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FOLOTYN- pralatrexate injection


  1. Patient Information
  2. Before You Receive Folotyn, Tell Your Doctor If You:
  3. How Will I Receive Folotyn?
  4. Low Blood Cell Counts:
  5. Low Platelet Count (thrombocytopenia):
  6. Low White Blood Cell Count (neutropenia):
  7. Low Red Blood Cell Count (anemia):
  8. Common Side Effects Of Folotyn Include:
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. What Is Ptcl?
  12. Revised: 10/2018document Id:

Patient Information 

See FDA-approved labeling (Patient Information).

Patients should be instructed to read the Patient Information carefully.

17.1 Need for Folic Acid and Vitamin B12

Advise patients treated with FOLOTYN to take folic acid and vitamin B12as a prophylactic measure to reduce the risk of possible side effects [see Dosage and Administration (2.1)].

17.2 Low Blood Cell Counts

Inform patients of the risk of low blood cell counts and to immediately contact their physician should any signs of infection develop, including fever. Inform patients to contact their physician if bleeding or symptoms of anemia occur.

17.3 Mucositis

Inform patients of the signs and symptoms of mucositis. Instruct patients on ways to reduce the risk of its development, and on ways to maintain nutrition and control discomfort from mucositis if it occurs.

17.4 Fatal Dermatologic Reactions

Advise patients about the risks for and the signs and symptoms of dermatologic reactions. Instruct patients to immediately notify their physician if any skin reactions occur [see Warnings and Precautions (5.3)].

17.5 Tumor Lysis Syndrome

Inform patients about the risk of and the signs and symptoms of tumor lysis syndrome. Patients should be instructed to notify their physician if they experience these symptoms [see Warnings and Precautions (5.4)].

17.6 Concomitant Medications

Patients should be instructed to inform their physician if they are taking any concomitant medications including prescription drugs (such as trimethoprim/sulfamethoxazole) and nonprescription drugs (such as nonsteroidal anti-inflammatory drugs) [see Drug Interactions (7)].

17.7 Pregnancy/Nursing

Patients should be instructed to tell their physician if they are pregnant or plan to become pregnant due to the risk of fetal harm. Patients should be instructed to tell their physician if they are nursing.

Manufactured for:
Acrotech Biopharma LLC
East Windsor, NJ 08520
1-888-255-6788

FOLOTYN is a registered trademark of Acrotech Biopharma LLC.
U.S. Patents: 6,028,071, 7,622,470 and 8,299,078
Rev. September 2019

Acrotech Biopharma LLC. All rights reserved.

Before You Receive Folotyn, Tell Your Doctor If You: 



have liver problems.
have kidney problems.
have any other medical conditions.
are pregnant or plan to become pregnant. FOLOTYN can harm your unborn baby. Talk to your doctor about the best way to prevent pregnancy while taking FOLOTYN. Tell your doctor right away if you become pregnant while taking FOLOTYN.
are breast-feeding or plan to breast-feed. It is not known if FOLOTYN passes into breast milk. You and your doctor should decide if you will take FOLOTYN or breast-feed. You should not do both. Talk to your doctor about the best way to feed your baby while you are being treated with FOLOTYN.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how FOLOTYN works, and FOLOTYN may affect how other medicines work. Especially tell your doctor if you take:

sulfamethoxazole trimethoprim (Bactrim , Septra , Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS)
non-steroidal anti-inflammatory drugs (NSAIDs)
probenecid (Probalan, Col-Probenecid)

Ask your doctor or pharmacist if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist each time you start a new medicine.

How Will I Receive Folotyn? 



FOLOTYN will be given to you as directed by your doctor, as an intravenous (IV) injection into your vein over 3 to 5 minutes.
FOLOTYN is usually given in cycles, one time each week for 6 weeks, with no treatment on the 7thweek. Treatment with FOLOTYN may be continued as long as it is helpful to you.

To lower your chances of harmful side effects, it is important that you take folic acid and vitamin B12during your treatment with FOLOTYN. Your doctor will give you specific instructions for vitamin supplementation.

You will take folic acid by mouth for 10 days before your first dose of FOLOTYN. Do not take more or less folic acid than your doctor tells you to take. Continue taking folic acid every day until your doctor tells you to stop.
Your doctor will give you a vitamin B12injection into your muscle (intramuscular) before your first dose of FOLOTYN and about every 8 to 10 weeks during treatment with FOLOTYN.

You should have regular blood tests before and during your treatment with FOLOTYN. Your doctor may change your dose of FOLOTYN or delay treatment based on the results of your blood tests and on your general condition.

Low Blood Cell Counts: 

FOLOTYN can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts.

