BIOTHERAPY
CERTIFICATION 2025 | 150+
Questions & Detailed
Answers | Pass Guaranteed -
A+ Graded
ART I: MULTIPLE CHOICE (Questions 1–80)
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Q1 (Safe handling): What is the minimum required personal protective equipment (PPE) when
preparing a hazardous drug in a biological safety cabinet (BSC) according to USP <800>?
A. Single pair of chemotherapy-tested gloves, non-permeable gown, face mask
B. Double pair of chemotherapy-tested gloves, non-permeable gown, eye/face protection
C. Single pair of latex gloves, surgical gown, goggles
D. Double pair of utility gloves, disposable gown, N95 respirator
[CORRECT] B
Rationale: USP <800> mandates double gloving with ASTM D6978-tested gloves, a
non-permeable gown, and eye/face protection when preparing hazardous drugs in a BSC. Latex
gloves (C) are not tested for chemotherapy permeation and are prohibited. N95 respirators (D)
are only required for aerosol-generating procedures, not standard preparation. Clinical pearl:
The inner glove is donned first, gown next, then outer glove—remove in reverse order to
prevent contamination.
Q2 (Pharmacology): A patient receives cyclophosphamide, an alkylating agent. Which cell cycle
phase is most affected by this drug class?
A. G1 phase
B. S phase
C. G2 phase
D. Cell cycle non-specific
,[CORRECT] D
Rationale: Alkylating agents such as cyclophosphamide are cell cycle non-specific; they
damage DNA at any phase of the cell cycle by forming covalent bonds with DNA bases.
Antimetabolites (B) are S-phase specific, and plant alkaloids like paclitaxel (C) are M-phase
specific. Clinical pearl: Cell cycle non-specific agents can be given as single bolus doses, while
phase-specific agents often require prolonged infusion for maximal effect.
Q3 (Administration): A nurse is administering vincristine via a peripheral IV. The patient reports
burning and the nurse notes swelling at the site. What is the FIRST priority action?
A. Apply warm compresses and continue infusion at slower rate
B. Stop infusion immediately, aspirate residual drug, and initiate extravasation protocol
C. Flush with normal saline and relocate the IV to the opposite arm
D. Administer hyaluronidase subcutaneously and document the incident
[CORRECT] B
Rationale: Vincristine is a vesicant; any signs of burning or swelling during administration
require immediate cessation of infusion, aspiration of residual drug, and initiation of the
extravasation protocol per ONS guidelines. Continuing infusion (A) worsens tissue damage.
Flushing (C) disperses the vesicant into surrounding tissue. Hyaluronidase (D) is not indicated
for vinca alkaloid extravasation—dexrazoxane is used for anthracyclines, and hyaluronidase is
for taxanes. Clinical pearl: Vesicants cause tissue necrosis; irritants cause pain and
inflammation but not necrosis—know your drug classification.
Q4 (Side effects): A patient receiving cisplatin develops acute kidney injury. Which electrolyte
abnormality is MOST characteristic of cisplatin nephrotoxicity?
A. Hypercalcemia
B. Hypomagnesemia
C. Hyperkalemia
D. Hyponatremia
[CORRECT] B
Rationale: Cisplatin causes dose-dependent nephrotoxicity primarily affecting the distal
convoluted tubule, resulting in magnesium wasting and profound hypomagnesemia that is often
refractory to replacement. Hypercalcemia (A) is associated with malignancy or
bisphosphonates. While AKI can cause hyperkalemia (C), hypomagnesemia is the hallmark
electrolyte disturbance of cisplatin. Clinical pearl: Magnesium must be aggressively replaced
before potassium will correct in cisplatin-induced hypomagnesemia—check and replace Mg2+
with every cycle.
Q5 (Biotherapy): A patient receiving pembrolizumab for metastatic melanoma presents with
dyspnea, dry cough, and bilateral ground-glass opacities on CT. What is the appropriate grading
and INITIAL management?
A. Grade 1; continue pembrolizumab and monitor
B. Grade 2; hold pembrolizumab, initiate prednisone 1 mg/kg/day
C. Grade 3; hold pembrolizumab, hospitalize, initiate prednisone 1-2 mg/kg/day
D. Grade 4; permanently discontinue, ICU admission, methylprednisolone 1-2 mg/kg/day
[CORRECT] C
Rationale: Symptomatic pneumonitis with radiographic changes and dyspnea limiting activities
of daily living constitutes Grade 3 immune-related adverse event (irAE) per ASCO/ONS
, uidelines; management requires holding the checkpoint inhibitor, hospitalization, and high-dose
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corticosteroids (prednisone 1-2 mg/kg/day). Grade 1 (A) is asymptomatic radiographic changes
only. Grade 2 (B) involves mild symptoms not limiting ADLs. Grade 4 (D) involves
life-threatening respiratory failure requiring intubation. Clinical pearl: Always rule out infection
before attributing pulmonary symptoms to irAE pneumonitis—obtain sputum cultures and
consider PJP prophylaxis with prolonged steroids.
Q6 (Safe handling): According to the updated NIOSH 2024/2025 hazardous drug list, which
drug is newly classified as a hazardous drug requiring safe handling precautions?
