Fludarabine Phosphate (Page 5 of 5)

17.2 Infections

Instruct patients to notify their physician promptly if fever or other signs of infection such as chills, cough, or burning pain on urination occurs while on therapy. [See Warnings and Precautions (5.4)]

17.3 Pregnancy

Women of childbearing potential and fertile males must take contraceptive measures during and at least for 6 months after the cessation of therapy.

Fludarabine phosphate may cause fetal harm when administered to a pregnant woman. [See Warnings and Precautions (5.9)]

17.4 Handling and Disposal

Instruct patients that caution should be exercised in the handling of fludarabine phosphate. Do not crush tablets. Avoid exposure by direct contact of the skin or mucous membranes or by inhalation. If contact occurs, wash thoroughly with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes. Consult healthcare provider in case of a skin reaction or if the drug gets in the eyes. Ask your healthcare provider or pharmacist for directions about how to safely dispose of fludarabine phosphate.

Manufactured for: Antisoma Research Limited, Cambridge, MA 02139

Manufactured by: Bayer Schering Pharma AG, Berlin, Germany

Patient Package Insert

[TRADENAME] (phonetic spelling)
(oral fludarabine phosphate film-coated tablets)

Read this Patient Information leaflet before you start taking [TRADENAME] and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What Is [TRADENAME]?

[TRADENAME] is a prescription anticancer medicine that slows or stops the growth of cancer cells in adults with chronic lymphocytic leukemia (CLL). [TRADENAME] also stops or slows the growth of some healthy cells. This can cause side effects that you should know about and report to your healthcare provider.

[TRADENAME] has not been studied in children.

What is the most important information I should know about [TRADENAME]?

On rare occasions people taking [TRADENAME] can have life-threatening symptoms. If you:

  • have problems seeing

  • feel very sleepy, tired, or confused

  • have shortness of breath or have trouble breathing

  • have yellow skin or dark urine

Tell your healthcare provider right away.

What should I tell my healthcare provider before taking [TRADENAME]?

Before taking [TRADENAME] , tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems

  • have bleeding problems

  • are pregnant or plan to become pregnant. It is not known if [TRADENAME] will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Women should not get pregnant during treatment with [TRADENAME] because the unborn baby may be harmed. Both men and women must take contraceptive measures during and for at least six months after cessation of therapy. Call your doctor right away if you become pregnant during or in the six months after treatment with [TRADENAME].

  • are breast- feeding or plan to breast-feed. It is not known if [TRADENAME] passes into your breast milk. You and your healthcare provider should decide if you will take [TRADENAME] or breast-feed. You should not do both.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Using [TRADENAME] with certain other medicines may affect each other. Using [TRADENAME] with other medicines may cause serious side effects.

Know the medicines you take. Keep a list of them with you to show your healthcare provider.

How should I take [TRADENAME]?

  • Take [TRADENAME] exactly as your healthcare provider tells you to take it.

  • Your healthcare provider will tell you how much and when to take [TRADENAME].

  • [TRADENAME] can be taken with or without food.

  • [TRADENAME] have to be swallowed whole with water; they should never be chewed, crushed, or broken. If you cannot swallow [TRADENAME] whole, ask your healthcare provider if you can take another form of fludarabine.

  • If you miss a dose call your healthcare provider.

  • If you take too much call your healthcare provider.

What should I avoid while taking [TRADENAME]?

  • Do not allow other people or pets to touch or take [TRADENAME].

  • Avoid letting the tablets (whole or broken) touch your skin

  • Do not chew tablets or hold them in your mouth. Swallow tablets right away.

  • Do not breathe in any powder or residue from a broken tablet.

  • If you touch a broken tablet, wash the area thoroughly with soap and water.

  • If any [TRADENAME] gets in your eyes, wash your eyes right away with water for at least 15 minutes, and call your healthcare provider right away.

  • Call your healthcare provider right away in case of a skin reaction.

What are the possible side effects of [TRADENAME]?

See “What is the most important information I should know about [TRADENAME]?”

[TRADENAME] may cause serious side effects, including:

Low blood cell counts.

[TRADENAME] lessens the number of blood cells that fight infection, help your blood to clot, and carry oxygen throughout your body. This can result in

  • Infection

  • Bleeding

  • Tiredness.

Avoid activities that can raise your chances of these conditions. Your healthcare provider will check your blood counts so that you will know when you are most at risk for infection, bleeding, and tiredness.

Call your healthcare provider right away if you have a temperature of 100.5 F. or above or do not feel well. Do not take a fever medicine until you check with your healthcare provider.

[TRADENAME] may cause other side effects, including:

  • nausea and vomiting

  • loss of appetite

  • skin rash

  • swelling in your legs

  • diarrhea

  • redness and irritation inside your mouth (stomatitis)

  • abdominal and muscle pain.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of [TRADENAME]. For more information, ask your healthcare provider or pharmacist.

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

How should I store and throw away [TRADENAME]?

  • Store [TRADENAME] at 59-86°F (15-30°C).

  • Keep under normal light in a child-resistant container.

  • Safely throw away medicine that is out of date or no longer needed.

  • Do not put [TRADENAME] in your regular household trash.

  • Ask your healthcare provider or pharmacist for directions about how to safely throw away and handle [TRADENAME].

Keep [TRADENAME] and all medicines out of the reach of children.

General information about [TRADENAME]

Medicines are sometimes prescribed for conditions that are not mentioned in patient information. Do not use [TRADENAME] for a condition for which it was not prescribed. Do not give [TRADENAME] to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about [TRADENAME]. For more information about [TRADENAME] , talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about [TRADENAME] that is written for health professionals. For more information go to www.fludarabine.com or call 1-8XX-XXX-XXXX.

What are the ingredients in [TRADENAME]?

Active ingredients: fludarabine phosphate

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silicon dioxide, croscarmellose sodium and magnesium stearate. The film-coat contains hypromellose, talc, titanium dioxide (E171) and ferric oxide pigment (red/E172, yellow/E172).

Rx only

PPI Issued August 11, 2008

Antisoma Research Ltd

FLUDARABINE PHOSPHATE
fludarabine phosphate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45414-311
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUDARABINE PHOSPHATE (FLUDARABINE) FLUDARABINE 10 mg
Inactive Ingredients
Ingredient Name Strength
microcrystalline cellulose
lactose monohydrate
colloidal anhydrous silicon dioxide
croscarmellose sodium
magnesium stearate
hypromellose
talc
titanium dioxide (E171)
ferric oxide pigment (red/E172, yellow/E172)
Product Characteristics
Color pink (salmon pink) Score no score
Shape OVAL (capsule shaped) Size
Flavor Imprint Code LN
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45414-311-15 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
1 3 BLISTER PACK (3 BLISTER PACK) in 1 BOTTLE This package is contained within the CARTON (45414-311-15) and contains a BLISTER PACK
1 5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK This package is contained within a BOTTLE and a CARTON (45414-311-15)
2 NDC:45414-311-20 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
2 4 BLISTER PACK (4 BLISTER PACK) in 1 BOTTLE This package is contained within the CARTON (45414-311-20) and contains a BLISTER PACK
2 5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK This package is contained within a BOTTLE and a CARTON (45414-311-20)
Labeler — Antisoma Research Limited

Revised: 02/2009 Antisoma Research Limited

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