Irinotecan Hydrochloride and Roxanol-T

• Generic Name: irinotecan
• Dosage Forms: n.a.
• Other Brand Names: Camptosar

Conventional irinotecan: Used as a component of first-line therapy in combination with fluorouracil and leucovorin for the treatment of metastatic carcinoma of the colon or rectum.

Conventional irinotecan: Used as a single agent for treatment of metastatic carcinoma of the colon or rectum in patients whose disease has recurred or progressed following initial therapy with fluorouracil-based antineoplastic regimens.

Liposomal irinotecan: Used in combination with fluorouracil and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas in patients whose disease has progressed following gemcitabine-based chemotherapy (designated an orphan drug by FDA for treatment of this cancer ).

Conventional irinotecan: Used in combination with cisplatin for the initial treatment of extensive small cell lung cancer.

Conventional irinotecan: Under investigation for the treatment of metastatic or recurrent cervical cancer.

• Generic Name: morphine
• Dosage Forms: n.a.
• Other Brand Names: Arymo ER, Kadian, MorphaBond ER, Avinza, MS Contin, Duramorph PF, Infumorph, Mitigo, RMS, Roxanol

Morphine tablet is used to relieve short-term (acute) or long-term (chronic) moderate to severe pain. The extended-release capsule and extended-release tablet are used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. Morphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Morphine extended-release capsules and extended-release tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.