Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.3 · PDF-Seite 7

HOS-152450 · Präparat HOS-100765

• Pregnancy. • Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6). • Male patients unable to follow or comply with the required contraceptive measures (see section 4.4). • 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 · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-152451 · Präparat HOS-100765

Effect of pomalidomide on other medicinal products

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

Wechselwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-152452 · Präparat HOS-100765

Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic interactions due to P450 isoenzyme inhibition or induction or transporter inhibition when co-administered with substrates of these enzymes or transporters. The potential for such interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically (see section 4.4 Teratogenicity).

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

Wechselwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-152453 · Präparat HOS-100765

Effect of other medicinal products on pomalidomide

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

Wechselwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12–13

HOS-152454 · Präparat HOS-100765

Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5. It is also a substrate for P- glycoprotein. Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide. Co-administration of the strong CYP1A2 inhibitor fluvoxamine with 12 pomalidomide in the presence of ketoconazole, increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% to 124%] compared to pomalidomide plus ketoconazole. In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co- administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone. If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%.

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): ciprofloxacin (HOS-085177) ketoconazole (HOS-084513) carbamazepine (HOS-085618) enoxacin (HOS-111703) fluvoxamine (HOS-085908)

Wechselwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13

HOS-152456 · Präparat HOS-100765

Dexamethasone

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): dexamethasone (HOS-084535)

Wechselwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13

HOS-152458 · Präparat HOS-100765

Co-administration of multiple doses of up to 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone.

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): dexamethasone (HOS-084535)

Wechselwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13

HOS-152459 · Präparat HOS-100765

The effect of dexamethasone on warfarin is unknown. Close monitoring of warfarin concentration is advised during treatment.

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): dexamethasone (HOS-084535) warfarin (HOS-085950)

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152460 · Präparat HOS-100765

Summary of the safety profile

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152461 · Präparat HOS-100765

Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (54.0%), thrombocytopenia (39.9%) and anaemia (32.0%). Other most frequently reported adverse reactions included peripheral sensory neuropathy (48.2%), fatigue (38.8%), diarrhoea (38.1%), constipation (38.1%), and oedema peripheral (36.3%). The most commonly reported Grade 3 or 4 adverse reactions were blood and lymphatic system disorders including neutropenia (47.1%), thrombocytopenia (28.1%) and anaemia (15.1%). The most commonly reported serious adverse reaction was pneumonia (12.2%). Other serious adverse reactions reported included pyrexia (4.3%), lower respiratory tract infection (3.6%), influenza (3.6%), pulmonary embolism (3.2%), atrial fibrillation (3.2%), and acute kidney injury (2.9%).

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152462 · Präparat HOS-100765

Pomalidomide in combination with dexamethasone The most commonly reported adverse reactions in clinical studies have been blood and lymphatic system disorders including anaemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%); in general disorders and administration site conditions including fatigue (28.3%), pyrexia (21%) and oedema peripheral (13%); and in infections and infestations including pneumonia (10.7%). Peripheral neuropathy adverse reactions were reported in 12.3% of patients and venous embolic or thrombotic (VTE) adverse reactions were reported in 3.3% of patients. The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema peripheral (1.3%). The most commonly reported serious adverse reaction was pneumonia (9.3%). Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %).

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152463 · Präparat HOS-100765

Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152464 · Präparat HOS-100765

Tabulated list of adverse reactions

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152465 · Präparat HOS-100765

The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone, pomalidomide in combination with dexamethasone and from post-marketing surveillance are listed in table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152466 · Präparat HOS-100765

Frequencies are defined in accordance with current guidance, as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be determined).

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14

HOS-152467 · Präparat HOS-100765

Table 7. Adverse reactions (ADRs) reported in clinical trials and post-market settings Combination of treatment Pomalidomide/ Pomalidomide/ bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs Infections and infestations Pneumonia Very common Very common Pneumonia (bacterial, viral Very common Common and fungal infections,

