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Taltz is a brand name for Ixekizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least…
Verbatim from this product's EMA label. Tap a section to expand.
This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated. Posology Plaque psoriasis in adults The recommended dose is 160 mg by subcutaneous injection at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg every 4 weeks (Q4W).
1). Available data do not support a posology below a body weight of 25 kg. The recommended dose given by subcutaneous injection in children is based on the following weight categories: Children’s body weight Recommended starting dose (week 0) Recommended 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 For children prescribed 80 mg, Taltz can be used directly from the pre-filled syringe.
If the 40 mg pre-filled syringe is not available, doses less than 80 mg must be prepared by a healthcare professional. 6. 4 Taltz is not recommended for use in children with a body weight below 25 kg. Paediatric body weights must be recorded and regularly re-checked prior to dosing.
Psoriatic arthritis The recommended dose is 160 mg by subcutaneous injection at week 0, followed by 80 mg every 4 weeks thereafter. For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
1 for further information). 1). Available data do not support a posology below a body weight of 25 kg. The recommended dose given by subcutaneous injection in children is based on the following weight categories: Children’s body weight Recommended starting dose (week 0) Recommended 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 For children prescribed 80 mg, Taltz can be used directly from the pre-filled syringe.
If the 40 mg pre-filled syringe is not available, doses less than 80 mg must be prepared by a healthcare professional. 6. Taltz is not recommended for use in children with a body weight below 25 kg. Paediatric body weights must be recorded and regularly re checked prior to dosing.
For all indications (plaque psoriasis in adults and children, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic arthritis including juvenile psoriatic arthritis and enthesitis-related arthritis) consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment.
4 %) (most frequently nasopharyngitis). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).
A total of 8 956 patients have been treated with Taltz in blinded and open-label clinical studies in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and other autoimmune conditions. Of these, 6 385 patients were exposed to Taltz for at least one year, cumulatively representing 19 833 adult patient years of exposure and 196 children cumulatively representing 343 patient years of exposure.
8 Table 1. List of adverse reactions in clinical studies and post-marketing reports System organ class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infection Common Tinea infection, Herpes simplex (mucocutaneous) Uncommon Influenza, Rhinitis, Oral candidiasis, Conjunctivitis, Cellulitis Rare Oesophageal candidiasis Blood and lymphatic system disorders Uncommon Neutropenia, Thrombocytopenia Immune system disorders Uncommon Angioedema Rare Anaphylaxis Respiratory, thoracic and mediastinal disorders Common Oropharyngeal pain Gastrointestinal disorders Common Nausea Uncommon Inflammatory bowel disease Skin and subcutaneous disorders Uncommon Urticaria, Rash, Eczema Dyshidrotic eczema Rare Exfoliative dermatitis General disorders and administration site conditions Very common Injection site reactionsa a See section description of selected adverse reactions Description of selected adverse reactions Injection site reactions The most frequent injection site reactions observed were erythema and pain.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). Taltz should be used with caution in patients with clinically important chronic infection or a history of recurrent infection.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If an infection develops, patients should be carefully monitored and Taltz discontinued if the patient is not responding to standard therapy or if the infection becomes serious.
Taltz should not be resumed until the infection resolves. Taltz must not be given to patients with active tuberculosis (TB). Anti-TB therapy prior to initiation of Taltz in patients with latent TB should be considered. 6 Hypersensitivity Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported.
If a serious hypersensitivity reaction occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated. 8). Ixekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, ixekizumab should be discontinued and appropriate medical management should be initiated.
Immunisations Taltz should not be used with live vaccines. 1). Excipients with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 40 mg dose and per 80 mg dose, that is to say essentially “sodium-free”.
30 mg/mL. 30 mg/mL. . Polysorbates may cause allergic reactions.
1. g. 4).
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Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks. 2). There is limited information in subjects aged ≥ 75 years. Renal or hepatic impairment Taltz has not been studied in these patient populations.
No dose recommendations can be made. 5 Paediatric population Paediatric plaque psoriasis and juvenile idiopathic arthritis (juvenile psoriatic arthritis or enthesitis- related arthritis) (below a body weight of 25 kg and below the age of 6 years) There is no relevant use of Taltz in children below a body weight of 25 kg and below the age of 6 years in the treatment of moderate to severe plaque psoriasis and juvenile idiopathic arthritis including juvenile psoriatic arthritis or enthesitis-related arthritis.
Method of administration Subcutaneous use. Taltz is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The solution/the syringe must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Taltz if a healthcare professional determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Comprehensive instructions for administration are given in the package leaflet and the user manual.
If the 40 mg pre-filled syringe is not available, doses less than 80 mg which require dose preparation should only be administered by a healthcare professional. 6.
These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of Taltz. In the adult plaque psoriasis studies, injection site reactions were more common in subjects with a body weight < 60 kg compared with the group with a body weight ≥ 60 kg (25 % vs.
14 % for the combined Q2W and Q4W groups). In the psoriatic arthritis studies, injection site reactions were more common in subjects with a body weight < 100 kg compared with the group with a body weight ≥ 100 kg (24 % vs. 13 % for the combined Q2W and Q4W groups).
In the axial spondyloarthritis studies, injection site reactions were similar in subjects with a body weight < 100 kg compared with the group with a body weight ≥ 100 kg (14 % vs. 9 % for the combined Q2W and Q4W groups). The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in either the plaque psoriasis, the psoriatic arthritis or the axial spondyloarthritis studies.
The results described above are obtained with the original formulation of Taltz. In a single-blinded, randomised cross-over study in 45 healthy subjects comparing the original formulation with the revised, citrate-free formulation, statistically significantly lower Visual Analogue Scale (VAS) pain scores were obtained with the citrate-free vs.
47). 9 % of patients treated with placebo. The majority of infections were non-serious and mild to moderate in severity, most of which did not necessitate treatment discontinuation. 4). 9 per 100 patient years). 5 per 100 patient years).
Infection rates observed in psoriatic arthritis and axial spondyloarthritis clinical studies were similar to those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Laboratory assessment of neutropenia and thrombocytopenia In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia. In most cases, the blood neutrophil count was ≥1 000 cells/mm3. Such levels of neutropenia may persist, fluctuate or be transient.
1% of patients receiving Taltz developed a neutrophil count <1 000 cells/mm3. In general, neutropenia did not require discontinuation of Taltz. 3% of patients exposed to Taltz had a shift from a normal baseline platelet value to <150 000 platelet cells/mm3 to ≥75 000 cells/mm3.
Thrombocytopenia may persist, fluctuate or be transient. The frequency of neutropenia and thrombocytopenia in psoriatic arthritis and axial spondyloarthritis clinical studies is similar to that observed in the plaque psoriasis studies.
Immunogenicity Approximately 9-17% of adult plaque psoriasis patients treated with Taltz at the recommended dosing regimen developed anti-drug antibodies, the majority of which were low titres and not associated with reduced clinical response up to 60 weeks of treatment.
However, approximately 1% of patients treated with Taltz had confirmed […]