eribulin mesylate

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Injection: 1 mg/2 mL (0.5 mg/mL) eribulin mesylate is a clear, colorless, sterile solution in a single-dose vial.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Overdosage of eribulin mesylate has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for eribulin mesylate overdose.

11 DESCRIPTION

DESCRIPTION SECTION

Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai . The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9 H ,15 H -furo[3,2- i ]furo[2',3':5,6]pyrano[4,3- b ][1,4]dioxacyclopentacosin-5(4 H )-one,2-[(2 S )-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-(2 R ,3 R ,3a S ,7 R ,8a S ,9 S ,10a R ,11 S ,12 R ,13a R ,13b S ,15 S ,18 S ,21 S ,24 S ,26 R ,28 R ,29a S ),methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C 40 H 59 NO 11 •CH 4 O 3 S. Eribulin mesylate has the following structural formula: Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

15 REFERENCES

REFERENCES SECTION

1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

NDC 60505-6289-0 Eribulin Mesylate Injection : 1 mg/2 mL (0.5 mg/mL) single-dose vial. Discard unused portion. One vial per carton. Eribulin mesylate injection is a clear, colorless solution. Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F). Do not freeze or refrigerate. Store the vials in their original cartons. Eribulin mesylate injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.¹

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information). Neutropenia Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination [see Warnings and Precautions ( 5.1 )] . Peripheral Neuropathy Advise patients to inform their healthcare providers of new or worsening numbness, tingling and pain in their extremities [see Warnings and Precautions ( 5.2 )] . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.3 ), Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with eribulin mesylate and for at least 2 weeks after the final dose [see Use in Specific Populations ( 8.3 )]. Advise males with female partners of reproductive potential to use effective contraception during treatment with eribulin mesylate and for 3.5 months following the final dose [see Use in Specific Populations ( 8.3 )]. Lactation Advise women not to breastfeed during treatment with eribulin mesylate and for 2 weeks after the final dose [see Use in Specific Populations ( 8.2 )]. Manufactured by: Gland Pharma Limited Visakhapatnam-530049, India Manufactured for: Apotex Corp. Weston, FL USA 33326 Revised: 02/2024

PATIENT INFORMATION ERIBULIN MESYLATE (ER-i-BUE-lin MES-i-late)injection, for intravenous use.

PATIENT MEDICATION INFORMATION SECTION

What is the most important information I should know about eribulin mesylate injection? Eribulin mesylate injection can cause serious side effects, including: Low white blood cell count (neutropenia) . This can lead to serious infections that could lead to death. Your healthcare provider will check your blood cell counts before you receive each dose of eribulin mesylate injection and during treatment. Call your healthcare provider right away if you develop any of these symptoms of infection: fever (temperature above 100.5°F cough chills burning or pain when you urinate Numbness, tingling, or pain in your hands or feet (peripheral neuropathy) Peripheral neuropathy is common with eribulin mesylate injection and sometimes can be severe. Tell your healthcare provider if you have new or worsening symptoms of peripheral neuropathy. Your healthcare provider may delay, decrease your dose, or stop treatment with eribulin mesylate injection if you have side effects. See “What are possible side effects of Eribulin Mesylate Injection?” for more information about side effects. What is Eribulin Mesylate Injection? Eribulin mesylate injection is a prescription medicine used to treat people with: Breast cancer that has spread to other parts of the body, and who have already received certain types of anticancer medicines after the cancer has spread Liposarcoma that cannot be treated with surgery or has spread to other parts of the body, and who have received treatment with a certain type of anticancer medicine It is not known if eribulin mesylate injection is safe and effective in children under 18 years of age. Before you receive Eribulin Mesylate Injection, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have heart problems, including a problem called congenital long QT syndrome have low potassium or low magnesium in your blood are pregnant or plan to become pregnant. Eribulin mesylate injection can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with eribulin mesylate injection. Females who are able to become pregnant should use an effective birth control during treatment with eribulin mesylate injection and for at least 2 weeks after the final dose of eribulin mesylate injection. Males should use an effective form of birth control when having sex with female partners who are able to become pregnant during treatment with eribulin mesylate injection and for 3 1/2 months (14 weeks) after the final dose of eribulin mesylate injection. are breastfeeding or plan to breastfeed. It is not known if eribulin mesylate passes into your breast milk. Do not breastfeed during treatment with eribulin mesylate injection and for 2 weeks after the final dose of eribulin mesylate injection. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive Eribulin Mesylate Injection? Eribulin mesylate injection is given by intravenous (IV) injection in your vein. Eribulin mesylate injection is given in “cycles” of treatment, with each cycle lasting 21 days. Eribulin mesylate injection is usually given on day 1 and day 8 of a treatment cycle. What are possible side effects of Eribulin Mesylate Injection? ” Eribulin mesylate injection may cause serious side effects, including: See “What is the most important information I should know about Eribulin Mesylate Injection?” Eribulin Mesylate Injection can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your healthcare provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with eribulin mesylate injection to check for heart problems. The most common side effects of eribulin mesylate injection in people with breast cancer include: low white blood cell count (neutropenia) low red blood cell count (anemia) weakness or tiredness hair loss (alopecia) nausea constipation The most common side effects of eribulin mesylate injection in people with liposarcoma include: tiredness nausea hair loss (alopecia) constipation stomach pain fever Your healthcare provider will do blood tests before and during treatment while you are taking eribulin mesylate injection. The most common changes to blood tests in people with liposarcoma include: low white blood cell count (neutropenia) decreased blood levels of potassium or calcium Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of eribulin mesylate injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about Eribulin Mesylate Injection Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about eribulin mesylate injection that is written for health professionals. What are the ingredients in Eribulin Mesylate Injection? Active Ingredient: eribulin mesylate Inactive Ingredients: dehydrated alcohol, water for injection, and sodium hydroxide or hydrochloric acid may be used for pH adjustment. For more information, contact Apotex Corp. at 1-800-706-5575. Manufactured by: Gland Pharma Limited Visakhapatnam-530049, India. Manufactured for: Apotex Corp. Weston, FL USA 33326 Revised: 02/2024 This Patient Information has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label : NDC 60505-6289-0 Rx only Eribulin Mesylate Injection 1 mg/2 mL (0.5 mg/mL) For Intravenous Use STERILE SOLUTION CAUTION: Cytotoxic Agent SINGLE-DOSE VIAL- discard unused portion. DOSAGE AND USE See accompanying prescribing information. 1 x 2 mL Single-Dose Vial Vial Label : NDC 68083-592-01 Rx only Eribulin Mesylate Injection 1 mg/2 mL (0.5 mg/mL) For Intravenous Use SINGLE DOSE VIAL-Discard unused portion