FENTORA

Main information

  • Trade name:
  • FENTORA fentanyl (as citrate) 600 microgram orally disintegrating tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FENTORA fentanyl (as citrate) 600 microgram orally disintegrating tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218434
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218434

FENTORA fentanyl (as citrate) 600 microgram orally disintegrating tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Teva Pharma Australia Pty Ltd

Postal Address

Locked Bag 2053,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

6/03/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. FENTORA fentanyl (as citrate) 600 microgram orally disintegrating tablet blister pack

Product Type

Single Medicine Product

Effective date

19/07/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Fentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic

cancer pain.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Other composite

material

2 Years

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S8) Controlled Drug

(S8) Controlled Drug

Components

1. FENTORA fentanyl (as citrate) 600 microgram orally disintegrating tablet blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Buccal

Visual Identification

White to off-white, flat-faced, round, bevelled tablet, debossed with "C" on

one side and with "6" on the other side

Active Ingredients

Fentanyl citrate

943 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:49:55 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

FENTORA

- CONSUMER MEDICINE INFORMATION V1.0

FENTORA

®

Orally Disintegrating Tablets

fentanyl (as citrate)

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Fentora. It does not

contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of your taking Fentora

against the benefits they expect it

will have for you.

If you have any concerns about

taking Fentora, talk to your doctor

or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What Fentora is used

for

Fentora contains a medicine called

fentanyl citrate. It is a pain-relieving

medicine known as an opioid, which

is used to treat breakthrough pain in

adult patients with cancer who are

already taking other opioid pain

medicines for their persistent

(around-the-clock) cancer pain.

Breakthrough pain is additional

sudden pain that occurs in spite of

you having taken your usual opioid

pain-relieving medicines.

Opioid medicines are those that

contain active ingredients such as

morphine, fentanyl citrate, codeine,

methadone, oxycodone, pethidine or

buprenorphine.

Ask your doctor if you have any

questions about why Fentora orally

disintegrating tablets have been

prescribed for you.

Your doctor may have prescribed it

for another use.

Fentora is only available on a

doctor's prescription.

Before you take it

Fentora is not suitable for everyone.

When you must not take it

Do not take Fentora if:

you suffer from short-term pain

other than breakthrough pain,

such as pain from injuries or

surgery, headaches or migraines

you have not been using a

prescribed opioid pain medicine

every day on a regular schedule,

for at least one week, to control

your persistent pain. If you have

not been using these medicines

you must not use Fentora,

because it may increase the risk

that breathing could become

dangerously slow and/or shallow,

or even stop.

you are allergic (hypersensitive)

to fentanyl, or any of the other

ingredients of Fentora (see list at

the end of this leaflet)

you suffer from severe breathing

problems or severe obstructive

lung conditions

Do not take Fentora after the

expiry date shown on the blister

package label and the carton.

Do not take Fentora if the

packaging seems to have been

opened.

Before you start to take it

Tell your doctor if:

you have any allergies

you are pregnant or intend to

become pregnant

you are breast feeding or planning

to breast feed

your other opioid pain medicine

you take for your persistent

(around-the-clock) cancer pain is

not stabilized yet

you are suffering from any

condition that has an effect on

your breathing (such as asthma,

wheezing, or shortness of breath).

You have a head injury

You have exceptionally slow

heart rate or other heart problems

You have liver or kidney

problems, as these organs have an

effect on the way in which your

system breaks down the

medicine.

You have low amount of fluid in

the circulation or low blood

pressure

These organs have an effect on the

way in which your system breaks

down the medicine.

FENTORA

- CONSUMER MEDICINE INFORMATION V1.0

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food store.

Take special care with Fentora if:

you are taking any medicines

which might normally have a

sedative effect (make you sleepy),

such as:

sleeping pills

medicines to treat anxiety

antihistamines

tranquillisers.

