Hexalen

DRUG DESCRIPTION

HEXALEN® (altretamine) capsules, is a synthetic cytotoxic antineoplastic s-triazine derivative. HEXALEN® capsules contain 50 mg of altretamine for oral administration. Inert ingredients include lactose, anhydrous and calcium stearate. Altretamine, known chemically as N,N,N',N',N“,N”-hexamethyl-1,3,5-triazine-2,4,6-triamine, has the following structural formula:

HEXALEN® (altretamine)  Structural Formula Illustration

Its empirical formula is C9H18N6 with a molecular weight of 210.28. Altretamine is a white crystalline powder, melting at 172°± 1°C. Altretamine is practically insoluble in water but is increasingly soluble at pH 3 and below.

What are the possible side effects of altretamine (Hexalen)?

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 your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • pain, tremors, tingling, burning, or prickling in hands or feet;
  • ...

Read All Potential Side Effects and See Pictures of Hexalen »

What are the precautions when taking altretamine (Hexalen)?

Before taking altretamine, 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, liver disease, brain/nerve disorders, blood/bone marrow disorders (e.g., low levels of platelets/white blood cells/red blood cells).

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.

To lower your risk of getting cut, bruised, or injured, use caution with...

Read All Potential Precautions of Hexalen »


Hexalen Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may reduce your dose or prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects. If 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.

Temporary hair loss may rarely occur. Normal hair growth should return after treatment has ended.

Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, dark urine, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 taking altretamine, 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, liver disease, brain/nerve disorders, blood/bone marrow disorders (e.g., low levels of platelets/white blood cells/red blood cells).

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.

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

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Hexalen Patient Information Including Side Effects

Brand Names: Hexalen

Generic Name: altretamine (Pronunciation: all TREH tah mean)

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

What is altretamine (Hexalen)?

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

Altretamine is used to treat cancer of the ovaries.

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

What are the possible side effects of altretamine (Hexalen)?

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 your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • pain, tremors, tingling, burning, or prickling in hands or feet;
  • mood changes;
  • severe drowsiness or loss of consciousness;
  • loss of coordination, weakness, dizziness, unsteadiness or falling; or
  • severe nausea or vomiting.

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

  • temporary hair loss;
  • itching or rash; or
  • mild to moderate nausea or vomiting.

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 altretamine (Hexalen)?

Altretamine 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 altretamine 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); neurologic problems (mood disorders, altered consciousness, weakness, dizziness, vertigo); and others. Talk to your doctor about the possible side effects from treatment with altretamine.

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