Pronunciation:

fos-net-UE-pi-tant, pal-oh-NOE-se-tron

Brand Names:

• Akynzeo

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Neurokinin-1 Receptor Antagonist

Uses of This Medicine:

Fosnetupitant and palonosetron combination injection is used together with dexamethasone to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy). Palonosetron and fosnetupitant work by blocking the signals to the brain that cause nausea and vomiting.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. 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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems 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 problems, 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 medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Apomorphine
• Eliglustat

Using this medicine with any of the following medicines is usually not recommended, 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 medicines.

• 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 medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dexamethasone

Other interactions—

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 also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly and to check for 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.

Side Effects of This Medicine:

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.