Cymbalta ® (duloxetin)

För fullständig produktresumé för Cymbalta® se FASS.

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Cymbalta (duloxetine): Biverkningar

De vanligast rapporterade biverkningarna hos patienter som behandlats med Cymbalta var illamående, huvudvärk, muntorrhet, somnolens, och yrsel.

a. Summary of the safety profile

The most commonly reported adverse reactions in patients treated with Cymbalta were nausea, headache, dry mouth, somnolence and dizziness. However, the majority of common adverse reactions were mild to moderate; they usually started early in therapy, and most tended to subside even as therapy was continued.

b. Tabulated summary of adverse reactions

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.

Table 1: Adverse reactions

Frequency estimate: 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Very common

Common

Uncommon

Rare

Very Rare

Infections and infestations



Laryngitis



Immune system disorders




Anaphylactic reaction

Hyper-sensitivity disorder


Endocrine disorders




Hypo-thyroidism


Metabolism and nutrition disorders


Decreased appetite

Hyperglycaemia (reported especially in diabetic patients)

Dehydration Hyponatraemia SIADH6


Psychiatric disorders


Insomnia Agitation

Libido decreased Anxiety

Orgasm abnormal Abnormal dreams

Suicidal ideation5,7

Sleep disorder Bruxism Disorientation Apathy

Suicidal behaviour5,7 Mania Hallucinations Aggression and anger4


Nervous system disorders

Headache Somnolence

Dizziness Lethargy Tremor Paraesthesia

Myoclonus Akathisia7 Nervousness Disturbance in attention Dysgeusia

Dyskinesia Restless legs syndrome

Poor quality sleep

Serotonin syndrome6

Convulsion1 Psychomotor restlessness6 Extra-pyramidal

Symptoms6


Eye disorders


Blurred vision

Mydriasis

Visual impairment

Glaucoma


Ear and labyrinth disorders


Tinnitus1

Vertigo Ear pain



Cardiac disorders


Palpitations

Tachycardia Supra-ventricular

arrhythmia, mainly atrial fibrillation



Vascular disorders


Blood pressure increase3 Flushing

Syncope2

Hypertension3,7

Orthostatic hypotension2 Peripheral coldness

Hypertensive crisis3,6


Respiratory, thoracic and mediastinal disorders


Yawning

Throat tightness Epistaxis

Interstitial lung disease10

Eosinophilic pneumonia6



Gastrointestinal disorders

Nausea Dry mouth

Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence

Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia

Stomatitis Haematochezia Breath odour Microscopic colitis9


Hepato-biliary disorders



Hepatitis3

Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury

Hepatic failure6 Jaundice6


Skin and subcutaneous tissue disorders


Sweating increased Rash

Night sweats Urticaria Dermatitis contact Cold sweat

Photo-sensitivity reactions

Increased tendency to bruise

Stevens-Johnson Syndrome6 Angio-neurotic oedema6

Cutaneous vasculitis

Musculoskeletal and connective tissue disorders


Musculo-skeletal pain

Muscle spasm

Muscle tightness Muscle twitching

Trismus


Renal and urinary disorders


Dysuria Pollakiuria

Urinary retention Urinary hesitation Nocturia

Polyuria Urine flow decreased

Urine odour abnormal


Reproductive system and breast disorders


Erectile dysfunction

Ejaculation disorder Ejaculation delayed

Gynaecological haemorrhage

Menstrual disorder Sexual dysfunction Testicular pain

Menopausal symptoms

Galactorrhoea Hyper- prolactinaemia


General disorders and administration site conditions


Falls8

Fatigue

Chest pain7

Feeling abnormal Feeling cold Thirst

Chills Malaise Feeling hot

Gait disturbance



Investigations


Weight decrease

Weight increase Blood creatine phosphokinase increased

Blood potassium increased

Blood cholesterol increased


1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.

2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.

3 See section 4.4.

4 Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.

5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.

6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.

7 Not statistically significantly different from placebo.

8 Falls were more common in the elderly (≥65 years old).

9 Estimated frequency based on all clinical trial data.

10 Estimated frequency based on placebo-controlled clinical trials.


c. Description of selected adverse reactions

Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.

Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting; however, in some patients they may be severe and/or prolonged. It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out.

In the 12-week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients. HbA1c was stable in both duloxetine-treated and placebo-treated patients. In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetine- treated group. There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients, while those laboratory tests showed a slight decrease in the routine care group.

The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients. No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.

d. Paediatric population

A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials. In general, the adverse reaction profile of duloxetine in children and adolescents was similar to that seen for adults.

A total of 467 paediatric patients initially randomized to duloxetine in clinical trials experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebo-treated patients. Subsequently, over the four- to six-month extension period, patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and gender-matched peers.

In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetine-treated paediatric patients.

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; website: www.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.

Reference

Cymbalta [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.

Datum fӧr senaste ӧversyn 2019 M07 24


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