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.
- Lumacaftor And Ivacaftor (Orkambi®) – 48:14.04 (Cystic Fibrosis Transmembrane Conductance Regulator Correctors)
- 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.
- Ocrelizumab (Ocrevus®) – 92:20 (Immunomodulatory Agents)
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.
- Affected Monographs
