Marketed by: Janssen Pharmaceuticals Inc (Raritan, NJ)
Indication: Janssen Pharmaceuticals Inc announced the FDA approval of Nucynta ER (tapentadol), an extended-release opioid analgesic indicated for the management of moderate to severe chronic pain in adults when an opioid analgesic is needed continuously for an extended time period. Nucynta ER contains tapentadol, a mu-opioid agonist and Schedule II drug with risks of misuse, abuse, and diversion similar to those of other opioids. The drug is not intended for use on an as-needed basis or for the relief of postoperative pain. To avoid potentially fatal adverse events, patients taking Nucynta ER should not consume alcoholic beverages or any prescription or nonprescription medications that contain alcohol, and should not split, break, chew, dissolve, or crush the tablets. The recommended dose is 100 to 250 mg twice daily approximately every 12 hours.
Dosage Form: Tablets: 50, 100, 150, 200, and 250 mg
For More Information: www.nucynta.com/nucynta-er
Marketed by: Pfizer Inc (New York, NY)
Indication: Pfizer Inc announced the approval of Xalkori (crizotinib), a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)–positive. Xalkori was approved after priority review with a companion FDAapproved diagnostic test, the Vysis ALK Break Apart FISH Probe Kit, which will determine if a patient has the abnormal ALK gene. Approximately 1% to 7% of NSCLC patients have the ALK gene abnormality, which causes cancer development and growth. The recommended dosage of Xalkori is 250 mg taken twice daily without regard for food.
Dosage Form: Capsules: 200 and 250 mg
For More Information: www.xalkori.com
Marketed by: Shire plc (Lexington, MA)
Indication: The FDA approved Firazyr (icatibant injection), an orphan drug indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years and older. HAE is a rare and debilitating disease that causes recurrent episodes of acute swelling that can be painful, disfiguring, and even life-threatening. A bradykinin B 2 receptor antagonist, Firazyr is available as a subcutaneous injection that patients can self-administer upon recognizing an HAE attack. The recommended dosage is 30 mg injected into the abdominal area. Injections should be at least 6 hours apart and should not exceed 3 injections in a 24-hour period.
Dosage Form: Subcutaneous injection: 10 mg/mL
For More Information: www.firazyr.com
Marketed by: Seattle Genetics Inc (Bothell, WA)
Indication: The FDA granted accelerated approval for Adcetris (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma after the failure of an autologous stem cell transplant (ASCT) or after the failure of at least 2 prior multiagent chemotherapy regimens in patients who are not ASCT candidates, as well as for the treatment of patients with systemic anaplastic large cell lymphoma after the failure of at least 1 prior multiagent chemotherapy regimen. The recommended dose of Adcetris, which is administered only as an intravenous infusion, is 1.8 mg/kg over 30 minutes every 3 weeks. Therapy can be continued for a maximum of 16 cycles.
Dosage Form: Single-use vial for intravenous infusion: 50 mg
For More Information: www.adcetris.com
Marketed by: Genentech, a member of the Roche Group (South San Francisco, CA)
Indication: Genentech announced that Zelboraf (vemurafenib), a kinase inhibitor, was approved for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. The cobas 4800 BRAF V600 Mutation Test, developed by Roche, was also approved by the FDA to help identify patients for treatment. Zelboraf is not recommended for patients with wild-type BRAF melanoma. The recommended dose of Zelboraf is 960 mg orally twice daily taken approximately 12 hours apart with or without a meal. The tablets should be swallowed whole with a glass of water and should not be chewed or crushed.
Dosage Form: Film-coated tablet: 240 mg
For More Information: www.zelboraf.com
Marketed by: Bristol-Myers Squibb Co (Princeton, NJ)
Indication: The FDA approved a subcutaneous formulation of Orencia (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). Orencia, a selective T-cell costimulation modulator, may be used as monotherapy or concomitantly with other disease-modifying antirheumatic drugs, excluding tumor necrosis factor antagonists. Orencia is also not recommended for concomitant use with other biologic RA therapy. Following a single intravenous infusion as a loading dose, 125 mg should be administered subcutaneously within 1 day, followed by 125-mg subcutaneous injections once a week.
Dosage Form: Subcutaneous injection: 125 mg/mL solution in a single-dose prefilled syringe; intravenous infusion: 250 mg lyophilized powder in a single-use vial
For More Information: www.orencia.com/index.aspx
Marketed by: Alexion Pharmaceuticals (Cheshire, CT)
Indication: Soliris (eculizumab) has been approved by the FDA to treat patients with atypical hemolytic uremic syndrome (aHUS), a rare, chronic blood disease. Soliris was previously approved to treat patients with paroxysmal nocturnal hemoglobinuria. Currently, there are no other FDA-approved treatments for aHUS, which can lead to kidney failure and is associated with an increased risk of stroke and death. The new indication is approved with an extension of the drug’s current Risk Evaluation and Mitigation Strategy, which provides information about the known risk of life-threatening meningococcal infections when taking Soliris.
Dosage Form: Intravenous infusion: 300-mg single-use vials, each containing 30 mL of 10 mg/mL sterile, preservative-free solution
For More Information: www.soliris.net; 888-SOLIRIS (888-765-4747)
Marketed by: Janssen Biotech Inc (Horsham, PA)
Indication: The FDA approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had an inadequate response to conventional therapy. Remicade, a tumor necrosis factor blocker, was previously approved for a variety of indications, including Crohn’s disease, rheumatoid arthritis, and plaque psoriasis. Remicade carries a boxed warning for the risk of serious infections, including tuberculosis, and malignancies. For UC, the dosing is 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks.
Dosage Form: Intravenous injection: 100 mg of lyophilized infliximab in a 20-mL vial to be reconstituted in 10 mL of sterile water for injection
For More Information: www.remicade.com