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Drug updates and approvals

2018 in review

doi: 10.1097/01.NPR.0000550096.44547.2f
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INSTRUCTIONS Drug updates and approvals: 2018 in review


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Lippincott Professional Development will award 1.5 contact hours for this continuing nursing education activity.

Lippincott Professional Development is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

This activity is also provider approved by the California Board of Registered Nursing, Provider Number CEP 11749 for 1.5 contact hours. Lippincott Professional Development is also an approved provider of continuing nursing education by the District of Columbia, Georgia, and Florida CE Broker #50-1223.

This activity has been assigned 1.5 pharmacology credits.

Drug updates and approvals: 2018 in review

General Purpose Statement: The purpose of this learning activity is to provide information about six drugs that received FDA approval in 2018. Learning Objectives/Outcomes: After completing this continuing-education activity, you should be able to: 1. Identify the indications, mechanisms of action, and dosages for six drugs that were approved by the FDA in 2018. 2. Recognize the adverse reactions, contraindications, warnings, and important nursing implications for these new drugs.

  1. Biktarvy, the three-drug combination of bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF), is indicated for
    1. unstable patients with HIV in treatment failure.
    2. initial therapy for adults who have not previously taken ART.
    3. adult patients in combination with other ART medications.
  2. BIC/FTC/TAF is not recommended for patients with which lab value?
    1. creatinine clearance of 52 mL/min
    2. nonfasting glucose level of 115 mg/dL
    3. AST of 680 units/L
  3. The boxed warning for BIC/FTC/TAF is for
    1. posttreatment acute exacerbation of hepatitis B.
    2. a risk of a myocardial infarction or heart failure.
    3. a risk of bleeding.
  4. Keep in mind when prescribing BIC/FTC/TAF that
    1. it is approved for patients younger than 18 years old.
    2. the safety and effectiveness for patients age 65 and older is unknown.
    3. it should be taken with an antacid because of irritation of stomach mucosa.
  5. Patients should be advised to take doxylamine succinate and pyridoxine hydrochloride (Bonjesta)
    1. in the morning with food on day 1.
    2. on an as-needed basis.
    3. up to a maximum of one tablet in the morning and one at bedtime.
  6. Doxylamine and pyridoxine is contraindicated in women taking
    1. oral contraceptives.
    2. an MAOI.
    3. an antacid for peptic ulcer.
  7. Use caution when prescribing doxylamine and pyridoxine for patients with
    1. a urinary tract infection.
    2. diabetes mellitus.
    3. narrow angle glaucoma.
  8. Advise the patient who is taking doxylamine and pyridoxine
    1. to not breastfeed while taking it.
    2. to avoid moderate physical activity.
    3. that the dose must be tapered to prevent withdrawal symptoms.
  9. Erenumab-aooe (Aimovig) is currently indicated for the
    1. prevention of cranial neuralgias, facial pain, and headaches in adults.
    2. treatment of cluster headaches and tension headaches in adults and children.
    3. prevention of migraines in adults.
  10. Which of the following instructions to patients about erenumab-aooe is not appropriate?
    1. It must be stored in the refrigerator and allowed to reach room temperature by sitting out for 30 minutes before administration.
    2. Discard the drug if not used within 5 days after reaching room temperature.
    3. Protect the drug from sunlight.
  11. Erenumab-aooe may cause which adverse reaction?
    1. orthostatic hypotension
    2. somnolence
    3. allergic reactions in patients with a latex allergy
  12. Lofexidine hydrochloride (Lucemyra) is approved for all of the following except
    1. managing opioid withdrawal symptoms in adults.
    2. to facilitate abrupt opioid discontinuation in adults.
    3. nonopioid maintenance treatment of opioid dependence.
  13. Lofexidine binds to receptors in the CNS to
    1. decrease the release of norepinephrine.
    2. increase release of serotonin.
    3. decrease the release of dopamine.
  14. When prescribing lofexidine, keep in mind that patients who discontinue opioids are at risk for
    1. tachycardia and dysrhythmias.
    2. fatal overdose due to decreased tolerance if opioid use is resumed.
    3. hepatic impairment when abruptly discontinued.
  15. When prescribing tezacaftor and ivacaftor (Symdeko), be mindful that
    1. patients with severe liver impairment should only take the blue evening dose of ivacaftor.
    2. the yellow combination tablet should be taken in the morning.
    3. it is approved for use in children over the age of 6 years.
  16. Which statement about tezacaftor and ivacaftor is accurate?
    1. Concomitant use of CYP3A inducers may reduce efficacy.
    2. Glaucoma has been observed in pediatric patients in clinical trials.
    3. Hold therapy if ALT and AST levels double from baseline during treatment.
  17. Which statement is correct about administering tildrakizumab-asmn (Ilumya)?
    1. It is designed for subcutaneous self-administration.
    2. It should only be given by a healthcare provider.
    3. It can only remain outside of the refrigerator for 30 minutes.
  18. Advise patients taking tildrakizumab-asmn that there could be an increased risk of
    1. significant orthostatic hypotension.
    2. bleeding.
    3. infection.


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