FOSAPREPITANT DIMEGLUMINE 150 mg/5mL
FOSAPREPITANT DIMEGLUMINE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Hikma Pharmaceuticals USA Inc.
FOSAPREPITANT DIMEGLUMINE is a injection, powder, lyophilized, for solution containing fosaprepitant dimeglumine at 150 mg/5mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- FOSAPREPITANT DIMEGLUMINE
- Generic Name
- FOSAPREPITANT DIMEGLUMINE
- NDC Code (Product)
0143-9428- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 150 mg/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213106
- Marketing Start
- 05/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of 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 has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of 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 n…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Adult Dosage ( 2.1 ) Fosaprepitant for injection 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes. ( 2.1 ) Complete the infusion approximately 30 minutes prior to chemotherapy. Recommended Dosage for Pediatric Patients (6 months to 17 years) Weighing at Least 6 kg ( 2.2 ) See full prescribing information for pediatric dosage regimens by age. For single dose chemotherapy regimens : single dose of fosaprepitant for injection on Day 1. For single or multi-day chemotherapy regimens : 3-day fosaprepitant regimen of fosaprepitant for injection on Days 1, 2, and 3. Fosaprepitant capsules or fosaprepitant for oral suspension may be used as an alternative on Days 2 and 3. Administer fosaprepitant for injection through a central venous catheter as an intravenous infusion over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years). Complete the infusion approximately 30 minutes prior to chemotherapy. Concomitant Antiemetics See full prescribing information for additional information. ( 2.1 , 2.2 ) 2.1 Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients The recommended dosage of fosapr…
Contraindications
4 CONTRAINDICATIONS Fosaprepitant is contraindicated in patients: who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ]. 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 [see Warnings and Precautions (5.1) ]. Known hypersensitivity to any component of this drug. ( 4 , 5.2 ) Concurrent use with pimozide. (4)
Drug Interactions
7 DRUG INTERACTIONS See full prescribing information for a list of clinically significant drug interactions. ( 4 , 5.1 , 5.4 , 5.5 , 7.1 , 7.2 ) 7.1 Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs When administered intravenously, fosaprepitant, a prodrug of aprepitant, is converted to aprepitant within 30 minutes. Therefore, drug interactions following administration of fosaprepitant 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 (12.3) ] . Some substrates of CYP3A4 are contraindicated with fosaprepitant [see Contraindications (4) ]. Dosage adjustment of some CYP3A4 and CYP2C9 substrates may be warranted, as shown in Table 7. Table 7 Effects of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs CYP3A4 Substrates Pimozide Clinical Impact Increased pimozide exposure In…
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 ) Adverse reactions in pediatrics are similar to adults. To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 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 1,800 adult and pediatric patients. Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with MEC In an active-controlled clinical trial in patients receiving ME…
Frequently Asked Questions
What is FOSAPREPITANT DIMEGLUMINE used for?
FOSAPREPITANT DIMEGLUMINE contains FOSAPREPITANT DIMEGLUMINE. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is FOSAPREPITANT DIMEGLUMINE a controlled substance?
FOSAPREPITANT DIMEGLUMINE is not classified as a controlled substance by the DEA.
What is the generic name for FOSAPREPITANT DIMEGLUMINE?
The generic name for FOSAPREPITANT DIMEGLUMINE is FOSAPREPITANT DIMEGLUMINE. There are 8 other brand versions of FOSAPREPITANT DIMEGLUMINE.
What is the NDC code for FOSAPREPITANT DIMEGLUMINE 150 mg/5mL?
The NDC (National Drug Code) for FOSAPREPITANT DIMEGLUMINE 150 mg/5mL is 0143-9428, listed by Hikma Pharmaceuticals USA Inc..