Author: AHFS

AHFS Drug Information/Essentials Update – May 2017

The May update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • New Full-Length Monographs
    • Lumacaftor And Ivacaftor (Orkambi®) – 48:14.04 (Cystic Fibrosis Transmembrane Conductance Regulator Correctors)
      • Treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene.
    • Uridine Triacetate (Xuriden, Vistogard®) – 92:12 (Antidotes)
      • Xuriden®: Treatment of hereditary orotic aciduria.
      • Vistogard®: A separate NDA approved for emergency treatment of fluorouracil or capecitabine overdose or patients who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., GI toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
  • New First-Release Monographs
    • Ocrelizumab (Ocrevus®) – 92:20 (Immunomodulatory Agents)
      • Treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis.
    • Dupilumab (Dupixent®) – 84:92 (Skin and Mucous Membrane Agents, Miscellaneous)
      • Treatment of adults with moderate-to-severe eczema (atopic dermatitis) not controlled adequately by topical therapies, or those for whom topical therapies are not advisable.
    • Etelcalcetide Hydrochloride (Parsabiv®) – 92:92 (Other Miscellaneous Therapeutic Agents)
      • A calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
    • Naldemedine Tosylate (Symproic®) – 56:92 (GI Drugs, Miscellaneous)
      • Treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.
    • Deutetrabenazine (Austedo®) – 28:92 (Central Nervous System Agents, Miscellaneous)
      • Treatment of chorea associated with Huntington’s disease.

FDA MedWatch Alerts

  • FDA is restricting the use of codeine and tramadol medicines in children.
    • Affected Monographs
      • 382065,”Codeine”,”28:08.08″
      • 382491,”Codeine”,”48:08″
      • 395011,”traMADol”,”28:08.08″
    •  FDA is now adding the following changes to the labeling of codeine and tramadol:
      • FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
      • A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
      • A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
      • A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

AHFS Drug Information/Essentials Update – April 2017

The April update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • New Full-Length Monographs
    • Sebelipase Alfa (Kanuma®) – 44:00 (Enzymes)
      • Sebelipase alfa is used for the treatment of lysosomal acid lipase deficiency and is designated an orphan drug by the FDA for management of this condition.
    • Reslizumab (Cinqair®) – 48:10.20 (Interleukin Antagonists)
      • Reslizumab is used as adjunctive maintenance therapy in adults with severe eosinophilic asthma (i.e., having an eosinophilic phenotype).
    • Lesinurad (Zurampic®) – 40:40 (Uricosuric Agents)
      • Lesinurad is used in combination with a xanthine oxidase inhibitor (e.g., allopurinol, febuxostat) for the management of hyperuricemia associated with gout in patients who have not attained target serum uric acid concentrations with xanthine oxidase inhibitor monotherapy.
    • Daclizumab (Zinbryta®) – 92:20 (Immunomodulatory Agents)
      • Daclizumab is used in the management of relapsing forms of multiple sclerosis (MS; e.g., relapsing-remitting MS [RRMS]).
    • Eliglustat (Cerdelga®) – 92:92 (Other Miscellaneous Therapeutic Agents)
      • Eliglustat is used for the long-term treatment of nonneuronopathic (type 1) Gaucher disease in patients who are extensive, intermediate, or poor metabolizers of cytochrome P-450 (CYP) 2D6.
  • New First-Release Monographs
    • Von Willebrand Factor (recombinant) (Vonvendi®) – 20:28.16 (Hemostatics)
      • Von Willebrand factor (recombinant) is a recombinant von Willebrand factor (VWF) indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease (VWD).
    • Oxymetazoline Hydrochloride (Rhofade®) – 84:92 (Skin and Mucous Membrane Agents, Miscellaneous)
      • Oxymetazoline hydrochloride is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
    • Deflazacort (Emflaza®) – 68:04 (Adrenals)
      • Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
    • Cholera Vaccine Live Oral (Vaxchora®) – 80:12 (Vaccines)
      • Cholera vaccine live oral is a vaccine indicated for active immunization against disease caused by V. cholera serogroup O1.
    • Plecanatide (Trulance®) – 56:92 (GI Drugs, Miscellaneous)
      • Plecanatide is a guanylate cyclase-C agonist indicated in adults for treatment of chronic idiopathic constipation (CIC).
    • Brodalumab (Siliq®) – 84:92 (Skin and Mucous Membrane Agents, Miscellaneous)
      • Brodalumab is a human interleukin-17 receptor A (IL-17RA) antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
    • Anthrax Immune Globulin (human) (Anthrasil®) – 80:04 (Antitoxins and Immune Globulins)
      • Anthrax immune globulin IV (human) is indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.
    • Telotristat Etiprate (Xermelo®) – 56:08 (Antidiarrhea Agents)
      • Telotristat etiprate is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
    • Ribociclib Succinate (Kisqali®) – 10:00 (Antineoplastic Agents)
      • Ribociclib succinate is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
    • Avelumab (Bavencio®) – 10:00 (Antineoplastic Agents)
      • Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).

FDA MedWatch Alerts

  • Eluxadoline (Viberzi®)
    • FDA is warning that eluxadoline (Viberzi), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.

Ocrevus (ocrelizumab) Approved

FDA approves new drug to treat multiple sclerosis

On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.

PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with MS have PPMS.

The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.

In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving Ocrevus showed a longer time to the worsening of disability compared to placebo.

Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus. Ocrevus must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Ocrevus can cause infusion-related reactions, which can be serious. These reactions include, but are not limited to, itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, tiredness, dizziness, headache, throat irritation, shortness of breath, swelling of the throat, nausea, and fast heartbeat. Additionally, Ocrevus may increase the risk for malignancies, particularly breast cancer. Delay Ocrevus treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving Ocrevus.

In addition to the infusion-related reactions, the most common side effect of Ocrevus seen in the clinical trials for relapsing forms of MS was upper respiratory tract infection. The most common side effects in the study of PPMS were upper respiratory tract infection, skin infection, and lower respiratory tract infection.

The FDA granted this application breakthrough therapy designation, fast track designation, and priority review.

The FDA granted approval of Ocrevus to Genentech, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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