Taltz 80 mg solution for injection in pre-filled pen

  • Name:

    Taltz 80 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Ixekizumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/01/18

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Summary of Product Characteristics last updated on medicines.ie: 20/8/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 August 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.5             Interaction with other medicinal products and other forms of interaction

 

In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated.

 

Cytochrome P450 Substrates

 

Results from a drug-drug interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with drugs metabolized by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these drugs.

No formal in vivo drug-drug interaction studies have been conducted. A role for IL‑17 in the regulation of CYP450 enzymes has not been reported. The formation of some CYP450 enzymes is, however, suppressed by increased levels of cytokines during chronic inflammation. Thus, anti‑inflammatory treatments, such as with the IL-17A inhibitor ixekizumab, may result in normalisation of CYP450 levels with accompanying lower exposure of CYP450-metabolised co-medications. Therefore, a clinically relevant effect on CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin), cannot be excluded. On initiation of ixekizumab therapy in patients being treated with these types of medicinal products, therapeutic monitoring should be considered.

 

4.8             Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie, or United Kingdom: Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

5.1             Pharmacodynamic properties

 

….

 

Postmarketing Phase 4, direct comparative study

Efficacy and safety of Taltz was investigated in a multicenter, randomized, open-label, rater-blinded, parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD). Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12, BSA≥10 and sPGA≥3).

Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and PASI 100 response at Week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 15.8%]). Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [-4.3%; 12.1%] ; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and superiority on PASI 100 at Week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were the major secondary endpoints in the study.

 

Figure 3: Primary Endpoint (Simultaneous ACR 50 & PASI 100) and Major Secondary Endpoints (ACR 50; PASI 100) Response Rates Week 0 – 24 [ITT population, NRI]**

*GRAPH*

 

** Taltz 160 mg Week 0, then 80 mg every 2 weeks to Week 12 and every 4 weeks thereafter for patients with moderate to severe plaque psoriasis or 160 mg Week 0, then 80 mg every 4 week for other patients, ADA 80 mg Week 0, then 40 mg every 2 weeks from Week 1 for patients with moderate to severe plaque psoriasis or 40 mg Week 0, then 40 mg every 2 weeks for other patients.

Significance level only provided for endpoint that was pre-defined and multiplicity tested.

 

10.          DATE OF REVISION OF THE TEXT

 

24 May 201818 July 2019

 

 

TA6MTA7M

Updated on 29 August 2018 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 24 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

5.1          Pharmacodynamic properties

 […]

Efficacy in Genital Psoriasis

[...]

            Table 7     Efficacy Results at Week 12 in Adults with Genital Psoriasis in Trial IXORA-Q; NRI a

            [...]

 Also changes to table references in text where applicable.

 

10.     DATE OF REVISION OF THE TEXT

           19 April 2018 24 May 2018

                                                                                                                                               TA5MTA6M

Updated on 29 May 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Added, deleted, summary of changes or formatting

 

4.2          Posology and method of administration

The solution/the syringe/pen must not be shaken.

 

5.1          Pharmacodynamic properties

Patients randomised to Taltz who were sPGA (0,1) responders (static Physicians Global Assessment) at […].

In all three studies, […] PASI 75 response (Psoriasis Area and Severity Index) and […]

 

Postmarketing Phase 3b, direct comparative study
Efficacy and safety of ixekizumab was also investigated in a double-blind study compared to ustekinumab with ixekizumab being superior on the primary study objective (PASI 90 response at week 12, Table 6). Onset of response was superior on PASI 75 as early as week 2 (p < 0.001) and on PASI 90 and PASI 100 by week 4 (p < 0.001). Superiority of ixekizumab versus ustekinumab was also demonstrated in the subgroups stratified by weight.

 

Table 6.           PASI-Response Rates from comparative study ixekizumab versus ustekinumab

 

[Addition of Table]

 

                        Table 76

 

                                                Minimal Disease Activity (MDA) n (%)

 

Table 87

 

SD = standard deviation.

 

Changes to table references in text where applicable.

 

10.     DATE OF REVISION OF THE TEXT

18 January 2018 19 April 2018

TA45M

Updated on 25 January 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Added (underline) deleted (strikethrough), summary of changes green

 

4.       CLINICAL PARTICULARS

 

4.1          Therapeutic indications   

 

Plaque psoriasis

 

Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

 

Psoriatic arthritis

 

Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1).

 

4.2          Posology and method of administration

 

Taltz is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Taltz is indicatedpsoriasis.

 

Posology

Plaque psoriasis

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 maintenance dosing of 80 mg (one injection) every 4 weeks.

 

Psoriatic arthritis

The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) 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.

 

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.

 

Paediatric population

The safety and efficacy of Taltz in children and adolescents aged 6 to 18 years in the treatment of moderate to severe plaque psoriasis have not yet been established. No data are available.

 

There is no relevant use of Taltz in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.

 

The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been established. No data are available. There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis.

 

4.5          Interaction with other medicinal products and other forms of interaction

 

In plaque psoriasis studies, Tthe safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated.

 

No interaction was seen when Taltz was administered concomitantly with methotrexate (MTX) and/or corticosteroids in patients with psoriatic arthritis.

 

4.8          Undesirable effects

 

Updated throughout including re-formatted table to include PsA and additional data including addition of Herpes simplex (mucocutaneous), rash and eczema.

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

                        Updated throughout to include PsA data.

 

5.2          Pharmacokinetic properties

 

                        Updated throughout to include PsA data.

 

6.       PHARMACEUTICAL PARTICULARS

 

6.6          Special precautions for disposal and other handling

 

Instructions for use

 

Pre-filled syringe

The instructions for using the syringe, included with the package leaflet, must be followed carefully.

The pre-filled syringe is for single use only.

