Altretamine

What is Altretamine?

• Altretamine (Hexalen) is an orally administered alkylating agent, formerly known as hexamethylmelamine, which is currently used as a secondary therapy for advanced ovarian carcinoma.

Altretamine

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What are the uses of this medicine?

• Altretamine (Hexalen) is used for use as a single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination.

How does this medicine work?

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Altretamine mechanism

• Altretamine (al tret' a meen) is a synthetic, orally available alkylating agent belonging to the methylmelamine class of these agents.
• The alkylating agents act by causing modification and cross linking of DNA, thus inhibiting DNA, RNA and protein synthesis and causing cell death in rapidly dividing cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have shown hypersensitivity to it.
• with preexisting severe bone marrow depression or severe neurologic toxicity.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• cimetidine (Tagamet), isocarboxazid (Marplan), phenelzine (Nardil), pyridoxine (Vitamin B6) and tranylcypromine (Parnate).
• Tell your doctor if you have ever received or taken certain chemotherapy medications such as bendamustine (Treanda), cisplatin (Platinol), carmustine (BiCNU, Gliadel Wafer), cyclophosphamide (Cytoxan), ifosfamide (Ifex), lomustine (CeeNU), melphalan (Alkeran), procarbazine (Mutalane), temozolomide (Temodar), or thioguanine.

Is this medicine FDA approved?

• Altretamine was approved for use in the United States in 1990.
• Current indications are advanced ovarian carcinoma in patients who have failed primary therapy with platinum-containing or other alkylating agents.

How should this medicine be used?

Recommended dosage:

• HEXALEN capsules may be administered either for 14 or 21 consecutive days in a 28 day cycle at a dose of 260 mg/m2/day.
• The total daily dose should be given as 4 divided oral doses after meals and at bedtime.

Administration:

• Altretamine comes as a capsule to take by mouth.
• It is usually taken four times a day (a dose after each meal and a dose at bedtime) for 14 or 21 days in a row.
• This cycle may be repeated once every 4 weeks depending on your response to the medication.
• Take altretamine at around the same time every day.

HEXALEN® capsules should be temporarily discontinued (for 14 days or longer) and subsequently restarted at 200 mg/m2/day for any of the following situations:

• Gastrointestinal intolerance unresponsive to symptomatic measures
• White blood count <2000/mm3 or granulocyte count <1000/mm3
• Platelet count <75,000/mm3
• Progressive neurotoxicity

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As CAPSULES 50 mg

This medicine is available in fallowing brand namesː

• HEXALEN

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• alopecia
• bone marrow suppression
• peripheral neuropathy
• rash

Altretamine may cause serious side effects, including:

• fever, chills, sore throat, ongoing cough and congestion, or other signs of an infection
• unusual bleeding or bruising
• bloody or black, tarry stools
• small, round, red or purple colored spots on the skin
• bloody vomit
• vomited material that looks like coffee grounds
• bleeding gums

What special precautions should I follow?

• Concurrent administration of HEXALEN capsules and antidepressants of the monoamine oxidase (MAO) inhibitor class may cause severe orthostatic hypotension.
• HEXALEN capsules causes mild to moderate myelosuppression and neurotoxicity. Blood counts and a neurologic examination should be performed prior to the initiation of each course of therapy and the dose of HEXALEN® capsules.
• HEXALEN capsules may cause fetal damage when administered to a pregnant woman. If HEXALEN® capsules is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.
• Neurologic examination should be performed regularly.
• Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of HEXALEN capsules.
• Altretamine therapy has been associated with low rates of serum enzyme elevations during therapy and with rare instances of acute, clinically apparent injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No case of acute overdosage in humans has been described.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• HEXALEN capsules may cause fetal damage when administered to a pregnant woman.
• If HEXALEN capsules is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.
• Women of childbearing potential should be advised to avoid becoming pregnant.

Can this medicine be used in children?

• The safety and effectiveness of HEXALEN capsules in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• altretamine

Inactive ingredients:

• lactose, anhydrous and calcium stearate

Who manufactures and distributes this medicine?

Manufactured by:

• AAIPharma Inc.
• Wilmington, NC

Manufactured for:

• Eisai Inc.
• Woodcliff Lake, NJ

What should I know about storage and disposal of this medication?

• Store up to 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F).

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• Dailymed label info on Altretamine
• FDA Altretamine

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