Other strong analgesics used to

manage pain such as morphine,

codeine, methadone, oxycodone,

pethidine or buprenorphine.

you are taking any medicines or

other substances that might have

an effect on the way in which

your body breaks down Fentora,

such as:

medicines used to treat fungal

infections, such as

ketoconazole, itraconazole,

and fluconazole

medicines that help control

HIV infection, such as

ritonavir, nelfinavir,

amprenavir, and

fosamprenavir

certain antibiotics such as

clarithromycin and

erythromycin

medicines used for severe

nausea

medicines used to treat high

blood pressure or heart

disease, such as diltiazem and

verapamil

medicines used for severe

depression known as selective

serotonin re-uptake inhibitors

(SSRIs) or serotonin

norepinephrine re-uptake

inhibitors (SNRIs) or have

done so in the past 2 weeks

medicines used for severe

depression called monoamine

oxidase inhibitors (MAOIs) or

have done so in the past 2

weeks

Using FENTORA with food

or drink

Fentora may be used before or

after, but not during, meals. You

may drink some water before

using Fentora to help moisten

your mouth, but you should not

drink or eat anything while taking

the medicine.

You should not drink grapefruit

juice while using Fentora because

it may affect the way your body

breaks down Fentora

Do not drink alcohol while using

Fentora. It can increase the risk of

experiencing dangerous side

effects

Pregnancy and breast-

feeding

Ask your doctor or pharmacist for

advice before taking any medicine.

Fentora should not be used during

pregnancy unless you have discussed

this with you doctor.

Driving and using machines

You should discuss with your doctor

whether it is safe for your to drive, or

operate machinery after taking

Fentora. Do not drive or operate

machinery if you: are feeling sleepy

or dizzy; have blurred or double

vision; or have difficulty in

concentrating. It is important you

know how you react to Fentora

before driving or operating

machinery.

Important information about

some of the ingredients of

Fentora

Each tablet of Fentora 100

micrograms contains 10 mg of

sodium. Each tablet of Fentora 200

micrograms, Fentora 400

micrograms, Fentora 600 micrograms

and Fentora 800 micrograms contains

20 mg of sodium. You should take

this into consideration and seek

advice from your doctor.

How to take it

Do not take Fentora to treat any

condition other than that directed

by your doctor.

Fentora orally disintegrating tablets

are for buccal use. When you place a

tablet in your mouth, it dissolves and

the medicine is absorbed through the

lining of your mouth, into the blood

system. Taking the medicine in this

way allows it to be absorbed quickly

to relieve your breakthrough pain.

How many to take

When you first start Fentora, your

doctor will work with you to find the

dose that will relieve your

breakthrough pain. This process is

called the titration process. Please

refer to the titration flowchart in the

Patient's guide for Fentora section of

the leaflet for more information.

It is very important that you use

Fentora exactly as the doctor tells

you.

The initial dose is 100 micrograms.

During determination of your right

dose, your doctor may instruct you to

take more than one tablet per

episode. If your breakthrough pain is

not relieved after 30 minutes, use

only 1 more tablet of Fentora during

the titration period.

Ask your doctor if you are not sure

about the right dose or if you have

any questions about taking

Fentora.

You should start to feel some pain

relief quickly while you are taking

Fentora.

Contact your doctor if your right

dose of Fentora does not relieve your

breakthrough pain. Your doctor will

decide if your dose needs to be

changed.

It is recommended that you wait at

least 4 hours before treating another

FENTORA

- CONSUMER MEDICINE INFORMATION V1.0

episode of breakthrough pain with

Fentora. The frequency may be

increased if instructed by your

doctor.

You must tell your doctor

immediately if you are using

Fentora more than four times per

day, as the doctor may wish to

change your medicine for your

persistent pain.

Once your persistent pain has been

controlled, your doctor may need to

change your dose of Fentora further.

For the most effective relief, let

your doctor know about your pain

and how Fentora is working for

you so that the dose can be

changed if needed.

Do not change doses of Fentora or

your other pain medicines on your

own. Any change in dosage must

be prescribed and monitored by

your doctor.

If you are not sure about the right

dose, or if you have questions

about taking this medicine, you

should contact your doctor.

DO NOT TAKE MORE THAN

THE DOSE YOUR DOCTOR

HAS RECOMMENDED.

