Can You Open Gilenya Capsules?

Answer

I can understand why you are receiving some conflicting information regarding whether or not it is safe to open Gilenya (fingolimod) capsules.

It is not an extended-release drug, and the outer capsule that stores the drug powder inside doesn't have any special properties that influences how the drug works or is absorbed.

In most cases, the assumption would be that these capsules can be opened safely.

However, the reason why Gilenya capsules are not recommended to be opened is because it has a NIOSH (National Institute of Occupational Safety and Health) Group 2 hazardous drug classification.

Anytime a drug is classified as hazardous, the blanket recommendation will always be that the drug should be handled carefully and not be split, crushed, opened or otherwise manipulated (unless medically necessary or necessary for drug preparation prior to administration).

While the FDA approved prescribing information for the drug doesn't touch on opening the capsules, the 'European Medicines Agency' information for the drug does state the capsule should be swallowed whole.

Gilenya Is Classified As A Hazardous Drug

Gilenya is classified as a NIOSH group 2 hazardous drug, which is defined as:

Group 2 - Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug: Some of these drugs may represent an occupational hazard to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breast feeding, because they may be present in breast milk. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers.

You can find Gilenya (fingolimod) on both the 2016 NIOSH hazardous drug list (in group 2) and the 2020 list (table 2).

Gilenya is classified as hazardous since studies have shown that doses lower than the usual recommended human doses can cause birth defects. Exposure to the drug should be limited.

Gilenya Must Be Handled Carefully

Anytime a drug is classified as hazardous, there are specific recommendations on how they should be handled to reduce the risk of exposure.

Appropriate precautions need to be taking when handling, preparing, administering or disposing hazardous drugs.

Now, if a drug is classified as hazardous, that doesn't necessarily mean the dosage form (e.g., tablets, capsules, liquid etc...) can't be modified.

For example, most chemotherapy drugs are classified as hazardous, but many times, they need to be compounded or made into an IV solution prior to administration.

However, cutting, crushing, or otherwise manipulating a hazardous drug will increase exposure and generally requires additional protective equipment to be utilized.

Can You Open Gilenya Capsules Even Though It Is Hazardous?

In your question, you made it clear that you are the individual taking the drug.

The NIOSH hazardous drug list is for occupational safety. Exposure to the drug needs to be limited in those who may be exposed to it who are not the ultimate patient.

You don't mention if you are of child-bearing age, but if you are, I'm sure your doctor or pharmacist has talked to you about the hazards of becoming pregnant while taking the drug.

If you administer Gilenya on your own (i.e., no one else prepares or otherwise comes into contact with the drug), you could certainly open the capsules and mix the powder with a liquid for immediate consumption.

Again, the capsules do not have any special properties that affect how the drug works.

If you do open the capsules, as I've discussed in this answer, it is extremely important to take precautions to limit potential exposure of the drug to others.

This would include thoroughly washing glasses used to mix the powder in, cleaning up any residue left on surfaces, properly disposing the capsules in some kind of container/packaging, etc...

Final Words

I hope you found this helpful, and it cleared up any confusion.

As I mentioned at the beginning of this answer, I understand why you're getting different recommendations from two different pharmacists. In a sense, both are right. The capsules are not recommended to be opened, but the 'why' here is important.

In certain situations, and with the right precautions, if it is medically necessary to open to capsules, they can be since the actual drug is not affected. Just be safe!

Thanks for reaching out.