Aloxi: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC # 62856-797-01, ALOXI Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton.

NDC # 62856-798-01, ALOXI Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials.

Storage

  • Store at controlled temperature of 20-25°C (68°F-77°F). Excursions permitted to 15-30°C (59-86°F).
  • Protect from freezing.
  • Protect from light.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labelling (Patient Information).

Instructions for Patients

Patients should be advised to report to their physician all of their medical conditions, including any pain, redness, or swelling in and around the infusion site [see Adverse Reactions (6.3)].

Advise patients of the possibility of serotonin syndrome, especially with concomitant use of ALOXI 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 whithout gastrointestinal symptoms [see Warnings and Precautions (5.2) ].

Patients should be instructed to read the Patient Information.

Patient Information

ALOXI® (Ah-lock-see)

(palonosetronHCl) Injection for Intravenous Use

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

What is ALOXI?

ALOXI is a prescription medicine called an “antiemetic.”

ALOXI is used in adults to help prevent the nausea and vomiting that happens:

  • right away or later with certain anti-cancer medicines (chemotherapy)
  • up to 24 hours while recovering from anesthesia after surgery

ALOXI is used in children 1 month old to less than 17 years of age to help prevent the nausea and vomiting that happens right away with certain anti-cancer medicines (chemotherapy).

  • It is not known if ALOXI is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy.
  • It is not known if ALOXI is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.

Who should not receive ALOXI?

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

What should I tell my doctor before receiving ALOXI?

Be fore receiving ALOXI, 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 ALOXI will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ALOXI passes into your breast milk. You and your doctor should decide if you will receive ALOXI if you breastfeed.

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

How will I receive ALOXI?

  • ALOXI will be given to you in your vein by intravenous (I.V.) injection.
  • ALOXI is usually given about 30 minutes before you receive your anti-cancer medicine (chemotherapy) or right before anesthesia for surgery.

What are the possible side effects of ALOXI?

ALOXI 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 ALOXI:

  • hives
  • swollen face
  • breathing trouble
  • chest pain

The most common side effects of ALOXI in adults are headache and constipation.

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

General information about the safe and effective use of ALOXI

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 ALOXI that is written for health professionals.

What are the ingredients in ALOXI? Active ingredient: palonosetron hydrochloride Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water

Mfd by OSO Biopharmaceuticals, LLC, Albuquerque, NM, USA or Pierre Fabre, Médicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals, Dublin, Ireland HELSINN, Mfd for Helsinn Healthcare SA, Switzerland

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677 under license of Helsinn Healthcare SA, SwitzerlandMarketed by Eisai Inc., Woodcliff Lake, NJ 07677 and Helsinn Therapeutics (U.S.), Inc. Iselin, NJ 08830, under license of Helsinn Healthcare SA, Switzerland.ALOXI® is a registered trademark of Helsinn Healthcare, SA, Lugano, Switzerland©2013 Eisai Inc., Woodcliff Lake, NJ 07677 U.S.A. 201227 For more information, go to www.ALOXI.com.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2015

PRINCIPAL DISPLAY PANEL — 0.075 mg/1.5 mL

NDC 62856-798-01

Aloxi®
palonosetron HCl injection
0.075 mg/1.5 mL

For intravenous injection only.
Five 1.5-mL single-use sterile vials.
Discard unused portion.

Store at 20°C-25°C (68°F-77°F)
Excursions permitted to 15°C-30°C (59°F-86°F) (see USP)Protect from light.

See package insert for dosage and administration information.

Rx Only

Contents: Each 1.5 mL vial contains 0.075 mg palonosetron base as 0.084 mg palonosetron hydrochloride. Each mL of palonosetron also contains 41.5 mg mannitol, 0.5 mg edetate disodium dihydrate, 3.7 mg trisodium citrate dihydrate, 1.56 mg citric acid monohydrate, and water for injection (q.s to 1 mL). Hydrochloric acid or sodium hydroxide may have been added to adjust pH.

US Patent No. 5,202,333

Jointly manufactured by OSO Biopharmaceuticals, LLC, Albuquerque, NM, USA or Pierre Fabre, Medicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals Ltd, Dublin, Ireland

Aloxi® is a registered trademark of Helsinn Healthcare, SA, Lugano, Switzerland, used under license.

