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Fosaprepitant Dimeglumine (Fosaprepitant)

Trade Name : Fosaprepitant

Baxter Healthcare Corporation

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 150 mg/5mL

FOSAPREPITANT DIMEGLUMINE Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fosaprepitant Dimeglumine (Fosaprepitant) which is also known as Fosaprepitant and Manufactured by Baxter Healthcare Corporation. It is available in strength of 150 mg/5mL per ml. Read more

Fosaprepitant Dimeglumine (Fosaprepitant) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions (5.2) 08/2017Warnings and Precautions (5.3) 03/2018
  • Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:
  • Limitations of Use
  • Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.u2019s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Fosaprepitant for Injection is a substance P/neurokinin-1 (NK) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ():
  • 1
  • Recommended Dosage (
  • )
  • 2.1
  • Fosaprepitant for Injection: 150 mg fosaprepitant, white to off-white lyophilized powder in single-dose glass vial for reconstitution
  • Fosaprepitant for Injection: 150 mg fosaprepitant, lyophilized powder in single-dose vial for reconstitution. ()
  • Fosaprepitant for Injection is contraindicated in patients:
  • 4n- 5.2
  • No data
  • CYP3A4 Interactions:
  • Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock):
  • Infusion Site Reactions (including thrombophlebitis, necrosis, and vasculitis):
  • Warfarin (a CYP2C9 substrate):
  • Hormonal Contraceptives:
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions in adults (u22652%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. ()
  • See Full Prescribing Information for a list of clinically significant drug interactions. (, , , , , )
  • Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.u2019s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • No data
  • There is no specific information on the treatment of overdosage with fosaprepitant or aprepitant.
  • In the event of overdose, Fosaprepitant for Injection should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of Fosaprepitant for Injection, drug-induced emesis may not be effective in cases of Fosaprepitant for Injection overdosage.
  • Aprepitant is not removed by hemodialysis.
  • Fosaprepitant for Injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2,3)-2-[(1)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1-1,2,4-triazol-1-yl]phosphonate (2:1) (salt).
  • Its empirical formula is CHFNOP u22c5 2(CHNO) and its structural formula is:
  • Fosaprepitant dimeglumine is a white to off-white amorphous powder with a molecular weight of 1004.83. It is freely soluble in water.
  • Each vial of Fosaprepitant for Injection for administration as an intravenous infusion contains 150u00a0mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (18.8 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment).
  • No data
  • Carcinogenesisn
  • Mutagenesis
  • Impairment of Fertility
  • No data
  • Storagen
  • The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25u00b0Cu00a0(77u00b0F)].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Hypersensitivityn n- [see ].
  • Infusion Site Reactionsn- [see ]
  • Drug Interactionsn- [see , ]
  • Warfarin:n- [see ]
  • Hormonal Contraceptives:n- [see , ]
  • Baxter is a registered trademark of Baxter International Inc.
  • Any other trademarks, product names, or brand images appearing herein are the property of their respective owners.
  • Manufactured for:n Deerfield, IL 60015 USA
  • Product of China
  • Revised: 09/201907-19-00-1553
  • Fosaprepitant
  • for Injection
  • Read this Patient Information before you start receiving Fosaprepitant for Injection and each time you are scheduled to receive Fosaprepitant for Injection. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • What is Fosaprepitant for Injection?n
  • Who should not receive Fosaprepitant for Injection?
  • Do not receive Fosaprepitant for Injection if you:
  • What should I tell my healthcare provider before receiving Fosaprepitant for Injection?
  • Before receiving Fosaprepitant for Injection, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Fosaprepitant for Injection may affect the way other medicines work, and other medicines may affect the way Fosaprepitant for Injection works, causing serious side effects.
  • Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
  • How will I receive Fosaprepitant for Injection?
  • Adults 18 years of age and older:
  • Fosaprepitant for Injection will be given on Day 1 of chemotherapy treatment. It will be given to you by intravenous (IV) infusion in your vein about 50 to 60 minutes before you start your chemotherapy treatment.
  • If you take the blood thinner medicine warfarin sodium (COUMADIN, JANTOVEN), your healthcare provider may do blood tests after you receive Fosaprepitant for Injection to check your blood clotting.
  • What are the possible side effects of Fosaprepitant for Injection?
  • Fosaprepitant for Injection may cause serious side effects, including:
  • In adults, the most common side effects of Fosaprepitant for Injection include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Fosaprepitant for Injection. For more information ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use of Fosaprepitant for Injection.
  • If you would like more information about Fosaprepitant for Injection, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Fosaprepitant for Injection that is written for health professionals. For more information about Fosaprepitant for Injection go to .
  • What are the ingredients in Fosaprepitant for Injection?
  • Active ingredient:
  • Inactive ingredients:
  • Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.u2019s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Manufactured for:n Deerfield, IL 60015 USA
  • Baxter is a registered trademark of Baxter International Inc.
  • Any other trademarks, product names or brand images appearing herein are the property of their respective owners.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Revised: 09/2019
  • Store vial refrigerated at2u00b0C-8u00b0C (36u00b0F-46u00b0F).n
  • Fosaprepitantfor Injectionn
  • 150 mg per vialSingle-Dose Vial -Discard Unused Portion
  • Rx onlyn- Array
  • Bar Code3 03380 00801 8n
  • Manufactured for:n Deerfield, IL 60015 USAProduct of ChinaBaxter is a registered trademark ofBaxter International Inc.Lot/Exp.07-32-00-0011
  • Fosaprepitant for Injection vial must be refrigerated at2u00b0C-8u00b0C (36u00b0F-46u00b0F).
  • The reconstituted final drug solutionis stable for 24 hours at ambientroom temperature [at or below25u00b0C (77u00b0F)].
  • Baxter is registered trademark of Baxter International Inc.
  • Manufactured for:n Deerfield, IL 60015 USAProduct of China
  • Arrayn- Baxter Logo
  • 07-01-00-0249
  • 2D DATA MATRIXBARCODEFOR POSITION ONLY
  • GTINSNEXPLOT
  • NDC n- Fosaprepitantfor Injection
  • 150 mg per vial
  • Reconstitue with 5 mL of 0.9% Sodium Chloride for Injection.
  • Sterile lyophilized powder for intravenous use only after reconstitution and dilution
  • DO NOT USE WITH SOLUTIONSCONTAINING DIVALENT CATIONS(e.g., Ca, Mg) INCLUDINGLACTATED RINGERu2019S SOLUTIONAND HARTMANNu2019S SOLUTION.
  • Rx only
  • Single-Dose Vial u2013Discard Unused Portion
  • Fosaprepitantfor Injection
  • 150 mg per vial
  • Single-Dose Vial u2013 Discard Unused Portion
  • Each vial contains:Fosaprepitantu2026u2026u2026u2026u2026u2026u2026.150 mg(equivalent to 245.3 mg of fosaprepitant dimeglumine)
  • Inactive Ingredients:edetate disodium (18.8 mg),polysorbate 80 (75 mg),lactose anhydrous (375 mg),sodium hydroxide and/orhydrochloric acid (for pH adjustment).
  • Usual Dosage: See prescribing information
  • Read accompanying directions carfully for the preparation of Fosaprepitant for Injection.
  • Vial for single use only.Discard unused portion.
  • Bar Code3 03380 00801 8

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