Change in dosage must be directed

and monitored by your doctor.

How to take it

Open the blister only when you

are ready to use the tablet.

The tablet must be used

immediately once removed

from the blister.

Separate one of the blister units

from the blister card by tearing

apart at the perforations.

Bend the blister unit along the

line where indicated.

Peel the blister backing to expose

the tablet. Do NOT attempt to

push the tablet through the blister,

because this can damage the

tablet.

Remove the tablet from the blister

unit and immediately place the

entire tablet near a molar tooth

between the gum and the cheek

(as shown in the picture).

Do not attempt to crush or split

the tablet.

Sometimes your doctor may tell

you to place the tablet under your

tongue instead.

Do not bite, suck, chew, or

swallow the tablet, as this will

result in less pain relief than

when taken as directed.

The tablet should be left between

the cheek and gum until

dissolved, which usually takes

approximately 14 to 25 minutes.

You may feel a gentle bubbling

sensation between your cheek and

gum as the tablet dissolves.

In case of irritation, you may

change the placement of the tablet

on the gum.

After 30 minutes, if pieces of the

tablet remain, they may be

swallowed with a glass of water.

Always write the date and time each

time you take Fentora tablet. A table

called the 'Titration Dose Record' and

'Maintenance Dosing Record' in the

leaflet located inside the box will

help you record this information.

This will help you and your doctor

monitor your pain level and if the

dose is right for you.

Fentora contains no added flavours.

You may sense a slight taste, or you

may notice nothing at all.

How long to take it

You should not normally stop taking

Fentora for breakthrough pain unless

your doctor tells you to.

Tell your doctor if you feel unwell

during your course of treatment.

If you take too many Fentora

units (overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

your nearest hospital if you think

that you or anyone else may have

taken too many Fentora units.

Do this even if there are no signs of

discomfort or poisoning.

The most common side effects are

feeling sleepy, sick or dizzy. If you

begin to feel very dizzy, or very

sleepy before the tablet is completely

dissolved, rinse your mouth with

water and spit the remaining pieces

of the tablet into a sink or toilet right

away. Call another person to help

you.

A serious side effect of Fentora is

slow and/or shallow breathing. This

can occur if your dose of this

medicine is too high or if you take

too much Fentora. You and your

carer should discuss this side effect

with your doctor immediately.

What to do if a child or adult

accidentally takes Fentora

If you think someone has

accidentally taken Fentora follow

these steps:

FENTORA

- CONSUMER MEDICINE INFORMATION V1.0

If the person is asleep, wake them

up by calling their name and

shaking their arm or shoulder.

CALL FOR EMERGENCY

HELP.

While waiting for emergency

help:

if the person seems to be

breathing slowly, prompt

them to breathe every 5-10

seconds

if the person has stopped

breathing give mouth to

mouth resuscitation until help

arrives.

While you are taking it

Things you must do

Make sure that all of your doctors

and pharmacists know about your

use of Fentora. Remind them if

any new medicines are about to be

started, including any medicines

that you may purchase without a

prescription.

Things that you must not do

Do not use Fentora to treat any

other complaints unless your

doctor tells you to.

It may not be safe to use Fentora for

another complaint.

Do not give Fentora to someone

else even if their symptoms are the

same.

Fentora should only be used by the

person for whom it was prescribed.

It may not be safe for another person

to use Fentora.

Do not stop using Fentora unless

your doctor advises you to do so. If

you have been using Fentora for a

long period of time but stop using it

suddenly without your doctor's

advice, you may experience

withdrawal symptoms ( such as

nausea, vomiting, diarrhoea, anxiety

and shivering). Seek your doctor's

advice if you experience these

symptoms.

If you become pregnant whilst

taking Fentora, you should stop

taking it and see your doctor

immediately.

Side Effects

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some

side effects. Do not be alarmed by

this list of possible side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor if you experience

any of the following:

headache

nausea/vomiting

feeling unwell

weakness, dizziness

sleepiness, sedation

constipation

anxiety.

If you feel excessively dizzy, sleepy

or otherwise ill while taking Fentora,

remove the Fentora unit and contact

your doctor for further directions on

using Fentora.