Low Platelet Count (thrombocytopenia): 

Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.

Low White Blood Cell Count (neutropenia): 

A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
fever
chills
cough
shortness of breath
pain or burning on urination

Low Red Blood Cell Count (anemia): 

Tell your doctor if you have any of these symptoms of anemia during treatment with FOLOTYN:
feeling weak, tired, or you get tired easily
you look pale
you feel short of breath
Redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis). Discomfort or pain due to mucositis may happen as early as a few days after treatment with FOLOTYN. Your doctor should tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and control the discomfort from mucositis.
Severe skin reactions.Severe skin reactions may happen after treatment with FOLOTYN, especially if you have lymphoma in or under your skin. If your skin reactions are severe, they may lead to serious illness or death. Tell your doctor right away if you have any of the following skin reactions:
rash
peeling and loss of skin
sores
blisters
Tumor Lysis Syndrome (TLS).FOLOTYN can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
Harm to an unborn baby.Females should avoid becoming pregnant while being treated with FOLOTYN. Talk to your doctor about how to avoid pregnancy while taking FOLOTYN.
Fever.Fever is often one of the most common and earliest signs of infection. Follow your doctor's instructions about how often to take your temperature, especially during the days after treatment with FOLOTYN. If you have a fever, tell your doctor or nurse right away.
Loss of too much fluid from the body (dehydration).If you feel tired and weak this could be a sign of dehydration. Follow your doctor's instructions for what to do to help prevent or treat dehydration.
Shortness of breath.Tell your doctor if this is a problem for you.

Common Side Effects Of Folotyn Include: 

nausea
vomiting
tiredness
constipation
swelling
cough
nosebleed
diarrhea

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of FOLOTYN. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

General information about FOLOTYN

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This patient information leaflet summarizes the most important information about FOLOTYN. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about FOLOTYN that is written for health professionals.

For more information, go to www.FOLOTYN.com or call 1-888-255-6788.

Active Ingredient: 

pralatrexate

Inactive Ingredients: 

sodium chloride, sodium hydroxide, and hydrochloric acid

What Is Ptcl? 

PTCL is a rare type of non-Hodgkin's lymphoma, a cancer of the lymphatic system. It happens when a type of T-cell (a kind of white blood cell) grows too much. PTCL may be found in different parts of the body, such as the lymph nodes, skin, bone marrow, liver, or spleen.

mobius triangle symbol

Spectrum Pharmaceuticals, Inc. and its wholly-owned subsidiary Allos Therapeutics, Inc.
Westminster, CO 80021

Issued: May 2010
Revised: November 2016

flower-symbol

FOLOTYN, ALLOS, the mobius triangle symbol, and the flower symbol are all registered trademarks of Allos Therapeutics, Inc.

2016 Spectrum Pharmaceuticals, Inc. and its wholly-owned subsidiary Allos Therapeutics, Inc. All rights reserved.

PACKAGE CARTON - FOLOTYN 20 mg/1 mL Vial

NDC 48818-001-01

FOLOTYN

(pralatrexate injection)

20 mg/mL

For intravenous use

Rx only

1 mL

Folotyn 20 mg/mL Carton

PACKAGE CARTON - FOLOTYN 40 mg/2 mL Vial

NDC 48818-001-02

FOLOTYN

(pralatrexate injection)

40 mg/2 mL

(20 mg/mL)

For intravenous use

Rx only

2 mL

Folotyn 40 mg/mL Carton

VIAL FOLOTYN 20 mg/1 ml

NDC 48818-001-01

FOLOTYN

(pralatrexate injection)

20 mg/mL

Rx only

1 mL

Folotyn 20 mg/mL Vial

VIAL FOLOTYN 40 mg/2 ml

NDC 48818-001-02

FOLOTYN

(pralatrexate injection)

40 mg/2 mL
(20 mg/mL)

Rx only

2 mL

Folotyn 20 mg/mL Vial
FOLOTYN
pralatrexate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48818-001
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
pralatrexate(UNII: A8Q8I19Q20) (pralatrexate - UNII:A8Q8I19Q20)pralatrexate20 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium chloride(UNII: 451W47IQ8X)
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48818-001-011 in 1 CARTON09/24/2009
11 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:48818-001-021 in 1 CARTON09/24/2009
22 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02246809/24/2009
Labeler -Allos Therapeutics (835393869)

Revised: 10/2018document Id: 

ad8dcfcc-888a-4a60-9b5a-4afe7dc429d7Set id: 5e4cf15b-bf7b-4b83-863e-e9ef27741a51Version: 20Effective Time: 20181031Allos Therapeutics



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