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TALTZ is a brand name for Ixekizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Plaque Psoriasis TALTZ (ixekizumab) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis who have responded…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • TALTZ is intended for use under the guidance and supervision of a health care professional. • Adult patients may self-inject after training in subcutaneous injection technique using the prefilled autoinjector or prefilled syringe.
TALTZ (ixekizumab) Page 5 of 73 • If a physician determines that it is appropriate, pediatric patients weighing more than 50 kg may self-inject 80 mg of TALTZ using the autoinjector or prefilled syringe after training and demonstration of proper subcutaneous injection technique; caregiver supervision is recommended.
2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment Plaque psoriasis • Adult The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg (one injection) every 4 weeks.
• Pediatric TALTZ is administered by subcutaneous injection every 4 weeks (Q4W). The recommended dose 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).
4 Administration, Pediatric psoriasis for specific instructions on the preparation and administration of this dose. Table 1 - Recommended Dosing for Pediatric Patients with Moderate-to-Severe Plaque Psoriasis 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 Psoriatic arthritis • The recommended dose 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 plaque psoriasis (see 4 DOSAGE AND ADMINISTRATION, Plaque psoriasis). For psoriatic arthritis patients with coexistent mild plaque psoriasis, use the dosing regimen for psoriatic arthritis: 160 mg at Week 0, followed by 80 mg every 4 weeks (see 14 CLINICAL TRIALS).
Ankylosing spondylitis • The recommended dose is 80 mg by subcutaneous injection every 4 weeks. Limited data suggests that some TNF inhibitor experienced patients with ankylosing spondylitis may benefit from a 160 mg starting dose. , sulfasalazine), corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with ixekizumab.
TALTZ should be used with caution in patients with clinically important chronic or active infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection or is not responding to standard therapy, the patient should be closely monitored and TALTZ should not be administered until the infection resolves.
TALTZ should not be given to patients with active tuberculosis (TB). Prior to initiating treatment with TALTZ, patients should be evaluated for TB infection. Treatment of latent TB infection should be initiated prior to administering TALTZ.
Anti-tuberculosis therapy should also be considered prior to initiation of TALTZ in patients with past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving TALTZ should be monitored closely for signs and symptoms of active TB during and after treatment.
Gastrointestinal • Inflammatory Bowel Disease Cases of new or exacerbations of inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, have been reported in TALTZ-treated patients. TALTZ is not recommended in patients with inflammatory bowel disease as patients treated with TALTZ may be at increased risk of inflammatory bowel disease.
Inflammatory bowel disease (in particular, Crohn’s disease) occurred more frequently in TALTZ-treated pediatric patients than adults. During TALTZ treatment, monitor patients closely for onset or exacerbation of pre-existing inflammatory bowel disease.
If a patient develops signs or symptoms of inflammatory bowel disease, discontinue TALTZ and initiate appropriate medical management. See 8 ADVERSE REACTIONS. TALTZ (ixekizumab) Page 9 of 73 Immune • Vaccination Prior to initiating therapy with TALTZ, consider completion of all age appropriate immunizations according to current immunization guidelines.
1 Dosing Considerations • TALTZ is intended for use under the guidance and supervision of a health care professional. • Adult patients may self-inject after training in subcutaneous injection technique using the prefilled autoinjector or prefilled syringe.
TALTZ (ixekizumab) Page 5 of 73 • If a physician determines that it is appropriate, pediatric patients weighing more than 50 kg may self-inject 80 mg of TALTZ using the autoinjector or prefilled syringe after training and demonstration of proper subcutaneous injection technique; caregiver supervision is recommended.
2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment Plaque psoriasis • Adult The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg (one injection) every 4 weeks.
• Pediatric TALTZ is administered by subcutaneous injection every 4 weeks (Q4W). The recommended dose 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).
4 Administration, Pediatric psoriasis for specific instructions on the preparation and administration of this dose. Table 1 - Recommended Dosing for Pediatric Patients with Moderate-to-Severe Plaque Psoriasis 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 Psoriatic arthritis • The recommended dose 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 plaque psoriasis (see 4 DOSAGE AND ADMINISTRATION, Plaque psoriasis). For psoriatic arthritis patients with coexistent mild plaque psoriasis, use the dosing regimen for psoriatic arthritis: 160 mg at Week 0, followed by 80 mg every 4 weeks (see 14 CLINICAL TRIALS).
