TEMOZOLOMIDE

COMMON BRAND NAME(S): Temodar

GENERIC NAME(S): TEMOZOLOMIDE

Description: Temozolomide, a triazene, is an inactive prodrug. It is chemically hydrolysed to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC), the active metabolite of dacarbazine. The cytotoxicity of MTIC is believed to be due alkylation of DNA, mainly at the O6 and N7 positions of guanine.

Pharmacokinetics:

Absorption: Rapidly and completely absorbed from GI tract. Peak plasma concentration: 0.5-1.5 hr. Rate and extent of absorption decreased by food.

Distribution: Protein binding: 15%. Cross blood-brain barrier.

Metabolism: Undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound MTIC and to temozolomide acid metabolite. MTIC is further hydrolysed to 5-amino-imidazole-4-carboxamide (AIC) and methylhydrazine.

Excretion: Excreted mainly in urine as unchanged drug, AIC, temozolomide acid metabolite and unidentified polar metabolites. Plasma half life: 1.8 hr.

Uses

This medication is a chemotherapy drug used to decrease the size of brain tumors by slowing cancer cell growth. Temozolomide may also be used to treat other types of cancer (such as bone cancer).

How to use temozolomide

Read the Patient Information Leaflet provided by your pharmacist before you start using temozolomide and each time you get a refill. If you have any questions about the information or if you are not certain which days of the treatment cycle to take your medication, consult your doctor or pharmacist.

Take this medication by mouth, usually once daily or as directed by your doctor. To reduce nausea and vomiting, take it on an empty stomach (1 hour before or 3 hours after a meal) or at bedtime, unless otherwise directed by your doctor. To make sure the amount of medicine in your body is kept at a constant level, take it at the same time every day in relation to a meal (e.g., always 1 hour before the evening meal or always 3 hours after the evening meal).

Swallow the capsules whole with a full glass of water (8 ounces or 240 milliliters). The dosage is based on your medical condition, body size, and response to therapy.

Do not crush, chew, or open the capsules. If the capsules are accidentally opened or damaged, avoid inhaling the medication, and do not let it touch the skin or mucous membranes (e.g., inside the nose). If contact occurs, flush the area with water. Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.

Do not increase your dose or take this medication more often without your doctor’s approval. Your condition will not improve any faster and the risk of serious side effects may be increased.

Warnings

Not available.

Side Effects

Tell your doctor or pharmacist promptly if these effects persist or worsen:

nausea
vomiting
loss of appetite
mouth sores
changes in taste
coughing
constipation
tiredness
headache

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

This medication may cause very serious blood disorders (such as decreased bone marrow function). It may also rarely cause another form of cancer (of the bone marrow).

Get medical help right away if you have seizures or symptoms of liver damage (such as persistent loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Precautions:

Allergic reaction to this medication
Patients with medical history of:
- kidney problems
- liver problems
- decreased bone marrow function
- blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia)

Do not have immunizations/vaccinations without the consent of your doctor
avoid contact with people who have recently received oral polio vaccine
The elderly and women may be more sensitive to the increased risk of infection and easy bruising/bleeding
This medication is not recommended for use during pregnancy
Consult your doctor before breast-feeding

Consult your doctor regarding the precautions mentioned above.

Interactions:

This drug should not be used with nalidixic acid because very serious interactions may occur.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose & Brands

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, liver function, brain scan) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Missed Dose

For the best benefits, it is important to take each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Brands:

Available Brands

Emzolam-100 [ Ambica ]
Gliotem 20/Gliotem 100/Gliotem 250 [ Sun Pharma ]
Temovex-20/Temovex-100/Temovex-250 [ VE Pharma ]

Also marketed as

Temodal [ Schering-Plough ]
Temozam [ Fresenius Kabi ]
Temozol [ Intas ]