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ABSTRAL- fentanyl citrate tablet


  1. Patient Information
  2. Do Not Take Abstral:
  3. Before Taking Abstral, Tell Your Healthcare Provider If You:
  4. Before You Can Begin To Take Abstral:
  5. Taking Abstral:
  6. Abstral Can Cause Serious Side Effects, Including:
  7. How Should I Dispose Of Unopened Abstral Tablets When They Are No Longer Needed?
  8. What Are The Ingredients In Abstral?
  9. When You Get An Episode Of Breakthrough Pain, Take The Dose Prescribed By Your Healthcare Provider As Follows:
  10. Revised: 11/2014document Id:

Patient Information 

ABSTRAL can cause life-threatening breathing problems which can lead to death.

  1. Do not take ABSTRAL if you are not opioid tolerant.
  2. If you stop taking your around-the-clock opioid pain medicine for your cancer pain,you must stoptaking ABSTRAL. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  3. Take ABSTRAL exactly as prescribed by your healthcare provider.
    • You must not take more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
    • Youmust wait two hours before treating a new episode of breakthrough pain with ABSTRAL.

      • ABSTRAL is a prescription medicine that contains the medicine fentanyl.
      • ABSTRAL is used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
      • ABSTRAL is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use ABSTRAL if you are not opioid tolerant.
      • ABSTRAL is a small tablet that is placed on the floor of the mouth under your tongue (sublingual) and allowed to dissolve.
      • You must stay under your healthcare provider's care while taking ABSTRAL.
      • ABSTRAL is only:
        • available through the TIRF REMS Access program
        • given to people who are opioid tolerant

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

Do Not Take Abstral: 

  • if you are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the- clock for your cancer pain, and your body is used to these medicines.
  • for short-term pain that you would expect to go away in a few days, such as:
    • pain after surgery
    • headache or migraine
    • dental pain
  • if you are allergic to any of the ingredients in ABSTRAL.

Before Taking Abstral, Tell Your Healthcare Provider If You: 

  • have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
  • have or had a head injury or brain problem
  • have liver or kidney problems
  • have seizures
  • have a slow heart rate or other heart problems
  • have low blood pressure
  • have mental health problems including major depression, schizophrenia or hallucinations (

Before You Can Begin To Take Abstral: 

  • Your healthcare provider will explain the TIRF REMS Access program to you.
  • You will sign the TIRF REMS Access program Patient-Prescriber Agreement form.
  • ABSTRAL is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your ABSTRAL prescription filled.

Taking Abstral: 

  • Take ABSTRAL exactly as prescribed. Do not take ABSTRAL more often than prescribed.
  • If you notice that your tablets are a different shape or color,be sure to check with your pharmacist to make sure you have the right strength of medicine.
  • Do notsuck, chew or swallow the tablet.
    • Do not drive, operate heavy machinery, or do other dangerous activitiesuntil you know how ABSTRAL affects you. ABSTRAL can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
    • Do not drink alcohol while using ABSTRAL.It can increase your chance of getting dangerous side effects.

Abstral Can Cause Serious Side Effects, Including: 

  1. Breathing problems that can become life-threatening.

    • Always keep ABSTRAL in a safe place away from children and from anyone for whom it has not been prescribed.Protect ABSTRAL from theft.
    • Store ABSTRAL at room temperature, 59 F to 86 F (15 C to 30 C) until ready to use.
    • Keep ABSTRAL in the original blister unit. Do not remove ABSTRAL tablets from their blister packaging for storage in a temporary container, such as a pillbox.

How Should I Dispose Of Unopened Abstral Tablets When They Are No Longer Needed? 

  • Dispose of any unopened ABSTRAL units remaining from a prescription as soon as you no longer need them:
    • remove the tablets from the blister cards and flush them down the toilet.
  • Do not flush the ABSTRAL blister cards, units or cartons down the toilet.
  • If you need help with disposal of ABSTRAL, call Galena Biopharma, Inc.., at 1-888-227-8725 or call your local Drug Enforcement Agency (DEA) office.

General information about ABSTRAL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.Use ABSTRAL only for the purpose for which it was prescribed. Do not give ABSTRAL to other people, even if they have the same symptoms you have.ABSTRAL can harm other people and even cause death. Sharing ABSTRAL is against the law.

