Fosnetupitant/palonosetron (Intravenous)

Fosnetupitant and palonosetron combination injection is used along with dexamethasone to prevent nausea and vomiting caused by cancer treatments (chemotherapy). Palonosetron and fosnetupitant block the signals to the brain that trigger nausea and vomiting.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor checks your progress closely while you are receiving this medicine to ensure it is working properly and to monitor for any unwanted effects.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medication must be weighed against the good it will do. This is a decision you and your clinician will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medications. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fosnetupitant and palonosetron combination injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of fosnetupitant and palonosetron combination injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart issues, which may require caution in patients receiving fosnetupitant and palonosetron combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medicine while breastfeeding.

Interactions with Medications

Although certain drugs should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially essential that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is not advised. Your doctor may decide not to treat you with this medication or change some of the other medications you take.

• Apomorphine
• Eliglustat

Using this medication with any of the following medications is usually not advised, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Abametapir
• Acalabrutinib
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amlodipine
• Amoxapine
• Amphetamine
• Aprepitant
• Aripiprazole
• Atorvastatin
• Avanafil
• Avapritinib
• Axitinib
• Benzhydrocodone
• Benzphetamine
• Bosutinib
• Brigatinib
• Bromocriptine
• Brompheniramine
• Budesonide
• Buprenorphine
• Buspirone
• Butorphanol
• Cabozantinib
• Carbamazepine
• Chlorpheniramine
• Cilostazol
• Cisapride
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Cobimetinib
• Cocaine
• Codeine
• Colchicine
• Conivaptan
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darifenacin
• Darunavir
• Dasatinib
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Diazepam
• Dibenzepin
• Dihydrocodeine
• Dihydroergotamine
• Diltiazem
• Docetaxel
• Dofetilide
• Domperidone
• Doxepin
• Dronedarone
• Duloxetine
• Efavirenz
• Elacestrant
• Elbasvir
• Eletriptan
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamide
• Eplerenone
• Ergotamine
• Erythromycin
• Escitalopram
• Estradiol
• Eszopiclone
• Everolimus
• Fedratinib
• Felodipine
• Fenfluramine
• Fentanyl
• Fexinidazole
• Finerenone
• Flibanserin
• Fluoxetine
• Fluticasone
• Fluvoxamine
• Fosaprepitant
• Fosphenytoin
• Frovatriptan
• Furazolidone
• Gepirone
• Granisetron
• Grazoprevir
• Guanfacine
• Haloperidol
• Hydrocodone
• Hydrocortisone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Ibrutinib
• Imatinib
• Imipramine
• Indinavir
• Infigratinib
• Iproniazid
• Irinotecan
• Irinotecan Liposome
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Lapatinib
• Larotrectinib
• Lasmiditan
• Lemborexant
• Lercanidipine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lomitapide
• Lorcaserin
• Lovastatin
• Lumacaftor
• Lumateperone
• Lurasidone
• Lurbinectedin
• Maraviroc
• Mavacamten
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Midazolam
• Milnacipran
• Mirtazapine
• Mitapivat
• Mitotane
• Mobocertinib
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naloxegol
• Naratriptan
• Nateglinide
• Nefazodone
• Nelfinavir
• Neratinib
• Nialamide
• Nifedipine
• Nilotinib
• Nisoldipine
• Nortriptyline
• Omaveloxolone
• Omeprazole
• Ondansetron
• Opipramol
• Oxycodone
• Oxymorphone
• Paclitaxel
• Pacritinib
• Palovarotene
• Paritaprevir
• Paroxetine
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Piperaquine
• Pralsetinib
• Primidone
• Procarbazine
• Progesterone
• Protriptyline
• Quetiapine
• Quinidine
• Ranolazine
• Rasagiline
• Reboxetine
• Remifentanil
• Repaglinide
• Rifabutin
• Rifampin
• Rimegepant
• Rizatriptan
• Rolapitant
• Salmeterol
• Saquinavir
• Saxagliptin
• Selegiline
• Selpercatinib
• Selumetinib
• Sertraline
• Sibutramine
• Sildenafil
• Simeprevir
• Simvastatin
• Sirolimus
• Sirolimus Protein-Bound
• Sonidegib
• Sparsentan
• St John's Wort
• Sufentanil
• Sumatriptan
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Tazemetostat
• Telithromycin
• Temsirolimus
• Tezacaftor
• Thiotepa
• Tianeptine
• Ticagrelor
• Tipranavir
• Tolvaptan
• Trabectedin
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trimipramine
• Tryptophan
• Ubrogepant
• Vardenafil
• Venetoclax
• Venlafaxine
• Verapamil
• Vilazodone
• Vinblastine
• Vincristine
• Vinorelbine
• Voclosporin
• Vorapaxar
• Vortioxetine
• Warfarin
• Zaleplon
• Zanubrutinib
• Ziprasidone
• Zolmitriptan
• Zolpidem

Using this medicine with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medications.

• Dexamethasone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may additionally cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Kidney disease, severe or
• Liver disease, serious—Use is not advised. Safety and efficacy have not been established in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Agitation
• confusion
• cough or hoarseness
• dizziness
• fast heartbeat
• fever
• hearing or seeing things that are not there
• hives, itching, skin rash
• irritation
• joint pain, stiffness or swelling
• muscle twitching
• overactive reflexes
• poor coordination
• redness of the skin
• shivering
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trembling or shaking
• trouble breathing or swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache
• unusual tiredness or weakness

Less common

• Constipation
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Akynzeo

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Neurokinin-1 Receptor Antagonist

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes, about 30 minutes before starting your cancer treatment.

This medicine should come with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.