Medicinal Products

EMEND 80 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Aprepitant
laboratory: Msd Chibret

capsule
case of 5
All forms

Indication

Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from 12 years.

EMEND 80 mg is administered as part of a treatment regimen (see section 4.2 ).

Dosage EMEND 80 mg capsule box of 5

Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from 12 years.

EMEND 80 mg is administered as part of a treatment regimen (see section 4.2 ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5 ).

Adverse effects Emend

Summary of the security profile

The safety profile of aprepitant was evaluated in approximately 6, 500 adults in more than 50 clinical trials and in 184 children and adolescents in 2 controlled pediatric clinical trials.

The most common adverse events, reported with a higher incidence in adults treated with aprepitant compared to those receiving standard therapy in highly emetic chemotherapy (HEC), were: hiccups (4.6% versus 2.9%), elevation of alanine aminotransferase (ALT) (2.8% versus 1.1%), dyspepsia (2.6% versus 2.0%), constipation (2.4% versus 2.0%). %), headache (2.0% versus 1.8%) and decreased appetite (2.0% versus 0.5%). The most common adverse event, reported with a higher incidence in patients treated with aprepitant compared to those receiving standard therapy in a Moderately Emeticating Chemotherapy (MEC), was fatigue (1.4%). versus 0.9%).

The most common adverse events, reported with a higher incidence in pediatric patients treated with aprepitant compared to those receiving controlled treatment during their emetogenic cancer chemotherapy, were: hiccups (3.3% versus 0.0%) and flushing (1.1% versus 0.0%).

List of adverse reactions presented in tabular form

The following adverse events were observed with a higher incidence in adult or pediatric patients treated with aprepitant compared to those receiving standard treatment based on a pooled analysis of clinical studies with highly and moderately emetogenic chemotherapies (CHE and CME). ), or since the placing on the market. The frequency categories mentioned in the table are based on studies conducted in adults; frequencies observed in pediatric studies were similar or lower, except in the table. Some less common side effects in the adult population have not been observed in pediatric studies.

Frequency definition: very common (> 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10 000 to <1/1000) and very rare (<1/10 000); indeterminate frequency (can not be estimated based on available data).

Classes of organ systems

Undesirable effect

Frequency

Infections and infestations

candidiasis, staphylococcal infection

rare

Blood and lymphatic system disorders

febrile neutropenia, anemia

rare

Immune system disorders

hypersensitivity reactions including anaphylactic reactions

frequency

unknown

Metabolism and nutrition disorders

decreased appetite

frequent

polydipsia

rare

Psychiatric disorders

anxiety

rare

disorientation, euphoric mood

rare

Nervous system disorders

headaches

frequent

dizziness, drowsiness

rare

cognitive disorders, lethargy, dysgeusia

rare

Eye disorders

conjunctivitis

rare

Affections of the ear and labyrinth

tinnitus

rare

Heart conditions

palpitations

rare

bradycardia, cardiovascular disorders

rare

Vascular disorders

flushing / flushing

rare

Respiratory, thoracic and mediastinal disorders

hiccough

frequent

Oropharyngeal pain, sneezing, coughing, back nasal discharge, throat irritation

rare

Gastrointestinal disorders

constipation, dyspepsia

frequent

eructation, nausea , vomiting , gastroesophageal reflux, abdominal pain, dry mouth, flatulence

rare

perforation of duodenal ulcer, stomatitis, abdominal distension, hard stool, neutropenic colitis

rare

Skin and subcutaneous tissue disorders

rash, acne

rare

photosensitivity reaction, hyperhydrosis, seborrhea, skin lesions, pruritic rash, Stevens-Johnson syndrome /

Lyell

rare

pruritus, urticaria

frequency

unknown

Musculoskeletal and systemic disorders

muscle weakness, muscle spasms

rare

Renal and urinary disorders

dysuria

rare

urinary frequency

rare

General disorders and administration site conditions

tired

frequent

asthenia, malaise

rare

edema, chest discomfort, gait disturbance

rare

investigations

ALT elevation

frequent

elevation of ASAT, elevation of blood alkaline phosphatase

rare

presence of red blood cells in the urine, decrease of blood sodium, weight loss, decrease in the number of neutrophils, presence of glucose in the urine, increase in diuresis

rare

Nausea and vomiting were efficacy parameters in the first 5 days after chemotherapy and were reported as adverse events only afterwards.

Description of some adverse effects

The adverse event profiles observed in adults when extending to multiple cycles of studies in highly and moderately emetogenic chemotherapy (CHE and CME), up to 6 additional cycles of chemotherapy, were generally similar. those observed in Cycle 1.

In an additional controlled clinical versus active comparator study in 1, 169 adult patients receiving aprepitant and highly emetogenic chemotherapy (CHE), the adverse event profile was generally similar to that observed in other studies with aprepitant in the context of highly emetic chemotherapy (CHE).

Other adverse reactions have been reported in adult patients treated with aprepitant for postoperative nausea and vomiting (PONV) with an incidence greater than that observed in patients treated with ondansetron: upper abdominal pain, intestinal noises abnormal, constipation *, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbances, stomach discomfort, subtle *, visual acuity decline, wheezing.

* Reported in patients taking a higher dose of aprepitant

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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