Drug Updates. Eve Van Wagoner, PharmD, BCACP Primary Care Clinical Pharmacist South Jordan Health Center

Transcription

1 Drug Updates Eve Van Wagoner, PharmD, BCACP Primary Care Clinical Pharmacist South Jordan Health Center October 2017

2 SAFETY ALERTS/ LABELING CHANGES

3 Opioid addiction medications Should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system The harm caused by untreated opioid addiction can outweigh these risks

4 Eluxadoline (Viberzi ) and Pancreatitis FDA review, patients without a gallbladder + Viberzi = increased risk for pancreatitis Recommendation: Avoid prescribing Viberzi in patients who do not have gallbladder, consider alternative options Warning signs: New/worsening stomach-area or abdomen pain or pain in upper right side of stomach

5 Restricted use of Codeine and Tramadol FDA approved for adult use only New Contraindication: Children <12 years old to treat pain or cough Children <18 years old to treat pain after surgery to remove tonsils and/or adenoids (Tramadol) New Warning: Recommend against use in adolescents years old who are obese, have OSA, or lung disease Avoid in breastfeeding mothers

6 Invokana and Amputation Risk New data from two large clinical trials Black box warning added to drug label Recommendation: Consider factors that may predispose patients to the need for amputations (prior amputation, PVD, neuropathy, diabetic foot ulcers) Warning signs: New pain or tenderness, sores or ulcers, or infections in legs or feet

7 ACEs and Neprilysin Inhibitor Contraindicated to be used at same time Do NOT administer ACE/ARB within 36 hours of switching to or from neprilysin inhibitor, such as Entresto

8 Amphetamine and serotonin syndrome Warning added to all amphetamine products of increased risk of serotonin syndrome Amphetamines metabolized through CPY2D6 Examples Fluoxetine Paroxetine Bupropion Ritonavir Cincalcet Sertraline Duloxetine

9 Oral contraceptives and Hep C drug combinations Oral contraceptives containing ethinyl estradiol should be discontinued before starting Hep C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir Potential for ALT elevations more than 5 times the upper limit, up to 20 times the upper limit

10 Orlistat co-administration Some medications may not work as well when co-administered with Orlistat, such as Anticoagulants Diabetes medications Thyroid medications Antiretrovirals

11 NSAIDs and heart conditions Warning of increased risk of heart attack, stroke and heart failure added or updated on drug facts labeling for: Ibuprofen Naproxen Warning is already a boxed warning for: Celecoxib Diclofenac Indomethacin

12 Rivaroxaban and Cyp3A4 inhibitors Avoid rivaroxaban and combined P-gp and Cyp3A4 inhibitors, especially in patients with CrCl ml/min Examples Ketoconazole Ritonavir Not clarithromycin Many health systems have anticoagulation monitoring available

13 Zyban /Chantix and Depression Mental health risk is present but serious consequences are minimal Consider risks of depression exacerbation with benefits of smoking cessation FDA removed Boxed Warning for serious mental health side effects from Chantix Many health systems have smoking cessation programs through pharmacists

14 Testosterone and Abuse/dependence New warning of possible abuse and dependence to include new safety info Serious adverse outcomes Heart attack, heart failure, stroke, liver toxicity, aggression, male infertility, depression Withdrawal symptoms Depression, fatigue, irritability, insomnia, decreased libido

15 Homeopathic Teething Products FDA found inconsistent amounts of belladonna in homeopathic teething tablets Risk of seizures, difficulty breathing, lethargy, excessive sleepiness, skin flushing, constipation, difficulty urinating

16 Pioglitazone and Bladder Cancer Updated review concluded pioglitazone may be linked to increased risk of bladder cancer Recommendation: Do not use in active bladder cancer Consider risks/benefits in patient with history of bladder cancer Warning signs: blood in urine, urge to urinate, pain w/ urination

17 Chlorhexidine Gluconate and Allergic Reactions Increased number of reports of serious allergic reactions Recommendation: Ask patients about allergic reactions to antiseptics prior to recommending Use alternatives when necessary Warning signs: Wheezing, difficulty breathing, swelling of face, hives, severe rash, shock

