SUSTOL (Page 5 of 5)

14 CLINICAL STUDIES

In a randomized, multicenter, double-blind, parallel group study, a single 10 mg subcutaneous dose of SUSTOL was compared to a single 0.25 mg intravenous dose of palonosetron hydrochloride in cancer patients administered moderately emetogenic (MEC) or anthracycline plus cyclophosphamide (AC) combination chemotherapy. SUSTOL or palonosetron hydrochloride was administered 30 minutes prior to chemotherapy on Day 1. Patients also received either 8 or 20 mg intravenous dexamethasone on Day 1 depending on chemotherapy regimen. Patients who received 20 mg of intravenous dexamethasone also received oral dexamethasone 8 mg twice daily on Days 2, 3, and 4.

In this study of 733 patients (371 in the SUSTOL 10 mg arm and 362 in the palonosetron arm), 79% of patients were female and 63% were Caucasian. The mean age was 57 years (range 22 to 91 years), 55% received MEC and 45% received AC combination chemotherapy regimens. The most common MEC regimens were carboplatin/paclitaxel (31%).

The primary endpoints were proportion of patients with complete response (CR) [defined as no emetic episodes (vomiting or retching) and no use of rescue medication] during the acute phase (0 to 24 hours) and the delayed phase (>24 to 120 hours) following the administration of chemotherapy in Cycle 1. The study design allowed for assessment of non-inferiority of SUSTOL to palonosetron hydrochloride in the acute and delayed phase of MEC and of AC combination chemotherapy.

Non-inferiority of SUSTOL to palonosetron hydrochloride was demonstrated in the acute and delayed phases of MEC and of AC combination chemotherapy [Table 4].

Table 4. Number and Percentage of Patients Who Achieved Complete Response with MEC or AC Combination Chemotherapy *
Moderately Emetogenic Chemotherapy
Complete Response SUSTOL10 mgsubcutaneous N=200n (%) Palonosetronhydrochloride,0.25 mgintravenousN=206n (%) Difference(95% CI ):SUSTOL minusPalonosetron
*
Complete response defined as no emetic episodes and no use of rescue medications.
This study was designed to show non-inferiority in the acute phase or delayed phase for patients receiving moderately emetogenic chemotherapy. A lower bound greater than -15% demonstrates non-inferiority between SUSTOL and comparator.
This study was designed to show non-inferiority in the acute phase and superiority in the delayed phase. A lower bound greater than -15% demonstrates non-inferiority between SUSTOL and comparator. Because a lower bound did not exceed 0%, superiority was not demonstrated between SUSTOL and comparator.
Acute Phase (0 – 24 hours) 166 (83) 183 (89) -6 (-13, 1)
Delayed Phase (>24 – 120 hours) 137 (69) 144 (70) -1 (-10, 8)
AC Combination Chemotherapy
Complete Response SUSTOL10 mgsubcutaneous N=171n (%) Palonosetronhydrochloride,0.25 mgintravenousN=156n (%) Difference(95% CI ):SUSTOL minusPalonosetron
Acute Phase (0 – 24 hours) 120 (70) 99 (64) 6 (-3, 17)
Delayed Phase (>24 – 120 hours) 85 (50) 74 (47) 2 (-9, 13)

16 HOW SUPPLIED/STORAGE AND HANDLING

SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06); each kit contains:

  • One sterile single-dose amber colored glass syringe which contains 10 mg granisetron/0.4 mL,
  • One sterile 18 Ga x 5/8″ special thin walled administration needle,
  • Two sodium acetate syringe warming pouches,
  • One Point Lok needle protection device.

Storage

Store SUSTOL in the refrigerator at 2°C to 8°C (36°F to 46°F).

SUSTOL can be placed back in the refrigerator after being kept at room temperature. SUSTOL can remain at room temperature for up to a maximum of 7 days.

Protect from light. Do not freeze.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration

  • SUSTOL is intended for subcutaneous injection by a health care provider.

Injection Site Reactions [see Warnings and Precautions (5.1)]

  • Inform the patient that ISRs may occur and may include infections, bruising and/or hematomas, bleeding, pain and tenderness, and nodules.
  • Inform the patient that some ISRs (infections, bruising, and hematoma) may occur up to 2 weeks or more after SUSTOL administration.
  • Instruct the patient to seek immediate medical care for the following ISRs:
    ο signs of infection at the injection site.
    ο injection site bleeding that is severe or lasts for longer than one day.
  • Advise the patient to tell their healthcare provider if they experience:
    ο pain or tenderness severe enough to require treatment with pain medication or interfere with daily activity.
    ο bruising and/or hematoma or a persistent nodule at the injection site.

