Mavec^® 

Imatinib 100 and 400 mg

Film-Coated Tablets for Oral Use

Product leaflet summary

Therapeutic Indications

• Mavec is a treatment for adults and children with:

Chronic myeloid leukemia (CML)

Philadelphia chromosome positive acute lymphoblastic leukemia (Ph-positive ALL)

• Mavec is also a treatment for adults with:

Myelodysplastic/myeloproliferative diseases (MDS/MPD)

Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL)

Gastrointestinal stromal tumors (GIST)

Dermatofibrosarcoma protuberans (DFSP)

Dosage and Administration

Use in adults

Your doctor will tell you exactly how many tablets of Mavec to take.

– If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

– 400 mg to be taken as 4 tablets once a day,

– 600 mg to be taken as 6 tablets once a day.

– If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 4 tablets once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

– If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 6 tablets once a day.

– If you are being treated for MDS/MPD:

The starting dose is 400 mg to be taken as 4 tablets once a day.

– If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as one tablet once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.

– If you are being treated for DFSP:

The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.

Use in children and adolescents

The doctor will tell you how many tablets of Mavec to give to your child. The amount of Mavec given will depend on your child’s condition, body weight and height. The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

Contraindications

If you are allergic to imatinib or any of the other ingredients of this medicine.

If this applies to you, tell your doctor without taking Mavec.

If you think you may be allergic but are not sure, ask your doctor for advice.

Pregnancy and Lactation

– If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

– Mavec is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Mavec during pregnancy.

– Women who might become pregnant are advised to use effective contraception during treatment.

– Do not breast-feed during the treatment with Mavec.

– Patients who are concerned about their fertility while taking Mavec are advised to consult with their doctor.

Ability to Drive and Use Machinery

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

Package Presentation:

Mavec Supplied in a Pack of 30 tablets