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Which of the following statements is/are TRUE ABOUT Spravato? [Select ALL THAT APPLY].

a. It is indicated for the treatment of treatment-resistant depression.
b. Lketamine is its active ingredient.
c. It is a schedule IV controlled substance.
d. It is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist.
e. It is available as a nasal spray.


Which of the following statements is/are TRUE ABOUT Spravato? [Select ALL THAT APPLY].

a. It is indicated for the treatment of treatment-resistant depression.
b. Lketamine is its active ingredient.
c. It is a schedule IV controlled substance.
d. It is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist.
e. It is available as a nasal spray.

Answer: (a,d,e)

The active ingredient found in Spravato is Esketamine. It is available in a nasal spray. It is a schedule III controlled substance.

Spravato is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of:

1. Treatment-resistant depression (TRD) in adults.

2. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

Spravato is administered intranasally under the supervision of a healthcare provider.

The recommended dosage of Spravato (Esketamine) for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior is 84 mg twice per week for 4 weeks. Dosage may be reduced to 56 mg twice per week based on tolerability.

Spravato (Esketamine) is for nasal use only. The nasal spray device delivers a total of 28 mg of Esketamine. To prevent loss of medication, do not prime the device before use. Use 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device.

Dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk are commonly reported side effects of Spravato.

Because of the risks for sedation, dissociation, and abuse and misuse, Spravato (Esketamine) is only available through a restricted program called the Spravato (Esketamine) Risk Evaluation and Mitigation Strategy (REMS) Program.

Spravato (Esketamine) can only be administered at healthcare settings certified in the Spravato (Esketamine) REMS Program and to patients enrolled in the program.



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Kesimpta (Ofatumumab) is indicated for the treatment of:

a. Hypertension
b. Gout
c. Multiple sclerosis
d. Type II diabetes
e. Parkinsonism


Kesimpta (Ofatumumab) is indicated for the treatment of:

a. Hypertension
b. Gout
c. Multiple sclerosis
d. Type II diabetes
e. Parkinsonism

The active ingredient found in Kesimpta is Ofatumumab. It is available in a single-dose prefilled syringe.

Kesimpta (Ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

The precise mechanism by which Ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.

Hepatitis B virus (HBV) and quantitative serum immunoglobulins screening are required before the first dose.

Initial Dosing: 20 mg subcutaneously administered at Week 0, 1, and 2.

Subsequent Dosing: 20 mg subcutaneously administered monthly starting at Week 4.

Respiratory tract infection, headache, injection-related reactions, and local injection site reactions are reported side effects of drug.

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Which of the following glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) is administered subcutaneously once daily? [Select ALL THAT APPLY].

a. Byetta
b. Adlyxin
c. Victoza
d. Trulicity
e. Tanzeum


Which of the following glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) is administered subcutaneously once daily? [Select ALL THAT APPLY].

a. Byetta
b. Adlyxin
c. Victoza
d. Trulicity
e. Tanzeum

Answer (b,c)



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Which of the following statements is/are TRUE ABOUT Winlevi? [Select ALL THAT APPLY].

a. The active ingredient is Clascoterone.
b. It is an estrogen receptor inhibitor.
c. Indicated for the treatment of acne vulgaris.
d. It should only be used in patients 12 years of age or younger.
e. It is available as topical gel.


Which of the following statements is/are TRUE ABOUT Winlevi? [Select ALL THAT APPLY].

a. The active ingredient is Clascoterone.
b. It is an estrogen receptor inhibitor.
c. Indicated for the treatment of acne vulgaris.
d. It should only be used in patients 12 years of age or younger.
e. It is available as topical gel.

Answer: (a,c).

The active ingredient found in Winlevi is Clascoterone. It is available as cream. Each gram of Winlevi cream contains 10 mg of Clascoterone. It is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Erythema/reddening, pruritus, scaling/dryness, edema, stinging, and burning are commonly reported side effects of Winlevi.

Clascoterone is first-in-class topical androgen receptor inhibitor that tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation.

Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation. Topical treatment options that target androgens, which largely drive sebum production and inflammation, presented a significant unmet need in the acne treatment market until now.

Elevated potassium levels (Hyperkalemia) were observed in some patients during the clinical trials.

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Who developed a Pharmacy Toolkit to help pharmacists engage and educate patients about the safe use, storage, and disposal of pain medicines?

a. CDC
b. CMSA
c. ASHP
d. AAOA
e. FTC


Answer: (d), In collaboration with its pharmacy partners and several state pharmacy associations, Allied Against Opioid Abuse (AAOA) developed a Pharmacy Toolkit to help pharmacists engage and educate patients about the safe use, storage, and disposal of pain medicines.

The AAOA Pharmacy Toolkit includes resources to help pharmacists raise awareness among patients about their rights, risks, and responsibilities associated with prescription opioids.

These resources include: a pharmacy display, patient handout, patient engagement guide, tips for talking with patients and caregivers, prescriber engagement guide, safe storage and disposal training, and social graphics.

To learn more about the Pharmacy Toolkit, please visit:

https://againstopioidabuse.org/

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The FDA has recently approved Xywav for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Another drug Xyrem is available for the same indication in the US. What is a principal advantage of using Xywav over Xyrem?

a. Less side effects
b. Less potential for abuse
c. Low sodium contents
d. More potency
e. Cheaper


The FDA has recently approved Xywav for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Another drug Xyrem is available for the same indication in the US. What is a principal advantage of using Xywav over Xyrem?

a. Less side effects
b. Less potential for abuse
c. Low sodium contents
d. More potency
e. Cheaper

Answer: C

The active ingredients found in Xywav is (calcium, magnesium, potassium, and sodium oxybates) oral solution. It is for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Xywav is an oxybate product with a unique composition of cations resulting in 92 percent less sodium - or approximately 1,000 to 1,500 mg/night - than sodium oxybate at the recommended dosage range of 6 to 9 grams.

