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Is it safe to have children while taking imatinib mesylate (IM)?

KH: There have been no clinical trials done on humans to determine the safety of having children while taking imatinib mesylate (IM). 

However, animal studies have shown that IM may be toxic when taken by pregnant women, and the risk of harmful effects to the fetus increases with higher doses of IM. 

The consensus is that IM should not be taken by women who are pregnant or who are trying to conceive. 

In addition, it is not known whether IM is excreted in human milk.  In animal studies, IM and its metabolites were clearly and extensively excreted in the animal milk.  Therefore, women who are taking IM should not breastfeed.

IM, in general, is not considered genotoxic (capable of causing changes in DNA) to male sperm.  However, data are limited.

Have there been cases of IM patients fathering a child ?

KH:  There have been several children fathered by men taking IM and the offspring have been healthy. 
Does IM affect male fertility ?

KH: IM, especially in higher doses, has been shown to decrease sperm motility and thus may decrease male fertility.

IM, in general, is not considered
genotoxic (capable of causing changes in DNA) to male sperm.  However, data are limited.

Are there  side effects do people experience while taking imatinib mesylate (IM)?

KH: Most side effects associated with imatinib mesylate (IM) therapy are mild and get better with time.  All side effects should be reported to a physician, and be sure to consult with a physician before using any remedies listed.

For the official l
ist of side effects, see the glivec site.

Is nausea and vomiting commonly experienced by IM patients?

KH:  Approximately 68% of patients in clinical trials reported nausea while taking IM.  Occasionally, the nausea was accompanied by vomiting and/or upper abdominal pain.


Novartis (the makers of IM) and many physicians suggest taking IM with meals and plenty of water to minimize these discomforts.  Splitting the dose of IM into two separate doses, each taken with a meal, may also alleviate this side effect.  If nausea persists, anti-nausea medications such as prochlorperazine or ondansentron, under the direction of a physician, may be appropriate.


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Has diarrhea been
reported in IM
patients ?

KH:  Diarrhea was reported by approximately 49% of patients taking IM in clinical trials.  It is usually mild, but should be reported to a physician because severe diarrhea may affect the absorption of IM and reduce its effectiveness.  Often, diarrhea is relieved through the use of over-the-counter remedies such as Imodium-AD

How about muscle cramps and bone pain ?

KH: Approximately 39% of patients in clinical trials reported muscle cramps and/or bone pain while taking IM.

Where and when do they  experience muscle cramping to occur ?

KH: Muscle cramps are usually experienced in the hands, feet, calves and thighs and may be worse with exertion or at night.

Many patients report relief from muscle cramps with the use of calcium supplements.  However, it is important to take the calcium supplements at least  two hours before or at least two hours after taking a dose of IM because the calcium may block the absorption of IM and reduce its effectiveness if IM and calcium supplements are taken too closely together.

Exercise and/or stretching may alleviate muscle cramps.  Some patients have reported relief from drinking tonic water with quinine, or from the use of Quinine Sulfate which requires a prescription from a doctor.

How about the bone pain, what have patients on IM reported ?

KH: Bone pain has been reported in 20% to 40% of patients and is most common in the first month of therapy with IM.

It has been suggested that bone pain may be due to clearing of leukemic cells from the marrow and often gets better with time as the marrow becomes healthier.

As in the case of muscle cramps, exercise or stretching may alleviate bone pain.  Some patients take ibuprofen to alleviate the discomfort.

Acetaminophen (brand name Tylenol) is not recommended for patients taking IM as it is metabolized through the liver, as is IM, and the combination may put undue stress on the liver.  For patients who are unable to take ibuprofen due to low platelets or GI bleeding, acetaminophen may be tried cautiously (only under a doctor's supervision) or mild narcotics pain relievers may be used.

-----
KH or Kelly Harless, wife of CML Mariner Rob works in clinical investigations. She narrates her husband Rob's participation in the HSP 70 vaccine trials and has worked hard at compiling information in answer to other CML patients' queries for the searchable Mariners FAQ and Glossary Database.

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