PlayingItSafe asked
Our daughter was prescribed mycophenolate mofetil (CellCept), but we are having difficulty affording the medication in the oral suspension form, and asked if we could get the less expensive tablet form to crush (as she has special needs and cannot easily swallow most solids). The doctor's office agreed to prescribe the 500 mg tablet instead, but the local pharmacy has advised us that it is not safe to crush this medication. We called the Dr.'s office again to check on this, and were told that the Dr. prescribed the "short-acting" form (not delayed-release), so it should be safe to crush. We then talked to the pharmacy again, and they maintained that long or short acting, the medication should not be crushed. Our daughter is currently taking a break from the medication while we decide what to do (Dr. is OK with us taking time to research our options). Is it in fact safe to crush the tablet form? We want to be sure before we begin to give her the medicine in this form. Thank you.
Answer
CellCept (Mycophenolate Mofetil) is available in multiple dosage forms including:
- Capsules
- Tablets
- Delayed-Release Tablets
- Power For Suspension
All dosage forms are not recommended to be opened (e.g. for capsules) or crushed (e.g. tablets).
Crushing Cellcept
It is well known that tablet or capsule dosage forms that have an extended release mechanism not be altered (i.e. crushed, split or opened). This could potentially destroy the extended release mechanism, releasing the medication too quickly. While this applies for delayed release tablets of CellCept, there is a different reason as to why the immediate release tablets and capsules should not be opened or crushed.
The prescribing information states that CellCept immediate release dosage forms are not to be crushed or opened as CellCept has known teratogenic effects. Exposure to the active ingredient (mycophenolate), can cause detrimental effects to a developing fetus.
The prescribing information gives the following warning:
"Mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits. CellCept tablets should not be crushed and CellCept capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules and CellCept Oral Suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Several studies have reviewed case reports of fetal malformations in pregnant women who were exposed to mycophenolate and there does appear to be an association. The FDA has mandated that mycophenolate products be added to the "REMS" (Risk Evaluation and Mitigation Strategy) program, which educates patients, pharmacists and prescribers on the risks associated with CellCept in regard to pregnancy.
If there are extenuating circumstances (e.g. financial hardship), you may be able to work with your doctor and pharmacy to come up with a plan to safely and effectively crush CellCept (mycophenolate) tablets so they can be administered to an individual in need of the medication.