Tell your doctor immediately, or

get someone to take you to

Accident and Emergency at your

nearest hospital if you notice any of

the following:

becoming very sleepy

having slow or shallow breathing

sudden signs of allergy such as

rash, itching or hives on the skin,

swelling of the lips, tongue or

throat, shortness of breath,

wheezing or trouble breathing.

Make sure that you are with someone

who can keep you awake by talking

to you or gently shaking you every

now and then.

Whilst using the Fentora tablet you

may experience irritation, pain, gum

bleeding or an ulcer at the site of

application.

Medicines like Fentora can lead to

addiction. This is unlikely when

Fentora is used correctly.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed in this

leaflet may also occur in some

patients.

After using it

Storage

Keep Fentora in the original

package until it is time to take the

dose.

If you take Fentora out of its blister

package, it may not keep as well.

Do not use it if the blister package

has been damaged or opened

before you are ready to use it.

Keep Fentora in a cool dry place

where the temperature stays below

25°C.

Do not store it or any other

medicine in the bathroom or near a

sink. Do not leave it in the car on

hot or cold days.

Heat, cold and dampness can destroy

some medicines.

Fentora orally disintegrating

tablets must be kept out of the

reach of children.

The pain-relieving medicine in

Fentora is very strong and could be

life-threatening if taken accidentally

by a child.

A locked cupboard at least one- and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Return all unused units to the

pharmacist or doctor if you are no

FENTORA

- CONSUMER MEDICINE INFORMATION V1.0

longer using Fentora or if you have

unwanted units.

Product description

What Fentora looks like

The orally disintegrating tablets are

flat-faced, round, beveled-edge

tablets, embossed one side with a "C"

and on the other side with "1" for

FENTORA 100 micrograms, with

"2" for FENTORA 200 micrograms,

with "4" for FENTORA 400

micrograms, with "6" for FENTORA

600 micrograms, with "8" for

FENTORA 800 micrograms.

FENTORA is supplied in

individually sealed, child-resistant

blister packs.

Ingredients

Active ingredient:

The active ingredient is fentanyl,

present in the product as fentanyl

citrate.

Inactive ingredients:

mannitol

sodium starch glycollate type A

sodium hydrogen carbonate

sodium carbonate anhydrous

anhydrous citric acid

magnesium stearate.

Manufacturer/Supplier

Fentora is manufactured in the USA.

Supplied in Australia by:

Teva Pharma Australia Pty Ltd

Level 2, 37 Epping Rd

Macquarie Park

NSW 2113

Telephone: 1800 288 382

Australian Registration Numbers:

Fentora 100 micrograms:

AUST R 218435

Fentora 200 micrograms:

AUST R 218437

Fentora 400 micrograms:

AUST R 218433

Fentora 600 micrograms:

AUST R 218434

Fentora 800 micrograms:

AUST R 218436

Fentora is a registered trademark of

Cima Labs Inc. A Delaware

corporation.

This leaflet was prepared in Oct 2015

5-11-2018

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FDA - U.S. Food and Drug Administration

22-10-2018

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

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FDA - U.S. Food and Drug Administration

19-9-2018

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

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FDA - U.S. Food and Drug Administration

1-8-2018

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FDA - U.S. Food and Drug Administration

24-7-2018

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July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

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July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

9-7-2018

July 6, 2018: Vero Beach Orthopedic Surgeon Sentenced to Life in Prison Following Conviction for Fentanyl Analog Drug Conspiracy Resulting in Death

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FDA - U.S. Food and Drug Administration

5-7-2018

July 3, 2018: Canton Man Indicted on Fentanyl and Firearms Charges

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FDA - U.S. Food and Drug Administration

22-6-2018

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2-5-2018

May 1, 2018: Vero Beach Orthopedic Surgeon Convicted at Trial of Fentanyl Analog Drug Conspiracy Resulting in Death

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FDA - U.S. Food and Drug Administration

19-4-2018

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

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FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Federal Jury Finds Three Guilty in Fentanyl Distribution Conspiracy

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1-6-2018

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