18 NEW DRUG APPROVALS

19 Abaloparatide (Tymlos ) Indication Osteoporosis in postmenopausal women at high risk Mechanism Human parathyroid hormone related analog Place in therapy New treatment option Dosing 80 mcg subq once daily

20 Abaloparatide (Tymlos ) Contraindications Warnings Adverse effects Other None Risk of osteosarcoma, orthostatic hypotension, hypercalcemia, hypercalciuria and urolithiasis Dizziness, nausea, HA, palpitations, increased uric acid, hypercalcemia Use for > 2 years not recommended

21 Tymlos vs Forteo Postmenopausal women only Subcutaneous injection into abdomen only 30 doses per pen Room temperature for up to 30 days after first use No REMS program AWP $1950 Postmenopausal women, osteoporosis in men, AND glucocorticoid-induced osteoporosis Subcutaneous injection into thigh or abdomen 28 doses per pen Must be stored in fridge at all times REMS program AWP $3597

22 Valbenazine (Ingrezza ) Indication Mechanism Tardive dyskinesia VMAT2 inhibitor Place in therapy Once daily option Dosing 40 mg once daily increasing to 80 mg once daily after 1 week *Dose adjust for renal, hepatic, and concurrent CYP3A4/CYP2D6 inhibitors/inducers

23 Valbenazine (Ingrezza ) Contraindications None. Caution in QT prolongation patients Warnings Adverse effects CNS depression, suicidal ideation, QT prolongation Drowsiness, fatigue, sedation

24 Deutetrabenazine (Austedo ) Indication Mechanism Place in therapy Dosing Chorea associated with Huntington s disease (and tardive dyskinesia) VMAT2 inhibitor Second treatment option with less frequent dosing 6 mg once daily, increasing weekly based on response. Administer in 2 divided doses if total daily dose >12 mg/day. MAX 48 mg/day. *Dose adjust with CYP2D6 inhibitors

25 Deutetrabenazine (Austedo ) Contraindications Warnings Adverse effects Hepatic impairment, suicidal or untreated depression, dose adjustments w/ tetrabenazine or w/in 14 days of an MAOI or 20 days of reserpine Depression and suicide, NMS, akathisia, QT prolongation Drowsiness, dry mouth

26 Austedo vs Ingrezza Twice daily Follow schedule if switching from tetrabenazine and/or MAOI Indicated for Chorea as well Black box warning for depression and suicide Once daily Caution with Cyp2D6 and 3A4 No contraindications Higher cost

27 Safinamide (Xadago ) Indication Parkinson s disease *Adjunctive treatment to levodopa/carbidopa in patients experiencing off episodes Mechanism Inhibitor of MAO-B Dosing 50 mg once daily. Increase to 100 mg once daily after 2 weeks.

28 Safinamide (Xadago ) Contraindications Severe hepatic impairment, use with MAOIs, opioids, SNRIs, TCAs, and others Warnings Adverse effects CNS depression, hypertension, impulse control disorders, serotonin syndrome Dyskinesia

29 Dupilumab (Dupixent ) Indication Moderate to severe atopic dermatitis not controlled with topical therapy Mechanism Interleukin-4 receptor alpha antagonist Dosing mg subcutaneous injections then 300 mg every other week

30 Dupilumab (Dupixent ) Contraindications None Warnings Adverse effects Asthma, conjunctivitis and keratitis, live vaccines Injection site reactions, conjunctivitis, keratitis

31 Naldemedine (Symproic ) Indication Opioid-induced constipation in patients with non-cancer pain Mechanism Mu opioid receptor antagonist Place in therapy Dosing Another option 0.2 mg once daily

32 Naldemedine (Symproic ) Contraindications GI obstruction, increased risk for recurrent obstruction Warnings Adverse effects Opioid withdrawal Abdominal pain, diarrhea, nausea, gastroenteritis

