Hexalen (Oral)

Altretamine is part of a group of medicines called antineoplastics. It is used to treat ovarian cancer. Your doctor may also use it to treat other types of cancer.

Altretamine works by interfering with the growth of cancer cells, which are eventually destroyed. This medicine can also affect the growth of normal body cells, leading to other effects. Some of these effects may be serious and should be reported to your doctor. Other effects may not be serious but could still be concerning. Some effects might not appear for months or even years after using the medicine.

Before starting treatment with altretamine, you and your doctor should discuss its benefits and the risks involved.

Altretamine is available only with a prescription from your doctor.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly and to monitor for unwanted effects.

While you are being treated with altretamine, and after you stop treatment with it, do not receive any immunizations (vaccinations) without your doctor's approval. Altretamine may lower your body's resistance, and there is a chance you might get the infection that the immunization is meant to prevent. Additionally, others in your household should not take oral polio vaccine, as they could pass the polio virus on to you. Also, avoid people who have taken oral polio vaccine within the last several months. Do not get close to them and do not stay in the same room with them for long. If you cannot take these precautions, consider wearing a protective face mask that covers your nose and mouth.

Altretamine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects like a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There is no specific information on how altretamine works in children compared to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be clear if they work the same way as they do in younger adults. Although there is no specific information on the use of altretamine in older people compared to other age groups, this medicine is not expected to cause different side effects or problems in older adults than in younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may modify the dose or frequency of one or both medicines.

• Pyridoxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine in relation to food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor about any other medical issues you have, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Nervous system problems—May be worsened by altretamine

• Infection—Altretamine may reduce your body's ability to fight infection

• Kidney disease—Effects of altretamine may be increased due to slower removal from the body

• Liver disease—Effects may change because altretamine is activated and cleared from the body by the liver

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, since of the way these medications act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your clinician.

Check with your physician immediately if any of the following adverse effects occur:

Less frequent or rare

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness, accompanied by fever or chills
• fever or chills
• lower back or side pain, accompanied by fever or chills
• sore or difficult urination, accompanied by fever or chills
• pinpoint red spots on skin
• unusual bleeding or bruising
• unusual fatigue

Check with your doctor as rapidly as possible if any of the following adverse effects occur:

More frequent

• Anxiety
• clumsiness
• confusion
• convulsions (seizures)
• light-headedness
• mental depression
• numbness in arms or legs
• weakness

Rare

• Skin rash or itching

Some adverse effects may occur that normally do not require medical attention. These side effects may go away during therapy as your body adjusts to the drug. Also, your health care professional may be capable to inform you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Nausea and vomiting

Less frequent

• Diarrhea
• loss of appetite
• stomach cramps

Other adverse effects not listed may also occur in some patients. If you notice any other effects, verify with your healthcare professional.

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

In the U.S.

• Hexalen

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Taking this medicine after meals will lessen stomach upset. Ask your health care professional for other ways to lessen these effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.