"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
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 EMEND for injection was evaluated in approximately 1600 individuals.
Adverse Reactions 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 EMEND for injection in combination with ondansetron and dexamethasone (EMEND regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy). The most common adverse reactions are listed in Table 4.
Table 4 : Most Common
Adverse Reactions in Patients Receiving MEC*
|EMEND for injection, ondansetron, and dexamethasone†
|Ondansetron and dexamethasone‡
|urinary tract infection||2%||1%|
|pain in extremity||2%||1%|
|*Reported in ≥ 2% of patients treated with the EMEND regimen and at
a greater incidence than standard therapy.
Infusion-site reactions were reported in 2.2% of patients treated with the EMEND 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 EMEND regimen compared to standard therapy, respectively.
Adverse Reactions 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 EMEND for injection compared to 1169 patients receiving the 3-day regimen of oral EMEND (aprepitant) [see Clinical Studies]. 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 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.
Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with EMEND for injection. See the full prescribing information for EMEND capsules for complete safety information regarding studies performed with oral aprepitant.
The following adverse reactions have been identified during post-approval use of EMEND. 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.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions [see CONTRAINDICATIONS].
Nervous system disorders: ifosfamide-induced neurotoxicity reported after EMEND and ifosfamide coadministration.
Read the Emend Injection (fosaprepitant dimeglumine injection) Side Effects Center for a complete guide to possible side effects
Effect Of Fosaprepitant/Aprepitant On The Pharmacokinetics Of Other Drugs
W hen administered intravenously, fosaprepitant, a prodrug of aprepitant, is converted to aprepitant within 30 minutes. Therefore, drug interactions following administration of EMEND for injection are likely to occur with drugs that interact with oral aprepitant.
Fosaprepitant, given as a single 150-mg dose, is a weak inhibitor of CYP3A4, and the weak inhibition of CYP3A4 continues for 2 days after single dose administration. Single dose fosaprepitant does not induce CYP3A4. Aprepitant is a substrate, an inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9 [see CLINICAL PHARMACOLOGY].
Some substrates of CYP3A4 are contraindicated with EMEND [see CONTRAINDICATIONS]. Dosage adjustment of some CYP3A4 and CYP2C9 substrates may be warranted, as shown in Table 5.
Table 5 : Effects of
Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs
|Clinical Impact||Increased pimozide exposure|
|Intervention||EMEND is contraindicated [see CONTRAINDICATIONS].|
|Clinical Impact||Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see CLINICAL PHARMACOLOGY].|
|Intervention||Monitor for benzodiazepine-related adverse reactions.|
|Clinical Impact||Increased dexamethasone exposure [see CLINICAL PHARMACOLOGY].|
|Intervention||Reduce the dose of oral dexamethasone by approximately 50% [see DOSAGE AND ADMINISTRATION].|
|Clinical Impact||Increased methylprednisolone exposure [see CLINICAL PHARMACOLOGY].|
|Intervention||Reduce the dose of oral methylprednisolone by approximately 50% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC. Reduce the dose of intravenous methylprednisolone by 25% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC.|
|Chemotherapeutic agents that are metabolized by CYP3A4|
|Clinical Impact||Increased exposure of the chemotherapeutic agent may increase the risk of adverse reactions [see CLINICAL PHARMACOLOGY].|
|Intervention||Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents
|Clinical Impact||Decreased hormonal exposure during administration of and for 28 days after administration of the last dose of EMEND [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].|
|Intervention||Effective alternative or back-up methods of contraception (such as condoms and spermicides) should be used during treatment with EMEND and for 1 month following administration of EMEND.|
|Examples||birth control pills, skin patches, implants, and certain IUDs|
|Clinical Impact||Decreased warfarin exposure and prolongation of prothrombin time (INR) [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].|
|Intervention||In patients on chronic warfarin therapy, monitor the prothrombin time (INR) in the 2-week period, particularly at 7 to 10 days, following administration of EMEND with each chemotherapy cycle.|
|Clinical Impact||No change in the exposure of the 5-HT3 antagonist [see CLINICAL PHARMACOLOGY].|
|Intervention||No dosage adjustment needed|
|Examples||ondansetron, granisetron, dolasetron|
Effect Of Other Drugs On The Pharmacokinetics Of Fosaprepitant/Aprepitant
Aprepitant is a CYP3A4 substrate [see CLINICAL PHARMACOLOGY]. Co-administration of EMEND with drugs that are inhibitors or inducers of CYP3A4 may result in increased or decreased plasma concentrations of aprepitant, respectively, as shown in Table 6.
Table 6 :Effects of Other
Drugs on Pharmacokinetics of Fosaprepitant/Aprepitant
|Moderate to Strong CYP3A4 Inhibitors|
|Clinical Impact||Significantly increased exposure of aprepitant may increase the risk of adverse reactions associated with EMEND [see ADVERSE REACTIONS and CLINICAL PHARMACOLOGY].|
|Intervention||Avoid concomitant use of EMEND|
|Examples||Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir|
|Strong CYP3A4 Inducers|
|Clinical Impact||Substantially decreased exposure of aprepitant in patients chronically taking a strong CYP3A4 inducer may decrease the efficacy of EMEND [see CLINICAL PHARMACOLOGY].|
|Intervention||Avoid concomitant use of EMEND|
|Examples||rifampin, carbamazepine, phenytoin|
Last reviewed on RxList: 2/16/2016
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