Akynzeo Inj, 20ml

Fosnetupitant is a prodrug of netupitant, a selective antagonist of the human substance P neurokinin-1 (NK1) receptor. Palonosetron is a selective serotonin-3 (5-HT3) receptor antagonist. Both NK1 and 5-HT3 receptors are involved in the emetic reflex. By blocking these receptors, the combination prevents both acute and delayed chemotherapy-induced nausea and vomiting (CINV).

Urgent Side Effects: Seek Medical Help 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 attention 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
Serotonin syndrome, a severe and potentially deadly condition, which may be more likely to occur if you are taking certain other medications. Watch for:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach
+ Vomiting
+ Severe headache

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 do not go away, contact your doctor:

Constipation
Headache
Redness
Feeling tired or weak
* Upset stomach

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Existing health conditions, such as kidney disease or liver disease, that may affect your ability to take this medication.
* 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 rifampin, St. John's Wort, and seizure medications, should not be taken with this drug. Please note that this is not an exhaustive list of interacting medications.

To ensure your safety, it is vital to discuss all of your medications and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication during pregnancy or breast-feeding to make an informed decision about its use.

• Pimozide (due to potential for QT prolongation and inhibition of CYP3A4 by netupitant)

• CYP3A4 substrates with narrow therapeutic index (e.g., cyclosporine, fentanyl, quinidine, ergot alkaloids, alfentanil, triazolam, midazolam, some antiarrhythmics)
• Dexamethasone (dose reduction required due to netupitant's CYP3A4 inhibition)
• QT-prolonging drugs (e.g., amiodarone, sotalol, quinidine, procainamide, disopyramide, dofetilide, cisapride, droperidol, haloperidol, methadone, moxifloxacin, erythromycin, tricyclic antidepressants, antipsychotics) - Palonosetron can cause dose-dependent QT prolongation.

• Other CYP3A4 substrates (e.g., oral contraceptives, tacrolimus, sirolimus, everolimus, some statins)

• Not specifically identified as minor for this combination, but general caution with drugs metabolized by CYP enzymes.

• Nausea
• Vomiting
• Headache
• Constipation
• Fatigue
• Dizziness
• Dyspepsia
• Hiccups
• Abdominal pain
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
• Signs of irregular heartbeat (palpitations, dizziness, fainting)

Limited data on use in pregnant women. Animal studies with netupitant and palonosetron do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Akynzeo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is unknown if fosnetupitant, netupitant, or palonosetron are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Akynzeo and for 1 month after the last dose.

Safety and effectiveness in pediatric patients have not been established.

No dose adjustment is necessary for elderly patients. Clinical studies did not identify differences in efficacy or safety between elderly and younger patients.

• Akynzeo IV is a single-dose regimen for the prevention of acute and delayed CINV associated with HEC and MEC.
• Administer approximately 30 minutes prior to the start of chemotherapy.
• Dexamethasone dose reduction is required when co-administered with Akynzeo due to netupitant's moderate CYP3A4 inhibitory effect (e.g., for HEC, reduce dexamethasone dose by approximately 50%).
• The long half-lives of both components provide extended protection against delayed CINV.
• Ensure proper IV administration over 30 minutes to minimize infusion-related reactions.

• Other NK1 receptor antagonists (e.g., aprepitant, rolapitant)
• Other 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron)
• Corticosteroids (e.g., dexamethasone)
• Olanzapine
• Dopamine receptor antagonists (e.g., prochlorperazine, metoclopramide)
• Cannabinoids (e.g., dronabinol, nabilone)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for 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; do not flush them down the toilet or drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, as they may be aware of local drug take-back programs. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.