This Medication Guide summarizes the most important information about ABSTRAL. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about ABSTRAL that is written for healthcare professionals.

For more information about the TIRF REMS Access program, go towww.TIRFREMSAccess.comor call 1866-822-1483.

What Are The Ingredients In Abstral? 

Active Ingredient: fentanyl citrate

Inactive Ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.

Patient Instructions for Use

Before you take ABSTRAL, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that you read, understand, and follow these Patient Instructions for Use so that you take ABSTRAL the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to take ABSTRAL.

When You Get An Episode Of Breakthrough Pain, Take The Dose Prescribed By Your Healthcare Provider As Follows: 

  • If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water. Dry your hands if they are wet before you handle ABSTRAL tablets.
  • ABSTRAL comes in a blister card with 4 blister units. Each blister unit contains an ABSTRAL tablet. It is important that the tablet stays sealed in the blister unit until you are ready to use it.
  • When you are ready to take an ABSTRAL tablet, pull apart 1 of the blister units from the blister card by tearing along the dotted lines (perforations) until it is fully separated. (SeeFigures 1 and 2)

    Figures 1 and 2

  • When the blister unit is fully separated, peel back the foil starting at the unsealed area where indicated. Gently remove the tablet.Do nottry to push ABSTRAL tablets through the foil. This will damage the tablet. (SeeFigures 3 and 4)

    Figures 3 and 4

  • As soon as you remove the ABSTRAL tablet from the blister unit:
    • place it on the floor of your mouth, under your tongue, as far back as you can (SeeFigures 5, 6, and 7).

      Figures 5, 6, and 7

    • If more than 1 tablet is required, spread them around the floor of your mouth under your tongue.
    • Let the tablet dissolve completely.
    • ABSTRAL dissolves under your tongue and will be absorbed by your body to help provide relief for your breakthrough cancer pain.
    • Do not suck, chew or swallow the tablet.
    • You should not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.

Manufactured by:
Pharmaceutics International, Inc.
Hunt Valley, MD 21031

Manufactured for:
Galena Biopharma, Inc.
Portland, OR 97239

Issued: November 2014

This Medication Guide has been approved by the U.S. Food and Drug Administration. Copyright 2013, Galena Biopharma, Inc. All rights reserved.

ABSTRAL and Galena Biopharma are trademarks owned by the Galena Biopharma, Inc.

Principal Display Panel 100 mcg Carton Label

ABSTRALCII

(fentanyl) sublingual tablets

NDC 57881-331-32

Rx only

equivalent to 100 mcg fentanyl base

32 Sublingual Tablets

(4 tablets x 8 cards)

Mfd. by: Pharmaceutics International, Inc., Hunt Valley, MD 21031

Mfd. for: Galena Biopharma Inc., Suite 208, 310 N. State St., Lake Oswego, OR 97034

For questions about ABSTRALcall: 1-888-ABSTRAL.

Principal Display Panel     100 mcg Carton Label

Principal Display Panel 200 mcg Carton Label

ABSTRALCII

(fentanyl) sublingual tablets

NDC 57881-332-32

Rx only

equivalent to 200 mcg fentanyl base

32 Sublingual Tablets

(4 tablets x 8 cards)

Mfd. by: Pharmaceutics International, Inc., Hunt Valley, MD 21031

Mfd. for: Galena Biopharma Inc., Suite 208, 310 N. State St., Lake Oswego, OR 97034

For questions about ABSTRALcall: 1-888-ABSTRAL.

Principal Display Panel     200 mcg Carton Label

Principal Display Panel 300 mcg Carton Label

ABSTRALCII

(fentanyl) sublingual tablets

NDC 57881-333-32

Rx only

equivalent to 300 mcg fentanyl base

32 Sublingual Tablets

(4 tablets x 8 cards)

Mfd. by: Pharmaceutics International, Inc., Hunt Valley, MD 21031

Mfd. for: Galena Biopharma Inc., Suite 208, 310 N. State St., Lake Oswego, OR 97034

For questions about ABSTRALcall: 1-888-ABSTRAL.