A. Methotrexate
B. Osimertinib
C. Doxorubicin
D. Cyclophosphamide
[CORRECT] B
Rationale: The NIOSH 2024/2025 update newly classified several oral targeted therapies,
including osimertinib (a third-generation EGFR TKI), as hazardous drugs requiring the same
safe handling precautions as parenteral chemotherapy. Methotrexate (A), doxorubicin (C), and
cyclophosphamide (D) have long been established as hazardous drugs. Clinical pearl: All oral
oncolytics now require hazardous drug handling protocols including double gloving,
non-permeable gowns, and dedicated counting trays—never assume oral equals safe.
Q7 (Administration): Which vascular access device is the preferred route for administration of a
vesicant chemotherapy agent when peripheral access is available?
A. 22-gauge peripheral IV in the hand
B. 20-gauge peripheral IV in the forearm
C. Central venous catheter or implanted port
D. Midline catheter in the upper arm
[CORRECT] C
Rationale: ONS guidelines recommend central venous access (PICC, tunneled catheter, or
implanted port) for all vesicant administration to minimize extravasation risk and ensure rapid
dilution in high blood flow. Peripheral veins (A, B) are acceptable only when central access is
unavailable and must be in the forearm (never hand/wrist) with vigilant monitoring. Midline
catheters (D) are contraindicated for vesicants due to tip location in peripheral veins. Clinical
pearl: If peripheral access is used for vesicants, a new 20-gauge or larger catheter in the
forearm is required, with blood return verified before, during, and after administration.
Q8 (Pharmacology): 5-Fluorouracil (5-FU) is classified as which type of antineoplastic agent?
A. Alkylating agent
B. Antimetabolite
C. Plant alkaloid
D. Antitumor antibiotic
[CORRECT] B
Rationale: 5-Fluorouracil is a pyrimidine analog antimetabolite that inhibits thymidylate
synthase, interfering with DNA synthesis during the S phase of the cell cycle. Alkylating agents
(A) cross-link DNA. Plant alkaloids (C) interfere with microtubule function. Antitumor antibiotics
(D) intercalate DNA or generate free radicals. Clinical pearl: Antimetabolites are S-phase
, pecific and structurally similar to normal metabolites—think "fraudulent building blocks" that
s
halt DNA construction.
Q9 (Side effects): A patient receiving high-dose dexamethasone as part of an antiemetic
regimen for highly emetogenic chemotherapy reports difficulty sleeping and hyperglycemia.
What is the optimal dexamethasone dosing strategy per ASCO 2025 guidelines?
A. Continue 12 mg twice daily for 4 days
B. Taper to 8 mg twice daily for 2 days then 4 mg twice daily for 2 days
C. Administer 12 mg on Day 1 only, then discontinue
D. Reduce to 4 mg once daily for 4 days
[CORRECT] B
Rationale: ASCO 2025 antiemetic guidelines recommend a tapering dexamethasone regimen
(12 mg day 1, then tapering over 2-4 days) to minimize steroid-related adverse effects while
maintaining antiemetic efficacy. Single-dose (C) or reduced-dose (D) regimens are insufficient
for highly emetogenic regimens. The 4-day BID regimen without taper (A) increases insomnia,
hyperglycemia, and mood disturbances. Clinical pearl: For patients with pre-existing diabetes or
severe insomnia, consider NK1 antagonist + 5-HT3 without dexamethasone, or use
olanzapine-containing regimens to reduce steroid exposure.
Q10 (Biotherapy): A patient receiving rituximab develops fever, chills, and bronchospasm 30
minutes into the first infusion. What is the appropriate immediate management sequence?
A. Stop infusion, administer diphenhydramine and acetaminophen, resume at same rate when
symptoms resolve
B. Stop infusion, administer oxygen, diphenhydramine, hydrocortisone, and acetaminophen;
resume at 50% reduced rate when stable
C. Continue infusion with increased monitoring; symptoms are expected with first rituximab dose
D. Stop infusion permanently and switch to biosimilar rituximab for next cycle
[CORRECT] B
Rationale: Rituximab infusion reactions are common with first doses; management requires
stopping the infusion, supportive care with oxygen, antihistamines, corticosteroids, and
antipyretics, then resuming at a 50% reduced rate once stable. Resuming at the same rate (A)
risks recurrence. Continuing infusion (C) is dangerous with bronchospasm. Permanent
discontinuation (D) is unnecessary unless Grade 3-4 reactions occur—rituximab can usually be
safely re-administered with premedications and slower rates. Clinical pearl: Pre-medicate all
patients with acetaminophen and diphenhydramine before first rituximab infusion; consider
corticosteroids for high-risk patients.
Q11 (Patient education): A patient is prescribed capecitabine, an oral oncolytic, for metastatic
breast cancer. Which statement by the patient indicates understanding of safe handling?
A. "I will crush the tablets and mix with applesauce if I have trouble swallowing."
B. "My spouse can handle the tablets with bare hands when helping me take them."
C. "I will wash my hands before and after handling the tablets, and keep them in their original
container."
D. "If I miss a dose, I will take two doses at the next scheduled time to make up for it."
[CORRECT] C
Rationale: Patients taking oral oncolytics must wash hands before and after handling, avoid
crushing/splitting tablets, and store in original containers with child-resistant caps. Crushing (A)