It’s been an active summer for pharmaceutical firms, who’ve been particularly busy adding and removing products from the marketplace and providing fresh information to professional users. Here’s a roundup of vital information that has emerged.
Because of an increased risk of death associated with aprotinin injection (Trasylol) compared with either aminocaproic acid or tranexamic acid, Bayer Pharmaceuticals has removed all remaining stocks of the agent from the U.S. market. Subsequent access to aprotinin injection will be limited to investigational use based on a special treatment protocol. For more information on this, call (888) 842-2937.
Meanwhile, nedocromil sodium inhalation aerosol (Tilade) has been discontinued. Once current supplies are depleted from pharmacies, it no longer will be available. A number of factors led to the decision, including the inability to find a qualified manufacturer of the chlorofluorocarbon propellant.
Certolizumab pegol (Cimzia) injection has been approved by the Food and Drug Administration (FDA) to treat adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. It is a pegylated tumor necrosis factor antagonist. The most common side effects are headache, upper respiratory infections, abdominal pain, injection site reactions, and nausea. It is dosed as an initial 400 mg SC injection followed by 400 mg SC injections at weeks two and our.
A maintenance regimen of 400 mg subcutaneous every four weeks is recommended for patients who obtain a clinical response after the initial three injections. The drug is available as a package that includes everything required to reconstitute and inject the drug (also two vials of drug, each with 200 mg Cimzia). Patients need to be evaluated for increased infection risk and opportunistic infections. Patients should be screened for tuberculosis prior to commencing therapy.
Desvenlafaxine 50 mg tablets (Pristiq), a serotonin-norepinephrine reuptake inhibitor (SNRI), have been FDA approved for the treatment of adults with major depressive disorder. It is dosed once daily. To reach the therapeutic dose, titration is unnecessary. Dose adjustments are necessary for severe renal impairment or end-stage renal disease patients, where the dose should be adjusted to 50 mg every other day. Nausea, dizziness, hyperhidrosis, constipation, and decreased appetite are the most common side effects.
Lubiprostone capsules (Amitiza) have been FDA approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in women 18 or older. Common side effects are nausea, diarrhea, and abdominal pain. It is dosed as 8 mcg twice a day with food and water. Patients should be periodically assessed for therapy continuation need.
Methylnaltrexone bromide (Relistor) has been FDA approved to assist in restoring bowel function in patients who are continuously receiving opioids for pain management and have late-stage, advanced illness. It works by blocking opioid entrance into smooth muscle. It is administered by injection as often as needed, but not to exceed more than one dose in a 24-hour period.
Aripiprazole (Abilify) has received a number of new indications from the FDA, mostly in adolescents and children. In adults, it has received approval as an adjunctive treatment to either lithium or valproate for patients age 10 or older with manic and mixed episodes associated with bipolar I disorder with or without psychotic features. When used as monotherapy for bipolar I disorder in adults, the recommended starting dose for these indications in adults is 15 mg/day with a target dose of 30 mg/day.