Principal Display Panel     300 mcg Carton Label

Principal Display Panel 400 mcg Carton Label

ABSTRALCII

(fentanyl) sublingual tablets

NDC 57881-334-32

Rx only

equivalent to 400 mcg fentanyl base

32 Sublingual Tablets

(4 tablets x 8 cards)

Mfd. by: Pharmaceutics International, Inc., Hunt Valley, MD 21031

Mfd. for: Galena Biopharma Inc., Suite 208, 310 N. State St., Lake Oswego, OR 97034

For questions about ABSTRALcall: 1-888-ABSTRAL.

Principal Display Panel     400 mcg Carton Label

Principal Display Panel 600 mcg Carton Label

ABSTRALCII

(fentanyl) sublingual tablets

NDC 57881-336-32

Rx only

equivalent to 600 mcg fentanyl base

32 Sublingual Tablets

(4 tablets x 8 cards)

Mfd. by: Pharmaceutics International, Inc., Hunt Valley, MD 21031

Mfd. for: Galena Biopharma Inc., Suite 208, 310 N. State St., Lake Oswego, OR 97034

For questions about ABSTRALcall: 1-888-ABSTRAL.

Principal Display Panel     600 mcg Carton Label

Principal Display Panel 800 mcg Carton Label

ABSTRALCII

(fentanyl) sublingual tablets

NDC 57881-338-32

Rx only

equivalent to 800 mcg fentanyl base

32 Sublingual Tablets

(4 tablets x 8 cards)

Mfd. by: Pharmaceutics International, Inc., Hunt Valley, MD 21031

Mfd. for: Galena Biopharma Inc., Suite 208, 310 N. State St., Lake Oswego, OR 97034

For questions about ABSTRALcall: 1-888-ABSTRAL.

Principal Display Panel     800 mcg Carton Label
ABSTRAL
fentanyl citrate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57881-331
Route of AdministrationSUBLINGUALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl100 ug
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
ColorBLUE (light blue)Scoreno score
ShapeROUND (ROUND)Size10mm
FlavorImprint Code1
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57881-331-328 in 1 CARTON
1NDC:57881-331-044 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02251008/08/2013
ABSTRAL
fentanyl citrate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57881-332
Route of AdministrationSUBLINGUALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl200 ug
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
ColorORANGE (dark orange)Scoreno score
ShapeOVAL (OVAL)Size10mm
FlavorImprint Code2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57881-332-328 in 1 CARTON
1NDC:57881-332-044 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02251008/08/2013
ABSTRAL
fentanyl citrate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57881-333
Route of AdministrationSUBLINGUALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl300 ug
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
ColorBROWN (brown)Scoreno score
ShapeTRIANGLE (TRIANGLE)Size10mm
FlavorImprint Code3
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57881-333-328 in 1 CARTON
1NDC:57881-333-044 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02251008/08/2013
ABSTRAL
fentanyl citrate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57881-334
Route of AdministrationSUBLINGUALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl400 ug
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
ColorPURPLE (violet)Scoreno score
ShapeDIAMOND (DIAMOND)Size10mm
FlavorImprint Code4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57881-334-328 in 1 CARTON
1NDC:57881-334-044 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02251008/08/2013
ABSTRAL
fentanyl citrate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57881-336
Route of AdministrationSUBLINGUALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl600 ug
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
ColorTURQUOISE (turquoise)Scoreno score
ShapeSEMI-CIRCLE (D-SHAPE)Size10mm
FlavorImprint Code6
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57881-336-328 in 1 CARTON
1NDC:57881-336-044 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02251008/08/2013
ABSTRAL
fentanyl citrate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57881-338
Route of AdministrationSUBLINGUALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl800 ug
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
ColorBLUE (indigo)Scoreno score
ShapeCAPSULE (CAPSULE)Size10mm
FlavorImprint Code8
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57881-338-328 in 1 CARTON
1NDC:57881-338-044 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02251008/08/2013
Labeler -Galena Biopharma, Inc. (044320456)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutics International, Inc.878265586MANUFACTURE(57881-331, 57881-332, 57881-333, 57881-334, 57881-336, 57881-338)

Revised: 11/2014document Id: 

621fd88b-b921-47a2-94bd-a778d6005353Set id: f969e2bc-6297-4e29-89d3-a3685a2c7c6bVersion: 2Effective Time: 20141130Galena Biopharma, Inc.



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