Drug Monographs
Drug monographs are concise reviews of medications recently approved by the Food and Drug Administration.
Pharmacists prepare these monographs with a focus on information that may be considered useful in a drug formulary decision-making process.
The monographs are targeted for health care professionals, and may not be ideal for patients and their families.
Each monograph has four key components that include a general overview of the medication, clinical trials evaluating efficacy, safety information and cost.
Information for each monograph is gathered from the drug’s product labeling as well as reviews of published literature. Data that is considered most important when making a formulary decision is included in an easy to read tabular format.
The monographs do not contain all published literature on a given medication, for this purpose the reader should consult other sources.
The monographs are based on information in an adult population. For information regarding pediatric population, the reader should consult other sources.
Pharmacists prepare these monographs with a focus on information that may be considered useful in a drug formulary decision-making process.
The monographs are targeted for health care professionals, and may not be ideal for patients and their families.
Each monograph has four key components that include a general overview of the medication, clinical trials evaluating efficacy, safety information and cost.
Information for each monograph is gathered from the drug’s product labeling as well as reviews of published literature. Data that is considered most important when making a formulary decision is included in an easy to read tabular format.
The monographs do not contain all published literature on a given medication, for this purpose the reader should consult other sources.
The monographs are based on information in an adult population. For information regarding pediatric population, the reader should consult other sources.
Added February 6, 2006
Nelarabine (ArraAnon®)
Manufacturer: GlaxoSmithKline
Labeled FDA Approved Indications: Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
Manufacturer: GlaxoSmithKline
Labeled FDA Approved Indications: Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
Added January 6, 2006
Conivaptan (Vaprisol®)
Manufacturer: Astellas Pharma
FDA Approved Indications: Treatment of euvolemic hyponatremia (e.g. SIADH, hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients. It is not indicated for the treatment of patients with congestive heart failure.
Manufacturer: Astellas Pharma
FDA Approved Indications: Treatment of euvolemic hyponatremia (e.g. SIADH, hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients. It is not indicated for the treatment of patients with congestive heart failure.
Added February 1, 2006
Abatacept (Orencia®)
Manufacturer: Bristol-Myers Squibb Company
FDA Approved Indications: To reduce signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
Manufacturer: Bristol-Myers Squibb Company
FDA Approved Indications: To reduce signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
Added July 1, 2006
Lenalidomide (Revlimid®)
Manufacturer: Celgene
Labeled FDA Approved Indications: Treatment of patients with transfusion-dependant anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Manufacturer: Celgene
Labeled FDA Approved Indications: Treatment of patients with transfusion-dependant anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.