient that two separate 75 mg single-dose injections are required toachieve the 150 mg dose.
The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation andadministration of SKYRIZI [see Instructions for Use]. Instruct the patient to read theInstructions for Use before administration.
2.4 Preparation for Use of SKYRIZI Prefilled Syringes
Before injecting, patients may remove the carton from the refrigerator and allow to reach roomtemperature out of direct sunlight (15 to 30 minutes) without removing the prefilled syringesfrom the carton.
Visually inspect SKYRIZI for particulate。
Visually inspect SKYRIZI for particulate matter and discoloration prior to administration.
SKYRIZI is a colorless to slightly yellow and clear to slightly opalescent solution. It may containa few translucent to white particles. Do not use if the solution contains large particles or iscloudy or discolored.
3 DOSAGE FORMS AND STRENGTHS
Injection: 75 mg/0.83 mL solution in each single-dose prefilled syringe. SKYRIZI is a colorlessto slightly yellow and clear to slightly opalescent solution.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Infections
SKYRIZI may increase the risk of infections. In clinical studies, infections occurred in 22.1% ofthe SKYRIZI group compared to 14.7% of the placebo group through 16 weeks of treatment.
Upper respiratory tract infections and tinea infections occurred more frequently in the SKYRIZIgroup than in the placebo group. Subjects with known chronic or acute infections were notenrolled in clinical studies [see Adverse Reactions (6.1)].
The rate of serious infections for the SKYRIZI group and the placebo group was ≤ 0.4%.
Treatment with SKYRIZI should not be initiated in patients with any clinically important activeinfection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks andbenefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs orsymptoms of clinically important infection occur. If a patient develops such an infection or is notresponding to standard therapy, monitor the patient closely and do not administer SKYRIZI untilthe infection resolves.
5.2 Pre-treatment eva luation for Tuberculosis
eva luate patients for tuberculosis (TB) |
