Ambrisentan Tablets and Imatinib Mesylate

• Generic Name: ambrisentan
• Dosage Forms: tablet, film coated
• Other Brand Names: Letairis

Ambrisentan lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Ambrisentan is used to treat pulmonary arterial hypertension (PAH) in adults. It improves your ability to exercise and prevents your condition from getting worse. Ambrisentan is sometimes used with a medicine called tadalafil (Adcirca).

For women, ambrisentan is available only from a certified pharmacy under a special program. You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing.

Ambrisentan may also be used for purposes not listed in this medication guide.

• 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.