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FOSAPREPITANT injection, powder, lyophilized, for solution


  1. Patient Information
  2. Warfarin:
  3. Hormonal Contraceptives:
  4. Distributor:
  5. What Is Fosaprepitant For Injection?
  6. Are Allergic To Fosaprepitant, Aprepitant, Or Any Of The Ingredients In Fosaprepitant For Injection. Adults 18 Years Of Age And Older:
  7. What Are The Possible Side Effects Of Fosaprepitant For I Njection?
  8. S Side Effects, Including:
  9. In Adults, The Most Common Side Effects Of Fosaprepitant For Injection Include:
  10. What Are The Ingredients In Fosaprepitant For I Njection?
  11. Edison, Nj 08837issued On:
  12. What Is Fosaprepitant For Injection?
  13. Before Receiving Fosaprepitant For Injection, Tell Your Healthcare Provider If You:
  14. Fosaprepitant For Injection?
  15. Fosaprepitant For Injection May Cause Serious Side Effects, Including:
  16. General Information About The Safe And Effective Use Of Fosaprepitant For Injection?
  17. What Are The Ingredients In Fosaprepitant For Injection?
  18. Do Not Receive Fosaprepitant For Injection If You:
  19. Adults 18 Years Of Age And Older:
  20. Fosaprepitant For Injection May Cause Serious Side Effects, Including:
  21. In Adults, The Most Common Side Effects Of Fosaprepitant For Injection Include:
  22. Active Ingredient:
  23. Inactive Ingredients:
  24. Manufactured For:
  25. Manufactured By:

Patient Information 

Advise the patient to read the FDAapproved patientlabeling (Patient Information).

Hypersensitivity

Advise patientsthat hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients taking fosaprepitant. Advisepatients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, flushing, difficulty in breathingor swallowing, or dizziness, rapid or weak heartbeat or feeling faint [see warnings and precautions (5.2)].

Infusion Site Reactions

Advise patients to seek medical attention if they experience new or worsening signs or symptoms of an infusion site reaction, such as erythema, edema, pain, necrosis, vasculitis, or thrombophlebitis at or near the infusion site [see Warnings and Precautions (5.3)].

Drug Interactions

Advise patients to discuss all medications they are taking, including other prescription, non prescription medication or herbal products[see Contraindications(4), Warnings and Precautions (5.1)].

Warfarin: 

Instruct patientson chronic warfarintherapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, followinginitiation of fosaprepitant with each chemotherapy cycle [see Warningsand Precautions (5.4)].

Hormonal Contraceptives: 

Advise patients that administration of fosaprepitant may reduce the efficacy of hormonal contraceptives. Instruct patients to use effectivealternative or back-upmethods of contraception (such as condomsand spermicides) during treatment with fosaprepitant and for 1 month following administration of fosaprepitant [see Warnings and Precautions (5.5),Use in Specific Populations (8.3)].

Distributor: 

Dr. Reddy s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 0319

What Is Fosaprepitant For Injection? 


Fosaprepitant for injection is a prescription medicine used with other medicines that treat nausea and vomiting in patients 18 years of age and older to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines.
  • Fosaprepitant for injection is not used to treat nausea and vomiting that you already have.
  • It is not known if fosaprepitant for injection is safe and effective in children less than 6 months of age.

Are Allergic To Fosaprepitant, Aprepitant, Or Any Of The Ingredients In 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 I Njection? 


Fosaprepitant for i njection may cause seriou

S Side Effects, Including: 

  • serious allergic reactions.Allergic reactions can happen with fosaprepitant for injection and may be serious. Tell your doctor or nurse right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness,a rapid or weak heartbeat, or you feel faint during or soon after you receive fosaprepitant for injection, as you may need emergency medical care.
  • Severe skin reactions, which may include rash, skin peeling, or sores, may occurs,
  • Infusion site reactions (ISR) at or near the infusion site have happened with fosaprepitant for injection.
    Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness. Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine. Most ISR can happen with the first, second, or third dose and some can last up to 2 weeks or longer. Tell your healthcare provider right away if you get any infusion site side effects.

In Adults, The Most Common Side Effects Of Fosaprepitant For Injection Include: 


  • tiredness
  • feeling weak or numb in your arms and legs
  • diarrhea
  • painful, difficult, or changes in your digestion (dyspepsia)
  • low white blood cell and red blood cell counts
  • urinary tract infection
  • weakness
  • pain in your arms and legs

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 call 1-848-200-1906 or go to www.msnlabs.com

What Are The Ingredients In Fosaprepitant For I Njection? 