TALTZ is contraindicated in patients with known serious hypersensitivity to ixekizumab or to any of the excipients. For a complete listing of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. See 7 WARNINGS AND PRECAUTIONS.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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TALTZ (ixekizumab) Page 6 of 73 Non-radiographic axial spondyloarthritis • The recommended dose is 80 mg by subcutaneous injection every 4 weeks. , sulfasalazine), corticosteroids, non- steroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with ixekizumab.
Dosing Considerations for Special Populations • Renal impairment/Hepatic impairment TALTZ has not been studied specifically in these patient populations. 4 Administration There are two presentations for TALTZ (prefilled autoinjector and prefilled syringe).
See the TALTZ Instructions for Use for each presentation for more detailed instructions on the preparation and administration of TALTZ. Before injection, remove TALTZ prefilled 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 discolouration prior to administration. The TALTZ solution is clear and colourless to slightly yellow. Do not use if the liquid contains visible particles, is discoloured or cloudy. TALTZ does not contain preservatives therefore discard any unused product remaining in the prefilled autoinjector or prefilled syringe after injection.
2 Recommended Dose and Dosage Adjustment for additional instruction on preparing pediatric doses of 20 mg and 40 mg. TALTZ is for subcutaneous administration. 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. Instruct patients using the prefilled autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg of TALTZ, according to the directions provided in the Instructions for Use.
Pediatric psoriasis TALTZ doses of 20 mg or 40 mg 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.
1. 5 mL or 1 mL disposable syringe • Sterile needle for withdrawal • 27-gauge sterile needle for administration • Sterile, clear glass vial. TALTZ (ixekizumab) Page 7 of 73 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. 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, TALTZ may be stored in the sterile vial, at room temperature, for up to 4 hours from first puncturing the vial. Discard any unused TALTZ and the disposable syringe in a puncture-resistant container immediately following administration.
5 Missed Dose Patients who miss a dose of TALTZ should be advised to inject this missed dose as soon as […]
Patients treated with TALTZ should not receive live vaccines. See
Ankylosing spondylitis • The recommended dose is 80 mg by subcutaneous injection every 4 weeks. Limited data suggests that some TNF inhibitor experienced patients with ankylosing spondylitis may benefit from a 160 mg starting dose. , sulfasalazine), corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with ixekizumab.
TALTZ (ixekizumab) Page 6 of 73 Non-radiographic axial spondyloarthritis • The recommended dose is 80 mg by subcutaneous injection every 4 weeks. , sulfasalazine), corticosteroids, non- steroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with ixekizumab.
Dosing Considerations for Special Populations • Renal impairment/Hepatic impairment TALTZ has not been studied specifically in these patient populations. 4 Administration There are two presentations for TALTZ (prefilled autoinjector and prefilled syringe).
See the TALTZ Instructions for Use for each presentation for more detailed instructions on the preparation and administration of TALTZ. Before injection, remove TALTZ prefilled 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 discolouration prior to administration. The TALTZ solution is clear and colourless to slightly yellow. Do not use if the liquid contains visible particles, is discoloured or cloudy. TALTZ does not contain preservatives therefore discard any unused product remaining in the prefilled autoinjector or prefilled syringe after injection.
2 Recommended Dose and Dosage Adjustment for additional instruction on preparing pediatric doses of 20 mg and 40 mg. TALTZ is for subcutaneous administration. 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. Instruct patients using the prefilled autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg of TALTZ, according to the directions provided in the Instructions for Use.
Pediatric psoriasis TALTZ doses of 20 mg or 40 mg 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.
1. 5 mL or 1 mL disposable syringe • Sterile needle for withdrawal • 27-gauge sterile needle for administration • Sterile, clear glass vial. TALTZ (ixekizumab) Page 7 of 73 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. 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, TALTZ may be stored in the sterile vial, at room temperature, for up to 4 hours from first puncturing the vial. Discard any unused TALTZ and the disposable syringe in a puncture-resistant container immediately following administration.
5 Missed Dose Patients who miss a dose of TALTZ should be advised to inject […]