Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.3 · PDF-Seite 5

HOS-129409 · Präparat HOS-096717

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 26

HOS-129443 · Präparat HOS-096717

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-129410 · Präparat HOS-096717

No interaction studies have been performed with Abilify Maintena. The information below is obtained from studies with oral aripiprazole.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-129411 · Präparat HOS-096717

Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-129412 · Präparat HOS-096717

Given the primary central nervous system (CNS) effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-129413 · Präparat HOS-096717

If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-129414 · Präparat HOS-096717

Potential for other medicinal products to affect aripiprazole

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 7–8

HOS-129415 · Präparat HOS-096717

7 Quinidine and other strong CYP2D6 inhibitors In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged. The AUC and Cmax of dehydro- aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively. Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): paroxetine (HOS-086246) quinidine (HOS-085593) fluoxetine (HOS-085946)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 8

HOS-129416 · Präparat HOS-096717

Ketoconazole and other strong CYP3A4 inhibitors In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively. The AUC and Cmax of dehydro- aripiprazole increased by 77 % and 43 %, respectively. In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolisers (see section 4.2). When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient. Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should, therefore, be applied (see section 4.2). Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dose of aripiprazole should be increased to the dose prior to the initiation of the concomitant therapy. When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): diltiazem (HOS-086288) protease (HOS-085623) ketoconazole (HOS-084513) itraconazole (HOS-084516) escitalopram (HOS-129417)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 8

HOS-129418 · Präparat HOS-096717

Carbamazepine and other CYP3A4 inducers Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when oral aripiprazole (30 mg) was administered alone. Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with oral aripiprazole alone. Concomitant administration of Abilify Maintena 400 mg/300 mg and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects. The concomitant use of CYP3A4 inducers with Abilify Maintena 400 mg/300 mg should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): phenobarbital (HOS-085617) carbamazepine (HOS-085618) rifabutin (HOS-086262) efavirenz (HOS-087947) nevirapine (HOS-088064) phenytoin (HOS-084531) primidone (HOS-090551)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.5 · PDF-Seite 8

HOS-129419 · Präparat HOS-096717

Serotonin syndrome Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as Selective Serotonin Reuptake Inhibitors/Serotonin Noradrenaline Reuptake Inhibitors (SSRI/SNRI), or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): serotonin (HOS-085477)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129444 · Präparat HOS-096717

No interaction studies have been performed with Abilify Maintena. The information below is obtained from studies with oral aripiprazole. The 2-month dosing interval and long half-life of aripiprazole after dosing with Abilify Maintena 960 mg or 720 mg should also be considered when assessing the drug- drug interaction potential.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129445 · Präparat HOS-096717

Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129446 · Präparat HOS-096717

Given the primary central nervous system (CNS) effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129447 · Präparat HOS-096717

If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129448 · Präparat HOS-096717

Potential for other medicinal products to affect aripiprazole

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129449 · Präparat HOS-096717

Quinidine and other strong CYP2D6 inhibitors In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged. The AUC and Cmax of dehydro- aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively. Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): paroxetine (HOS-086246) quinidine (HOS-085593) fluoxetine (HOS-085946)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129450 · Präparat HOS-096717

Ketoconazole and other strong CYP3A4 inhibitors In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively. The AUC and Cmax of dehydro- aripiprazole increased by 77 % and 43 %, respectively. In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolisers (see section 4.2). When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient. Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should, therefore, be applied (see section 4.2). Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dose of aripiprazole should be increased to the dose prior to the initiation of the concomitant therapy. When weak inhibitors of CYP3A4 (e.g., diltiazem) or CYP2D6 (e.g., escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): diltiazem (HOS-086288) protease (HOS-085623) ketoconazole (HOS-084513) itraconazole (HOS-084516) escitalopram (HOS-129417)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29

HOS-129451 · Präparat HOS-096717

Carbamazepine and other CYP3A4 inducers

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): carbamazepine (HOS-085618)

Wechselwirkungen · Abilify Maintena

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 29–30

HOS-129452 · Präparat HOS-096717

29 Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when oral aripiprazole (30 mg) was administered alone. Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with oral aripiprazole alone. Concomitant administration of Abilify Maintena 960 mg/720 mg and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects. The concomitant use of CYP3A4 inducers with Abilify Maintena 960 mg/720 mg should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): phenobarbital (HOS-085617) carbamazepine (HOS-085618) rifabutin (HOS-086262) efavirenz (HOS-087947) nevirapine (HOS-088064) phenytoin (HOS-084531) primidone (HOS-090551)