PRINCIPAL DISPLAY PANEL NDC 62856-798-01 Aloxi® palonosetron HCl injection 0.25 mg/5 mL (0.05 mg/mL) For intravenous injection only. 5 mL single-use sterile vial.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.075 mg/1.5 mL

Aloxi®
palonosetron HCl injection
0.075 mg/1.5 mL single-use vial

For intravenous injection only.
1.5-mL single-use sterile vial.
Discard unused portion.

NDC 62856-798-01
Rx only

Dist. by Eisai Inc.,
Woodcliff Lake, NJ 07677

Store at 20°C-25°C(68°F-77°F)

Protect from light

PRINCIPAL DISPLAY PANEL -- 0.075 mg/1.5 mL Injection NDC 62856-798-01 Rx only Aloxi® palonosetron HCl injection 0.075 mg/1.5 mL single-use vial For intravenous injection only. 1.5-mL single-use sterile vial. Discard unused portion.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mg/5 mL


NDC 62856-797-01
Aloxi®
palonosetron HCl injection
0.25 mg/5 mL (0.05 mg/mL)

For intravenous injection only.
5-mL single-use sterile vial.
Discard unused portion.

Store at 20°C-25°C (68°F-77°F)

Excursions permitted to 15°C-30°C (59°F-86°F) (see USP)

Protect from light.

See package insert for dosage and administration information.

Rx Only

Contents: Each mL of aqueous solution contains palonosetron hydrochloride equivalent to 0.05 mg palonosetron. Each mL also contains 41.5 mg mannitol, 0.5 mg edetate disodium dihydrate, 3.7 mg trisodium citrate dihydrate, 1.56 mg citric acid monohydrate, and water for injection (q.s to 1.0 mL). Hydrochloric acid or sodium hydroxide may have been added to adjust pH.

Jointly manufactured by OSO Biopharmaceuticals, LLC, Albuquerque, NM, or Pierre Fabre, Medicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals Ltd, Dublin, Ireland

Distributed by Eisai Inc.
Woodcliff Lake, NJ 07677
under license of Helsinn Healthcare, SA,Switzerland

Marketed by Eisai Inc. and Helsinn Therapeutics (U.S.), Inc.

carton ndc 62856-797-01
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mg/5 mL

NDC 62856-797-01

Rx only
Aloxi®
palonosetron HCl injection
0.25 mg/5 mL (0.05 mg/mL)

For intravenous injection only.
5-mL single-use sterile vial.

Store at 20°C-25°C (68°F-77°F)
Protect from light.

Dist. by Eisai Inc., Woodcliff Lake, NJ 07677

bottle label
(click image for full-size original)
ALOXI palonosetron hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-797
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALONOSETRON HYDROCHLORIDE (PALONOSETRON) PALONOSETRON 0.25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-797-01 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (62856-797-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021372 05/28/2014
ALOXI palonosetron hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-798
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALONOSETRON HYDROCHLORIDE (PALONOSETRON) PALONOSETRON 0.075 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-798-01 5 VIAL in 1 CARTON contains a VIAL
1 1.5 mL in 1 VIAL This package is contained within the CARTON (62856-798-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021372 05/28/2014
Labeler — Eisai Inc. (831600833)
Establishment
Name Address ID/FEI Operations
Helsinn Advanced Synthesis SA 481296960 API MANUFACTURE (62856-797), API MANUFACTURE (62856-798)
Establishment
Name Address ID/FEI Operations
Helsinn Birex Pharmaceuticals Limited 985084409 PACK (62856-797), PACK (62856-798)
Establishment
Name Address ID/FEI Operations
Oso BioPharmaceutical Manufacturing, LLC 826977121 MANUFACTURE (62856-797), MANUFACTURE (62856-798)
Establishment
Name Address ID/FEI Operations
Pierre Fabre Medicament Production 504638276 MANUFACTURE (62856-797), MANUFACTURE (62856-798)

Revised: 12/2015 Eisai Inc.

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