Akynzeo

(Netupitant/Palonosetron Hydrochloride)

The active ingredients in Akynzeo capsules are netupitant and palonosetron hydrochloride. The active ingredients in Akynzeo injection are fosnetupitant and palonosetron. Netupitant and fosnetupitant belong to a class of medications known as substance P or neurokinin-1/NK-1 receptor antagonists. It is thought that much of the nausea and vomiting that occurs for days after chemotherapy is due to elevated levels of substance P in the body, and inhibiting its actions can help prevent the delayed onset of nausea and vomiting. Palonosetron, on the other hand, belongs to a class of medications known as 5-HT3 receptor antagonists. These medications block the effects of serotonin at key vomiting centers in the body’s nervous system. This mechanism of action, along with that of netupitant/fosnetupitant, allows Akynzeo to work as a highly effective antiemetic for both the prevention of acute and delayed phases of nausea and vomiting.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Akynzeo. However, the following is a synopsis of the general guidelines for the use of Akynzeo:

• Akynzeo should be used exactly as prescribed.
• For those on cancer chemotherapy, Akynzeo capsules should be taken about 1 hour before your appointment. The capsule may be taken with or without food. The Akynzeo injection, on the other hand, will be given to you by IV infusion about 30 minutes before treatment. This is typically repeated for each chemotherapy cycle, and the recommended dose is either 1 capsule or 1 injection.

Some of the mild or most common side effects of Akynzeo seen in clinical trials include:

• Headache
• Weakness
• Fatigue
• Upset stomach
• Constipation
• Erythema or skin redness

Some individuals may experience serious side effects while using Akynzeo. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of anaphylaxis or a severe allergic reaction, such as hives, rash, difficulty breathing, and swelling of the face, lips, eyes, or tongue.
• Symptoms of serotonin syndrome such as agitation, hallucinations, dizziness, rapid heartbeat, sweating, high body temperature, tremors, muscle twitching, and seizures. This is a life-threatening condition that requires prompt medical attention and is more common when other serotonergic drugs that cause serotonin syndrome are also used.

These are not all of the possible side effects of Akynzeo. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Akynzeo, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A past allergic reaction to palonosetron or any other medicine for nausea and vomiting
• Liver problems or hepatic impairment
• Renal impairment or end-stage renal disease
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

There are no contraindications to using Akynzeo.

A single dose of Akynzeo begins to work immediately for the prevention of nausea and vomiting.

When Akynzeo is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Dexamethasone
• Midazolam
• Alprazolam
• Triazolam
• Ketoconazole
• Docetaxel
• Paclitaxel
• Etoposide
• Irinotecan
• Cyclophosphamide
• Ifosfamide
• Imatinib
• Vinorelbine
• Vinblastine
• Vincristine
• Warfarin
• Rifampin
• SSRIs
• SNRIs
• Any other strong CYP3A4 inducers or strong CYP3A4 inhibitors

Akynzeo is available in two different dosage forms.

Akynzeo capsules contain 300 mg netupitant and 0.5 mg palonosetron.

Akynzeo injection contains 235 mg fosnetupitant and 0.25 mg palonosetron.

Akynzeo should be stored at room temperature, away from light and moisture, and out of reach of children.

Akynzeo is manufactured by the pharmaceutical company Helsinn Therapeutics.

Currently, there is no generic available for the brand-name Akynzeo.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Akynzeo.

Akynzeo may cause adverse reactions and harm to the unborn child. Due to the unclear safety profile, talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Akynzeo passes into the breast milk. Generally, concomitant use of Akynzeo while breastfeeding should be avoided. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.