Emend Tri-Pack Side Effects

The overall safety of aprepitant was evaluated in approximately 6500 individuals.
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV): Highly Emetogenic Chemotherapy (HEC): In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy (HEC), 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. EMEND was given in combination with ondansetron and dexamethasone (aprepitant regimen) and was generally well tolerated. Most adverse experiences reported in these clinical studies were described as mild to moderate in intensity.
In Cycle 1, drug-related clinical adverse experiences were reported in approximately 19% of patients treated with the aprepitant regimen compared with approximately 14% of patients treated with standard therapy. Treatment was discontinued due to drug-related clinical adverse experiences in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.
The most common drug-related adverse experiences reported in patients treated with the aprepitant regimen and greater than standard therapy were: hiccups (4.6%), ALT increased (2.8%), dyspepsia (2.6%), constipation (2.4%), headache (2.0%), and decreased appetite (2.0%).
In an additional active-controlled clinical study in 1169 patients receiving aprepitant and HEC, the adverse experience profile was generally similar to that seen in the other HEC studies with aprepitant.
Moderately Emetogenic Chemotherapy (MEC): In 2 well-controlled clinical trials in patients receiving moderately emetogenic cancer chemotherapy (MEC), 868 patients were treated with aprepitant during Cycle 1 of chemotherapy and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In both studies, EMEND was given in combination with ondansetron and dexamethasone (aprepitant regimen) and was generally well tolerated. Most adverse experiences reported in these clinical studies were described as mild to moderate in intensity. In the combined analysis of Cycle 1 data for these 2 studies, drug-related adverse experiences were reported in approximately 14% of patients treated with the aprepitant regimen compared with approximately 15% of patients treated with standard therapy. Treatment was discontinued due to drug-related adverse experiences in 0.7% of patients treated with the aprepitant regimen compared with 0.2% of patients treated with standard therapy.
The most common drug-related adverse experience reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy was fatigue (1.4%).
Highly and Moderately Emetogenic Chemotherapy: In a pooled analysis of the HEC and MEC studies, the following drug-related adverse experiences were reported in patients treated with the aprepitant regimen and at a greater incidence than standard therapy: [Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000)].
Infection and infestations: Rare: candidiasis, staphylococcal infection.
Blood and the lymphatic system disorders: Uncommon: anemia, febrile neutropenia.
Metabolism and nutrition disorders: Common: decreased appetite.
Rare: polydipsia.
Psychiatric disorders: Uncommon: anxiety.
Rare: disorientation, euphoric mood.
Nervous system disorders: Uncommon: dizziness, somnolence.
Rare: cognitive disorder, lethargy, dysgeusia.
Eye disorders: Rare: conjunctivitis.
Ear and labyrinth disorders: Rare: tinnitus.
Cardiac disorders: Uncommon: palpitations.
Rare: bradycardia, cardiovascular disorder.
Vascular disorders: Uncommon: hot flush.
Respiratory, thoracic and mediastinal disorders: Common: hiccups.
Rare: oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation.
Gastrointestinal disorders: Common: dyspepsia.
Uncommon: eructation, nausea, gastroesophageal reflux disease, vomiting, abdominal pain, dry mouth, flatulence.
Rare: feces hard, duodenal ulcer perforation, neutropenic colitis, stomatitis, abdominal distension.
Skin and subcutaneous tissue disorders: Uncommon: rash, acne.
Rare: photosensitivity reaction, hyperhidrosis, seborrhoea, skin lesion, rash pruritic.
Musculoskeletal and connective tissue disorders: Rare: muscle spasms, muscular weakness.
Renal and urinary disorders: Uncommon: dysuria.
Rare: pollakiuria.
General disorders and administration site conditions: Common: fatigue.
Uncommon: asthenia, malaise.
Rare: edema, chest discomfort, gait disturbance.
Investigations: Common: ALT increased.
Uncommon: AST increased, blood alkaline phosphatase increased.
Rare: urine output increased, red blood cells urine positive, blood sodium decreased, weight decreased, glucose urine present, neutrophil count decreased.
The adverse experience profiles in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to those observed in Cycle 1.
In another CINV study, Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy.
Other Studies: Single 40-mg doses of EMEND have also been studied for the prevention of post-operative nausea and vomiting (PONV) in non-chemotherapy patients receiving general balanced anesthesia. In these studies, additional adverse reactions that were observed at a greater incidence than with the active comparator (ondansetron) included: ALT increased, abdominal pain upper, bowel sounds abnormal, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
In addition, two serious adverse experiences were reported in PONV clinical studies in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus.
One case of angioedema and urticaria was reported as a serious adverse event in a patient receiving aprepitant in a non-CINV/non-PONV study.
Post-Marketing Experience: The following adverse reactions have been identified during post-marketing use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the drug.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions.