Emend Injection

DRUG DESCRIPTION

EMEND (fosaprepitant dimeglumine) for Injection is a sterile, lyophilized prodrug of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, and is chemically described as 1-Deoxy-1(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phosphonate (2:1) (salt).

Its empirical formula is C23H22F7N4O6P 2(C7H17NO5) and its structural formula is:

EMEND (fosaprepitant dimeglumine) Structural Formula Illustration

Fosaprepitant dimeglumine is a white to off-white amorphous powder with a molecular weight of 1004.83. It is freely soluble in water.

EMEND (fosaprepitant dimeglumine injection) for Injection is a lyophilized prodrug of aprepitant containing polysorbate 80 (PS80), to be administered intravenously as an infusion.

Each vial of EMEND (fosaprepitant dimeglumine injection) for Injection 115 mg for intravenous administration contains 188 mg of fosaprepitant dimeglumine equivalent to 115 mg of fosaprepitant free acid and the following inactive ingredients: edetate disodium (14.4 mg), polysorbate 80 (57.5 mg), lactose anhydrous (287.5 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). Each vial of EMEND (fosaprepitant dimeglumine injection) for Injection 150 mg for intravenous administration contains 245.3 mg of fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant free acid 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). Fosaprepitant dimeglumine hereafter will be referred to as fosaprepitant.

What are the possible side effects of fosaprepitant (Emend for Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • slow heart rate;
  • pale skin, easy bruising or bleeding; or
  • pain or burning when you urinate.

Less serious side effects may include:

  • nausea, vomiting, heartburn, stomach pain;
  • ...

Read All Potential Side Effects and See Pictures of Emend Injection

What are the precautions when taking fosaprepitant dimeglumine injection (Emend Injection)?

Before using fosaprepitant, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Emend Injection


Emend Injection Consumer (continued)

SIDE EFFECTS: See also How To Use section.

Tiredness and hiccups may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fosaprepitant, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Emend Injection Patient Information Including Side Effects

Brand Names: Emend for Injection

Generic Name: fosaprepitant (Pronunciation: FOS a PREP i tan t)

  • What is fosaprepitant (Emend Injection)?
  • What are the possible side effects of fosaprepitant (Emend Injection)?
  • What is the most important information I should know about fosaprepitant (Emend Injection)?
  • What should I discuss with my health care provider before I receive fosaprepitant (Emend Injection)?
  • How is fosaprepitant given (Emend Injection)?
  • What happens if I miss a dose (Emend Injection)?
  • What happens if I overdose (Emend Injection)?
  • What should I avoid while receiving fosaprepitant (Emend Injection)?
  • What other drugs will affect fosaprepitant (Emend Injection)?
  • Where can I get more information?

What is fosaprepitant (Emend Injection)?

Fosaprepitant blocks the actions of chemicals in the body that trigger nausea and vomiting.

Fosaprepitant is used together with other medications to prevent nausea and vomiting that may be caused by cancer chemotherapy.

Fosaprepitant is given ahead of time and will not treat nausea or vomiting that you already have.

Fosaprepitant may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fosaprepitant (Emend Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • slow heart rate;
  • pale skin, easy bruising or bleeding; or
  • pain or burning when you urinate.

Less serious side effects may include:

  • nausea, vomiting, heartburn, stomach pain;
  • diarrhea or constipation;
  • loss of appetite;
  • hiccups;
  • increased thirst or hot, dry skin;
  • weakness, dizziness, tired feeling;
  • headache;
  • ringing in your ears;
  • fever, chills, body aches, flu symptoms;
  • sleep problems (insomnia); or
  • pain or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fosaprepitant (Emend Injection)?

You should not receive fosaprepitant if you are taking cisapride (Propulsid) or pimozide (Orap). These drugs may cause life-threatening interactions when taken together with fosaprepitant.

Before you receive fosaprepitant, tell your doctor if you have liver disease. You may need a dose adjustment or special tests to safely use this medication.

Fosaprepitant can make birth control pills less effective, resulting in pregnancy. This effect can last for up to 28 days after your last dose of this medication. Talk to your doctor about the use of a non-hormonal back-up form of birth control (such as condoms, a diaphragm, or spermicides) during treatment with fosaprepitant, and for 1 month afterward.

There are many other medicines that can interact with fosaprepitant. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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