Gastrointestinal

Advise the patient to report new or worsening constipation to their healthcare provider and seek immediate medical care if signs and symptoms of an ileus occur [Warnings and Precautions (5.2)].

Hypersensitivity reactions

Advise the patient that hypersensitivity reactions may occur up to 7 days or longer following SUSTOL administration. Inform the patient of the signs and symptoms of hypersensitivity reactions, and have them seek immediate medical care should signs and symptoms occur [see Warnings and Precautions (5.1, 5.3)].

Serotonin Syndrome

Advise the patient of the possibility of serotonin syndrome, especially with concomitant use of SUSTOL and another serotonergic agent such as medications to treat depression and migraines. Advise the patient 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 (5.4)].

SUSTOL® is a registered trademark of Heron Therapeutics, San Diego, CA 92121
© 2017 HERON THERAPEUTICS, San Diego, CA, 92121, USA

MEDICATION GUIDE

SUSTOL® (sus’ tol)

(granisetron)

extended-release injection, for subcutaneous use

What is the most important information I should know about SUSTOL?

SUSTOL can cause serious side effects, including:

  • Injection site reactions. Some injection site reactions may be serious and require medical care. Injection site reactions may include infections, bruising, swelling that is caused by blood that collects under the skin (hematoma), bleeding, pain and tenderness, and small bumps (nodules) at the injection site. Infections, bruising, and hematomas can happen up to 2 weeks or more after receiving SUSTOL.
    Tell your healthcare provider if you have:
    ο pain or tenderness that you need to take pain medicine for or if you have pain that interferes with your daily activity.
    ο bruising, hematoma, or a nodule at the injection site that does not go away. Your risk of severe bruising and hematomas at the injection site is increased if you take a blood thinner medicine (anticoagulant or antiplatelet medicine).
    Get medical care right away if you have:
    ο signs of an infection at the injection site, including continued redness or warmth, or if you have a fever.
    ο bleeding at the injection site that is severe or lasts for longer than 24 hours.
  • Stomach and intestinal problems. Problems having a bowel movement (constipation) that may be serious, can happen up to 7 days after treatment with SUSTOL. These problems may be more likely in people taking opioid pain medicines. SUSTOL can make it harder to identify certain stomach and bowel problems you may have. Tell your healthcare provider if you have constipation or your constipation worsens after you receive SUSTOL. Get medical care right away if you have pain or swelling in your stomach-area (abdomen).
  • Serious allergic reactions. Serious allergic reactions have happened in people who receive SUSTOL and who have had allergic reactions to other medicines used to help prevent nausea and vomiting called 5-HT3 receptor antagonists. Serious allergic reactions can happen up to 7 days or longer after treatment. Get emergency medical help right away if you have any signs or symptoms of a serious allergic reaction, including:
    ο hives
    ο breathing trouble
    ο swollen face
    ο chest pain

What is SUSTOL?

  • SUSTOL is a prescription medicine called an “antiemetic.”
  • SUSTOL is used in adults to help prevent the nausea and vomiting that happens right away or later with certain anti-cancer medicines (chemotherapy).

It is not known if SUSTOL is safe and effective in children under 18 years of age.

Who should not receive SUSTOL?

Do not receive SUSTOL if you are allergic to:

  • granisetron or any of the ingredients in SUSTOL. See the end of this Medication Guide for a complete list of ingredients in SUSTOL.
  • any other 5-HT3 receptor antagonist medicine used to help prevent nausea and vomiting.

What should I tell my healthcare provider before receiving SUSTOL?

Before receiving SUSTOL, tell your healthcare provider about all of your medical conditions, including if you:

  • have constipation
  • have had recent stomach-area (abdominal) surgery
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if SUSTOL will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SUSTOL passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you will receive SUSTOL.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using SUSTOL with certain other medicines can cause serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How will I receive SUSTOL?

