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Eli Lilly and Company (Ireland) Limited

Dunderrow, Kinsale, Co. Cork, P17 NY71, Ireland
Telephone: +353 1 661 4377
WWW: http://www.lilly.ie
Medical Information Direct Line: +44 (0)1256 315 000
Summary of Product Characteristics last updated on medicines.ie: 11/01/2018
SPC Taltz 80 mg solution for injection

When a pharmaceutical company changes an SPC or PIL, 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 11/01/2018 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   08-Dec-2017
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 19/10/2016 and displayed until 11/01/2018
Reasons for adding or 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
Date of revision of text on the SPC:   12-Oct-2016
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 06/06/2016 and displayed until 19/10/2016
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Ixekizumab