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

a. The active ingredient is Dulaglutide.
b. It is indicated for the treatment of migraine.
c. It is a glucagon-like peptide-1 (GLP-1) receptor agonist.
d. Initiate at 0.75 mg subcutaneously once weekly.
e. Contraindicated in patients with a personal or family history of medullary thyroid carcinoma.


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

a. The active ingredient is Dulaglutide.
b. It is indicated for the treatment of migraine.
c. It is a glucagon-like peptide-1 (GLP-1) receptor agonist.
d. Initiate at 0.75 mg subcutaneously once weekly.
e. Contraindicated in patients with a personal or family history of medullary thyroid carcinoma.

Answer: (a,c,d,e)

The active ingredient found in Trulicity is Dulaglutide. It is available as an injection (0.75mg/0.5ml, 1.5mg/0.5ml) administered subcutaneously in the abdomen, thigh, or upper arm.

It is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated:

1. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

2. to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.

The drug should be administered once weekly. The drug should be initiated at 0.75 mg subcutaneously once weekly. Dose can be increased to 1.5 mg once weekly for additional glycemic control.

If a dose is missed, administer the missed dose as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose.

It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.

Nausea, diarrhea, vomiting, abdominal pain, and decreased appetite are commonly 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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Which of the following information is/are reported signs and symptoms of coronavirus infection? [Select ALL THAT APPLY].

a. fever
b. cough
c. loss of smell
d. difficulty concentrating
e. somnolence


Which of the following information is/are reported signs and symptoms of coronavirus infection? [Select ALL THAT APPLY].

a. fever
b. cough
c. loss of smell
d. difficulty concentrating
e. somnolence

Answer: a,b,c, and d

While a fever and cough have seemed to be the early warning signs of COVID-19, new research shows almost half of hospitalized patients experience a host of neurological problems.

In fact, headaches, dizziness, strokes, weakness, decreased alertness or other neurological symptoms can appear before the more commonly known symptoms of infection with the new coronavirus (known as SARS-COV-2), the researchers said.

Those neurological symptoms can also include loss of smell and taste, seizures, muscle pain and difficulty concentrating.


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Which of the following information is TRUE ABOUT the simultaneous administration of Remdesivir and Chloroquine phosphate?

a. The simultaneous administration of Remdesivir and Chloroquine phosphate will increase Chloroquine phosphate potency in treating coronavirus infection.

b. FDA is warning health care providers that co-administration of Remdesivir and Chloroquine phosphate is not recommended as it may result in reduced antiviral activity of Remdesivir.

c. The simultaneous administration of Remdesivir and Chloroquine phosphate will increase toxicity of Remdesivir in treating coronavirus infection.

d. The simultaneous administration of Remdesivir and Chloroquine phosphate will increase Remdesivir potency in treating coronavirus infection.

e. FDA is recommending health care providers that Remdesivir shall be co-administered with Hydroxychloroquine sulfate since this combination shows 50% effectiveness in controlling coronavirus symptoms compared to co administration of Remdesivir with Chloroquine phosphate.


Which of the following information is TRUE ABOUT the simultaneous administration of Remdesivir and Chloroquine phosphate?

a. The simultaneous administration of Remdesivir and Chloroquine phosphate will increase Chloroquine phosphate potency in treating coronavirus infection.

b. FDA is warning health care providers that co-administration of Remdesivir and Chloroquine phosphate is not recommended as it may result in reduced antiviral activity of Remdesivir.

c. The simultaneous administration of Remdesivir and Chloroquine phosphate will increase toxicity of Remdesivir in treating coronavirus infection.

d. The simultaneous administration of Remdesivir and Chloroquine phosphate will increase Remdesivir potency in treating coronavirus infection.

e. . FDA is recommending health care providers that Remdesivir shall be co-administered with Hydroxychloroquine sulfate since this combination shows 50% effectiveness in controlling coronavirus symptoms compared to co administration of Remdesivir with Chloroquine phosphate.


Answer: b

FDA is warning health care providers that co-administration of Remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of Remdesivir.


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Which of the following is recently approved biosimilar drug to Neulasta?
 
a. Neupogen
b. Nyvepria
c. Opdivo
d. Taltz
e. Brilinta


Which of the following is recently approved biosimilar drug to Neulasta?
 
a. Neupogen
b. Nyvepria
c. Opdivo
d. Taltz
e. Brilinta

Answer: b
 
The active ingredient found in Nyvepria is Pegfilgrastim-apgf.

Nyvepria, a biosimilar to Neulasta, is approved by the FDA to help reduce the chance of infection due to a low white blood cell count in people with non-myeloid cancer who receive anti-cancer medicines, like chemotherapy, that can cause fever and low white blood cell count. This condition, known as febrile neutropenia, is a common side effect of many types of chemotherapy and lowers the body’s ability to defend itself against infections.

Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Nyvepria is contraindicated in patients with a history of serious allergic reactions to Pegfilgrastim products (e.g. Neulasta) or filgrastim products (e.g. Neupogen).
Bone pain and pain in extremity are 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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Dupixent (Dupilumab) is a fully-human monoclonal antibody that inhibits the signaling of the: [Select ALL THAT APPLY].
 
a. IL-4
b. IL-8
c. IL-13
d. IL-20
e. IL-23


Dupixent (Dupilumab) is a fully-human monoclonal antibody that inhibits the signaling of the: [Select ALL THAT APPLY].
 
a. IL-4
b. IL-8
c. IL-13
d. IL-20
e. IL-23

Answer: a, c

Atopic dermatitis usually develops in early childhood and is more common in people who have a family history of the condition.

The main symptom is a rash that typically appears on the arms and behind the knees, but can also appear anywhere.

The active ingredient found in Dupixent (Dupilumab) is Dupilumab. It is the first biologic medicine for children aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis.
Dupixent (Dupilumab) is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant.

IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent (Dupilumab) is an interleukin-4 receptor alpha antagonist indicated:

1. for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

2. as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma.

3. as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

The recommended dose is an initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week.
 
Most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.

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