Fosemred Adverse Reactions

Since fosaprepitant is converted to aprepitant, those adverse experiences associated with aprepitant might also be expected to occur with FOSEMRED.
Oral Aprepitant: Highly Emetogenic Chemotherapy (HEC): The 3-day oral aprepitant regimen was given in combination with ondansetron and dexamethasone and was generally well tolerated. Most adverse experiences reported were described as mild to moderate in intensity.
In Cycle 1, drug-related clinical adverse experiences were reported in patients treated with the 3-day oral aprepitant regimen. Treatment was discontinued due to drug-related clinical adverse experiences in patients treated with the 3-day oral aprepitant regimen.
The most common drug-related adverse experiences reported in patients treated with the 3-day oral aprepitant regimen and greater than standard therapy were: hiccups, ALT increased, dyspepsia, constipation, headache, and decreased appetite.
The adverse experience profile was generally similar to that seen in the other HEC regimen with the 3-day oral aprepitant regimen.
Moderately Emetogenic Chemotherapy (MEC): The 3-day oral aprepitant regimen was given in combination with ondansetron and dexamethasone and was generally well tolerated. Most adverse experiences reported were described as mild to moderate in intensity.
In the combined analysis of Cycle 1 data, drug-related adverse experiences were reported in patients treated with the 3-day oral aprepitant regimen. Treatment was discontinued due to drug-related adverse experiences in patients treated with the 3-day oral aprepitant regimen.
The most common drug-related adverse experience reported at a greater incidence in patients treated with the 3-day oral aprepitant regimen was fatigue.
Highly and Moderately Emetogenic Chemotherapy: The following drug-related adverse experiences were reported in patients treated with the 3-day oral aprepitant regimen and at a greater incidence than standard therapy: [Common, Uncommon, Rare].
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 regimen for up to 6 cycles of chemotherapy were generally similar to those observed in Cycle 1.
Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy.
Fosaprepitant: Moderately Emetogenic Chemotherapy (MEC): The following clinically important drug-related adverse experiences were reported in patients treated with the fosaprepitant regimen and at a greater incidence than in the control group: [Common, Uncommon].
Cardiac disorders: Uncommon: palpitations.
Gastrointestinal disorders: Common: constipation.
Uncommon: abdominal distension, abdominal pain, abdominal pain upper, dyspepsia.
General disorders and administration site conditions: Common: infusion site pain.
Uncommon: asthenia.
Infections and infestations: Uncommon: oral candidiasis.
Metabolism and nutrition disorders: Uncommon: decreased appetite.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough, oropharyngeal pain, throat irritation.
Vascular disorders: Uncommon: hot flush.
Highly Emetogenic Chemotherapy (HEC): The safety profile was generally similar to that seen in the MEC regimen with fosaprepitant.
The following additional clinically important drug-related adverse experiences occurred with fosaprepitant 150 mg and have not been reported in earlier data with oral aprepitant, or in the MEC regimen with fosaprepitant: [Uncommon, Rare].
General disorders and administration site conditions: Uncommon: infusion site erythema, infusion site pruritus.
Rare: infusion site induration.
Investigations: Uncommon: blood pressure increased.
Skin and subcutaneous tissue disorders: Uncommon: erythema.
Vascular disorders: Uncommon: flushing, thrombophlebitis (predominantly, infusion-site thrombophlebitis).
Other Data: 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, dyspnea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
In addition, serious adverse experiences were reported in patients taking a higher dose of aprepitant: constipation, and sub-ileus.
Angioedema and urticaria was reported as a serious adverse event in a patient receiving aprepitant in a non-CINV/non-PONV data.
Post-Marketing Experience: The following adverse reactions have been identified during post-marketing use. 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, rarely Stevens-Johnson syndrome/toxic epidermal necrolysis.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions/anaphylactic shock.
Immediate hypersensitivity reactions have been observed during the infusion of fosaprepitant which may include the following: flushing, erythema, dyspnea (see Precautions).