Strattera ® (atomoxetin)

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Strattera® (atomoxetin): Biverkningar

Sammanfattning av säkerhetsprofilen av atomoxetin

Paediatric population:

Summary of the safety profile

In paediatric placebo-controlled trials, headache, abdominal pain1 and decreased appetite are the adverse events most commonly associated with atomoxetine, and are reported by about 19%, 18% and 16% of patients, respectively, but seldom lead to drug discontinuation (discontinuation rates are 0.1% for headache, 0.2 % for abdominal pain and 0.0% for decreased appetite). Abdominal pain and decreased appetite are usually transient.

Associated with decreased appetite, some patients experienced growth retardation early in therapy in terms of both weight and height gain. On average, after an initial decrease in weight and height gain, patients treated with atomoxetine recovered to mean weight and height as predicted by group baseline data over the long-term treatment.

Nausea, vomiting and somnolence2 can occur in about 10% to 11% of patients, particularly during the first month of therapy. However, these episodes were usually mild to moderate in severity and transient, and did not result in a significant number of discontinuations from therapy (discontinuation rates ≤ 0.5%).

In both paediatric and adult placebo-controlled trials, patients taking atomoxetine experienced increases in heart rate, systolic and diastolic blood pressure.

Because of its effect on noradrenergic tone, orthostatic hypotension (0.2%) and syncope (0.8%) have been reported in patients taking atomoxetine. Atomoxetine should be used with caution in any condition that may predispose patients to hypotension.

The following table of undesirable effects is based on adverse event reporting and laboratory investigations from clinical trials and post-marketing spontaneous reports in children and adolescents:

Tabulated list of 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).


System Organ Class

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

Metabolism and nutrition disorders

Appetite decreased

Anorexia (loss of appetite)



Psychiatric disorders


Irritability, mood swings, insomnia3, agitation , anxiety, depression and depressed mood,

tics

Suicide-related events, aggression, hostility, emotional lability Psychosis (including hallucinations)


Nervous system disorders

Headache, somnolence2

Dizziness

Syncope, tremor, migraine, paraesthesia, hypoaesthesia, Seizure


Eye disorders


Mydriasis

Vision blurred


Cardiac disorders



Palpitations, sinus tachycardia. QT interval prolongation


Vascular disorders




Raynaud’s phenomenon

Respiratory, thoracic and mediastinal disorders



Dyspnoea


Gastro-intestinal disorders

Abdominal pain1, vomiting, nausea

Constipation, dyspepsia



Hepatobiliary disorders



Blood bilirubin increased

Abnormal/ increased liver

function tests, jaundice, hepatitis, liver injury, acute hepatic failure

Skin and subcutaneous tissue disorders


Dermatitis, pruritis, rash

Hyperhydrosis, allergic reactions


Renal and urinary disorders




Urinary hesitation, urinary retention

Reproductive system and breast disorders




Priapism, male genital pain

General disorders and administration site conditions


Fatigue, lethargy, chest pain

Asthenia


Investigations

Blood pressure increased4, heart rate increased4

Weight decreased



1Also includes abdominal pain upper, stomach discomfort, abdominal discomfort and epigastric discomfort.

2 Also includes sedation

3 Includes initial, middle and terminal (early morning wakening) insomnia

4 Heart rate and blood pressure findings are based on measured vital signs.


CYP2D6 poor metabolisers (PM):

The following adverse events occurred in at least 2% of CYP2D6 poor metaboliser (PM) patients and were statistically significantly more frequent in PM patients compared with CYP2D6 extensive metaboliser (EM) patients: appetite decreased (24.1% of PMs, 17.0% of EMs); insomnia combined (including insomnia, middle insomnia and initial insomnia, 14.9% of PMs, 9.7% of EMs); depression combined (including depression, major depression, depressive symptom, depressed mood and dysphoria, 6.5% of PMs and 4.1% of EMs), weight decreased (7.3% of PMs, 4.4% of EMs), constipation 6.8% of PMs, 4.3% of EMs); tremor (4.5% of PMs, 0.9% of EMs); sedation (3.9% of PMs, 2.1% of EMs); excoriation (3.9% of PMs, 1.7% of EMs); enuresis (3.0% of PMs, 1.2% of EMs); conjunctivitis (2.5% of PMs, 1.2% of EMs); syncope (2.5% of PMs, 0.7% of EMs); early morning awakening (2.3% of PMs, 0.8% of EMs); mydriasis (2.0% of PMs, 0.6% of EMs). The following event did not meet the above criteria but is noteworthy: generalised anxiety disorder (0.8% of PMs and 0.1% of EMs). In addition, in trials lasting up to 10 weeks, weight loss was more pronounced in PM patients (mean of 0.6 kg in EM and 1.1kg in PM).

