Imatinib Mesylate and Nexiclon XR

• Generic Name: imatinib
• Dosage Forms: n.a.
• Other Brand Names: Gleevec

First-line treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) CML in adult and pediatric patients who are in the chronic phase of the disease (designated an orphan drug by FDA for this use); follow-up is limited.

Second-line treatment of Ph+ CML in adults who are in blast crisis, in the accelerated phase, or in the chronic phase of the disease after failure of interferon alfa therapy (designated an orphan drug by FDA for this use).

Second-line treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplantation or who are resistant to interferon alfa therapy.

Efficacy in pediatric patients determined based on overall hematologic and/or cytogenetic response rates; actual clinical benefits (e.g., decrease in disease-related symptoms, increase in survival) not adequately studied.

Treatment of relapsed or refractory Ph+ ALL in adults (designated an orphan drug by FDA for this use).

Treatment of MDS or MPD associated with gene rearrangements of platelet-derived growth factor receptor (PDGFR) in adults (designated an orphan drug by FDA for this use).

Treatment of aggressive systemic mastocytosis (ASM) in adults who lack the D816V c-Kit mutation or in whom c-Kit mutational status is unknown (designated an orphan drug by FDA for this use).

Ineffective for ASM with the D816V c-Kit mutation; other therapy is indicated.

Has not been shown to be effective in patients with less aggressive forms of SM. Therefore, not recommended for use in patients with cutaneous mastocytosis, indolent SM (smoldering SM or isolated bone marrow mastocytosis), SM with an associated clonal hematologic non-mast cell lineage disease, mast cell leukemia, mast cell sarcoma, or extracutaneous mastocytoma.

Treatment of HES and/or CEL in adults who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion), patients who are negative for FIP1L1-PDGFRα fusion kinase, or patients in whom expression of FIP1L1-PDGFRα fusion kinase is unknown (designated an orphan drug by FDA for this use).

Treatment of unresectable, recurrent, and/or metastatic DFSP in adults (designated an orphan drug by FDA for this use).

Treatment of patients with Kit (CD117)-positive unresectable and/or metastatic malignant GIST (designated an orphan drug by FDA for this use).

Efficacy determined based on objective response rates; actual clinical benefits (e.g., decrease in disease-related symptoms, increase in survival) not adequately studied.

• Generic Name: clonidine
• Dosage Forms: tablet, extended release
• Other Brand Names: Catapres, Catapres-TTS, Duraclon, Kapvay, Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-3

Clonidine is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk for heart attacks. These problems may be less likely to occur if the blood pressure is controlled.

Clonidine belongs to the class of medicines called antihypertensives. It works in the brain to change some of the nerve impulses. As a result, the blood vessels relax and blood passes through them more easily, which lowers blood pressure. When the blood pressure is lowered, the amount of blood and oxygen going to the heart is increased.

This medicine will not cure your high blood pressure, but it does help control it. Therefore, you must continue to use it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life.

Kapvay® extended-release tablets is used alone or together with other medicines to treat attention deficit hyperactivity disorder (ADHD). It works by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.