* Pegvisomant. The U.S. Food and Drug Administration (FDA) has approved pegvisomant (Somavert) for the treatment of acromegaly in patients who have had an inadequate response to existing therapies.
Pegvisomant is the first in a new class of medications called growth hormone receptor antagonists. In clinical trials, it normalized concentrations of IGF-I in more than 90 percent of patients by blocking the effects of growth hormone. The most common side effects were injection site reactions, sweating, headache, and fatigue. Patients should have tests to monitor their liver function during the first six months of therapy.
* Enfuvirtide. The FDA has approved enfuvirtide (Fuzeon) for use in combination with other anti-human immunodeficiency virus (HIV) medications to treat advanced HIV infection in adults and children ages six years and older.
Enfuvirtide is the first in a new class of medications called fusion inhibitors. It interferes with the entry of HIV into cells by inhibiting the fusion of viral and cellular membranes. This inhibition blocks the virus from infecting certain components of the immune system.
Because HIV infection must be treated with a combination of medications to be effective, enfuvirtide can be used as part of a medication regimen in patients for whom there are limited options. It should only be used in patients who have previously used other anti-HIV medications and have ongoing evidence of viral replication. It is administered as a subcutaneous injection.
Physicians should carefully monitor patients for signs and symptoms of pneumonia. Although bacterial pneumonia was uncommon in clinical study participants, more patients treated with enfuvirtide developed bacterial pneumonia than did patients who did not receive enfuvirtide. Patients are advised to seek medical evaluation immediately if they develop signs or symptoms suggestive of pneumonia, such as cough with fever, rapid breathing, and shortness of breath.
In addition, enfuvirtide can cause both serious systemic allergic reactions and local skin reactions at the site of injection. Patients taking enfuvirtide should contact their physician immediately if they develop any of the following symptoms of an allergic reaction: trouble breathing, fever, skin rash, chills, vomiting, and low blood pressure.
Local skin reactions from enfuvirtide injections are common, occur in almost all patients, and may be painful. Patients must be careful that their skin does not become infected at the injection site.
COPYRIGHT 2003 American Academy of Family Physicians
COPYRIGHT 2003 Gale Group