  • SUSTOL will be given to you by an injection under your skin (subcutaneously) in the back of your upper arm or in your stomach-area (abdomen) on Day 1 of your chemotherapy cycle.
  • SUSTOL will be given to you by a healthcare provider.
  • SUSTOL is usually given about 30 minutes before you receive your anti-cancer medicine (chemotherapy).
  • You should not receive SUSTOL more often than 1 time every 7 days.

What are the possible side effects of SUSTOL?

SUSTOL may cause serious side effects, including:

  • See “What is the most important information I should know about SUSTOL?”
  • Serotonin Syndrome. A possible life-threatening problem called serotonin syndrome can happen with medicines called 5-HT3 receptor antagonists, including SUSTOL, 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 healthcare provider or nurse right away if you have any of the following symptoms of serotonin syndrome:
    ο agitation, seeing things that are not there (hallucinations), confusion, or coma
    ο fast heartbeat or unusual and frequent changes in your blood pressure
    ο dizziness, sweating, flushing, or fever
    ο tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination
    ο seizures
    ο nausea, vomiting, or diarrhea

The most common side effects of SUSTOL include: injection site reactions, constipation, fatigue, headache, diarrhea, stomach-area (abdominal) pain, trouble sleeping or falling asleep, indigestion, dizziness, weakness, and heartburn.

These are not all the possible side effects of SUSTOL. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

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 SUSTOL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUSTOL for a condition for which it was not prescribed. Do not give SUSTOL to other people, even if they have the same symptoms that you have. It may harm them.You can ask your healthcare provider or pharmacist for information about SUSTOL that is written for health professionals.

What are the ingredients in SUSTOL?

Active ingredient: granisetron

Inactive ingredients: triethylene glycol poly(orthoester) polymer and polyethylene glycol monomethyl ether

Manufactured by: Lifecore Biomedical, Chaska, MN 55318

Marketed by: Heron Therapeutics, Inc., San Diego, CA 92121

SUSTOL® is a registered trademark of Heron Therapeutics, Inc.
© 2017 HERON THERAPEUTICS, San Diego, CA, 92121, USA

For more information, go to www.SUSTOL.com or call 1-844-437-6611.

This Medication Guide has been approved by the U.S. Food and Drug Administration
Issued: May 2017