Adults:

Summary of the safety profile:

In adult ADHD clinical trials, the following system organ classes had the highest frequency of adverse events during treatment with atomoxetine: gastrointestinal, nervous system and psychiatric disorders. The most common adverse events (≥5%) reported were appetite decreased (14.9%), insomnia (11.3%), headache (16.3%), dry mouth (18.4%) and nausea (26.7%). The majority of these events were mild or moderate in severity and the events most frequently reported as severe were nausea, insomnia, fatigue and headache. A complaint of urinary retention or urinary hesitancy in adults should be considered potentially related to atomoxetine.

The following table of undesirable effects is based on adverse event reporting and laboratory investigations from clinical trials and post-marketing spontaneous reports in adults.

Tabulated list of 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).

System Organ Class

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

Metabolism and nutrition disorders

Appetite decreased




Psychiatric disorders

Insomnia2

Agitation, libido decreased, sleep disorder, depression and depressed mood, anxiety

Suicide-related events, aggression, hostility and emotional lability, restlessness, tics

Psychosis (including hallucinations)

Nervous system disorders

Headache

Dizziness, dysgeusia, paraesthesia, somnolence (including sedation), tremor

Syncope, migraine, Hypoaesthesia

Seizure

Eye disorders



Vision blurred


Cardiac disorders


Palpitations, tachycardia

QT interval prolongation


Vascular disorders


Flushing, hot flush

Peripheral coldness

Raynaud’s phenomenon

Respiratory, thoracic and mediastinal disorders



Dyspnoea


Gastrointestinal disorders

Dry mouth, nausea

Abdominal pain1, constipation,

dyspepsia, flatulence, vomiting



Hepato-biliary disorders




Abnormal/increas ed liver function tests, jaundice, hepatitis, liver injury, acute hepatic failure, blood bilirubin increased

Skin and subcutaneous tissue disorders


Dermatitis, hyperhydrosis, rash

Allergic reactions4, pruritis, urticaria


Musculoskeletal and connective tissue disorders



Muscle spasms


Renal and urinary disorders


Dysuria, pollakuria, urinary hesitation, urinary retention

Micturation urgency


Reproductive system and breast disorders


Dysmenorrhoea, ejaculation disorder, erectile dysfunction, prostatitis, male genital pain

Ejaculation failure, menstruation irregular, orgasm abnormal

Priapism

General disorders and administration site conditions


Asthenia, fatigue, lethargy, chills, feeling jittery, irritability, thirst

Feeling cold, chest pain


Investigations

Blood pressure increased3, heart rate increased3

Weight decreased



1Also includes abdominal pain upper, stomach discomfort, abdominal discomfort and epigastric discomfort.

2 Also includes initial insomnia, middle insomnia and terminal (early morning wakening) insomnia.

3 Heart rate and blood pressure findings are based on measured vital signs.

4 Includes anaphylactic reactions and angioneurotic oedema.


CYP2D6 poor metabolisers (PM)

The following adverse events occurred in at least 2% of CYP2D6 poor metaboliser (PM) patients and were statistically significantly more frequent in PM patients compared with CYP2D6 extensive metaboliser (EM) patients: vision blurred (3.9% of PMs, 1.3% of EMs), dry mouth (34.5% of PMs, 17.4% of EMs), constipation (11.3% of PMs, 6.7% of EMs), feeling jittery (4.9% of PMs, 1.9% of EMs), decreased appetite (23.2% of PMs, 14.7% of EMs), tremor (5.4% of PMs, 1.2% of EMs), insomnia (19.2% of PMs, 11.3% of EMs), sleep disorder (6.9% of PMs, 3.4% of EMs), middle insomnia (5.4% of PMs, 2.7% of EMs), terminal insomnia (3 % of PMs, 0.9% of EMs), urinary retention (5.9% of PMs, 1.2% of EMs), erectile dysfunction (20.9% of PMs, 8.9% of EMs), ejaculation disorder (6.1% of PMs, 2.2% of EMs), hyperhidrosis (14.8% of PMs, 6.8% of EMs), peripheral coldness (3% of PMs, 0.5% of EMs).

REFERENCE

Strattera Summary of Product Characteristics

Datum fӧr senaste ӧversyn 2018 M11 13

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