Taltz should not be used if particles appear or if the solution is cloudy and/or distinctly brown.

Taltz that has been frozen must not be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

          Date of first authorisation: 25 April 2016

 

 

10.     DATE OF REVISION OF THE TEXT

 

          18 January 2018

 

 

 

                                                                                                                                                        TA4M

Updated on 25 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 January 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 January 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 January 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes

 

Added (underline) deleted (strikethrough)

 

 

TALTZ® (ixekizumab)

 

1.         NAME OF THE MEDICINAL PRODUCT

 

Taltz]80 mg solution for injection in pre-filled syringe.

Taltz 80 mg solution for injection in pre-filled pen.

 

4.4          Special warnings and precautions for use

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.

 

Tabulated list of adverse reactions

ADRs from clinical studies and postmarketing reports (Table 1) are listed by MedDRA system organ class.

 

 

Table 1.            List of adverse reactions in clinical studiesa and postmarketing reports

 

System Organ Class

Taltz

Placebo

Q4W

(N = 1161)

n (%)

Q2W

(N = 1167)

n (%)

 

(N = 791)

n (%)

Infections and infestations

Very Common

Upper respiratory tract infectionb

155 (13.4)

163 (14.0)

101 (12.8)

Common

Tinea infection

10 (0.9)

17 (1.5)

1 (0.1)

Uncommon

 

Influenza

10 (0.9)

8 (0.7)

0

Rhinitis

10 (0.9)

9 (0.8)

0

Oral candidiasisc

2 (0.2)

9 (0.8)

0

Conjunctivitis

1 (0.1)

8 (0.7)

3 (0.4)

Cellulitisd

10 (0.9)

9 (0.8)

2 (0.3)

Blood and lymphatic system disorders

Uncommon

Neutropeniaf

3 (0.3)

6 (0.5)

1 (0.1)

Thrombocytopeniaf

2 (0.2)

2 (0.2)

0

Immune system disordersg

Rare

Anaphylaxisg

N/A

N/A

N/A

Respiratory, thoracic, and mediastinal disorders

Common

Oropharyngeal pain

20 (1.7)

16 (1.4)

4 (0.5)

Gastrointestinal disorders

Common

Nausea

15 (1.3)

23 (2.0)

5 (0.6)

Skin and subcutaneous tissue disorders

Uncommon

Urticaria

6 (0.5)

10 (0.9)

0

General disorders and administration site conditions

Very Common

Injection site reactions e

150 (12.9)

196 (16.8)

26 (3.3)

a Placebo-controlled clinical studies (phase III) in moderate to severe plaque psoriasis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 12 weeks of treatment duration

b Upper respiratory tract infection includes nasopharyngitis and upper respiratory tract infection

c Oral candidiasis defined as events with the preferred terms oral candidiasis and oral fungal infection

d Cellulitis includes staphylococcal and external ear cellulitis, and erysipelas

e 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)

f Based on reported adverse events

g Based on postmarketing reports

 

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie, or United Kingdom: Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

 

10.       DATE OF REVISION OF THE TEXT

 

                08th December 2017 12 October 2017

TALTZ] (Ixekizumab) is a trademark of Eli Lilly and Company TA2MTA3M

Updated on 19 October 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Added (bold) deleted (strikethrough)

 

5.1          Pharmacodynamic properties

 

Table 3. Efficacy results at Week 12 in UNCOVER-2

 

Endpoints

Number of patients (%)

Difference from Placebo in Response Rate (95% CI)

Placebo
(N = 168)

Taltz

80 mg Q4W

(N = 347)

Taltz
80 mg Q2W
(N = 351)

Etanercept
50 mg twice weekly
(N = 358)

Taltz

80 mg Q4W

 

Taltz
80 mg Q2W

sPGA of “0” (clear) or “1” (minimal)

4 (2.4)

253 (72.9)a

292 (83.2)a

129 (36.0)

70.5 (65.3, 75.7)

80.8 (76.3, 85.4)

sPGA of “0” (clear)

1 (0.6)

112 (32.3)a,b

147 (41.9)a,b

21 (5.9)c

31.7 (26.6, 36.7)

41.3 (36.0, 46.6)

PASI 75

4 (2.4)

269 (77.5)a,b

315 (89.7)a,b

149 (41.6)a

75.1 (70.2, 80.1)

87.4 (83.4, 91.3)

PASI 90

1 (0.6)

207 (59.7)a,b

248 (70.7)a,b

67 (18.7)a

59.1 (53.8, 64.4)

70.1 (65.2, 75.0)

PASI 100

1 (0.6)

107 (30.8)a,b

142 (40.5)a,b

19 (5.3)c

30.2 (25.2, 35.2)

39.9 (34.6, 45.1)

Itch NRS reduction ≥ 4d

19 (14.1)

225 (76.8)a,b

258 (85.1)a,b

177 (57.8)a

62.7 (55.1, 70.3)

71.1 (64.0, 78.2)

Abbreviations: N = number of patients in the intent-to-treat population

Note: patients with missing data were counted as non-responders.

a p < 0.001 compared with placebo

b p < 0.001 compared with etanercept

c p < 0.01 compared with placebo

d Patients with Itch NRS > = 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306

 

 

6.4          Special precautions for storage

 

Store in a refrigerator (2 ºC – 8 ºC).

Do not freeze.

Store in the original package in order to protect from light.

 

Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30 °C.

 

 

10.       DATE OF REVISION OF THE TEXT

 

                25 April 201612 October 2016

 

 

]TALTZ (Ixekizumab) is a trademark of Eli Lilly and Company.                                                           TA12M

Updated on 19 October 2016 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 6 June 2016 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 3 June 2016 PIL

Reasons for updating

  • New PIL for new product