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14–15

HOS-152468 · Präparat HOS-100765

14 Combination of treatment Pomalidomide/ Pomalidomide/ bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs including opportunistic infections) Bronchitis Very common Common Common Uncommon Upper respiratory tract Very common Common Common Common infection Viral upper respiratory tract Very common infection Sepsis Common Common Septic shock Common Common Neutropenic sepsis Common Common Clostridium difficile colitis Common Common Bronchopneumonia Common Common Respiratory tract infection Common Common Common Common Lower respiratory tract Common Common infection Lung infection Common Uncommon Influenza Very common Common Bronchiolitis Common Common Urinary tract infection Very common Common Nasopharyngitis Common Herpes zoster Common Uncommon Hepatitis B reactivation Not known* Not known* Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma Common Uncommon Basal cell carcinoma of the Uncommon Uncommon skin Squamous cell carcinoma Uncommon Uncommon of the skin Blood and lymphatic system disorders Neutropenia Very common Very common Very common Very common Thrombocytopenia Very common Very common Very common Very common Leucopenia Very common Common Very common Common Anaemia Very common Very common Very common Very common Febrile neutropenia Common Common Common Common Lymphopenia Common Common Pancytopenia Common* Common* Immune system disorders Angioedema Common* Uncommon* Urticaria Common* Uncommon* Anaphylactic reaction Not known* Not known* Solid organ transplant Not known* rejection Endocrine disorders

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 15–16

HOS-152469 · Präparat HOS-100765

15 Combination of treatment Pomalidomide/ Pomalidomide/ bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs Hypothyroidism Uncommon* Metabolism and nutrition disorders Hypokalaemia Very common Common Hyperglycaemia Very common Common Hypomagnesaemia Common Common Hypocalcaemia Common Common Hypophosphataemia Common Common Hyperkalaemia Common Common Common Common Hypercalcaemia Common Common Hyponatraemia Common Common Decreased appetite Very common Uncommon Hyperuricaemia Common* Common* Tumour lysis syndrome Uncommon* Uncommon* Psychiatric disorders Insomnia Very common Common Depression Common Common Confusional state Common Common Nervous system disorders Peripheral sensory Very common Common Common Uncommon neuropathy Dizziness Very common Uncommon Common Uncommon Tremor Very common Uncommon Common Uncommon Syncope Common Common Peripheral sensorimotor Common Common neuropathy Paraesthesia Common Dysgeusia Common Depressed level of Common Common consciousness Intracranial haemorrhage Common* Uncommon* Cerebrovascular accident Uncommon* Uncommon* Eye disorders Cataract Common Common Ear and labyrinth disorders Vertigo Common Common Cardiac disorders Atrial fibrillation Very common Common Common* Common* Cardiac failure Common* Common* Myocardial infarction Common* Uncommon* Vascular disorders Deep vein thrombosis Common Uncommon Common Uncommon Hypotension Common Common Hypertension Common Common

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 16–17

HOS-152470 · Präparat HOS-100765

16 Combination of treatment Pomalidomide/ Pomalidomide/ bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs Respiratory, thoracic and mediastinal disorders Dyspnoea Very common Common Very common Common Cough Very common Very common Uncommon Pulmonary embolism Common Common Common Uncommon Epistaxis Common* Uncommon* Interstitial lung disease Common* Uncommon* Gastrointestinal disorders Diarrhoea Very common Common Very common Common Vomiting Very common Common Common Common Nausea Very common Uncommon Very common Uncommon Constipation Very common Common Very common Common Abdominal pain Very common Common Abdominal pain upper Common Uncommon Stomatitis Common Uncommon Dry mouth Common Abdominal distension Common Uncommon Gastrointestinal Common Uncommon haemorrhage Hepatobiliary disorders Hyperbilirubinaemia Uncommon Uncommon Hepatitis Uncommon* Skin and subcutaneous tissue disorders Rash Very common Common Common Common Pruritus Common Drug Reaction with Not known* Not known* Eosinophilia and Systemic Symptoms Toxic Epidermal Not known* Not known* Necrolysis Stevens-Johnson Syndrome Not known* Not known* Musculoskeletal and connective tissue disorders Muscular weakness Very common Common Back pain Very common Common Bone pain Common Uncommon Very common Common Muscle spasms Very common Very common Uncommon Renal and urinary disorders Acute kidney injury Common Common Chronic kidney injury Common Common Urinary retention Common Common Common Uncommon Renal failure Common Common Reproductive system and breast disorders Pelvic pain Common Common General disorders and administration site conditions

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

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17–18

HOS-152471 · Präparat HOS-100765

17  Combination of treatment Pomalidomide/ Pomalidomide/ bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs Fatigue Very common Common Very common Common Pyrexia Very common Common Very common Common Oedema peripheral Very common Common Very common Common Non-cardiac chest pain Common Common Oedema Common Common Investigations Alanine aminotransferase Common Common Common Common increased Weight decreased Common Common Neutrophil count decreased Common Common White blood cell count Common Common decreased Platelet count decreased Common Common Blood uric acid increased Common* Uncommon* Injury, poisoning and procedural complications Fall Common Common * Reported during post-marketing use.

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