Fosaprepitant
Generic: FOSAPREPITANT
Basic Information
Manufacturer
Dr. Reddy's Laboratories Inc.,
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
d624667d-ee3b-3501-53fe-da453352042d
Indications & Usage
1 INDICATIONS AND USAGE Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nauseaand vomiting associated with initial and repeat coursesof highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.
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.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat coursesof highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use ( 1 ) Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.
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.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat coursesof highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use ( 1 ) Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion Site Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions in adults (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 at 1-848-200-1906 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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 dimeglumine regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy).
The most common adverse reactions are listed in Table 6.
Table 6 Most Common Adverse Reactions in Patients Receiving MEC * 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% * Reported in ≥2% of patients treated with the fosaprepitant dimeglumine regimen and at a greater incidence than standard therapy.
† fosaprepitant dimeglumine regimen ‡ Standard therapy Infusion-site reactions were reported in 2.2% of patients treated with the fosaprepitant dimeglumine 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 dimeglumine 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 patientsreceiving the 3-day regimen of oral aprepitant [see Clinical Studies (14.1) ] .
The safety profile was generallysimilar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant.
However,infusion- site reactionsoccurred at a higher incidence in patients in the fosaprepitant group (3.0%) comparedto those in the aprepitant group (0.5%).
The following additional infusion-site reactions occurredin HEC study and were not reportedin the MEC study describedabove: 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 aprepitant 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of fosaprepitant.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possibleto reliably estimatetheir frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermalnecrolysis.
[see Warnings and Precautions (5.2) ] .
Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock [see Contraindications (4) , Warnings and Precautions (5.2) ] .
Nervous system disorders: ifosfamide-induced neurotoxicity reported after fosaprepitant and ifosfamide coadministration.
6.1 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 dimeglumine regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy).
The most common adverse reactions are listed in Table 6.
Table 6 Most Common Adverse Reactions in Patients Receiving MEC * 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% * Reported in ≥2% of patients treated with the fosaprepitant dimeglumine regimen and at a greater incidence than standard therapy.
† fosaprepitant dimeglumine regimen ‡ Standard therapy Infusion-site reactions were reported in 2.2% of patients treated with the fosaprepitant dimeglumine 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 dimeglumine 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 patientsreceiving the 3-day regimen of oral aprepitant [see Clinical Studies (14.1) ] .
The safety profile was generallysimilar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant.
However,infusion- site reactionsoccurred at a higher incidence in patients in the fosaprepitant group (3.0%) comparedto those in the aprepitant group (0.5%).
The following additional infusion-site reactions occurredin HEC study and were not reportedin the MEC study describedabove: 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 aprepitant 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of fosaprepitant.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possibleto reliably estimatetheir frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermalnecrolysis.
[see Warnings and Precautions (5.2) ] .
Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock [see Contraindications (4) , Warnings and Precautions (5.2) ] .
Nervous system disorders: ifosfamide-induced neurotoxicity reported after fosaprepitant and ifosfamide coadministration.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 at 1-848-200-1906 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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 dimeglumine regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy).
The most common adverse reactions are listed in Table 6.
Table 6 Most Common Adverse Reactions in Patients Receiving MEC * 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% * Reported in ≥2% of patients treated with the fosaprepitant dimeglumine regimen and at a greater incidence than standard therapy.
† fosaprepitant dimeglumine regimen ‡ Standard therapy Infusion-site reactions were reported in 2.2% of patients treated with the fosaprepitant dimeglumine 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 dimeglumine 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 patientsreceiving the 3-day regimen of oral aprepitant [see Clinical Studies (14.1) ] .
The safety profile was generallysimilar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant.
However,infusion- site reactionsoccurred at a higher incidence in patients in the fosaprepitant group (3.0%) comparedto those in the aprepitant group (0.5%).
The following additional infusion-site reactions occurredin HEC study and were not reportedin the MEC study describedabove: 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 aprepitant 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of fosaprepitant.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possibleto reliably estimatetheir frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermalnecrolysis.
[see Warnings and Precautions (5.2) ] .
Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock [see Contraindications (4) , Warnings and Precautions (5.2) ] .
Nervous system disorders: ifosfamide-induced neurotoxicity reported after fosaprepitant and ifosfamide coadministration.
6.1 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 dimeglumine regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy).
The most common adverse reactions are listed in Table 6.
Table 6 Most Common Adverse Reactions in Patients Receiving MEC * 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% * Reported in ≥2% of patients treated with the fosaprepitant dimeglumine regimen and at a greater incidence than standard therapy.
† fosaprepitant dimeglumine regimen ‡ Standard therapy Infusion-site reactions were reported in 2.2% of patients treated with the fosaprepitant dimeglumine 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 dimeglumine 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 patientsreceiving the 3-day regimen of oral aprepitant [see Clinical Studies (14.1) ] .
The safety profile was generallysimilar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant.
However,infusion- site reactionsoccurred at a higher incidence in patients in the fosaprepitant group (3.0%) comparedto those in the aprepitant group (0.5%).
The following additional infusion-site reactions occurredin HEC study and were not reportedin the MEC study describedabove: 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 aprepitant 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of fosaprepitant.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possibleto reliably estimatetheir frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermalnecrolysis.
[see Warnings and Precautions (5.2) ] .
Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock [see Contraindications (4) , Warnings and Precautions (5.2) ] .
Nervous system disorders: ifosfamide-induced neurotoxicity reported after fosaprepitant and ifosfamide coadministration.