Emend 150mg Soln For Inj, 1 Vial

Fosaprepitant is a prodrug of aprepitant. After intravenous administration, fosaprepitant is rapidly converted to aprepitant. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. It augments the antiemetic activity of 5-HT3 receptor antagonists and corticosteroids and inhibits both the acute and delayed phases of chemotherapy-induced emesis.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Flushing
Dizziness or fainting
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
If the medication leaks from the vein, it may cause tissue damage. Inform your nurse immediately if you experience:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid at the injection site
Low blood cell counts can occur with this medication, increasing the risk of:
+ Bleeding problems
+ Infections
+ Anemia
+ If you experience signs of infection, such as fever, chills, or sore throat, or notice unexplained bruising or bleeding, or feel extremely tired or weak, contact your doctor right away

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

Feeling tired or weak
Stomach pain or diarrhea
Heartburn
Pain in arms or legs

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken together.

Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of taking this medication. Therefore, it is vital to discuss all of your medications and health conditions with your doctor and pharmacist to ensure safe use.

To guarantee your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
* Changing the dose of any medication

Never modify your medication regimen without first consulting your doctor to confirm that it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To avoid potential interactions, do not consume grapefruit or grapefruit juice while taking this drug.

If you are using birth control pills or other hormone-based birth control methods, be aware that this medication may reduce their effectiveness in preventing pregnancy. As a precaution, use an additional form of birth control, such as a condom, during treatment and for 1 month after the last dose.

If you are pregnant, planning to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• Pimozide (due to potential for increased pimozide levels and serious/life-threatening reactions, including QT prolongation)

• Warfarin (may decrease INR; monitor INR closely for 2 weeks after fosaprepitant administration)
• Oral contraceptives (may decrease efficacy of hormonal contraceptives; use alternative or back-up contraception)
• CYP3A4 substrates with narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, ergot alkaloids like ergotamine and dihydroergotamine, irinotecan, vinblastine, vincristine, etoposide, ifosfamide, docetaxel, alprazolam, triazolam, midazolam, diltiazem, verapamil, corticosteroids like dexamethasone and methylprednisolone - dose adjustments may be needed)
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital - may decrease aprepitant plasma concentrations and efficacy)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir - may increase aprepitant plasma concentrations)

• Dexamethasone (reduce dexamethasone dose by approximately 50% when co-administered with fosaprepitant)
• Methylprednisolone (reduce methylprednisolone dose by approximately 50% when co-administered with fosaprepitant)
• Tolbutamide (CYP2C9 substrate; aprepitant may induce CYP2C9, potentially reducing tolbutamide levels)
• Phenytoin (CYP2C9 substrate; aprepitant may induce CYP2C9, potentially reducing phenytoin levels)
• Theophylline (CYP1A2 substrate; aprepitant may induce CYP1A2, potentially reducing theophylline levels)

• Not specifically categorized as minor, but general caution with other drugs metabolized by CYP3A4, CYP2C9, or CYP1A2.

• Nausea
• Vomiting
• Hiccups
• Fatigue
• Headache
• Dizziness
• Constipation
• Diarrhea
• Dyspepsia
• Abdominal pain
• Injection site reactions (pain, erythema, swelling, induration, thrombophlebitis)

Available data from published studies and postmarketing reports on aprepitant use in pregnant women are not sufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies with aprepitant showed no adverse developmental effects. Use only if clearly needed.

It is not known whether aprepitant is excreted in human milk. Aprepitant is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from aprepitant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Approved for pediatric patients 6 months and older for CINV. Dosing is weight-based for younger children (6 months to <12 years) and a fixed dose for adolescents (12-17 years). Safety and effectiveness in pediatric patients younger than 6 months of age have not been established.

No dose adjustment is necessary based on age. However, elderly patients may be more susceptible to some adverse reactions. Monitor for age-related comorbidities and polypharmacy that may increase interaction risk.

• Fosaprepitant is a prodrug that converts to aprepitant, the active antiemetic.
• Administer IV infusion slowly over 20-30 minutes to minimize injection site reactions.
• It is typically used as part of a multi-drug antiemetic regimen for CINV, often with a 5-HT3 antagonist and a corticosteroid (e.g., dexamethasone).
• Remember to adjust the dose of co-administered corticosteroids (e.g., dexamethasone) by approximately 50% due to aprepitant's CYP3A4 inhibitory effects.
• Monitor INR closely for patients on warfarin for up to 2 weeks after fosaprepitant administration.

• Other NK1 receptor antagonists (e.g., rolapitant, netupitant/palonosetron combination)
• 5-HT3 receptor antagonists (e.g., ondansetron, palonosetron, granisetron, dolasetron)
• Corticosteroids (e.g., dexamethasone)
• Dopamine receptor antagonists (e.g., prochlorperazine, metoclopramide)
• Olanzapine (often used in highly emetogenic regimens)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.