Active ingredient: fosaprepitant dimeglumine
Inactive ingredients: edetate disodium, lactose anhydrous, polysorbate 80,sodium hydroxide and/ or hydrochloric acid (for pH adjustment).
The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse MSN Pharmaceuticals Inc.
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.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by:
MSN Laboratories Private Limited

Telangana 509 216
INDIA
Distributed by:
MSN Pharmaceuticals Inc.

Edison, Nj 08837issued On: 


January 2019

What Is Fosaprepitant For Injection? 

Fosaprepitant for injection is a prescription medicine used with other medicines that treat nausea and vomiting in patients 18 years of age and older to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines.

Fosaprepitant for injection is not used to treat nausea and vomiting that you already have.

It is not known if fosaprepitant for injection is safe and effective in children less than 6 months of age.

Before Receiving Fosaprepitant For Injection, Tell Your Healthcare Provider If You: 

have liver problems

are pregnant or plan to become pregnant. It is not known if fosaprepitant for injection can harm your unborn baby.

Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use a backup method of birth control that does not contain hormones, such as condoms and spermicides, during treatment with fosaprepitant for injection and for 1 month after receiving fosaprepitant for injection.

are breastfeeding or plan to breastfeed. It is not known if fosaprepitant for injection passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive fosaprepitant for injection.

Tellyourhealthcare provideraboutallthe medicinesyou take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.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.

Fosaprepitant For Injection May Cause Serious Side Effects, Including: 

Serious allergic reactions.Allergic reactions can happen with fosaprepitant for injection and may be serious. Tell your doctor or nurse right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness, a rapid or weak heartbeat, or you feel faint during or soon after you receive fosaprepitant for injection, as you may need emergency medical care.

Severe skin reactions, which may include rash, skin peeling, or sores, may occur.

Infusion site reactions (ISR) at or near the infusion site have happened with fosaprepitant for injection.

Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness. Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine. Most ISR can happen with the first, second, or third dose and some can last up to 2 weeks or longer. Tell your healthcare provider right away if you get any infusion site side effects.

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 call 1-848-200-1906 or go to www.msnlabs.com.

What Are The Ingredients In Fosaprepitant For Injection? 

Active ingredient: fosaprepitant dimeglumine

Inactive ingredients: edetate disodium, lactose anhydrous, polysorbate 80, sodium hydroxide and/ or hydrochloric acid (for pH adjustment).The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse MSN Pharmaceuticals Inc.

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

.This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributor:Dr. Reddy s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 0319

Do Not Receive Fosaprepitant For Injection If You: 

are allergic to fosaprepitant, aprepitant, or any of the ingredients in 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.

or

1. Fosaprepitant for injection 115 mg given along with capsules of aprepitant.

o
Day 1 (Day of chemotherapy): Fosaprepitant for injection 115 mg will be given to you by intravenous (IV) infusion in your vein about 30 minutes before you start your chemotherapy treatment.
o
You will get a prescription for two capsules of aprepitant
o
Day 2 and Day 3 (the two days after chemotherapy): Take one 80 mg capsule of aprepitant (white) by mouth, each morning for the 2 days after 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.

Fosaprepitant For Injection May Cause Serious Side Effects, Including: 

Serious allergic reactions.Allergic reactions can happen with fosaprepitant for injection and may be serious. Tell your doctor or nurse right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness, a rapid or weak heartbeat, or you feel faint during or soon after you receive fosaprepitant for injection, as you may need emergency medical care.
Severe skin reactions, which may include rash, skin peeling, or sores, may occur.
Infusion site reactions (ISR) at or near the infusion site have happened with fosaprepitant for injection.

Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness. Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine. Most ISR can happen with the first, second, or third dose and some can last up to 2 weeks or longer. Tell your healthcare provider right away if you get any infusion site side effects.

In Adults, The Most Common Side Effects Of Fosaprepitant For Injection Include: 

tiredness
diarrhea
low white blood cell and red blood cell counts
weakness
feeling weak or numb in your arms and legs
painful, difficult, or changes in your digestion (dyspepsia)
urinary tract infection
pain in your arms and legs

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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or 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 call 1-877-446-3679 (1-877-4-INFO-RX) or to FDA at 1-800-FDA-1088.

Active Ingredient: 

fosaprepitant dimeglumine

Inactive Ingredients: 

edetate disodium, polysorbate 80, lactose anhydrous, sodium hydroxide and/or hydrochloric acid (for pH adjustment)

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.

The brands listed are the registered trademarks of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured For: 

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufactured By: 

Mylan Laboratories Limited

Bangalore, India

FEBRUARY 2019



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