What are the possible side effects of Fosaprepitant?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Belching; constipation; diarrhea; dizziness; headache; hiccups; loss of appetite; tiredness; upset stomach; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); confusion; difficult, decreased, or increased urination; fast, slow, or irregular heartbeat; flushing; mental or mood changes (eg, depression); pain, hardness, redness, or itching at the injection site; pain, redness, or swelling in the legs; red, swollen, blistered, or peeling skin; severe or persistent heartburn or stomach pain; severe rash with fever, mouth sores, or red and irritated eyes; shortness of breath; signs of infection (eg, fever, chills, persistent sore throat); soreness of the mouth or tongue; strong urge to urinate.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Side effects of Fosaprepitant in details
The following clinically significant adverse reactions are described elsewhere in the labeling:
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- Hypersensitivity Reactions
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- Infusion Site Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The overall safety of Fosaprepitant for Injection was evaluated in approximately 1600 adult patients.
Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with MEC
In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of Fosaprepitant for Injection in combination with ondansetron and dexamethasone (Fosaprepitant for Injection regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy). The most common adverse reactions are listed in Table 6.
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| Fosaprepitant for Injection, ondansetron, and dexamethasone† (N=504) | Ondansetron and dexamethasone‡ (N=497) | |
| fatigue | 15% | 13% |
| diarrhea | 13% | 11% |
| neutropenia | 8% | 7% |
| asthenia | 4% | 3% |
| anemia | 3% | 2% |
| peripheral neuropathy | 3% | 2% |
| leukopenia | 2% | 1% |
| dyspepsia | 2% | 1% |
| urinary tract infection | 2% | 1% |
| pain in extremity | 2% | 1% |
Infusion-site reactions were reported in 2.2% of patients treated with the Fosaprepitant for Injection regimen compared to 0.6% of patients treated with standard therapy. The infusion-site reactions included: infusion-site pain (1.2%, 0.4%), injection-site irritation (0.2%, 0.0%), vessel puncture-site pain (0.2%, 0.0%), and infusion-site thrombophlebitis (0.6%, 0.0%), reported in the Fosaprepitant for Injection regimen compared to standard therapy, respectively.
Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with HEC
In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single dose of Fosaprepitant for Injection compared to 1169 patients receiving the 3-day regimen of oral Fosaprepitant (aprepitant). The safety profile was generally similar to that seen in the MEC study with Fosaprepitant and prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the Fosaprepitant group (3.0%) compared to those in the aprepitant group (0.5%). The following additional infusion-site reactions occurred in the HEC study and were not reported in the MEC study described above: infusion-site erythema (0.5%, 0.1%), infusion-site pruritus (0.3%, 0.0%), and infusion-site induration (0.2%, 0.1%), reported in the Fosaprepitant group compared to the aprepitant group, respectively.
Because Fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with Fosaprepitant for Injection. See the full prescribing information for Fosaprepitant capsules for complete safety information regarding studies performed with oral aprepitant.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (Fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Fosaprepitant for Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis.
Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock.
Nervous system disorders: ifosfamide-induced neurotoxicity reported after Fosaprepitant for Injection and ifosfamide coadministration.
What is the most important information I should know about Fosaprepitant?
- Fosaprepitant may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fosaprepitant with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Fosaprepitant. To prevent pregnancy, be sure to use an extra form of birth control (eg, condoms) while using Fosaprepitant and for 1 month following the last dose of Fosaprepitant.
- Lab tests, including liver function, may be performed while you use Fosaprepitant. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Fosaprepitant with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosaprepitant while you are pregnant. It is not known if Fosaprepitant is found in breast milk. Do not breast-feed while taking Fosaprepitant.
Fosaprepitant contraindications
Fosaprepitant for Injection is contraindicated in patients:
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- who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported.
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- taking pimozide. Inhibition of CYP3A4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide.
References
- DailyMed. "FOSAPREPITANT DIMEGLUMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Fosaprepitant Dimeglumine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- KEGG. "Target-based classification of drugs". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Fosaprepitant are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fosaprepitant. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
