Aprepitant aprepitant

Get an overview of APREPITANT (capsule), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Aprepitant can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Aprepitant.

Drug Basics

Brand Name: Aprepitant

Generic Name: APREPITANT

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE

Data Current As Of: 2018-10-11

indications & usage

prevention of chemotherapy induced nausea & vomiting (cinv)

Aprepitant capsules, in combination with other antiemetic agents, are indicated 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.
  • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

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.

prevention of postoperative nausea & vomiting (ponv)

Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting.

limitations of use

  • Aprepitant capsules have not been studied for the treatment of established nausea and vomiting.
  • Chronic continuous administration of aprepitant capsules is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

patient counseling 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

patient information

Aprepitant Capsules

(a-PRE-pi-tant)

Read this Patient Information before you start taking aprepitant and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

What are aprepitant capsules?

  •  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 is not used to treat nausea and vomiting that you already have. Aprepitant should not be used continuously for a long time (chronic use).

Who should not take aprepitant capsules?

Do not take aprepitant capsules if you:

  • are allergic to aprepitant capsules or any of the ingredients in aprepitant capsules. See the end of this leaflet for a complete list of ingredients in aprepitant capsules.
  • are taking pimozide (ORAP®)
  •   What should I tell my doctor before taking 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.
    • oWomen 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:
    • oYour doctor will prescribe a 40 mg capsule of aprepitant for you before surgery. Take aprepitant capsule within three hours before surgery.
    • oFollow 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.

  •   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 Patient Information leaflets. Do not use aprepitant capsules for a condition for which it was not prescribed. Do not give aprepitant capsules to other people, even if they have the same symptoms you have. It 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 Sandoz Inc., at 1-800-525-8747.

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

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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