SUSTOL® (granisetron) extended-release injection 10 mg/0.4 mLInstructions for UseYou must read these complete instructions before you administer SUSTOL for the first time.SUSTOL must be administered by a healthcare provider.
What is SUSTOL?SUSTOL is a subcutaneous injection that provides long-acting antiemetic medication to patients receiving chemotherapy. SUSTOL contains a highly viscous polymer that provides sustained release of granisetron.SUSTOL is supplied as part of an administration kit.
When should you administer SUSTOL?Administer SUSTOL at least 30 minutes before chemotherapy on Day 1 of chemotherapy treatment and not more frequently than once every 7 days, because of the extended-release properties of the formulation.
Before you begin to prepare SUSTOL InjectionRead these critical instructions. Do not substitute any of the components from the kit for administration. Check to make sure the SUSTOL kit contains:
  • One sterile single-dose glass syringe which contains 10 mg granisetron
  • One sterile 18G x 5/8″ administration needle
  • Two sodium acetate warming pouches
  • One Point-Lok® needle protection device
  • Instructions for Use, Package Insert and Medication Guide
Bring SUSTOL to room temperatureSTEPTo bring SUSTOL to room temperature:
Image of iFU Instruction 11Remove SUSTOL kit from refrigeration. Open carton and remove tray. Open tray and unpack warming pouches. Wait a minimum of 60 minutes prior to use to allow SUSTOL and the warming pouches to warm to room temperature.SUSTOL may be left out at room temperature overnight, and for up to 7 days, before it must be discarded. SUSTOL may be re-refrigerated if not used within the 7 day period.Warming SUSTOL prior to injection decreases the viscosity and makes administration easier. Bringing SUSTOL to room temperature prior to warming with the sodium acetate warming pouch will facilitate warming of SUSTOL to body temperature.
Prepare the syringeSTEPFollow these steps to prepare SUSTOL for use:
1Image of iFU Instruction -- CautionExamine all contents of the package. Do not use if any component is damaged.
2Check the expiration date on the syringe. Do not use if the expiration date has passed.
3Image of iFU Instruction -- OptionalRemove the perforated flag label from the plunger rod.
Image of iFU Instruction 24To ensure that the syringe contains the full dose, check that the gray stopper is close to or below the black line on the syringe barrel label as shown in the illustration.Do NOT expel air bubbles. For a subcutaneous injection, air bubbles in the syringe will not harm the patient.
Image of iFU Instruction 35Unscrew the tip cap from the end of the pre-filled glass syringe.Do NOT use if the tip cap is missing or has been tampered with. Do NOT use if the Luer fitting is missing or dislodged.
6Remove the hub cover from the 18G x 5/8″ needle supplied with the syringe. Attach the needle to the syringe and seat the needle securely. Do NOT remove the blue needle cover. Do not substitute with any other needle Image of iFU Instruction -- CautionUse ONLY the 18G x 5/8″ needle provided with the syringe because of the highly viscous nature of the medication.
Warm SUSTOL to body temperatureSTEPJust prior to administering the injection, follow these steps:
Image of iFU Instruction 4SUSTOL must be warmed to body temperature immediately prior to injection to reduce viscosity and facilitate administration.SUSTOL is packaged with two warming pouches. The warming pouches use a non- toxic solution of sodium acetate to create an exothermic (warming) reaction. The second warming pouch can be used if SUSTOL is not immediately administered within the 15 minutes provided by the first warming pouch and needs to be re-warmed. Before activating the warming pouch, make sure that the SUSTOL kit was removed from the refrigerator and that the warming pouches were unpacked from the kit at least 60 minutes prior to use to allow SUSTOL and the warming pouches to warm to room temperature.
Image of iFU Instruction 51To activate the warming pouch, locate the metal disc and grasp with thumb and forefingers of both hands. Flex (bend) the disc rapidly until crystals begin to form (fluid will start to turn white). Massage warming pouch for a few seconds to soften and to increase the activation rate.
Image of iFU Instruction 62Wrap the SUSTOL syringe and needle in the syringe warming pouch. Use the outline on the warming pouch label as a placement guide for the syringe and needle. Fold the warming pouch over the syringe and press fastening strips together.Allow SUSTOL to warm for 5 — 6 minutes in the warming pouch.SUSTOL must be warmed to body temperature immediately prior to injection to reduce viscosity and facilitate administration.
Image of iFU Instruction 73Keep the SUSTOL syringe and needle in the warming pouch until you are ready to administer SUSTOL. The warming pouch will keep the SUSTOL syringe at body temperature for 10 — 15 minutes. If more than 15 minutes has elapsed since warming the SUSTOL syringe, then re-warm the syringe using the second warming pouch prior to injecting SUSTOL.Image of iFU Instruction -- CautionSodium acetate is a non-toxic salt. In case of a puncture to a warming pouch and the spilling of the solution or crystals, clean up with soap and water. In case of eye contact, flush with water for 15 minutes. In case of skin contact, wash with soap and water. Seek medical attention if irritation develops or persists.Used warming pouches may be safely disposed of in the trash.
Select an injection siteSTEPTo select an injection site, use these guidelines:
Image of iFU Instruction 81Use the skin of the abdomen at least one inch from the umbilicus or the skin of the back of the upper arms as sites for subcutaneous injections.Image of iFU Instruction -- WarningFor SUBCUTANEOUS injection only.Do NOT inject within 1 inch of the umbilicus or anywhere the skin is:• Burned • Hardened • Inflamed • Swollen • CompromisedFor subsequent injections, use the same general area of the body. However, be sure not to inject in the exact same place. Administer new injections at least 1 inch from the previous site.
Inject SUSTOLSTEPFollow these steps to inject SUSTOL:
1Remove the syringe from the warming pouch.Image of iFU Instruction -- CautionThe white finger flange on the syringe provides better control when administering SUSTOL. Do NOT remove white finger flange.
2Remove the blue needle cover. Use standard sharps safety techniques to avoid needle sticks.
Image of iFU Instruction 93Use standard aseptic technique when performing the injection.Pinch the skin and underlying subcutaneous tissue with your non-dominant hand to create a “tent.”Insert the needle into the subcutaneous tissue at a 30° — 45° angle with your dominant hand.Image of iFU Instruction -- WarningAdminister SUSTOL ONLY as a subcutaneous injection. NEVER administer intravenously, intramuscularly or intraperitoneally.
Image of iFU Instruction 104Image of iFU Instruction -- OptionalFor additional stability, once the needle is inserted into the subcutaneous tissue, release the “tent” and hold the syringe barrel with your non-dominant hand.
5Press the plunger using a slow, firm, and steady push until you have delivered the entire dose. Do not use excessive force to inject the material more quickly, as this will only result in greater difficulty with the injection.Image of iFU Instruction -- CautionDue to the high viscosity of SUSTOL, you will experience resistance when injecting SUSTOL. Apply firm and steady pressure to the plunger for about 20-30 seconds. Pressing harder will NOT expel SUSTOL faster.Do NOT advance or reposition the syringe in the subcutaneous tissue during the injection.
Image of iFU Instruction 116Because SUSTOL is highly viscous, before withdrawing the needle, make sure that the medication is completely expelled by checking the position of the stopper at the base of the syringe barrel.
Image of iFU Instruction 127Withdraw the needle. Do not remove the needle from the syringe. Use the enclosed Point-Lok® device to prevent needle sticks.Place the Point-Lok needle protection device, supplied within the SUSTOL kit, on a secured flat surface. Do not hold the Point-Lok device in your hand. Carefully insert the exposed needle into the opening at the top of the Point-Lok device and push down until the needle is fully seated in the Point-Lok device. This action will seal the needle tip and lock the needle firmly into the Point-Lok device. Discard the protected needle and attached syringe using your organization’s standard sharps disposal procedures.
8Dispense enclosed Medication Guide to each Patient.
Marketed by: Heron Therapeutics, Inc.4242 Campus Point Court, Suite 200San Diego, CA 92121© 2017 Heron Therapeutics, Inc.Revision Date: May 2017Questions about how to use SUSTOL? Call the support line toll-free at 844-HERON11 (844-437-6611) or visit www.SUSTOL.comLAM-0000363

