Palonosetron Hydrochloride (Page 4 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

H ow Supplied

Palonosetron Hydrochloride Injection is clear and colorless and is supplied in single-dose vials as follows:

NDC Number Strength P ackage

0143-9513-01 0.25 mg/2 mL (0.125 mg/mL) 1 vial/carton

Storage

• Store at 20° to 25°C (68° to 77°F); [Excursions permitted to 15° to 30°C (59° to 86°F)].
• Protect from freezing.
• Protect from light.

17 PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-approved patient labeling (Patient Information).

H y persensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients with or without known hypersensitivity to other 5-HT₃ receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron HCl Injection [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome, especially with concomitant use of Palonsetron HCl Injection and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [ see Warnings and Precautions (5.2)].

Manufactured by:
Exela Pharma Sciences LLC
Lenoir, NC 28645 USA

Distributed by:
WEST-WARD
A HIKMA COMPANY
Eatontown, NJ 07724 USA

9513-0617-00

Issued June 2017

P atient Information
P alonosetron Hydrochloride Injection (PAL-oh-NOE-se-tron HYE-droe-KLOR-ide)
fo r intravenous use

Read this Patient Information before you receive Palonosetron Hydrochloride Injection and each time you receive Palonosetron Hydrochloride Injection. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

W h at is Palonosetron Hydrochloride Injection?

Palonosetron Hydrochloride Injection is a prescription medicine called an “antiemetic.”

Palonosetron Hydrochloride Injection is used in adults to help prevent the nausea and vomiting that happens right away or later with certain anti-cancer medicines (chemotherapy).

This product has not been approved for use in children to help prevent nausea and vomiting after chemotherapy.

W h o should not receive Palonosetron Hydrochloride Injection?

Do not receive Palonosetron Hydrochloride Injection if you are allergic to palonosetron hydrochloride or any of the ingredients in Palonosetron Hydrochloride Injection. See the end of this leaflet for a complete list of ingredients in Palonosetron Hydrochloride Injection.

W h at should I tell my doctor before receiving Palonosetron Hydrochloride Injection?

Before receiving Palonosetron Hydrochloride Injection, tell your doctor about all of your medical conditions, including if you:

• have had an allergic reaction to another medicine for nausea or vomiting

• are pregnant or plan to become pregnant. It is not known if Palonosetron Hydrochloride Injection will

harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if Palonosetron Hydrochloride Injection passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you will receive Palonosetron Hydrochloride Injection.

T ell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.

Palonosetron Hydrochloride Injection and certain other medicines can affect each other, causing serious side effects.

How will I receive Palonosetron Hydrochloride Injection?

• Palonosetron Hydrochloride Injection will be given to you in your vein by I.V. (intravenous) injection.

• Palonosetron Hydrochloride Injection is usually given about 30 minutes before you receive your anti­-cancer medicine (chemotherapy).

W h at are the possible side effects of Palonosetron Hydrochloride Injection?

Palonosetron Hydrochloride Injection may cause serious side effects, including:

• S erious allergic reactions. Palonosetron Hydrochloride Injection can cause allergic reactions that can sometimes be serious. Tell your doctor or nurse right away if you have any of the following symptoms of a serious allergic reaction with Palonosetron Hydrochloride Injection:

o hives

o swollen face

o breathing trouble

o chest pain

• S erotonin Syndrome. A possible life-threatening problem called serotonin syndrome can happen with medicines called 5-HT₃ receptor antagonists, including Palonosetron Hydrochloride Injection, especially when used with medicines used to treat depression and migraine headaches called serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and certain other medicines. Tell your doctor or nurse right away if you have any of the following symptoms of serotonin syndrome:

o agitation, seeing things that are not there (hallucinations), confusion, or coma

o fast heartbeat or unusual and frequent changes in your blood pressure

o dizziness, sweating, flushing, or fever

o tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination

o seizures

o nausea, vomiting, or diarrhea

The most common side effects of Palonosetron Hydrochloride Injection in adults are headache and constipation.

These are not all the possible side effects of Palonosetron Hydrochloride Injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

G eneral information about the safe and effective use of Palonosetron Hydrochloride Injection Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about Palonosetron Hydrochloride Injection that is written for health professionals.

W h at are the ingredients in Palonosetron Hydrochloride Injection?

Active ingredient: palonosetron hydrochloride

Inactive ingredient: water for intravenous administration

Rx Only

Manufactured by: Exela Pharma Sciences LLC, Lenoir, NC 28645 USA

Distributed by: WEST-WARD, A HIKMA COMPANY, Eatontown, NJ 07724 USA

For Product Inquiry call 1-877-845-0689.

This Patient Information has been approved by the U.S. Food and Drug Administration.

9513-0617-00

Issued June 2017

PRINCIPAL DISPLAY PANEL

NDC 0143-9513-01 Rx only
Palonosetron
HCl Injection
0.25 mg/2 mL
(0.125 mg/mL)
For Intravenous Injection Only
2 mL Single Dose Sterile Vial
Check concentration prior to
preparation. See package insert for complete instructions.

NDC 0143-9513-01 Rx only
Palonosetron
HCl Injection
0.25 mg/2 mL
(0.125 mg/mL)
For Intravenous
Injection Only
2 mL Single
Dose Sterile Vial

Check concentration prior to
preparation. See package insert for complete instructions.