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APREPITANT capsuleAPREPITANT kit


  1. Patient Information
  2. Do Not Take Aprepitant Capsules If You:
  3. Before You Take Aprepitant Capsules, Tell Your Doctor If You:
  4. How Should I Take Aprepitant Capsules?
  5. Intravenous (iv) Injection Into A Vein On Day 1 Of Chemotherapy, Then Capsules By Mouth On The Two Days After Chemotherapy:
  6. If You Are An Adult And Are Having Surgery:
  7. What Are The Possible Side Effects Of Aprepitant Capsules?
  8. What Are The Ingredients In Aprepitant Capsules?
  9. Aprepitant Capsules Are A Prescription Medicine Used:
  10. Capsules Of Aprepitant By Mouth For All 3 Doses:
  11. Day 2 And Day 3:
  12. Day 1 (day Of Chemotherapy):
  13. How Should I Store Aprepitant Capsules?
  14. Active Ingredient:
  15. Inactive Ingredients:
  16. Manufactured By:
  17. Manufactured For:

Patient Information 

Advise the patient to read the FDA-Approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients taking aprepitant. Advise patients to stop taking aprepitant and seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, or difficulty in breathing or swallowing.

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 patients on chronic warfarin therapy 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, following initiation of the 3-day regimen of aprepitant with each chemotherapy cycle, or following administration of a single 40-mg dose of aprepitant for the prevention of postoperative nausea and vomiting[see Warnings and Precautions (5.2)].

Hormonal Contraceptives

Advise patients that administration of aprepitant may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with aprepitant and for 1 month following the last dose of aprepitant[see Warnings and Precautions (5.3), Use in Specific Populations (8.3)].

The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Finished Drug Product Manufactured by

Lek Pharmaceuticals d.d.,

SI-1526 Ljubljana, Slovenia for

Sandoz Inc., Princeton, NJ 08540

Product of India

Rev.: June 2017

Do Not Take Aprepitant Capsules If You: 

are allergic to aprepitant capsules or any of the ingredients in aprepitant capsules.

Before You Take Aprepitant Capsules, Tell Your Doctor If You: 

have liver problems
are pregnant or plan to become pregnant. It is not known if aprepitant capsules can harm your unborn baby.
o
Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use a back-up method of birth control during treatment with aprepitant capsules and for 1 month after your last dose of aprepitant capsules.
are breastfeeding or plan to breastfeed. It is not known if aprepitant passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take aprepitant capsules.
Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Aprepitant capsules may affect the way other medicines work, and other medicines may affect how aprepitant works causing serious side effects.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How Should I Take Aprepitant Capsules? 

Take aprepitant capsules exactly as prescribed.
Swallow aprepitant capsules whole.
If you are receiving chemotherapy, aprepitant capsules may be taken with or without food.
If you take too many aprepitant capsules, call your doctor, or go to the nearest hospital emergency room.
If you are receiving cancer chemotherapy, aprepitant capsules is taken as 3 doses over 3 days - starting on the day you have chemotherapy, and for the following 2 days.
In adults who are receiving chemotherapy, there are 2 ways that your doctor may prescribe aprepitant capsules for you:
1.
Capsules of aprepitant by mouth for all 3 doses:
You should get a package that has three capsules of aprepitant.
Day 1 (Day of chemotherapy): Take one 125 mg capsule of aprepitant (opaque light blue and opaque white) by mouth 1 hour before you start your chemotherapy treatment.
Day 2 and Day 3: Take one 80 mg capsule of aprepitant (opaque white/clear transparent) by mouth1 hour before you start your chemotherapy treatment. If no chemotherapy treatment is given on Days 2 and 3, aprepitant capsules should be taken in the morning.
2.

Intravenous (iv) Injection Into A Vein On Day 1 Of Chemotherapy, Then Capsules By Mouth On The Two Days After Chemotherapy: 

Day 1 (Day of chemotherapy): Aprepitant will be given to you by intravenous (IV) injection in your vein 30 minutes before you start your chemotherapy treatment.
You should get a package that has two capsules of aprepitant.
Day 2 and Day 3: Take one 80 mg capsule of aprepitant (opaque white/clear transparent) by mouth1 hour before you start your chemotherapy treatment. If no chemotherapy treatment is given on Days 2 and 3, aprepitant capsules should be taken in the morning.

