Creating quality CME for doctors, NPs, PAs, and other clinicians has been Pri-Med’s focus for 20+ years – we’ve educated more than 275,000 clinicians and helped them meet CME requirements. Our online medical education and conferences are created with patient safety and patient care in mind and span a variety of topics, from practice management to timely medical updates, such as Dr. Gerald W. Smetana’s course on New Drugs in Primary Care Practice. Dr. Smetana answers questions he’s frequently asked on this topic in the post below.
Author: Gerald W. Smetana, MD
Recently, there have been important advances that could represent novel additions to our existing treatments in primary care practice. Below are a few frequently asked questions from a recent continuing medical education session I presented that focused on three drugs in particular: zoster vaccine – recombinant adjuvanted (SHINGRIX), erenumab (Aimovig®), and baloxavir marboxil (Xofluza™). The full free CME course covers these drugs in detail.
Zoster Vaccine – Recombinant Adjuvanted (SHINGRIX)
How long does arm pain last after SHINGRIX, the shingles vaccine?
This is one of the questions clinicians most frequently ask, and one my patients also ask quite regularly. Arm pain at the injection site is the most common side effect after the shingles vaccine. It affects about 80% of patients getting the vaccine and commonly lasts up to a week, and sometimes longer. For practical purposes, I tell patients, “You should expect this for about a week.”
Can SHINGRIX be given if there has been a prior shingles attack?
It can. The CDC is recommending it for all persons over age 50 who are not immunocompromised, regardless of their prior history of shingles. However, if we look at patients who’ve had shingles once before, the act of having shingles results in an anamnestic antibody response, so the chance of getting shingles a second time is already diminished. While the vaccine is being recommended by the CDC even for those who have had shingles, it would be less beneficial for those people, since the initial baseline risk after shingles is already substantially lower, which means the absolute risk reduction is therefore lower. I’d have that conversation with patients, and if they want to reduce their risk even further, then they’re eligible for the vaccine.
If patients can’t get the second injection of the series in less than six months after the first one, do we have to restart the series?
This has been a huge issue because there’s been a distribution problem with the vaccine since it first came out. From the beginning, the manufacturer underestimated the interest in the vaccine, and there hasn’t been enough to meet the need, so this question comes up for patients who get the first vaccine dose but can’t manage to get an appointment for the second one before the six-month window closes.
Currently, there’s no recommendation to repeat the series in this instance, but rather the recommendation is to give the booster when it does finally become available. I think it’s fair to say we don’t know whether that provides the same degree of benefit as getting it in the six-month window, which is what’s recommended, but there’s no recommendation to repeat the series if the second dose has to be delayed past the six-month window.
Case Study: Noor Algia
- 70-year-old woman with diabetes, congestive heart failure
- Requires some help from visiting nurse for activities of daily living
- Husband has had severe postherpetic neuralgia
- Should she take the new shingles vaccine?
What to Advise
- Yes! Take the new shingles vaccine
- Two doses, 2-6 months apart
Is it okay to use erenumab for treating migraine with aura?
Erenumab is safe to use in patients who have migraine with aura and does not increase the risk of stroke or subject them to any additional risk. In fact, that’s a group of patients for which erenumab will be particularly attractive to use, since the migraine with aura can be more disabling.
Is it safe to inject at home?
Yes – there have been rare post-marketing reports of hypersensitivity reactions, but they aren’t frequent enough to require that the injection be done in a supervised setting. Patients can self-inject from the very first injection. If patients don’t have experience with injections, it can help to bring them into the office to teach them how to use the injection, but not because there’s any risk in doing it unsupervised at home.
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What are the prior authorization criteria?
I imagine this is going to be a moving target and may vary depending on the particular insurance plan and the state in which health professionals practice. In general, getting prior authorization has not been as onerous of a hurdle as I expected when the drug first came on the market. In the prior authorization criteria, you may see failure of at least two prior medication trials for the prevention of migraines. There may also be a recommendation based on the number of days per month that patients take acute or abortive treatment, and the combination of those two may be important factors in whether it would be covered.
What do you recommend regarding onabotulinumtoxinA (Botox®) or erenumab?
Either of these can be used as a third-line option if the migraines are disabling and existing preventive treatments don’t work or are not tolerated. The cost is significant for both but fairly similar. The one advantage of erenumab is that it can be given at home, so it doesn’t require patients to go in for a visit every 12 weeks.
Can you still use triptans if receiving erenumab for migraine prevention?
Yes, you can. In patients who are getting erenumab or one of the other CGRP-based treatments for prevention of migraines, the full repertoire of options we have for abortive treatment of migraine, including triptans, is still available to us and can be used safely. Most patients, in fact, still do need some type of acute or abortive treatment. The optimal goal would be a 50% reduction in the migraine burden.
Case Study: Ann Hedonia
- 34-year-old woman with disabling migraines 15 days per month
- Intolerant of most preventive prescription drugs
- Triptans limited by chest pressure
- NSAIDs cause dyspepsia
- Wants to know: What about this new biologic Rx? Is it right for me?
What to Recommend
- Begin erenumab 70 mg by subcutaneous injection once monthly (or one of the other CGRP-based biologicals depending on insurance formularies)
- You can expect a 50% reduction in migraine frequency
Baloxavir Marboxil (Xofluza™)
Can it be used together with oseltamivir if influenza is severe?
Baloxavir is a new drug that was approved by the FDA last year, so we don’t have a lot of experience with it yet. The primary treatment trial that led to its approval was a trial of monotherapy of baloxavir versus oseltamivir.
However, they do work by different mechanisms, so it’s probably safe to use the two together. Combination therapy with both drugs has not been studied. While it may be attractive in hospitalized patients with severe influenza, it is unknown whether this strategy would be more effective than either drug alone. I wouldn’t recommend using them at the same time routinely in primary care practice yet though; this is an area where we’d like to see some further study.
Can resistance occur?
Yes – resistance is said to have occurred in the two primary trials that led to its approval. Between 2% and 10% of patients who were given a single dose of baloxavir were found to develop viral resistance, but the clinical significance is not known at this point.
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Will it cover oseltamivir-resistant strains?
It appears to cover many, but it’s not known whether it would cover all. However, since the two drugs work by different mechanisms, some patients who have influenza that is resistant to existing therapy, which would be oseltamivir, may respond well to baloxavir. I think that’s going to be a particularly important role. If there’s a high likelihood of resistance to oseltamivir in a certain community in a particular year, based on prevalent strains, then baloxavir would be the appropriate first-line drug.
What are the dose adjustments for weight?
The dose varies based on the weight of the patient. In patients who are 40-80 kilograms, use 40 milligrams of baloxavir as a single dose. For patients who are 80 kilograms or more, the dose would be 80 milligrams as a single dose.
Is it safe during pregnancy?
This was not studied in the trials, so safety is unknown, and for that reason, it’s not currently recommended for pregnant patients. Whether it would be safe or not is a subject of future study, but it’s not currently recommended.
Case Study: Tom E. Fleu
- 58-year-old man
- 36 hours of fever, myalgia, cough
- Unable to work
- Wants to resume painting as soon as possible
- What about baloxavir marboxil?
What to Recommend
- PO fluids
- Either oseltamivir x 5 days or single dose baloxavir marboxil
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