Usual Adult Dose for Plaque Psoriasis

160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks

Comments:

• Evaluate patients for tuberculosis (TB); this drug is not recommended in patients with active TB.
• All age-appropriate immunizations should be completed according to current immunization guidelines prior to starting this drug.
• For each dose, rotate the injection site to a different anatomic location.

Use: For the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Usual Adult Dose for Psoriatic Arthritis

160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks

Comments:

• Evaluate patients for TB; this drug is not recommended in patients with active TB.
• All age-appropriate immunizations should be completed according to current immunization guidelines prior to starting this drug.
• For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis.
• This drug may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
• For each dose, rotate the injection site to a different anatomic location.

Use: For the treatment of adult patients with active psoriatic arthritis

Usual Adult Dose for Ankylosing Spondylitis

160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks

Comments:

• Evaluate patients for TB; this drug is not recommended in patients with active TB.
• All age-appropriate immunizations should be completed according to current immunization guidelines prior to starting this drug.
• cDMARDs (e.g., sulfasalazine), corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be used during therapy with this drug.
• For each dose, rotate the injection site to a different anatomic location.

Use: For the treatment of adult patients with active ankylosing spondylitis

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

80 mg subcutaneously every 4 weeks

Comments:

• Evaluate patients for TB; this drug is not recommended in patients with active TB.
• All age-appropriate immunizations should be completed according to current immunization guidelines prior to starting this drug.
• For each dose, rotate the injection site to a different anatomic location.

Use: For the treatment of adult patients with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Usual Pediatric Dose for Plaque Psoriasis

6 to less than 18 years:

• Less than 25 kg: 40 mg subcutaneously at Week 0, followed by 20 mg every 4 weeks
• 25 to less than 50 kg: 80 mg subcutaneously at Week 0, followed by 40 mg every 4 weeks
• Greater than 50 kg: 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks

Comments:

• Evaluate patients for TB; this drug is not recommended in patients with active TB.
• All age-appropriate immunizations should be completed according to current immunization guidelines prior to starting this drug.
• A qualified healthcare professional must prepare and administer doses of 20 or 40 mg.
• Before administering this drug to pediatric patients weighing 50 kg or less, remove the needle from the syringe and replace it with a 27-gauge needle.
• For each dose, rotate the injection site to a different anatomic location.

Use: For the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 6 years with plaque psoriasis.
Safety and efficacy have not been established in patients younger than 18 years with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advise:

• Administer under the supervision and guidance of a physician.
• After training, adult patients may self-inject, or caregivers may give injections of this drug to patients.
• A qualified healthcare professional must prepare and administer doses of 20 or 40 mg.
• Before administering this drug to pediatric patients weighing 50 kg or less, remove the needle from the syringe and replace it with a 27-gauge needle.

Storage requirements:

• Protect from light until use.
• Store refrigerated at 2C to 8C (36F to 46F).
• Do not freeze or shake. Do not use this drug if it has been frozen.
• Discard the single-dose autoinjector or syringe after use, in a puncture-resistant container.
• Not made with natural rubber latex.
• After first puncturing the sterile vial, this drug can be stored at room temperature for up to 4 hours.
• If needed, the drug may be stored in the original carton at room temperature up to 30C (86F) for up to 5 days. If the drug is not used within 5 days, it should be discarded.

Reconstitution/preparation techniques:
Preparation for Use of Autoinjector and Prefilled Syringe:

• Before injection, remove autoinjector or prefilled syringe from the refrigerator and allow it to reach room temperature (30 minutes) without removing the needle cap.
• Inspect visually for particulate matter and discoloration prior to administration. The solution should be clear and colorless to slightly yellow.
• Do not use if the liquid contains visible particles, is discolored or cloudy (other than clear and colorless to slightly yellow).
• The product does not contain preservatives, therefore discard any unused product remaining in the autoinjector or prefilled syringe.
• Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg of drug, according to the directions provided in the manufacturer product information.

General:

• There are 2 delivery systems (i.e., autoinjector and prefilled syringe). The instructions for use of each system contain more detailed instructions on the preparation and administration.
• This drug is intended for use under the guidance and supervision of a physician.
• Patients may self-inject after training in subcutaneous injection technique using the autoinjector or prefilled syringe.
• Administer each injection at a different anatomic location (such as upper arms, thighs, or any quadrant of the abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
• Administration in the upper, outer arm may be performed by a caregiver or healthcare provider.
• If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled intervals.

Monitoring:
Infection: Tuberculosis

Patient advice:

• Read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
• This drug may lower the ability of the patient's immune system to fight infections.
• Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection.
• Seek immediate medical attention if any symptoms of serious hypersensitivity reactions are experienced.
• A pregnancy exposure registry is available.

Frequently asked questions

• What are the new drugs for the treatment of plaque psoriasis?
• How long before Taltz works?
• Can I drink alcohol with Taltz?
• Is weight gain a side effect of Taltz?
• How does Taltz work?