Principal Panel — Carton of Six Kits

SUSTOL®
(granisetron) extended-release injection 10 mg/0.4 mL

FOR SUBCUTANEOUS USE ONLY.

REMOVE CARTON FROM REFRIGERATOR AND UNPACK ALL CONTENTS AT LEAST 60 MINUTES PRIOR TO USE.

Each single-dose unit contains:
One sterile single-dose glass syringe which contains 10 mg granisetron
One sterile 18Gx5/8″ administration needle
Two sodium acetate warming pouches
One Point-Lok® ,needle protection device
Instructions for Use and Package Insert

Must be refrigerated
Store at 2°C to 8°C (36°F to 46°F); DO NOT FREEZE.
Protect from Light.

SUSTOL is to be administered once weekly.

NDC: 47426-101-06

Contains:
6 single-dose
PRE-FILLED syringe units

Rx only

HERONTHERAPEUTICS

Image of Six Pack Carton -- Principle Panel
(click image for full-size original)
SUSTOL granisetron injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47426-101
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRANISETRON (GRANISETRON) GRANISETRON 10 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
METHOXY PEG-10
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47426-101-06 6 KIT in 1 CARTON contains a KIT
1 1 SYRINGE, GLASS in 1 KIT This package is contained within the CARTON (47426-101-06) and contains a SYRINGE, GLASS
1 0.4 mL in 1 SYRINGE, GLASS This package is contained within a KIT and a CARTON (47426-101-06)
2 NDC:47426-101-01 1 KIT in 1 CARTON contains a KIT
2 1 SYRINGE, GLASS in 1 KIT This package is contained within the CARTON (47426-101-01) and contains a SYRINGE, GLASS
2 0.4 mL in 1 SYRINGE, GLASS This package is contained within a KIT and a CARTON (47426-101-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022445 08/09/2016
Labeler — Heron Therapeutics (102099843)
Registrant — Heron Therapeutics (102099843)
Establishment
Name Address ID/FEI Operations
Wavelength Enterprises LTD 600077101 api manufacture (47426-101)
Establishment
Name Address ID/FEI Operations
INKE, S.A. 460094139 api manufacture (47426-101)
Establishment
Name Address ID/FEI Operations
Lifecore Biomedical 085358869 manufacture (47426-101), analysis (47426-101)
Establishment
Name Address ID/FEI Operations
Lifecore Biomedical 080057170 analysis (47426-101)

Revised: 08/2022 Heron Therapeutics

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