TALTZ

TALTZ- ixekizumab injection, solution
Eli Lilly and Company

1 INDICATIONS AND USAGE

1.1 Plaque Psoriasis

TALTZ^® is indicated 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.

1.2 Psoriatic Arthritis

TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis.

1.3 Ankylosing Spondylitis

TALTZ is indicated for the treatment of adult patients with active ankylosing spondylitis.

1.4 Non-radiographic Axial Spondyloarthritis

TALTZ is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

2 DOSAGE AND ADMINISTRATION

​2.1 Testing and Procedures Prior to Treatment Initiation

​Perform the following evaluations prior to TALTZ initiation:

• Evaluate patients for tuberculosis (TB) infection. TALTZ initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of TALTZ [see Warnings and Precautions (5.2)].
• ​Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with TALTZ [see Warnings and Precautions (5.5)].

2.2 Adult Plaque Psoriasis

TALTZ is administered by subcutaneous injection. The recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

2.3 Pediatric Plaque Psoriasis

TALTZ is administered by subcutaneous injection every 4 weeks (Q4W). The recommended dosage in pediatric patients from 6 to less than 18 years of age with moderate-to-severe plaque psoriasis is based on the following weight categories.

Table 1: Recommended Dosing and Administration for Pediatric Patients

Pediatric Patient’s Weight	Starting Dose (Week 0)	Dose every 4 weeks (Q4W) Thereafter
Greater than 50 kg	160 mg (two 80 mg injections)	80 mg
25 to 50 kg	80 mg	40 mg
Less than 25 kg	40 mg	20 mg

2.4 Psoriatic Arthritis

The recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for adult plaque psoriasis [see Dosage and Administration (2.2)].

TALTZ may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

2.5 Ankylosing Spondylitis

The recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

2.6 Non-radiographic Axial Spondyloarthritis

The recommended dosage is 80 mg by subcutaneous injection every 4 weeks.

2.7 Important Administration Instructions

TALTZ is intended for use under the guidance and supervision of a physician. Adult patients may self-inject or caregivers may give injections of TALTZ 80 mg after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Caregivers may give injections of TALTZ 80 mg to pediatric patients weighing more than 50 kg using the autoinjector or prefilled syringe after training and demonstration of proper subcutaneous injection technique.

The TALTZ “Instructions for Use” contains more detailed instructions on the preparation and administration of TALTZ [see Instructions for Use].

Before injection, remove TALTZ autoinjector or TALTZ prefilled syringe from the refrigerator and allow TALTZ to reach room temperature (30 minutes) without removing the needle cap. Inspect TALTZ visually for particulate matter and discoloration prior to administration. TALTZ is a clear and colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy (other than clear and colorless to slightly yellow).

Administer each injection at a different anatomic location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of TALTZ in the upper, outer arm may be performed by a caregiver or healthcare provider [see Instructions for Use].

TALTZ does not contain preservatives, therefore discard any unused product.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Pediatric Patients Weighing 50 kg or Less

TALTZ doses of 20 mg or 40 mg [see Dosage and Administration (2.3)] must be prepared and administered by a qualified healthcare professional. Use only the commercial TALTZ 80 mg/1 mL prefilled syringe when preparing the prescribed 20 mg and 40 mg pediatric dose [see Instructions for Use].

1. Gather the following necessary supplies for preparation:
   • 0.5 mL or 1 mL disposable syringe
   • Sterile needle for withdrawal
   • 27-gauge sterile needle for administration
   • Sterile, clear glass vial.
2. Expel the entire contents of the prefilled syringe into the sterile vial. DO NOT shake or swirl the vial. No other medications should be added to solutions containing TALTZ.
3. Using the 0.5 mL or 1 mL disposable syringe and sterile needle, withdraw the prescribed dose from the vial (0.25 mL for 20 mg; 0.5 mL for 40 mg).
4. Remove the needle from the syringe and replace it with a 27-gauge needle prior to administering TALTZ to the patient.

Storage

If necessary, the prepared TALTZ may be stored at room temperature for up to 4 hours from first puncturing the sterile vial.

3 DOSAGE FORMS AND STRENGTHS

TALTZ is a clear and colorless to slightly yellow solution available as:

Autoinjector

• Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled autoinjector

Prefilled Syringe

• Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled syringe

4 CONTRAINDICATIONS

TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS

5.1 Infections

TALTZ may increase the risk of infection. In clinical trials in adult patients with plaque psoriasis, the TALTZ group had a higher rate of infections than the placebo group (27% vs. 23%). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the TALTZ group than in the placebo group. A similar increase in risk of infection was seen in placebo-controlled trials in patients with pediatric psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis [see Adverse Reactions (6.1)].

Instruct patients treated with TALTZ to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TALTZ until the infection resolves.