DepoCyt

DRUG DESCRIPTION

DepoCyt® (cytarabine liposome injection) is a sterile, injectable suspension of the antimetabolite cytarabine, encapsulated into multivesicular lipid-based particles. Chemically, cytarabine is 4amino-1 -?-D-arabinofuranosyl-2(1H)-pyrimidinone, also known as cytosine arabinoside (C9H13N3O5, molecular weight 243.22).

DEPOCYT® (cytarabine) Structural Formula Illustration

The following is an artist's rendition of a DepoCyt particle:

Artist’s rendition of a DepoCyt particle -llustration

Nonconcentric vesicles, each with an internal, aqueous chamber containing encapsulated cytarabine solution, surrounded by a bilayer lipid membrane.

DepoCyt is available in 5 mL, ready-to-use, single-use vials containing 50 mg of cytarabine. DepoCyt is formulated as a sterile, non-pyrogenic, white to off-white suspension of cytarabine in Sodium Chloride 0.9% w/v in Water for Injection. DepoCyt is preservative-free. Cytarabine, the active ingredient, is present at a concentration of 10 mg/mL, and is encapsulated in the particles. Inactive ingredients at their respective approximate concentrations are cholesterol, 4.4 mg/mL; triolein, 1.2 mg/mL; dioleoylphosphatidylcholine (DOPC), 5.7 mg/mL; and dipalmitoylphosphatidylglycerol (DPPG), 1.0 mg/mL. The pH of the product falls within the range from 5.5 to 8.5.

What are the possible side effects of cytarabine liposomal (DepoCyt)?

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; difficulty breathing; swelling of the lips, face, or tongue; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; unusual bruising or bleeding; black, bloody or tarry stools; or fever, chills, sore throat, or signs of infection); or
  • chemical arachnoiditis (a syndrome characterized by...

Read All Potential Side Effects and See Pictures of DepoCyt »

What are the precautions when taking cytarabine liposome injection (DepoCyt)?

Before using cytarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: brain infection (e.g., bacterial/fungal/viral meningitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous chemotherapy, previous radiation therapy.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or...

Read All Potential Precautions of DepoCyt »


DepoCyt Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, or fever may occur. If any of these effects persist or worsen, tell your doctor promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects.

Tell your doctor right away if you have any serious side effects, including: headache, tingling/numbness, muscle pain, back pain, neck pain/stiffness, seizures, swelling, loss of bladder/bowel control, unusual weakness/tiredness, easy bruising/bleeding, signs of infection (e.g., persistent sore throat), mental/mood changes (e.g., confusion).

Get medical help right away if any of these rare but very serious side effects occur: weakness/loss of movement on one side of the body, vision/hearing changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using cytarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: brain infection (e.g., bacterial/fungal/viral meningitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous chemotherapy, previous radiation therapy.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


DepoCyt Patient Information Including Side Effects

Brand Names: DepoCyt

Generic Name: cytarabine liposomal (Pronunciation: sye TAR ah been lye poe SEW mul)

  • What is cytarabine liposomal (DepoCyt)?
  • What are the possible side effects of cytarabine liposomal (DepoCyt)?
  • What is the most important information I should know about cytarabine liposomal (DepoCyt)?
  • What should I discuss with my healthcare provider before taking cytarabine liposomal (DepoCyt)?
  • How should I take cytarabine liposomal (DepoCyt)?
  • What happens if I miss a dose (DepoCyt)?
  • What happens if I overdose (DepoCyt)?
  • What should I avoid while taking cytarabine liposomal (DepoCyt)?
  • What other drugs will affect cytarabine liposomal (DepoCyt)?
  • Where can I get more information?

What is cytarabine liposomal (DepoCyt)?

Cytarabine liposomal is a cancer (antineoplastic) medication. Cytarabine liposomal interferes with the growth of cancer cells and slows their growth and spread in the body.

Cytarabine liposomal is used to treat lymphomatous meningitis.

Cytarabine liposomal may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of cytarabine liposomal (DepoCyt)?

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; difficulty breathing; swelling of the lips, face, or tongue; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; unusual bruising or bleeding; black, bloody or tarry stools; or fever, chills, sore throat, or signs of infection); or
  • chemical arachnoiditis (a syndrome characterized by neck pain or rigidity, back pain, nausea, vomiting, headache, fever).

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • muscle weakness;
  • fatigue or confusion;
  • constipation; or
  • swelling or water retention.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cytarabine liposomal (DepoCyt)?

Cytarabine liposomal should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of cytarabine liposomal including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); chemical arachnoiditis (a syndrome characterized by neck pain or rigidity, back pain, nausea, vomiting, headache, fever), and others. Talk to your doctor about the possible side effects from treatment with cytarabine liposomal.

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