PALFORZIA
First treatment for peanut allergy
An estimated 1 million children in the US have peanut allergy, and only one in five outgrows it, according to the FDA. In these individuals, inadvertent exposure to peanuts can cause severe allergic reactions, including anaphylaxis. To mitigate such allergic reactions, the FDA has approved Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp). It can be initiated in pediatric patients ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals age 4 and older. These patients must continue to avoid peanuts in their diets. Used in conjunction with peanut avoidance, Palforzia has been shown to reduce the risk of allergic reactions to peanuts in children.
Treatment with Palforzia consists of three phases:
* The Initial Dose Escalation phase is given on a single day.
* The Up-Dosing phase consists of 11 increasing dose levels and occurs over several months.
* Maintenance, which begins after the patient completes all Up-Dosing levels, consists of a daily maintenance dose.
Because it is manufactured from peanuts, Palforzia carries a risk for anaphylaxis in patients with peanut allergy. Consequently, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) with this approval. Palforzia will be available only through specially certified healthcare providers, healthcare settings, and pharmacies to patients who are enrolled in the REMS program.
Palforzia is a powder that is packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food, such as applesauce, yogurt, or pudding, for the patient's consumption.
Source: US Food and Drug Administration. FDA approves first drug for treatment of peanut allergy for children. News release. January 31, 2020.
TEPEZZA
First drug approved for thyroid eye disease
Thyroid eye disease is a rare disorder in which inflammation in the muscle and fatty tissue behind the eye cause proptosis (exophthalmos). Signs and symptoms, such as eye pain, diplopia, photophobia, and difficulty closing the eye, can interfere with the ability to drive and other normal daily activities. The FDA has approved Tepezza (teprotumumab-trbw) for adults with thyroid eye disease.
An insulin-like growth factor-1 receptor inhibitor, Tepezza is the first drug approved to treat thyroid eye disease, a disorder with limited treatment options. According to the FDA, this new treatment may spare some patients from multiple invasive procedures.
Tepezza is administered via I.V. infusion over 60 to 90 minutes. Treatments are administered every 3 weeks for a total of eight infusions. Patients should be monitored for infusion reactions, hyperglycemia, and exacerbation of preexisting inflammatory bowel disease.
Sources: US Food and Drug Administration. FDA approves first treatment for thyroid eye disease. News release. January 21, 2020. Tepezza (teprotumumab-trbw) for injection, for intravenous use. Prescribing information. http://www.hzndocs.com/TEPEZZA-Prescribing-Information.pdf.
IMMUNIZATION SCHEDULES
ACIP releases updated guidelines for adults
The Advisory Committee on Immunization Practices (ACIP) has issued its 2020 recommendations for immunization of adults. Changes include the following:
* Routine annual influenza vaccination is recommended for everyone age 6 months and older unless contraindicated. For example, those with a history of Guillain-Barre syndrome within 6 weeks of a previous dose of influenza vaccine generally should not be vaccinated unless vaccination benefits outweigh the risk of severe influenza complications. No preference is expressed for one influenza vaccine product over another.
* All persons with HIV infection age 1 year or older should be routinely vaccinated with the hepatitis A vaccine. The hepatitis A vaccine is also recommended for persons working in settings of exposure.
* Catch-up human papillomavirus (HPV) vaccination is recommended for all adults through age 26 who are not adequately vaccinated. Shared clinical decision-making is recommended regarding HPV vaccination for adults ages 27 to 45 who are not adequately vaccinated.
* Language has been added in the notes section to clarify indications for measles, mumps, and rubella vaccination in healthcare workers.
The complete recommendations are available at https://annals.org/aim/fullarticle/2760656/recommended-adult-immunization-schedu.
Source: Freedman M, Kroger A, Hunter P, Ault KA, for the Advisory Committee on Immunization Practices. Recommended adult immunization schedule, United States, 2020. Ann Intern Med. [e-pub Feb. 4, 2020]
LORCASERIN
FDA warns about cancer risk
Based on a recent clinical trial, the FDA is warning healthcare professionals and the public about a possible increased risk of cancer associated with the weight management medication lorcaserin (Belviq, Belviq XR). Approved in 2012, lorcaserin is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who are obese or overweight and who have at least one weight-related comorbidity. The FDA recommends that healthcare professionals weigh the benefits of taking lorcaserin against the potential risks when deciding whether to prescribe or continue patients on lorcaserin. Patients currently taking lorcaserin should talk with their healthcare provider about the benefits and risks.
According to the FDA, the relationship between lorcaserin and cancer is unclear. The FDA is continuing to evaluate the clinical trial results and will communicate final conclusions and recommendations when the review is complete.
Source: US Food and Drug Administration. Belviq, Belviq XR (lorcaserin): drug safety communication-due to possible increased risk of cancer. News release. January 14, 2020.
MIGRAINE
Aspirin may be an effective treatment
Although many prescription drugs have proven beneficial in the treatment of migraine, they may not be available or affordable for many patients, or they may be contraindicated or poorly tolerated. New evidence supports the use of aspirin as another option to both treat acute migraine and prevent recurrent attacks. Examining the totality of evidence, including data from randomized trials, researchers concluded that high-dose aspirin (from 900 to 1,300 mg) taken at the onset of symptoms is both effective and safe. In addition, they found "the possibility" that daily aspirin in lower doses (81 mg to 325 mg) may be effective and safe for migraine prevention. Inexpensive and available without a prescription, aspirin "may provide additional clinical options for primary healthcare providers in the treatment of both acute and recurrent migraine headaches," the authors conclude.
Source: Biglione B, Gitin A, Gorelick PB, Hennekens C. Aspirin in the treatment and prevention of migraine headaches: possible additional clinical options for primary healthcare providers. Am J Med. [e-pub Nov. 9, 2019]