Akynzeo 235-0.25 Inj, 1vial

Fosnetupitant is a prodrug that is converted to netupitant. Netupitant is a selective antagonist of the human substance P neurokinin-1 (NK1) receptor. Palonosetron is a selective serotonin-3 (5-HT3) receptor antagonist. By blocking these receptors, Akynzeo inhibits both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Very bad 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 unusual symptoms, contact your doctor or seek medical help:

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 about side effects, consult 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.
Existing health conditions, particularly kidney disease or liver disease, as these may affect how your body processes the medication.

Additionally, disclose all medications you are currently taking, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Certain medications should not be taken with this drug, such as rifampin, St. John's Wort, or specific seizure medications. However, this is not an exhaustive list, and it is crucial to discuss all your medications with your doctor to avoid potential interactions.

To ensure your safety, consult with your doctor and pharmacist about all your medications and health conditions before starting this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm 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. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. Your doctor will need to weigh the benefits and risks of this medication for both you and your baby to determine the best course of action.

• Dexamethasone (reduce dose by approximately 50%)
• CYP3A4 substrates with narrow therapeutic index (e.g., midazolam, fentanyl, quinidine, ergot alkaloids, certain chemotherapy agents like docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, doxorubicin)

• Other CYP3A4 substrates (monitor for increased exposure)

• Nausea
• Vomiting
• Headache
• Constipation
• Fatigue
• Dizziness
• Signs of hypersensitivity reactions

There are no available data on Akynzeo use in pregnant women to inform a drug-associated risk. Animal studies with netupitant and palonosetron have not shown adverse developmental effects at clinically relevant exposures. Use only if the potential benefit justifies the potential risk to the fetus.

Advise women not to breastfeed during treatment with Akynzeo and for 1 month after the last dose due to the potential for serious adverse reactions in breastfed infants.

Safety and effectiveness have not been established in pediatric patients.

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

• Akynzeo IV is a single-dose regimen, administered as a 30-minute infusion prior to chemotherapy.
• It effectively prevents both acute and delayed CINV due to its dual mechanism of action (NK1 and 5-HT3 receptor antagonism).
• A 50% dose reduction of dexamethasone is recommended when co-administered with Akynzeo due to netupitant's CYP3A4 inhibitory effect.
• The long half-lives of both components provide prolonged antiemetic protection.
• Ensure proper IV infusion technique and monitor for infusion-related reactions.

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

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. 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 pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may have additional patient information leaflets, 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.