If You Are An Adult And Are Having Surgery: 

o
Your doctor will prescribe a 40 mg capsule of aprepitant for you before surgery. Take aprepitant capsule within three hours before surgery.
o
Follow your doctor's instructions about restrictions on eating and drinking before surgery.
If you take the blood thinner medicine warfarin sodium (COUMADIN, JANTOVEN), your doctor may do blood tests after you take aprepitant to check your blood clotting.

What Are The Possible Side Effects Of Aprepitant Capsules? 

In adults taking aprepitant to prevent nausea and vomiting caused by chemotherapy, the most common side effects of include tiredness, diarrhea, weakness, indigestion, stomach (abdominal) pain, hiccups, decrease in white blood cell count, dehydration, changes in liver function tests.
In adults taking aprepitant to prevent nausea and vomiting after surgery, the most common side effect include constipation, low blood pressure (hypotension).

Tell your doctor 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 aprepitant capsules. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088.

What Are The Ingredients In Aprepitant Capsules? 

Active ingredient: aprepitant

Inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose.

The capsule shell for 40 mg and 80 mg contains gelatin and titanium dioxide. The capsule shell for 125 mg contains FD&C Blue # 1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac.

Pediatric use information is approved for Merck Sharp & Dohme Corp. s EMEND(aprepitant) capsules. However, due to Merck Sharp & Dohme Corp s marketing exclusivity rights, this drug product is not labeled with that information.

The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Finished Drug Product Manufactured by

Lek Pharmaceuticals d.d.,

Sl-1526 Ljubljana, Slovenia for

Sandoz Inc., Princeton, NJ 08540

Product of India

Rev.: June 2017

Aprepitant Capsules Are A Prescription Medicine Used: 

In adults to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines. When used for this purpose, aprepitant capsules are always used with other medicines that treat nausea and vomiting.
In adults to prevent nausea and vomiting after surgery

Aprepitant capsules are not used to treat nausea and vomiting that you already have.

Aprepitant capsules should not be used continuously for a long time (chronic use).

Capsules Of Aprepitant By Mouth For All 3 Doses: 

You should get a package that has 3 capsules of aprepitant.

Day 2 And Day 3: 

Take one 80 mg capsule of aprepitant (white) by mouth 1 hour before you start your chemotherapy treatment. If no chemotherapy treatment is given on Days 2 and 3, aprepitant capsules should be taken in the morning.

Day 1 (day Of Chemotherapy): 

Aprepitant will be given to you by intravenous (IV) injection in your vein 30 minutes before you start your chemotherapy treatment.
You should get a package that has 2 capsules of aprepitant.

How Should I Store Aprepitant Capsules? 

Store at room temperature, between 68 F to 77 F (20 C to 25 C).

Keep aprepitant capsules and all medicines out of the reach of children.

General information about the safe and effective use of aprepitant capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use aprepitant capsules for a condition for which they were not prescribed. Do not give aprepitant capsules to other people, even if they have the same symptoms you have. They may harm them. You can ask your doctor or pharmacist for information about aprepitant capsules that is written for health professionals. For more information about aprepitant capsules call 1-888-721-7115.

Active Ingredient: 

aprepitant

Inactive Ingredients: 

colloidal silicon dioxide, hydroxyethyl cellulose, microcrystalline cellulose, mannitol, poloxamer, povidone, sodium stearyl fumarate, vitamin E polyethylene glycol succinate, and purified water. The capsule shell excipients are gelatin, sodium lauryl sulphate and titanium dioxide. The 40-mg capsule shell also contains iron oxide yellow, and the 125-mg capsule also contains FD&C Red #3. Non-volatile solvents in the imprinting ink are shellac, iron oxide black and potassium hydroxide.

Pediatric use information is approved for Merck Sharp & Dohme Corp.'s EMEND(aprepitant) capsules. However, due to Merck Sharp & Dohme Corp's marketing exclusivity rights, this drug product is not labeled with that information.

The brands listed in the above sections "Who should not take aprepitant capsules?" and "How should I take aprepitant capsules?" are the registered trademarks of their respective owners and are not trademarks of Glenmark Pharmaceuticals Inc., USA.

Manufactured By: 

Glenmark Pharmaceuticals Ltd.

Plot No. 2, Phase-2, Pharma Zone SEZ

Pithampur, Dist.-Dhar

Madhya Pradesh 454 775, India

Manufactured For: 

logo

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

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

Revised: June 2017



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