Emend Injection
- Generic Name: fosaprepitant dimeglumine injection
- Brand Name: Emend Injection
Emend Injection (Fosaprepitant Dimeglumine Injection) side effects drug center
Emend (fosaprepitant dimeglumine injection) is a substance P/neurokinin-1 (NK1) receptor antagonist that works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting and is used together with other medications to prevent nausea and vomiting that may be caused by cancer chemotherapy. Emend is given ahead of time and will not treat nausea or vomiting that is already present. Common side effects of Emend include:
- tiredness,
- hiccups,
- nausea,
- vomiting,
- heartburn,
- stomach pain,
- diarrhea,
- constipation,
- loss of appetite,
- increased thirst,
- hot and dry skin,
- weakness,
- dizziness,
- 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
The dose of Emend for Injection is 150 mg administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Emend may interact with diltiazem, tolbutamide, blood thinners, midazolam or similar medicines, antidepressants, antibiotics, antifungals, birth control pills, cancer medicines, HIV medicines, seizure medications, or steroids. Tell your doctor all medications and supplements you use. During pregnancy, Emend should be used only when prescribed. Emend can make birth control pills less effective, resulting in pregnancy. This effect can last for up to 28 days after the last dose of this medication. Consult your doctor about using a non-hormonal back-up form of birth control (i.e., condoms, diaphragm, or spermicides) during treatment and for at least 1 month after treatment ends. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Emend (fosaprepitant dimeglumine injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching, skin sores or peeling; warmth or tingly feeling; fast or weak heartbeats, severe dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- pain, redness, swelling, burning, blistering, or skin changes where the chemotherapy medicine was injected;
- a light-headed feeling, like you might pass out;
- pain or burning when you urinate; or
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.
Common side effects may include:
- weakness, tired feeling;
- fever;
- low blood cell counts;
- painful urination;
- diarrhea, indigestion; or
- pain, numbness, or weakness in your arms or legs.
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.
Read the entire detailed patient monograph for Emend Injection (Fosaprepitant Dimeglumine Injection)
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The overall safety of EMEND for injection was evaluated in approximately 1600 individuals.
Adverse Reactions for the Prevention of Nausea and Vomiting Associated with MEC
In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of EMEND for injection in combination with ondansetron and dexamethasone (EMEND regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy). The most common adverse reactions are listed in Table 4.
Table 4 : Most Common
Adverse Reactions in Patients Receiving MEC*
| EMEND for injection, ondansetron, and dexamethasone† (N=504) |
Ondansetron and dexamethasone‡ (N=497) |
|
| fatigue | 15% | 13% |
| diarrhea | 13% | 11% |
| neutropenia | 8% | 7% |
| asthenia | 4% | 3% |
| anemia | 3% | 2% |
| peripheral neuropathy | 3% | 2% |
| leukopenia | 2% | 1% |
| dyspepsia | 2% | 1% |
| urinary tract infection | 2% | 1% |
| pain in extremity | 2% | 1% |
| *Reported in ≥ 2% of patients treated with the EMEND regimen and at
a greater incidence than standard therapy. †EMEND regimen ‡Standard therapy |
||
Infusion-site reactions were reported in 2.2% of patients treated with the EMEND regimen compared to 0.6% of patients treated with standard therapy. The infusion-site reactions included: infusion-site pain (1.2%, 0.4%), injection-site irritation (0.2%, 0.0%), vessel puncture-site pain (0.2%, 0.0%), and infusion-site thrombophlebitis (0.6%, 0.0%), reported in the EMEND regimen compared to standard therapy, respectively.
Adverse Reactions for the Prevention of Nausea and Vomiting Associated with HEC
In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single dose of EMEND for injection compared to 1169 patients receiving the 3-day regimen of oral EMEND (aprepitant) [see Clinical Studies]. The safety profile was generally similar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared to those in the aprepitant group (0.5%). The following additional infusion-site reactions occurred in HEC study and were not reported in the MEC study described above: infusion-site erythema (0.5%, 0.1%), infusion-site pruritus (0.3%, 0.0%), and infusion-site induration (0.2%, 0.1%), reported in the fosaprepitant group compared to the aprepitant group, respectively.
Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with EMEND for injection. See the full prescribing information for EMEND capsules for complete safety information regarding studies performed with oral aprepitant.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of EMEND. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions [see CONTRAINDICATIONS].
Nervous system disorders: ifosfamide-induced neurotoxicity reported after EMEND and ifosfamide coadministration.
Read the entire FDA prescribing information for Emend Injection (Fosaprepitant Dimeglumine Injection)
© Emend Injection Patient Information is supplied by Cerner Multum, Inc. and Emend Injection Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.