Viread approved for use in younger patients with chronic HBV
The FDA has approved a new age indication for the use of tenofovir disoproxil fumarate (Viread) in patients age 2 years and older who weigh at least 22 lb (10 kg) and are diagnosed with chronic hepatitis B virus (HBV) infection. According to the FDA, the expanded approval is based on safety, efficacy, and pharmacokinetic data from the GS-US-174 0144 trial.
The trial 0144 (n = 89) included hepatitis B e-antigen (HBeAg)-positive patients ages 2 to under 12 years who were assigned to tenofovir disoproxil fumarate 8 mg/kg (maximum dose, 300 mg) or placebo once daily for 48 weeks. At week 48, 77% of tenofovir disoproxil fumarate-treated patients had HBV DNA of under 400 copies/mL versus 7% of placebo-treated patients. HBeAg seroconversion was seen in 25% and 24% of patients treated with tenofovir disoproxil fumarate and placebo, respectively.
The safety and efficacy of tenofovir disoproxil fumarate has not been established in patients under age 2 years and weighing under 22 lb (10 kg).
FDA warns of severe worsening of MS after stopping fingolimod (Gilenya)
The FDA warned that when patients stop taking fingolimod (Gilenya), a medication to treat multiple sclerosis (MS), the disease can become much worse than before the medication was started or while it was being taken. Although rare, this worsening of MS can result in permanent disability, the FDA states. The FDA notes that since fingolimod was approved in September 2010, 35 cases of severely increased disability accompanied by the presence of multiple new lesions on MRI occurring 2 to 24 weeks after patients stopped taking fingolimod have been identified.
Most patients experienced this worsening within 12 weeks of stopping the drug, but there may be additional cases of which the FDA is unaware. The increase in disability in the affected patients was more severe than in those with typical MS relapses, and in cases in which baseline disability was known, it appeared unrelated to the patients' prior disease state, the FDA explains. Several patients who were able to walk without assistance prior to discontinuing fingolimod progressed to needing wheelchairs or becoming totally bedbound.
Recovery varied for patients who experienced an increase in disability after stopping fingolimod. The FDA recommends that healthcare professionals take the following steps:
* Inform patients before starting treatment about the potential risk of severe increase in disability after stopping fingolimod.
* Carefully assess patients for evidence of an exacerbation of their MS and treat appropriately when fingolimod is stopped.
* Advise patients to seek immediate medical attention if they experience new or worsened MS symptoms after fingolimod is stopped.
* Encourage patients to read the medication guide they receive with fingolimod prescriptions.
Pediatric hexavalent combination vaccine approved
The FDA approved diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine (Vaxelis). Vaxelis is indicated for use in children from ages 6 weeks through 4 years (before age 5) to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type B. Vaxelis is manufactured by both Sanofi and Merck & Co.
The vaccine is approved for use as a 3-dose series consisting of a 0.5 mL I.M. injection administered at 2, 4, and 6 months of age. The manufacturers note that the 3-dose series of the vaccine does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.
The vaccine has numerous contraindications, warnings, and precautions; consult the manufacturers' prescribing label for complete prescribing information. According to Sanofi, the commercial supply of the vaccine will not be available in the US before 2020.