Exalgo: The New Long Acting Hydromorphone Pill

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
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When you hear about Exalgo you may wonder why we need such a high dose of hydromorphone in one pill, and you may feel worried about that. Well, physicians feel the same way. Here is the deal.

Dilaudid is the short acting hydromorphone most people are familiar with. In August 2012, the Food and Drug Administration (FDA) approved a 32 mg strength of Exalgo (hydromorphone) extended-release tablets for use in opioid-tolerant patients with moderate-to-severe chronic pain who require opioids for an extended period of time. To give you an example of how high this dose is, the largest pill Dilaudid comes in is 8 mg. For some people though, this is a good thing.

Who would need Exalgo? Exalgo already exists in 8 mg, 12 mg, and 16 mg tableta. Now, there is a 32 mg tablet. Patients who are opioid-tolerant will benefit from this. For example, patients taking at least 60 mg of oral morphine per day, a 25 μg fentanyl patch per hour, 30 mg of oral oxycodone per day, or 8 mg of hydromorphone per day. I have many cancer patients on these doses.

What else is new about Exalgo? Exalgo uses a drug delivery system that allows the release of the opioid at a controlled rate. These properties of Exalgo also make it difficult to extract the active ingredient by chewing, crushing, or dissolving the pill.

Isn’t a high dose, 32 mg, kind of scary? Yes, even in people who are already on high doses of opioids. Respiratory depression may occur with Exalgo even when the drug has been used as recommended. Only health care professionals who are knowledgeable in the use of potent opioids for the management of chronic pain should be prescribing this. Also recognize that crushing, chewing or dissolving an Exalgo tablet can cause rapid absorption and may be fatal.

Scary or not?

Dr. O.

When Exalgo is covered by insurance, it is typically a Tier 3 drug, meaning you’ll likely pay your highest copay. Cash prices typically run around $1250 for 30 tablets of the 32 mg strength, not significantly different from the cost of 60 tablets of 16 mg. Generic hydromorphone is a lower cost option, though the highest dose available is 8 mg. The manufacturer of Exalgo does offer a patient assistance program for patients who meet income and eligibility requirements, and other assistance programs may be available. You can find more information here: http://www.exalgo.com/patient/patient-assistance.aspx

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