Temozolomide Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Temozolomide Capsule contains the active ingredient Temozolomide, an antineoplastic agent belonging to the alkylating agent class. It is a chemotherapy (antitumour) medicine taken as a capsule, swallowed whole with water, used to treat certain types of brain tumours. It is used in adults with newly-diagnosed glioblastoma multiforme alongside radiotherapy and then alone afterward, and in children aged 3 and older, adolescents, and adults with malignant glioma that has come back or worsened after standard treatment.

What is Temozolomide Capsule

Temozolomide is a chemotherapy (antitumour) medicine that works on cancer cells. It is taken as a capsule, swallowed whole with water, and is used to treat certain types of brain tumours.

Temozolomide Capsule uses

• Treatment of adults with newly-diagnosed glioblastoma multiforme (a type of brain tumour), used together with radiotherapy and then on its own afterward
• Treatment of children aged 3 years and older, adolescents, and adults with malignant glioma (such as glioblastoma multiforme or anaplastic astrocytoma) that has come back or gotten worse after standard treatment

Benefits of Temozolomide Capsule

• Treats certain glioblastomas
• Treats anaplastic astrocytoma
• Interferes with cancer-cell DNA replication
• Can be combined with radiotherapy
• Available as an oral chemotherapy capsule

How Temozolomide Capsule works

Temozolomide changes into an active substance in the body that attaches small chemical tags onto the DNA of cells. This damages the DNA, particularly in fast-growing cancer cells, which stops them from multiplying.

Temozolomide Capsule dosage

Take your capsules on an empty stomach, for example at least one hour before breakfast. Swallow the capsule(s) whole with a glass of water; do not open, crush, or chew them. If a capsule is damaged, avoid letting the powder touch your skin, eyes, or nose; if this happens, flush the area with water. Take your dose once a day, preferably at the same time each day.

If you vomit after taking your dose, do not take another dose that same day — wait until your next scheduled dose. Treatment for newly-diagnosed tumours happens in two phases: first alongside radiotherapy, then alone afterward in repeating cycles with several days on treatment followed by a longer break. Your doctor may give you anti-sickness medicine before or after your dose to help prevent nausea and vomiting.

Elderly patients (over 70) may be more likely to develop low blood cell counts and should be monitored closely. This medicine should not be given to children under 3 years of age.

Available forms and strengths

Hard capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg strengths)

Side effects of Temozolomide Capsule

Common

• Nausea and vomiting
• Loss of appetite
• Headache
• Tiredness (fatigue)
• Constipation or diarrhoea
• Hair loss (alopecia)
• Rash, dry skin, itching
• Difficulty speaking
• Convulsions (seizures)
• Low blood cell counts (anaemia, low white blood cells, low platelets)
• Fever, flu-like symptoms, feeling generally unwell
• Muscle weakness, aches, joint pain, back pain
• Blurred or abnormal vision, double vision, painful eyes
• Dizziness, memory or concentration problems, confusion, depression, anxiety, trouble sleeping
• Swelling in the legs or other fluid retention
• Weight loss or weight gain
• Elevated liver enzymes on blood tests

Serious

• Severe allergic reaction (hives, wheezing, breathlessness, swelling of face/lips/tongue/throat)
• Signs of serious infection (fever, chills, sore throat) due to low white blood cell counts
• Uncontrolled bleeding or severe bruising due to low platelet counts
• Severe, prolonged drop in blood cell counts that can lead to a very severe form of anaemia (aplastic anaemia), which can be fatal
• Severe headache that does not go away
• Liver problems, including liver failure, which can be fatal
• Reactivation of hepatitis B infection, which can be fatal
• A serious lung infection called Pneumocystis jirovecii pneumonia (PCP)
• Herpes brain infection (meningoencephalitis), including fatal cases
• Serious skin reactions with blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Secondary blood cancers, including myelodysplastic syndrome and leukaemia
• Lung scarring or inflammation (interstitial pneumonitis, pulmonary fibrosis)

Warnings and precautions

• Serious, sometimes fatal, drops in blood cell counts can occur, including a severe form of anaemia. Regular blood tests are needed to monitor for this.
• People receiving this medicine together with radiotherapy for 42 days are at particular risk of developing a serious lung infection called PCP, so preventive medicine is required.
• If you have had hepatitis B in the past, this infection could become active again during treatment, which has in some cases caused death. Your doctor should check for hepatitis B before you start treatment.
• Serious, sometimes fatal, herpes brain infections have been reported, usually in people also receiving radiotherapy and steroids.
• This medicine may cause permanent infertility in men. Men should use effective contraception and avoid fathering a child during treatment and for a period after, and should consider sperm storage before starting treatment.
• Capsules must never be opened, crushed, or chewed. If a capsule is damaged, avoid any contact of the powder with your skin, eyes, or nose.
• This medicine should not be used during pregnancy because it can harm the unborn baby. Women who could become pregnant must use effective contraception during treatment and for at least 6 months after finishing treatment.
• It is not known if this medicine passes into breast milk, so breastfeeding should be stopped during treatment.
• There is limited information on using this medicine in people with kidney problems, so your doctor will use caution, though a dose change is not usually expected to be needed.
• This medicine can cause serious, sometimes fatal, liver injury. Your doctor will check your liver function with blood tests before you start treatment and regularly during treatment.
• This medicine can make you feel tired or sleepy. Do not drive, cycle, or use tools or machines until you know how it affects you.

Storage

• Store in the original package
• Do not store above 30°C
• Keep the bottle tightly closed in order to protect from moisture
• Keep out of the sight and reach of children, preferably in a locked cupboard; accidental ingestion can be lethal for children
• Any unused medicine or waste material should be disposed of according to local requirements; do not throw medicines away via wastewater or household waste

When to see a doctor

• Get medical help right away if you have signs of a severe allergic reaction, such as hives, wheezing, or difficulty breathing.
• Contact your doctor immediately if you have uncontrolled bleeding.
• Contact your doctor immediately if you have a seizure (convulsion).
• Contact your doctor immediately if you develop a fever or chills, which could be a sign of infection.
• Contact your doctor immediately if you have a severe headache that does not go away.
• Contact your doctor right away if you develop symptoms that could suggest hepatitis, such as mild fever, feeling sick, tiredness, loss of appetite, joint or stomach pain, or yellowing of the skin or eyes.

Alternatives

• Lomustine
• Bevacizumab
• Radiation therapy