Palonosetron (injection)

Palonosetron helps adults avoid nausea and vomiting that can occur after surgery or when getting cancer treatment (chemotherapy).

In children who are at least 1 month old, palonosetron is used only to prevent nausea and vomiting caused by cancer treatment.

Palonosetron may also be used for other reasons that are not mentioned in this medication guide.

Palonosetron is given as an infusion into a vein. A healthcare provider will give you this injection.

Palonosetron is usually given 30 minutes before chemotherapy or just before you receive anesthesia for surgery.

Before you get palonosetron, inform your doctor about all your medical conditions or allergies, as well as all the medicines you are taking. Also, make sure your doctor is aware if you are pregnant or breast-feeding.

You should not be treated with palonosetron if you are allergic to it.

Tell your doctor if you have ever had an allergic reaction to a similar medicine for nausea or vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran).

Make sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with palonosetron and cause a serious condition called serotonin syndrome.

Tell your doctor if you are pregnant or breast-feeding.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of palonosetron may include:

• nausea, vomiting;
• constipation;
• slow heartbeats; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

0.25 mg via IV infusion over 30 seconds ONCE 30 minutes before the start of chemotherapyComments:-The infusion line should be flushed with normal saline prior to and after administration of this drug.-This drug should not be mixed with other drugs.Uses:-Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy-Prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Usual Adult Dose for Nausea/Vomiting -- Postoperative:

0.075 mg via IV injection over 10 seconds ONCE immediately before induction of anesthesiaComments:-Efficacy beyond 24 hours has not been determined.-Routine prophylaxis is not recommended in patients in whom there is little expectation of postoperative nausea/vomiting (PONV).-Use is recommended in situations where nausea/vomiting must be avoided in the postoperative period, even when the incidence of PONV is low.Use: Prevention of PONV for up to 24 hours following surgery

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

1 month to younger than 17 years: 20 mcg/kg via IV infusion over 15 seconds ONCE 30 minutes before the start of chemotherapy-Maximum dose: 1.5 mg17 years and older: 0.25 mg via IV infusion over 30 seconds ONCE 30 minutes before the start of chemotherapyComments:-The infusion line should be flushed with normal saline prior to and after administration of this drug.-This drug should not be mixed with other drugs.Uses:-Patients 1 month to younger than 17 years: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy-Patients 17 years and older: Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy-Patients 17 years and older: Prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Because you will get palonosetron in a clinical setting, it is unlikely that you will miss a dose.

Since palonosetron (injection) is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Many drugs can affect palonosetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Inform your doctor about all your current medicines and any medicine you begin or stop using.