Multiple Xywav dosing options are available for adult and pediatric patients. Prescribers can titrate Xywav into unequal doses taken over the course of the night. When patients start Xywav after sodium oxybate, Xywav treatment is initiated at the same dose and regimen as sodium oxybate (gram for gram) and titrated as needed based on efficacy and tolerability.

Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association. Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease.

Xyrem (Sodium oxybate) carries warnings about its high sodium content,10 and was previously the only product approved to treat both cataplexy and EDS in patients with narcolepsy 7 years of age and older and designated as a standard of care for the treatment of cataplexy and EDS by the American Academy of Sleep Medicine.
Xywav has a Boxed Warning as a central nervous system depressant, and for its potential for abuse and misuse. Because of the risks of CNS depression and abuse and misuse, Xywav is available only through a restricted program under a REMS called the Xywav and Xyrem REMS Program.

Most common adverse reactions in adults are headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety and vomiting.

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Entresto is indicated for the treatment of:

a. Hypertension
b. Heart failure
c. Depression
d. Type II diabetes mellitus
e. Panic disorder


Entresto is indicated for the treatment of:

a. Hypertension
b. Heart failure
c. Depression
d. Type II diabetes mellitus
e. Panic disorder

Answer: b. The active ingredients found in Entresto are Sacubitril and Valsartan. Sacubitril is a neprilysin inhibitor whereas Valsartan is an angiotensin II receptor blocker.

It is available as tablets (24/26 mg, 49/51 mg and 97/103 mg).

It is indicated:

1. to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.

2. for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.



Hypotension, hyperkalemia, cough, dizziness and renal failure are reported side effects of the drug.

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Rexulti (Brexpiprazole) is indicated for: [Select ALL THAT APPLY].

a. OCD
b. Schizophrenia
c. Hypertension
d. Arrhythmia
e. Depression


Rexulti (Brexpiprazole) is indicated for: [Select ALL THAT APPLY].

a. OCD
b. Schizophrenia
c. Hypertension
d. Arrhythmia
e. Depression

Answer: b, e
 
The active ingredient found in Rexulti is Brexpiprazole. It is available as tablets (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg).

The recommended dose is 0.5 to 3 mg per day once daily with or without food.

The mechanism of action of Brexpiprazole in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of Brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

Rexulti (Brexpiprazole)  is an atypical antipsychotic indicated for:

1. Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).

2. Treatment of schizophrenia

Dosing adjustments:

1. Moderate to Severe Hepatic Impairment (Child-Pugh score ≥7): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia.

2. Moderate, Severe or End-Stage Renal Impairment (ClCr<60 mL/minute): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia.

3. Known CYP2D6 Poor Metabolizers: Reduce the usual dosage by half.
 
Weight gain and akathisia are commonly reported side effects of the drug.



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What is the probable mechanism of action of Sirturo (Bedaquiline)?

a. Inhibits 5-alpha azo reductase
b. Inhibits DNA gyrase
c. Inhibits mycobacterial ATP synthase
d. Inhibits RNA polymerase
e. Inhibits CGAP ligase


What is the probable mechanism of action of Sirturo (Bedaquiline)?

a. Inhibits 5-alpha azo reductase
b. Inhibits DNA gyrase
c. Inhibits mycobacterial ATP synthase
d. Inhibits RNA polymerase
e. Inhibits CGAP ligase

Answer: c

The active ingredient found in Sirturo is Bedaquiline. is the first anti-TB drug to interfere with bacterial energy metabolism.

Sirturo (Bedaquiline)® specifically inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, by binding to subunit c of the enzyme that is essential for the generation of energy in Mycobacterium tuberculosis.

Sirturo (Bedaquiline)® is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (12 to less than 18 years of age and weighing at least 30 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB).

Reserve Sirturo (Bedaquiline)® for use when an effective treatment regimen cannot otherwise be provided.
 
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Recently FDA approved pediatric suspension of VESIcare for used in pediatric patients aged 2 years and older for the treatment of:

a. Overactive bladder
b. Neurogenic detrusor overactivity
c. Nausea and vomiting
d. Preventing excessive gastrin secretion
e. Diarrhea associated with C. difficile


Recently FDA approved pediatric suspension of VESIcare for used in pediatric patients aged 2 years and older for the treatment of:

a. Overactive bladder
b. Neurogenic detrusor overactivity
c. Nausea and vomiting
d. Preventing excessive gastrin secretion
e. Diarrhea associated with C. difficile

Answer: b

The active ingredient found in VESIcare is Solifenacin succinate. It is a muscarinic antagonist. It is available in tablet and pediatric oral suspension dosage forms.

VESIcare LS oral suspension will come in a 5 mg/5 mL (1 mg/mL) oral suspension and will be available in the United States in late 2020.

The tablet dosage form is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The recommended dose is 5 to 10 mg orally once daily.

Recently, Food and Drug Administration (FDA) has approved VESIcare LS (Solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older. 

Patients with NDO may experience involuntary bladder contractions, which can lead to symptoms of urinary urgency, frequency and incontinence. Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.

The most common adverse reactions (more than 4% in VESIcare-treated patients and placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose.

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