Frequently Asked Questions About Hexalen® (altretamine)
Generic Name: altretamine (al-TRET-uh-meen), hexamethylmelamine, HMM
Trade Name: Hexalen®
For which conditions is Hexalen approved for? Hexalen is FDA approved as a single agent for the treatment of ovarian cancer that has stopped responding to previous therapy with a cisplatin and/or alkylating-based chemotherapy regimen.
What is the mechanism of action? Hexalen produces anti-cancer effects through several possible mechanisms. The most widely accepted explanation of its effects on cancer cells is the fact that it produces a chemical reaction that damages the DNA of a cell. The DNA damage caused by Hexalen results in inhibition of cellular growth and/or cellular death.
How is Hexalen typically given (administered)? Hexalen is a capsule that is taken orally. Typically, patients are instructed to take Hexalen in divided doses following a meal and at bedtime. Precise doses and scheduling will be determined by a patient’s physician.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Hexalen. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Patients may also undergo neurologic assessments, as Hexalen may cause damage to the nervous system, although this is uncommon.
What are the most common (occur in 30% or more of patients) side effects of treatment with Hexalen?
- Nausea and vomiting
- Loss of appetite
- Low levels of white blood cells – increases risk of infection
- Low platelet levels – increases risk of bleeding
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Hexalen?
- Numbness and/or tingling of fingers and/or toes
- Changes in mood, consciousness or balance, depression, agitation
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Wear sunscreen and protective clothing and try to minimize sun exposure.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
- Maintain adequate rest and nutrition.
- If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
- Wash hands often to reduce the risk of infection.
- Avoid activities that may cause injury or bruising.
- Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
- Eat small meals frequently to help alleviate nausea.
- Take Hexalen following meals, as this may help relieve nausea or stomach upset.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should tell their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, infection, heart disease, kidney disease, liver disease, lung disease, thyroid disease, etc.) as they may worsen with this drug.
- Patients should inform their physician if they have ever had convulsions or seizures.
- Patients should inform their physician about any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
- Patients should use caution when driving or operating heavy machinery, as Hexalen may affect mental status or balance.
- Patients who miss an oral dose should not double up on doses, but instead should contact their physician.
- It is important that patients keep capsules out of the reach of children and return any unused tablets to the pharmacy for safe disposal if treatment is terminated.
When should patients notify their physician?
- Sore throat
- Signs of infection
- Prolonged nausea or vomiting
- Prolonged diarrhea
- Prolonged or severe confusion
- Severe fatigue
- Unusual bleeding or bruising
- Black, tarry stools
- Blood in the urine
- Significant numbness or pain of fingers or toes
- Severe or persistent depression
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.