33 Plecanatide (Trulance ) Indication Chronic idiopathic constipation Mechanism Guanylate cyclase-c agonist Place in therapy Dosing Another choice for constipation 3 mg once daily with or without food

34 Plecanatide (Trulance ) Contraindications <6 years due to the risk of dehydration, gastrointestinal obstruction Warnings Adverse effects Severe diarrhea Diarrhea

35 Lixisenatide/Insulin glargine (Soliqua ) Indication Type 2 diabetes Mechanism GLP-1 and basal insulin Place in therapy Narrow use Dosing Start at 15 units/5 mcg or 30 units/10 mcg. Max 60 units/20 mcg

36 Lixisenatide/Insulin glargine (Soliqua ) Contraindications Hypersensitivity Warnings Adverse effects Administration Pancreatitis, hypoglycemia, medication error, AKI, immunogenicity, hypokalemia, Same as either separately 1 hour before first meal

37 Insulin aspart (Fiasp ) Indication Type 1 and 2 diabetes in adults Mechanism Binds to insulin receptors facilitating cellular uptake of glucose Place in therapy For patients who forget to inject prior to meals Dosing Unit to unit conversion. Inject within 20 minutes of a meal.

38 Insulin aspart (Fiasp ) Contraindications Hypoglycemia Warnings Adverse effects Hypersensitivity, hypoglycemia, hypokalemia Hypoglycemia, injection site reactions, weight gain

39 Indication Allopurinol and lesinurad (Duzallo ) Hyperuricemia associated with gout not controlled on allopurinol Mechanism URAT1 inhibitor and xanthine oxidase inhibitor Place in therapy After allopurinol trial to improve continued symptoms Dosing 300/200 mg once daily or 200/200 mg for CrCl of ml/min

40 Allopurinol and lesinurad (Duzallo ) Contraindications Severe renal impairment, ESRD, tumor lysis syndrome Warnings Adverse effects Administration Acute renal failure, rash, hepatotoxicity, bone marrow suppression Headache, flu, reflux, increased blood creatinine Take with breakfast

41 SUPPLY UPDATES

42 Supply updates Atenolol 25- and 50-mg tablets Amoxicillin and ClavulanateER 1000/62.5-mg Carisoprodol and aspirin discontinued Furosemide 20- and 40-mg tablets Indomethacin 25- and 50-mg tablets Tanzeum discontinued Drug Info Resource Center-Drug Shortages

43 NEW GENERIC DRUG APPROVALS

44 Quetiapine ER (Seroquel XR ) Dexmethylphenidate ER (Focalin XR ) Pitavastatin (Livalo ) Fluticasone/salmeterol (Advair Diskus ) not available Memantine-donepezil (Namzaric ) Dexlansoprazole Delayed Release (Dexilant ) Ezetimibe and Simvastatin (Vytorin ) Prasugrel (Effient )

45 Sevelamer carbonate (Renvela ) Scopolamine patch (Transderm ) Atomoxetine (Strattera ) Mesalamine Delayed Release (Lialda ) Exenatide (Byetta ) October 2017 Sildenafil (Viagra ) December 2017 Efavirenz (Sustiva ) December 2017

46 QUIZ QUESTIONS

47 Quiz question #1 When switching from an angiotensin converting enzyme inhibitor to a neprilysin inhibitor, how long should the patient wait to take the neprilysin inhibitor? A. 24 hours B. 12 hours C. 36 hours D. 42 hours

48 Quiz question #2 Which of the following medications require Risk Evaluation and Mitigation Strategy (REMS)? A. Soliqua B. Tymlos C. Fiasp D. Forteo

49 Quiz question #3 Where would you find information regarding drug supply shortages? A. CDC website B. Drug Information website C. Poison control hotline D. Manufacturer websites

50 Quiz question #4 I know how I will use these drug warnings and updates to positively impact my current practice. A. True B. False

51 Questions? Eve Van Wagoner, PharmD, BCACP Primary Care Clinical Pharmacist South Jordan Health Center