Totect

DRUG DESCRIPTION

Totect® (dexrazoxane) for injection is a sterile, pyrogen-free lyophilizate intended for intravenous (IV) administration. Totect (dexrazoxane for injection, intravenous infusion only ) ® is packaged as a kit for single patient use. Each kit contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent, which provides a complete three day treatment

Chemically, dexrazoxane is 2,6-piperazinedione,4,4'-(1-methyl-1,2ethanediyl)bis-,(S)- or (S)-(+)-1,2-bis(3,5-dioxopiperazin-1-yl)propane. The following diagram shows the chemical structure:

Totect (dexrazoxane) Structural Formula Illustration

The molecular formula is C11H16N4O4; the molecular weight is 268.3. Dexrazoxane is a white to off-white powder, with a melting point of 194 ± 3 °C. It is soluble in dioxane and 0.1 N HCl, sparingly soluble in water, tetrahydrofuran, citrate buffer at pH 4.0, phosphate buffer at pH 7.0, and borate-potassium chloride sodium hydroxide buffer at pH 9.0. The acid dissociation constants, pKa, are 2.5 (for the tertiary piperazine nitrogen) and 9.7 (for the nitrogen imide). Log P is -2.135.

The finished product is supplied in a sterile form for intravenous infusion only following mixing and diluting.

Each kit contains twenty 50 mL Type I glass vials. Ten vials each contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane and 10 vials each contains diluent (0.167M Sodium Lactate Injection, USP). Each vial of dexrazoxane for injection is closed with an aluminum flip-off cap covered with a dark red overcap. Each vial of diluent is closed with an aluminum flip-off cap covered with a white overcap.

When reconstituted as directed, the admixture contains dexrazoxane and the following excipients: hydrochloric acid, sodium lactate, water for injection, sodium hydroxide and lactic acid [see DOSAGE AND ADMINISTRATION]. The admixture should be further diluted in 0.9 % NaCl prior to administration to patients.

What are the possible side effects of dexrazoxane (Totect, Zinecard)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, weakness; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • hair loss;
  • nausea, vomiting, diarrhea, loss...

Read All Potential Side Effects and See Pictures of Totect »

What are the precautions when taking dexrazoxane for injection, intravenous infusion only (Totect)?

Before using dexrazoxane, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before...

Read All Potential Precautions of Totect »


Totect Consumer (continued)

SIDE EFFECTS: Because this medication is used with another medication, it is difficult to tell which side effects are caused by dexrazoxane. Nausea, vomiting, loss of appetite, trouble swallowing, diarrhea, temporary hair loss, or pain/irritation at the injection site have been reported. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

When combined with chemotherapy, dexrazoxane may worsen the effects that these medications can have on your bone marrow. Tell your doctor right away if you have any serious side effects, including: unusual weakness, mouth sores, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

Very rarely, people with cancer who have been treated with this medication have developed other cancers (e.g., leukemia, lymphoma). Consult your doctor for more details.

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 dexrazoxane, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Totect Patient Information Including Side Effects

Brand Names: Totect, Zinecard

Generic Name: dexrazoxane (Pronunciation: dex ray ZOX ane)

  • What is dexrazoxane (Totect)?
  • What are the possible side effects of dexrazoxane (Totect)?
  • What is the most important information I should know about dexrazoxane (Totect)?
  • What should I discuss with my health care provider before receiving dexrazoxane (Totect)?
  • How is dexrazoxane given (Totect)?
  • What happens if I miss a dose (Totect)?
  • What happens if I overdose (Totect)?
  • What should I avoid after receiving dexrazoxane (Totect)?
  • What other drugs will affect dexrazoxane (Totect)?
  • Where can I get more information?

What is dexrazoxane (Totect)?

Dexrazoxane is used to protect the heart from harmful side effects caused by doxorubicin (Adriamycin).

Dexrazoxane is used in women who are receiving doxorubicin for metastatic breast cancer.

Dexrazoxane may also be used for purposes not listed in this medication guide.

What are the possible side effects of dexrazoxane (Totect)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, weakness; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • hair loss;
  • nausea, vomiting, diarrhea, loss of appetite;
  • tired feeling;
  • pain where the medicine is injected;

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dexrazoxane (Totect)?

You should not receive this medication if your chemotherapy does not include doxorubicin or a similar medication such as daunorubicin (Cerubidine), epirubicin (Ellence), idarubicin (Idamycin), or mitoxantrone (Novantrone).

Before you receive dexrazoxane, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need dose adjustments or special tests during treatment.

Tell your doctor at once if you have serious side effects such as fever, chills, body aches, flu symptoms, easy bruising or bleeding, weakness, or white patches or sores inside your mouth or on your lips.

Related Drug Centers
  • Zinecard
  • Totect


Related Drugs Index: